cancer institute nsw monograph · australian tissue banks 6 3.4.1 survey development and scoping...

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Heidi Welberry, Usha Salagame, Peter Wejbora, Deborah Roczo,

Ruth Fernandez, Parisa Glass, Anthea Hepburn and Jim Bishop

A comprehensive review of cancer-related biobanks

in New South Wales

October 2009

Cancer Institute NSW Monograph

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Cancer Institute NSW catalogue number: RM-2009-01

National Library of Australia Cataloguing-in-Publication data:

A comprehensive review of cancer-related biobanks in New

South Wales

State Health Publication Number: (CI) 090060

ISBN: 978-1-74187-398-6

Keywords: Biobanks, tissue banks, New South Wales, Australia.

Suggested citation:

Welberry, H., Salagame, U, Wejbora, P, Roczo, D, Fernandez, R,

Glass, P, Hepburn, A, Bishop, J. A comprehensive review of cancer-

related biobanks in New South Wales Sydney: Cancer Institute

NSW, October 2009

Cancer Institute NSW

Australian Technology Park

Biomedical Building

Suite 101

1 Central Avenue

Eveleigh NSW 2015

PO Box 41

Alexandria NSW 1435

Telephone (02) 8374 5600

Facsimile (02) 8374 5700

E–mail [email protected]

Homepage www.cancerinstitute.org.au

Publications www.cancerinstitute.org.au/publications

Copyright © Cancer Institute NSW October 2009.

This work is copyright. It may be reproduced in whole or

part for study or training purposes subject to the inclusion of

acknowledgement of the source. It may not be reproduced for

commercial usage or sale. Reproduction for purposes other

than those indicated above requires written permission from

the Cancer Institute NSW.

Authors

Heidi Welberry1, Usha Salagame1, Peter Wejbora1,

Deborah Roczo2, Ruth Fernandez2, Parisa Glass1,

Anthea Hepburn1, Jim Bishop1.

1Cancer Institute NSW2Healthcare Management Advisors Pty Ltd.

iii

Contents

Foreword from the Minister v

Report from the Director of Cancer Research vi

Executive summary vii

1 Introduction 1

1.1.1 What is biobanking and why is it

important for NSW? 1

1.1.2 What is involved in biobanking? 2

1.1.3 Working together to maximise

this potential 3

2 Defi nitions 4

Biobank defi nitions 4

3 Project methodology 5

3.1 Project scope 5

3.2 Review of worldwide governance

arrangements of biobanks 5

3.3 Identifi cation of biobank locations in

New South Wales 5

3.4 Survey of governance arrangements of

Australian tissue banks 6

3.4.1 Survey development and scoping study 6

3.4.2 Final survey instruments 6

3.4.3 Survey recipients 7

3.4.4 Follow up and additional information 7

3.5 Survey of researchers 7

3.6 Limitations 7

4 Worldwide governance arrangements 8

4.1 Entity status and funding sources 8

4.1.1 Non-profi t organisations 8

4.1.2 For-profi t organisations 9

4.1.3 Funding of non-profi t biobanks 10

4.2 Organisational structures 10

4.2.1 Individual biobanks: one or more

collection sites 10

4.2.2 Biobank consortia 11

4.2.3 Population-based biobanks 11

4.3 Biobank governance arrangements 13

4.3.1 Governance Boards 13

4.3.2 Other committees 14

4.4 Standard operating procedures 14

4.5 International and Australian

biobanking netoworks 16

4.5.1 Stakeholder and peak body networks 16

4.5.2 Specimen locator networks 16

5 Australian governance arrangements 18

5.1 Australian standards of governance 18

5.2 Victorian Cancer Biobank 18

5.2.1 Organisation and Governance 18

5.2.2 Benefi ts and hurdles 19

5.2.3 Standard operating procedures

and bioinformatics 21

5.2.4 Researcher access 21

5.2.5 Cost recovery 22

5.3 Biobanking in Western Australia 22

5.3.1 Biobanks within pathology departments 22

5.3.2 Data management tools and linkages 23

A Comprehensive Review of Cancer-Related Biobanks in New South Wales

iv

6 Biobank locations in New South Wales 25

6.1 Biobank locations in New South Wales

by geographic hub 25

7 Biobank governance in New South Wales 29

7.1 Biobank general characteristics 29

7.2 Biobank design 33

7.2.1 Patient consent and types of

specimens collected 33

7.2.2 Specimen processing and storage 34

7.2.3 Single or multicentre collection and

storage sites 34

7.2.4 Specimen locator network 35

7.3 Entity status and funding sources 35

7.3.1 Entity status 35

7.3.2 Current funding 35

7.3.3 Future funding 36

7.4 Organisational structure and

governance arrangements 36

7.4.1 Biobank governance 36

7.4.2 Personnel 37

7.4.3 Biobank performance measures 37

7.5 Standard operating procedures (SOP) 39

7.5.1 Development of SOPs 39

7.5.2 Patient consent 39

7.5.3 Data collection 40

7.5.4 Data storage 40

7.5.5 Quality control measures 41

7.6 Researcher access 41

7.6.1 Key themes from biobank

governance surveys 41

7.6.2 Key themes from researcher surveys 43

8 Future options for New South Wales biobanking 44

8.1 Summary of New South Wales formalised

biobank governance 44

8.2 Future opportunities for governance

models for biobanks 44

8.2.1 Stakeholder Network 45

8.2.2 Accreditation 46

8.2.3 Specimen Locator Network 46

8.2.4 Consortia by tumour type in NSW 47

8.2.5 Consortia by tumour type Australia-wide 48

8.2.6 Consortium of all NSW Biobanks 48

8.2.7 Extension of pathology services 49

8.2.8 Data management and data linkage 49

8.2.9 Epidemiological research opportunities 49

8.2.10 Comparison of models 49

8.2.11 Infrastructure and resources required 51

8.3 Other observations to consider in the

future of biobanking 53

8.3.1 Governance committee(s) 53

8.3.2 Funding arrangements 53

8.3.3 Sample ‘ownership’ 54

8.3.4 Sharing of resources 54

8.3.5 Good will and relationships 54

8.3.6 Other types of collections 54

8.3.7 Bio-ethical Issues and considerations 55

v

8.4 Conclusion 55

9 Appendixes 57

Appendix A

Example questionnaires 57

Appendix B

Governance arrangements of

international biobanks 61

Appendix C

Comparison of international

biobank guidelines 63

Appendix D

Summary of design and governance

fi ndings for each biobanks 69

Abbreviations 79

References 81


vi

Acknowledgments

We would like to thank all NSW and other biobank staff

and researchers who made the time to contribute their

information and insights to this review. We would also like to

thank Peter Geary from the Canadian Tumour Repository

Network and members of the Cancer Research Advisory

Committee for reviewing this report.

vii

Foreword from the Minister

Providing access to key enabling infrastructure is one of

the NSW State Government’s strategies for ensuring

that we can attract and retain the best cancer researchers

in our State. Such research infrastructure will allow research

discoveries of international signifi cance to be made.

To make the most effi cient use of current infrastructure

resources, the NSW State Government is working to fi nd

new ways that cancer research and associated research

platforms can be shared by a wide range of researchers.

One such research platform that has gained signifi cant

prominence over recent years is tumour and tissue banking.

The systematic collections of biospecimens have become an

indispensable and invaluable resource for cancer researchers

in both basic and clinical research settings.

As it is such a recent phenomenon, much work still needs

to be undertaken to capture fully the opportunities that

are opened up by this resource. Consequently, we now see

a world wide emphasis on identifying the best practices

for tissue banking in respect to the methods of storing,

cataloguing and distributing samples, as well as to the most

effective fi nancial and governance structures.

This report is a timely review that contributes to these

efforts by examining the scope, nature and future potential

of cancer tissue banking in NSW. This document will help

inform further development of these resources in our State,

enabling researchers, clinicians and ultimately patients to

benefi t from the exciting new technological and scientifi c

advances in the fi ght against cancer.

I commend this report to you.

The Hon. Barbara Perry MP

Minister for Local Government

Minister Assisting the Minister for Health

(Mental Health and Cancer)


viii

Report from the Director of Cancer Research

A ‘Biospecimen bank’ or ‘biobank’ refers to a standardised

collection of human biological materials, including tissue

and tumour samples, blood and blood products, DNA and

relevant donor medical and demographic data collected and

stored with appropriate ethical consent.

Biobanking is now internationally recognised as a basic

enabling tool for cancer research, with the future of

molecular and translational research relying heavily on the

availability of high quality biospecimens linked to data on

actual clinical outcomes.

This publication, A comprehensive review of cancer-related

biobanks in NSW, provides a snapshot of tumour tissue

banking activity across the State, identifying and mapping the

‘biobanks’ used for cancer research across the 12 geographic

research hubs in NSW.

Furthermore, this review examines the governance

structures of national and international tumour and tissue

banks. It explores a number of cost-effective administrative

options, such as the possible networking of NSW tissue

banks, which could assist in creating internationally

competitive and sustainable biobanking facilities in NSW.

There are still many challenges ahead of us before we enable

researchers to fully utilise the potential of biobanking for the

benefi t of future cancer patients. However, it is clear that,

in addressing these challenges, a key challenge is to improve

access to high-quality tissue samples for researchers.

It is hoped that the information contained in this review will

provide a further step towards this goal by enhancing our

understanding of the current state of biobanking. Such data

should provide a solid basis to develop a better, fi nancially

more viable future network of biobanks. This essential

infrastructure will assist cancer researchers to answer

research questions in the area of cancer prevention and early

detection and develop new cancer therapies.

Dr Peter Wejbora Grad Dip (Arts Mgt) MA PhD

Director of Cancer Research, Cancer Institute NSW

ix

Executive summary

Within NSW, 23 tumour collections were identifi ed, 17 of which were confi rmed as formalised tissue banks.

This report presents an overview of the scope and nature

of tissue banking in NSW by mapping their geographic

location across the 12 cancer research hubs in NSW, as

well as examining their governance arrangements. Through

increasing knowledge and awareness of NSW cancer bio-

banking activities, the ultimate goals of this review are to

assist in:

assessing the current level of investment in tissue banking ▪and identify future resource requirements

improving researcher access to tissues collected in a ▪range of cancers

improving effi ciency and reducing duplication of ▪administrative processes

building capacity that is cost-effective and sustainable. ▪

The project included a review of international and national

biobanks, with a focus on organisational structures and

governance models. It also included a two-phase survey

within NSW to fi rstly identify active biobanks and then

to understand in more detail the current operational and

governance structures of these banks.

International models for biobanking

The majority of international biobanks reviewed were

operating as part of a consortium or network where

individual banks work together to develop consistent

approaches to biobanking and, in some instances, the

pooling of resources. Less frequently, the international

banks reviewed fell within the categories of either

individual biobanks (with one or multiple collection sites) or

population-based epidemiological biobanks.

The use of standard operating procedures was common

among all biobanks and there are many international

guidelines on procedure development for consideration, such

as the National Cancer Institute Guidelines in the US, the

Confederation of Cancer Biobanks Guidelines in the UK and

the International Society for Biological and Environmental

Repositories Guidelines in Europe.


x

Australian biobanking

Australian biobanks are constituted in a similar manner and

their operations also require ethics and scientifi c advisory

committees’ approval.

The Victorian Cancer Biobank provides an example of a

consortium model for clinical biobanking where four separate

clinical biobanks are linked through one over-arching

management committee. A slightly different approach has

been taken in Western Australia, where tissue banking is

embedded within certain pathology services and core data

management and linkage platforms are being developed

to ensure consistent and effi cient management of research

studies involving biospecimens. The Western Australian

approach is wider than just cancer and aims to maximise

linked datasets to answer epidemiological as well as clinical

research questions.

The Australasian Biospecimen Network (ABN) is an example

of a network approach that aims to assist researchers locate

biospecimens through an online facility that allows searching

of multiple biobanks at one time. It also provides a forum to

address technical, legal/ethical, and managerial issues relevant

to human biospecimen repositories within Australia and

New Zealand.

Cancer biobank locations in New South Wales

Within NSW, 23 tumour collections were identifi ed, 17 of

which were confi rmed as formalised tissue banks.

Biobank activities in New South Wales: key themes from surveys

Design

Each of the formal biobanks in NSW gains patient ▪consent for broad, as yet unspecifi ed future research

with specimens at most tissue banks also being collected

for specifi c research projects on request.

Specimens routinely collected and stored generally ▪include fresh frozen tumour tissue and, at most banks,

matched normal tissue, blood and blood products.

Several banks also store paraffi n embedded specimens.

DNA and RNA are not routinely extracted at most

banks but can be extracted on request.

The design of the biobanks in terms of single or multiple ▪collection and/or storage sites is in large part dictated by

the original intent of the bank and by tumour incidence,

patient type, specifi c collection and storage requirements

for the tumour or institution, availability and funding

for dedicated tumour bank staff and storage facilities,

and how to best develop expertise in tissue and data

collection, storage and distribution.

Two of the biobanks have specimen locators for ▪researchers to search for specimen availability within a

specifi c tumour bank and three others are members of

the Australasian Biospecimen Network (ABN).

Entity status and funding sources

All exist as non-profi t organisations or as departments ▪(or units within departments) within hospitals or

research institutions.

All but four banks rely to some extent on grant funding ▪for their operation, with 85–90 per cent of funds

generally spent on staffi ng.

Organisational structure and governance arrangements

All biobanks collecting from multiple non-local ▪geographical sites are governed in some capacity by

executive or management committees or independent

arm’s length advisory groups. In addition, these large

biobanks have other committees under this governing

committee, responsible for the development of policies,

procedures and operations and either have already got,

or are in the process of establishing, scientifi c advisory

groups.

Biobanks with either single or local-only collection ▪and storage sites are generally governed by a Biobank

Committee constituted from within the hosting

institution. Expert advice is sought by these committees

as required.

Where more than one biobank exists at an institution, ▪storage facilities are often shared, yet with individual

biobank committees responsible for operational

issues and, in most cases, researcher requests and

specimen distribution.

xi

Standard operating procedures and data management

Although there are some variances across the NSW ▪biobanks, standard operating procedures are similar and/

or are based on the same source (with the exception

of procedures specifi c to a certain type of tumour or

specimen not routinely collected).

All banks had established their own databases to register ▪basic client information and link this information to the

physical sample through a coded system (generally in

Microsoft Excel or Access). Clinical information and

follow up data were often kept separately from the

biobank database with manual searches often required

to include this information with samples for researchers.

Banks varied widely in the extent of clinical information ▪collected and recorded and the extent to which the data

was governed by data dictionaries.

Researcher access and performance measures

Almost all biobanks interviewed have a formal ▪researcher access policy, with most stipulating priority

access for participating institutions or their affi liates

and collaborators.

Most tumour banks charge researchers either nothing or ▪freight costs only.

Almost all biobanks require researchers to acknowledge ▪the biobank in any publications arising and to send copies

of publications to the bank.

Biobanks generally measure their performance by: the ▪number of donors and specimens collected; the number

of specimens accessed by researchers; and the numbers

of publications arising.

Future options for New South Wales biobanking

From the review of current NSW biobanking activities,

several opportunities exist for maximising the potential

of biobanking in NSW. First, alternative organisational or

networking models of existing biobanks could be considered.

These range in complexity from minimal changes to the

current arrangements and infrastructure to substantial

change and re-structure. Second, core infrastructure

requirements could be examined including the current role

of pathology providers in tissue banking, data management

and linkage platforms.

Alternative models for biobanking

Minimal change approach

Stakeholder network with or without biospecimen locator

Related individual biobanks could form (or join existing)

stakeholder networks while retaining their current

organisational arrangements (e.g. samples are still ‘owned’

by the individual banks and the researcher must still apply

individually to each bank when samples are located). This

networked structure provides a forum for working with

other banks to improve consistency of approach and

standardised procedures. In addition, a biospecimen locator

could further benefi t researchers by increasing their ability

to quickly and easily search multiple banks and/or multiple

storage/collection nodes at one time for samples.

However, there are limitations to this approach, particularly

in respect to the quality and consistency of tissue samples

across the network, which, in the absence of an over-arching

monitoring body or mandating process, may be diffi cult

to achieve.

Accreditation

Accreditation procedures across multiple banks could be

implemented to increase consistency and coordination.

There are signifi cant benefi ts to researchers if the quality

and consistency of stored tissue are increased. However, this

approach would not assist in location of specimens across

banks, so a biospecimen locator approach may also need to

be considered.

No changes would be required to the organisation or entity

status of the individual biobanks, although there may be

procedural changes required within individual banks in order

to meet accreditation standards and would require fi nancial

investment from banks.


xii

Consortia approach

Biobanks could also look at the option of forming a

consortium, which would override their entity as individual

biobanks. This would have implications on governance

arrangements of individual banks and would require

the formation of an over-arching body, such as a central

management committee to lead the consortium. Issues,

including sample storage and ownership, SOPs, funding

and cost recovery, may all have to be dealt with through

consensus among the members.

This approach has the greatest potential to increase the

consistency and quality of biospecimens and associated

clinical and outcome data. It may require considerable

investment to provide enough resources and incentive

to ensure compatibility of processes and systems among

individual banks.

A consortium could be set up within NSW or could be

Australia-wide. It could also be tumour-specifi c, restricted to

certain cancers or could be general for all cancer types.

Enhancing biobanking infrastructure

Pathology-based biobanking

Pathology departments play an integral role in all

biospecimen banks. There are currently few well-established

data linkage networks between pathology and clinical

databases in NSW biobanks. Most biobanks interviewed

are aiming to establish more sophisticated networks but are

constrained by fi nancial and human resources including lack

of technical expertise.

Data management and tracking systems

As biobanking activities expand and more collaborations

are established, sophisticated data management and tissue

sample tracking will become essential. Software applications

such as the Laboratory Information Management System

(LIMS) of WAGER and the VCBs custom designed database

are two examples of systems specifi cally developed for the

Australian market. There are also international initiatives,

such as the National Cancer Institute’s caBIG and the

Canadian CTRNet project which seek to establish common

data-sharing platforms for biobanks. While it is outside the

scope of this study to make any detailed assessment of the

various tools currently available, it is clear that any further

developments of biobanking collaborations in NSW should

build on and learn from the experiences of the established

systems, rather than duplicating these efforts.

Data linkage and epidemiological biobanks

The WAGER initiative also provides the basis by which

Western Australia is increasing the depth of their

epidemiological datasets, in addition to managing clinical

samples. Most biobanks identifi ed within NSW have been

set up for clinical research purposes rather than focussing on

epidemiological research questions. The Centre for Health

Record Linkage (CHeReL) currently provides excellent

capacity within NSW for linking existing statewide datasets

and, other than Western Australia, is the only such facility in

Australia. There may be an opportunity to leverage off this

existing data linkage capacity.

1

1 Introduction

Biospecimen banks have rapidly become key pieces of research infrastructure, particularly in fi elds such as cancer research.

1.1.1 What is biobanking and why is it important for NSW?

A ‘biospecimen bank’ or ‘biobank’ refers to a standardised

collection of human biological materials, including tissue

and tumour samples, blood and blood products, DNA and

relevant donor medical and demographic data collected and

stored with appropriate ethical consent.

Biobanks generally fall into three categories: population-

based biobanks; disease-oriented epidemiological biobanks;

and disease-oriented clinical biobank.1 The fi rst two are

within the domain of epidemiology that seeks to understand

factors affecting the health and disease of a population.

The latter type of biobank falls more within the realms

of clinical and translational research which focus more on

patients following diagnosis of a disease. All three have the

ultimate aim of improving health by increasing the quality of

preventative or clinical healthcare.

Population-based biobanks seek to collect samples of

biospecimens (generally DNA) that are representative of

the whole population (both healthy and diseased) and may

be used to address questions of genetic susceptibility to

disease. While research questions may be disease-specifi c, for

example identifying genes that place an individual at higher

risk of melanoma and understanding how these interact with

environmental factor,2 the collection of biospecimens tends

to be large scale and represent the whole population. The

research arising from such collections could help to develop

more targeted and more effective prevention strategies.

Disease-oriented epidemiological biobanks generally focus on

individuals with particular risk factors or particular diseases.

An aim of such collections may be to understand in which

circumstances risk factors lead to disease. The Kathleen

Cuningham Foundation Consortium for research into

Familial Breast cancer (kConFab) is one such example of an

Australian-based disease-oriented biospecimen resource.

The primary aim of kConFab is to facilitate research into

familial cancers by amassing a large and comprehensive

resource of epidemiological and clinical data with

biospecimens from individuals at high risk of breast and/or

ovarian cancer, and from their close relatives.3

Disease-oriented clinical biobanks again tend to focus on

a particular disease, but generally after a diagnosis of the

disease and may include collection of diseased and healthy

tissue as well as blood products and DNA. Rather than

address questions related to exposure and risk factors, these

collections provide opportunities to focus on understanding

disease progression and may be used to try to identify

determinants of good and poor prognosis and response to

particular treatments. Rapid advances in the understanding of

biological pathways of disease and the increase in therapies

that target particular pathways have opened the door to a

new ‘personalised’ approach to treatment. For example, it is

now apparent that a complex array of molecular pathways

may be implicated in understanding how a healthy cell makes

the transition to a cancerous cell. Knowing which pathways

have been disrupted at a molecular level in a tumour will

allow treatments to be chosen based on their ability to

combat the particular molecular defects. Clinical biobanks

which link biospecimens to rich clinical and patient outcome

datasets have been, and will continue to be, essential in

building knowledge of such pathways and mechanisms of

disease and testing the effectiveness of treatments.

Biospecimen banks have rapidly become key pieces of

research infrastructure particularly in fi elds such as cancer

research. There are many compelling reasons for developing

and expanding this important infrastructure and some

urgency is required if the benefi ts of such information-rich

resources are to be fully maximised.

Since the completion of the human genome project in

2003,4 there have been rapid technological advances in the

study of genetic components of disease. This has resulted in

accelerated research interest and, as a result, rapidly reduced

cost and timelines to generate research data. However,

while the ability to rapidly analyse biospecimens is ever

increasing, the timelines required to collect a large sample


2

of biospecimens and outcome data is generally quite long

- typically ranging from two to 15 years depending on the

disease site and study design.1 This suggests that the future

benefi ts of such genomic advances will only be fully realised

if appropriate high quality data sources (such as biobanks)

are developed now. An additional concern for the future of

clinical biobanks is the ever decreasing size of biospecimen

samples due to increasing success of early detection and

screening programs. There is already a perception that some

collections, such as breast cancer, are being biased towards

later stage disease.

NSW already has a very substantial medical and health

research capacity, including strengths in many areas of

biomedical, clinical, public health and health services

research.5 The identifi cation of biobanks in NSW and

identifi cation and implementation of best practices in

biobanking should continue to build on this NSW research

capacity by further facilitating cancer research and assisting in

the utilisation and collection of biospecimens. This will allow

NSW researchers to assist in the ‘global research effort to

control cancer but will also place NSW in a better position for

tackling local health problems and encourages research oriented

health system that is able to rapidly incorporate the most recent

evidence based medicine into practice’.5

1.1.2 What is involved in biobanking?

Successful biobanking is dependant on the coordinated

activity of a number of personnel with different areas of

expertise. While the size of the biobank may determine

the number of dedicated staff involved in the activities, it is

important to consider all the possible key players involved to

explore the optimal models for biobanking.

Biospecimen Collection

The process of procuring samples requires informed consent

from the patient, which is usually dependant on the treating

clinician or nurse. The surgeon and his staff in the operation

theatre then have to be informed of this consent so that

the tissue may be collected and snap frozen if necessary.

The biobank offi cer has to be informed so that the sample

may be immediately transported to the storage centre,

either within the same institution or at a central storage

facility, where it is processed, coded, catalogued and stored.

For epidemiological banks the process would be similar,

substituting study participants for patients noting that the

collection would generally include only a blood sample.

Storage and cataloguing

Laboratory technicians may be involved in processing of

the tissue and blood products, which may include DNA

extraction and making of paraffi n blocks. Additionally,

pathologists and pathology technicians will likely be involved

in histological analysis and microscopic analysis, grading etc.

Usually the tumour bank offi cer is responsible for monitoring

the freezers and cryostats where the samples are stored

and a database manager develops and manages the database

for an inventory of the stored samples. The database

manager also: develops and maintains the system for linkage

of the samples to unique identifi ers as well as to associated

information about the sample; tracks the addition of new as

well as any returned and unused tissue samples; and manages

the removal and despatch of samples for researchers.

Management of the bank

Generally a biobank will have an appointed manager who

is responsible for the overall day-to-day running of the

biobank. The manager is the link between the personnel

employed within the bank and any governing biobank

committee. This body, or the biobank committee, usually

consists of representations from the stakeholders, scientifi c

advisory committee, the ethics committee, as well as the

host institution. Additionally, a host institution may have

a management committee, which could be involved in

decisions regarding facilities and equipment related to

the biobank.

The successful running of a biobank is a complex operation

and this highlights the necessity of good governance

principles, as well as the implementation of best practice

guidelines.

The more complex organisational structures of biobanks,

such as those with multiple collection sites or a consortium

of biobanks, involve more personnel. This could include more

staff for collection and transport of samples, overarching

3

governing bodies with members from all collecting nodes, IT

personnel who design and maintain integrated information

systems and specimen locators.

1.1.3 Working together to maximise this potential

The concept of collecting and storing human tissues and

other biological samples for research purposes is not a new

one. However, many small clinical biobanks have arisen from

individual laboratories or projects and they are often reliant

on the passion of one researcher to champion it. It has not

been until recently that the need for more structured and

extensive biobanks has been realised due to the advances in

scientifi c technologies, especially genomics and proteomics,

driving the demand for high-quality tissue samples and large

scale collections. The scale of population-based biobanks by

defi nition is very large and these types of epidemiological

banks have emerged more recently, due again to advances in

genomics and proteomics. It is not possible to contemplate

the development of population-based biobanks without a

high level of cooperation and signifi cant funding.

There are several benefi ts to having a consolidated approach

to biobanking, including: increased researcher awareness of

specimen availability; increased access for researchers from

larger pools of samples; increased quality and consistency

of samples from standardised collection procedures; and

increased effi ciencies and economies of scale.6

To be able to answer new research questions, biobanks are

evolving to cover more geographical sites for collections,

increasing types and quality of samples stored and improving

the clinical data associated with samples. Consequently, the

IT infrastructure of biobanks is also evolving to track and

monitor increased sample numbers, track clinical data and

follow-up data and provide biospecimen search functions

for researchers. As such, the governance, structure and

regulation of biobanks are also evolving to encompass the

new directions taken.

Governance of biobanks has to now consider at least:

type of entity (e.g. not for profi t, for profi t, charity) ▪

separate entity (with a separate board of directors) or ▪included as a part of a hospital/health service and as such

reporting to the hospital/health service board

of directors

single or multiple collection sites ▪

a part of a consortium of biobanks or single entity ▪

research approval board (in addition to ethical approval ▪for research)

standard operating procedures ▪

reporting commitments and transparency ▪

stakeholders ▪

funding arrangements ▪

pricing of samples and priority of sample provision (e.g. ▪to academia or commercial companies)

quality assurance measures and review processes ▪

risk assessment and mitigation. ▪

‘Tissue banking, or the standardised collection of tissues and

associated clinical and demographic data with appropriate

ethics consent, is now internationally recognised as a basic

tool for cancer research. Whilst the value of biorepositories

to the research community is not in question, the collection

of samples and data from an adequately large number of cases

is typically beyond the scope of any single institution. It is also

clear that duplication is uneconomical, and an active network

of like-minded “bankers” should facilitate information sharing

as well as resource sharing whilst increasing the overall value

and quantity of tissue resources available.’7


4

This report has used the terminology biobank to include banks collecting any biospecimens that have a focus on cancer research.

2 Defi nitions

In addition to the distinction between epidemiological and

clinical biobanks, there are also many different types of

clinical biobanks and several different naming conventions.

Historically, tissue banks would refer to all collections of

human tissue, including tissue collected for transplantation

purposes. Tissue banks could also refer to collections of

blood and blood products. Tumour banks, as the name

suggests, refer to collections of tumour tissue, but also often

contain ‘matched-normal’ tissue from the same donor, as well

as blood and blood products. Tumour banks can be general

across many cancer types, or specialised with a focus on one

or two specifi c cancers.

A new terminology emerging is ‘biospecimen bank’ or

‘biobank’. These refer to collections of human biological

samples including tissue samples (and can include tumour

samples), blood and blood products, DNA and associated

relevant donor medical information.

This report has used the terminology biobank to include

banks collecting any biospecimen, including tissue and

blood products that have a focus on cancer research. Banks

collecting samples specifi cally for other disease research (eg

neurological diseases) or for transplantation purposes have

not been considered.

Biobank defi nitions

The structure and organisation of biobanks and tissue

collections can vary depending on the nature and purpose of

collections. Therefore, for the purposes of this project, the

following defi nitions have been applied:

Formalised biobank

Tissue repository established to bank biospecimens for future

unspecifi ed research, with the intent to distribute samples

to requesting researchers (subject to approval). May or may

not also collect for specifi ed research project(s). These may

have single collection and storage site, multiple collection

but single storage sites, or multiple collection and multiple

storage sites.

Specifi ed specimen collection

Tissue repository established to collect and store

biospecimens for specifi ed research project(s), generally for

use within the host laboratory/institution.

Note that this defi nition of a specifi c specimen collection

does not include tissue repositories at anatomical pathology

or other laboratories if they are collected and stored

solely as part of routine diagnostic procedures and storage

requirements. These collections can include large repositories

of often paraffi n-embedded tissue but, as reported by one

head of pathology, may have been collected or stored in an

‘ad hoc manner’.

Biobank consortium

Consortium refers to the collaboration of two or more

biobanks under an overarching governance arrangement,

so that individual banks continue to manage their own

collection and storage site(s), but the consortium has overall

responsibility and manages requests for samples centrally.

Stakeholder network

Stakeholder/peak body networks refer to collaborations

between biobank managers and other stakeholders to

discuss universal topics in the fi eld such as standard operating

procedures for collection, storage, treatment and shipping of

biospecimens, ethics and informed consent for donors and

data/information storage and retrieval.

Specimen locator networks

Specimen locator networks provide the ability for

researchers to search multiple biobanks or consortia via a

website to identify availability of specimens.

5

3 Project methodology

This project aimed to identify the location of biobanks used for cancer research across 12 geographic cancer research hubs in NSW.

3.1 Project scope

This project aimed to identify the location of biobanks used

for cancer research across 12 geographic cancer research

hubs in NSW, and understand the governance arrangements

of cancer biobanks and networks in a subset of six

geographical research hubs. The ultimate aims of this project

are to:

improve researcher access to tissues collected in a range ▪of cancers

improve effi ciency and reduce duplication of ▪administrative processes

build capacity that is cost-effective and sustainable ▪

identify the current investment in tissue banking and ▪strategies to optimise value for money.

The project comprised the following stages: a literature

review of international biobank governance arrangements

focussing on the US, UK and Canada; a literature review

and web search on biobank governance arrangements

within Australia with telephone or face-to-face interviews

with three biobanks in non-NSW states (with the aim of

informing survey design); identifi cation of biobank locations

in NSW and collection of high-level information, including

cancer type and purpose of tissue collection; telephone or

email survey of biobank governance arrangements in the six

major geographical hubs that were identifi ed as comprising a

high proportion of cancer research in NSW5 (Central Sydney,

Darlinghurst, Northern Sydney, Newcastle/Hunter, Western

Sydney and Randwick); identifi cation and contact with

researchers to gather information on barriers or facilitators

to access of biospecimens; and development of future

options for biobanking in NSW.

3.2 Review of worldwide governance arrangements of biobanks

Peer-reviewed literature was sought from internet searches

using GoogleTM and Entrez-PubMed database searches using

key words (and key word combinations) including:

Tissue/tumour/biobank. ▪

Networks. ▪

Governance. ▪

Ethics. ▪

Regulations. ▪

Standard operating procedures. ▪

Information on international biobanks was obtained from

web searches and publically available information on the

biobanks’ websites. Further clarifi cation was sought via email

in some instances.

3.3 Identifi cation of biobank locations in New South Wales

To identify the locations of cancer-related biobanks in NSW,

a contact list was created for the initial identifi cation phase of

the project via a number of mechanisms:

A list of research organisations, institutes, university 1.

departments and hospital departments was created

based on a recent survey of cancer researchers in

NSW.5 This provided a list of possible locations for

biobanks or specimen collections. Prior to contacting

these organisations, a further web search was conducted

where possible for each site to obtain additional

information on the research group and the most

appropriate contact person (i.e. research group head).

Research governance offi cers, cancer regulatory affairs 2.

offi cers and cancer services development managers in

NSW were also identifi ed as personnel who may be able

to provide additional information. Contact was made

with these people via email.


6

In addition, executive offi cers for all NSW Health 3.

Human Research Ethics Committees were contacted via

email and asked to provide any additional information

regarding biobank locations, collection sites and details of

contact personnel if known.

Additionally, any information discovered through website 4.

searches, or given from the contacts/researchers listed

above was used in order to compile an exhaustive list of

biobanks in NSW.

In total, more than 150 individual contacts were made via

email or telephone across 69 organisations. Contact was

made via telephone where possible, or via email if telephone

details were unavailable or if no response was obtained via

telephone. Where contact details were only available for an

institution switchboard or where research group details were

found to be incorrect, a telephone call was made to the

institution requesting to be transferred to the Anatomical

Pathology Department and/or Cancer Research Group/Unit

to identify the appropriate person to speak with.

Information regarding biobank status was gained on the

majority of contact institutions or organisations. Only six

of the 69 organisations contacted were unable to provide

comment in any capacity regarding biobank status (note:

this does not include the many individual researchers or

contacts within these organisations who did not respond).

It was not possible to obtain responses from some research

organisations / institutes / university departments / hospital

departments within the timeframe of the study.

3.4 Survey of governance arrangements of Australian tissue banks

3.4.1 Survey development and scoping study

A questionnaire on governance arrangements for biobanks

in Australia was developed based on suggested best practice

recommendations from the international literature. The

questionnaire addressed fi ve major areas:

general information including specimen type and ▪collection/storage facilities

entity status and funding sources ▪

organisational structure and governance arrangements ▪


researcher access. ▪

Before rolling out this survey to NSW biobanks in the six

major geographical hubs, three banks were selected to pilot

the questionnaire and scope for further detail that may

need to be incorporated or modifi ed in the document. This

scoping survey was used in face-to-face interviews with two

large non-NSW-based bio banks (Victorian Cancer Biobank

and Australian Prostate Cancer Collaboration BioResource)

and in a telephone interview with a large NSW-based

biobank (Breast Cancer Tissue Bank). Non-NSW biobanks

were included in the scoping study to ensure the Australian

as well as the NSW perspective was obtained.

The three scoping interviews highlighted the diversity of

arrangements in biobanks. In addition, interim results of

telephone/email contact with potential biobank locations

indicated that biobank numbers were unlikely to exceed

20–30 banks. Therefore, the governance surveys were

conducted via teleconference rather than as an emailed

questionnaire (as originally planned), as this method was

likely to generate a higher response rate and also allow more

exploratory discussions regarding organisational structure

and governance arrangements. Contacts were emailed the

survey questions prior to the teleconference to allow time to

consider or prepare responses. Where telephone interviews

were not possible, biobank representatives were emailed a

written version of the questionnaire to complete.

3.4.2 Final survey instruments

Following the testing of the governance questionnaire in the

scoping survey, the survey instrument was modifi ed slightly

and used as a telephone questionnaire to enable biobank

heads or managers to describe the following characteristics

of their biobank(s): general information regarding specimen

type and collection/storage; entity status and funding sources;

organisational structure and governance arrangements;

standard operating procedures; and researcher access.

A copy of this survey instrument appears in Appendix A, Section 9.1.1. Where the biobank was identifi ed as a

specimen collection based on initial contact – and therefore

7

only collecting and banking specimens for a specifi c research

project(s) – the contact person was asked to respond

to a short list of emailed questions relating to collection,

cancer type, specimens collected, and whether specifi c or

unspecifi ed consent had been obtained. A copy of these

survey questions appears in Appendix A, Section 9.1.2.

3.4.3 Survey recipients

In the initial identifi cation phase of the project, 23 biobanks

or collections were identifi ed. Of these, six were classifi ed

as specifi ed collections or banks in planning rather than

existing folmalised biobanks. Each of the specifi ed collections

completed a short emailed questionnaire covering basic

information on the types of patient consent, types of tissues

and type of cancer.

The remaining 17 biospecimen resources were identifi ed

as formalised biobanks and 13 of these responded within

the specifi ed timeframe and completed the fi rst telephone

survey on governance arrangements.

The data was collected via either telephone or email.

Where telephone contact was unavailable or diffi cult for the

recipient, an offer was made to send the survey via email for

completion and return.

3.4.4 Follow up and additional information

Additional information was sought from the biobanks

to capture further details of the number of donors and

tissue samples held by the banks, the number of samples

distributed, funding arrangements and measures of success

for the bank. This information was captured using a second

survey tool distributed to managers of formalised biobanks

identifi ed during the initial surveying. A copy of this tool

appears in Appendix A section 9.1.3.

The four biobank managers who were unable to be

interviewed initially were included in this follow-up survey

and they were recontacted to complete both the original

and second surveys regarding their biobank. Surveys were

distributed to biobank managers electronically via email.

Biobank managers were given the option to either return

the survey electronically, via fax, or request a telephone

interview for the survey. Responses were received from 13

biobanks (all electronically), including two of the four biobank

managers that did not respond to the initial survey.

3.5 Survey of researchers

As part of the survey of governance arrangements, biobanks

were asked to provide name(s) of researchers who had

used their biobank and could be contacted to discuss

access arrangements. Four researchers were contacted to

participate in the telephone survey, with two researcher

telephone interviews subsequently conducted using a

questionnaire designed to allow researchers to report on

access arrangements to biospecimens and the barriers/

facilitators to this access. A copy of these survey questions is

at Appendix A, Section 9.1.4.

3.6 Limitations

The ability to accurately locate all biobanks in NSW,

both formalised banks and specimen collections, is largely

dependent on the following: a comprehensive contact list of

those with an interest in this fi eld; the availability of contacts

to confi rm biobank status during the period of the project;

and the willingness of contacts to share information regarding

their biobanks.

While it is believed that most of the more formalised

biobanks have been identifi ed during this project via the

contact lists, it is possible that there are many more small

banks or specimen collections housed by researchers for

current or historical specifi c research project purposes.


8

Non-profi t companies are by far the most common entity status for biobanks and networks worldwide.

4 Worldwide governance arrangements

This chapter discusses the evidence in the literature and

from examples of biobanks on governance arrangements for

biobanks worldwide. It includes examples of good practices

as well as highlights issues that banks have encountered. Key

themes of discussion include:

entity status and funding sources ▪

organisational structure and governance arrangements ▪


international biobanking networks. ▪

4.1 Entity status and funding sources

There are several different types of entity that a biobank

could be established as, such as:

A non-profi t company (or charity) funded by public, ▪private (e.g. philanthropic) and government funding.

A non-profi t company (or charity) funded by public and ▪private (e.g. philanthropic) funding (but not funded by

government).

A company privately owned or publicly listed by shares. ▪

4.1.1 Non-profi t organisations

Non-profi t companies are by far the most common entity

status for biobanks and networks worldwide (Europe, UK,

US and Canada). Some of the advantages of a non-profi t

company are:

fl exibility in funding arrangements and funders ▪

positive public perceptions regarding use and intent of ▪bio-samples, i.e. the samples will be used in a way which

will best benefi t science and medical discoveries and not

purely to profi t stockholders

avoids, to some extent, legal issues regarding the ‘sale’ ▪of human bio-samples for profi t (distinct from cost

recovery fees for collection, storage, modifi cations

and shipping of samples) and enables more fl exible fee

setting in line with what researchers can and will pay

for samples.8

It is for these reasons that the research into establishing

a National Biospecimen Network (NBN) in the US

recommended that the network be established as a non-

profi t company with a mix of public and private funding (e.g.

charitable and philanthropic donations, industry funding,

government funding and fees for service).8 Similarly, in the

UK, onCore UK (the national biosample and information

resource for cancer research) was established as a non-profi t

and charitable organisation, which is funded by government

and non-government agencies (the Department of Health

in England and the Medical Research Council and Cancer

Research UK). The collaboration operates under the

umbrella of the National Cancer Research Institute (NCRI),

which is a partnership of all the major funders of cancer

research from the public, charity and private sectors.9

Other international biobanks that are non-profi t with

government or mixed funding include:

The Cooperative Human Tissue Network ▪ (CHTN),

supported by the National Cancer Institute (NCI),

provides investigator-defi ned, prospective procurement

of malignant, benign, diseased and ‘normal’ adjacent

tissues, as well as tissue microarrays for researchers

across the US.10

The Early Detection Research Network ▪ (EDRN),

supported by the NCI, which collects samples to

develop diagnostic biomarker tests for cancer.11

Cooperative Breast Cancer Tissue Resource ▪ (CBCTR)

funded by the NCI, supplies researchers with primary

breast cancer tissues and associated clinical data.12

The Canadian Tumour Repository Network ▪ (CTRN),

funded by the Canadian Institute of Health Research

(CIHR) under direction of the Canadian Association of

Provincial Cancer Agencies (CAPCA), is a consortium of

9

leading biobanks and programs and provides researchers

with a streamlined process of obtaining biosamples.13

Generation Scotland ▪ broad health study of the Scottish

population:

Generation Scotland: Donor DNA Databank – ,

funded by the Chief Scientist Offi ce (CSO)

Biomedical and Therapeutic Research Committee,

aiming to provide well characterised control DNA

samples for the Scottish population for future

research projects.14

Generation Scotland: Genetic Health in the 21st –

Century (GS:21CGH) funded by the Scottish

Higher Education Funding Council (now the

Scottish Funding Council) through their Strategic

Research Development Grant Initiative. The aim

of GS:21CGH is to build control cohorts that

are representative of Scotland’s sub-populations

by recruiting 2,500 individuals (500 each from

fi ve different regions of Scotland) to supply basic

physical measurements, a blood sample, and

lifestyle information.15

Generation Scotland: Scottish Family Health –

Study (GS:SFHS) project funded by the Scottish

Executive’s Genetics and Healthcare Initiative,

which aims to build up a large, intensively

phenotyped, family-based cohort with which

to study the genetic basis of common complex

diseases and response to treatments.16

The Spanish National Cancer Research Centre ▪ (CNIO)

Tumour Bank Network (TBN) is coordinated by the

Molecular Pathology Programme (MMP) and aims to

promote biobanks in Spanish hospitals through the

application of standardised operating procedures for the

collection, processing and storage of tumour and normal

tissue samples.17 CNIO was founded by the Carlos III

Institute of Health, dependent upon the Ministry of

Health, in 1998.18

The Genome Austria Tissue Banks ▪ (GATiB) (part

of the BioResource-Med at the Medical University of

Graz, Austria) is an internationally focused collection of

diseased human tissues designed to support the needs

of research into human diseases, drug discovery and

public health. The bank is currently funded through

research grants primarily from the Genome Research in

Austria Fund (supported by the Ministry for Science and

Research).19,20

Examples of the governance arrangements for some of the

biobanks researched for this document are presented at

Appendix B.

4.1.2 For-profi t organisations

In the US, there are also private companies that provide

biobank services, such as:

Bioserve is a for-profi t company, which provides, among ▪other services and manipulation techniques, a global

repository (in partnership with Genomics Collaborative)

containing human DNA, RNA, tissue samples and serum

samples collected from four continents.21

Asterand is a publicly listed for-profi t company, which ▪supplies human tissue and human tissue-based research

services to drug discovery scientists. The company was

formed in 2006 from a merger of Asterand, a human

tissue biorepository, and Pharmagene, a human tissue-

based drug discovery company and has offi ces in the UK

(Royston) and US (Detroit, Michigan).22

Other private companies in the US provide bioinformatic

support for companies and researchers, such as HealthCare

IT, which provides web-based software solutions for

biomedical research and drug development.23

In Australia, however, there is no precedence for ‘for-

profi t’ biobanks or networks to date. Establishing a for-

profi t company for the distribution of human bio-samples

would also necessitate discussion regarding the legality of

selling human tissues or bio-samples (versus cost-recovery

pricing) as well as the need to distinguish between when the

sample has been modifi ed suffi ciently (e.g. DNA and RNA

extractions, micro array tiles) to no longer be regulated by

human-tissue regulations.


10

4.1.3 Funding of non-profi t biobanks

The amount of funding the non-profi t biobanks receive

worldwide varies enormously. Some examples are

provided below:

onCore UK1. : In the fi nancial year ending 31 March 2007,

the principle grant funding for onCore UK was just over

£2m. Funds used during the fi nal year totalled £864,000

(with £865,000 on operating costs and £19,000 on

governance related costs.9

Generation Scotland: Donor DNA Databank2. (GS:3D)

is a £170,209 project funded by the Chief Scientist

Offi ce (CSO) Biomedical and Therapeutic Research

Committee.14

Generation Scotland: Genetic Health in the 21st 3. Century (GS:21CGH), funded by a £1.79m grant from

the Scottish Higher Education Funding Council (now

the Scottish Funding Council) through their Strategic

Research Development Grant Initiative.15

Generation Scotland: Scottish Family Health Study 4. (GS:SFHS) is a £4.4 million project funded by the Scottish

Executive’s Genetics and Healthcare Initiative.16

4.2 Organisational structures

The organisational structure of a biobanks will infl uence the

types of governance arrangements established for the bank.

Internationally, disease-specifi c or clinical biobanks either

operate as individual banks with one or more collection

sites or as part of a biobank consortium. Population-based

biobanks differ again on structure.

4.2.1 Individual biobanks: one or more collection sites

Historically, many biobanks originated from individual

research laboratories collecting for specifi c research purposes

(specimen collections). As technology improved and

demand subsequently increased, some of these collections

have become more formalised biobanks with established

governance arrangements. Many of these biobanks remain

departments within hospital or institutions and as such are

governed by the hospital boards and committees. Some,

however, have been established as independent entities and

therefore have their own governing bodies and committees,

although may still be subject to regulations of the hospital/

institution in which they are housed.

An example of a non-profi t biobank is provided in Case Study 1.

Case Study 1: Genome Austria Tissue Bank (GATiB)

The Genome Austria Tissue Banks (GATiB) is a part of the

BioResource-Med (a research core facility) at the Medical

University of Graz, Austria. The biobank previously established

at the at the Medical University of Graz has been developed

into an internationally focused collection of diseased human

tissues designed to support the needs of research into human

diseases, drug discovery and public health. In order to minimise

international distribution of the limited human samples, GATiB

places an emphasis on sample analysis, allowing the distribution

of high quality tissue-derived data, rather than the original tissue

samples themselves.19

Key components of GATiB are a) archival tissue samples

associated with long-term follow up and medical data, b)

prospectively collected tissue and blood samples associated

with standardised information on disease and environmental

exposure, c) animal models molecularly validated for their human

disease relevance and d) IT-tools supporting sample tracking, data

storage, data mining and protecting sample donor privacy.19

The resource currently contains biological samples from 888,000

patients representing a non-selected patient group characteristic

for central Europe. These are samples from all human diseases

treated by surgery or diagnosed by biopsy, thus representing

cancers and non-cancerous diseases from all organs.19

In 2006, GATiB had paraffi n embedded samples from 888,000

patients and a further 8,090 fresh frozen samples. Medical

information routinely associated with samples includes disease

diagnosis, histopathological report (classifi cation, grading and

staging of tumours), immunohistochemical characterisation

and molecular genetic characterisation. Follow-up survival data

is available for 63,000 samples (24,000 patients). In addition,

medical records are available for 470,000 patients and this is in

the process of being uploaded into a searchable database for

electronic accessibility.19

A secure data management systems support collection,

administration and retrieval of data. In addition, a data mart was

designed to enable complex queries combining genetic data with

detailed medical information, while protecting sample donor

privacy by preventing re-identifi cation of individual patients.19

11

4.2.2 Biobank consortia

More recently the idea of biobank networks or consortia

are emerging both overseas and within Australia. A biobank

consortium typically includes several biobanks under

one overarching governance arrangement. Most of the

international biobanks researched in section 4.1.1 have been

established as a consortium, providing an umbrella under

which multiple biobanks can network.

For example:

onCore UK1. was established as a non-profi t and

charitable organisation, funded by both government

and non-government agencies. onCore UK works

with selected public hospitals across the UK to collect

biosamples (primarily blood and paraffi n embedded

tissue) donated by cancer patients. Training and standard

operating procedures (e.g. for collection and sample

preparation) are provided to the hospital and samples

are transported from the participating hospital to a

central storage repository and data entered onto a

central database.9

The US National Biospecimen Network2. (NBN) trialled

a biobank consortium for prostate cancer in 2004 and

2005, the Prostate SPORE (Specialised Program of

Research Excellence) National Biospecimen Network

Pilot.24 This project was discontinued in 2005 as it was

considered to be not technically optimal and therefore

not cost effective. However, the NCI continue to work

on the NBN concept and have learned much from the

Prostate SPORE trial including the need for bioinformatic

tools and the development of the Cancer Biomedical

Informatics Grid (caBIG).25

The Spanish National Cancer Research Centre (CNIO) 3.

Tumour Bank Network (TBN) is a biobank consortium

which provides standardised operating procedures and

training for the collection, processing and storage of

tumour and normal tissue samples in Spanish hospitals.

The participating banks are a part of hospital pathology

departments and routinely collected paraffi n embedded

and fresh frozen biospecimen samples. The success

of the TBN has prompted use of this model in other

biobank consortium development including the Biobank

Ireland Trust.26 For further details, see Case Study 2.

The Canadian Tumour Repository Network4. (CTRN)

is a non-profi t consortium of leading biobanks to aid

Canadian health research. CTRN provides researchers

with a streamlined process to obtain quality human

tissue and human tissue products from member

biobanks.13 For further details, see Case Study 3 below.

More detailed examples of biobank consortia are provided in

Case Study 2 and 3.

4.2.3 Population-based biobanks

Population-based biobanks are designed to collect genetic

information representative of population cohorts. Examples

of this are the Generation Scotland projects (DNA

Databank, Genetic Health Study and Family Health Study)

and UK biobank.

UK Biobank (a registered charity funded by the Wellcome

Trust, the Medical Research Council, the Department of

Health, the Scottish Executive and the Northwest Regional

Development Agency) aims to improve the prevention,

diagnosis and treatment of a wide range of serious and life-

threatening illnesses (e.g. cancer, heart diseases, diabetes,

arthritis and forms of dementia) through the collection of

blood and urine from 500,000 people aged 40–69 across

England. As well as the samples, UK biobank collects basic

health information and health checks (e.g. blood pressure and

weight). UK biobank is designed as a long-term project and

does not expect to provide results from the epidemiological

studies that will be performed for at least 10 years. To date

the project has collected samples and information from more

than 200,000 people.

As opposed to collecting tissue samples for future research

projects on specifi c disease, these population-based

banks are collecting information on which large scale

epidemiological studies can be performed to examine trends

and linkages between genetic information and disease/

population health. These studies generally collect blood and

DNA products, as well as clinical information, but do not

typically collect tissue samples.


12

Case Study 2: The Spanish National Cancer Research Centre (CNIO) Tumour Bank Network (TBN)

The Spanish National Cancer Research Centre (CNIO) Tumour Bank Network (TBN) is a biobank consortium coordinated by the

Molecular Pathology Programme (MMP) and aims to promote biobanks in Spanish hospitals through the application of standardised

operating procedures for the collection, processing and storage of tumour and normal tissue samples. The purpose of the consortium is

to facilitate molecular studies by avoiding the bias of multi-centre studies possible. This model does not have a centralised bank, rather a

cooperative and coordinated consortium of banks based in the pathology department of participating hospitals. The banks are connected

through a computer data system which enables biospecimens to remain at the hospital of collection whilst encouraging multi-hospital

cancer research and of cooperation between basic and clinical researchers. The TBN is promoted by CNIO which undertake the role of

coordinating, database maintenance and adherence to quality control.17

There are currently 16 participating hospitals across Spain and each are required to sign a memorandum of understanding (MOU) in order

to participate. The MOU states that for a hospital biobank to collaborate with the TBN the following criteria need to be met:

acceptance of the collaboration by the entire hospital, with the collaboration of the hospital management and (at least) the oncology ▪and pathology departments

guarantee that the procedural manual of the TBN ▪is respected

provision of adequate material resources for the correct handling and preservation of the tissue, including -80ºC freezers with the ▪appropriate security measures

a technician working for the biobank ▪

a part-time medical specialist in pathology ▪

provision of appropriate infrastructure and physical space for the banks and IT requirements ▪

the existence of protocols from the surgical area that facilitate the rapid mobilisation of surgical specimens from the surgeons to ▪pathology.17

The TBN has standard operating procedures (SOPs) for:

transfer of tissue from surgeons to the pathologist ▪

fi rst examination of the biopsy or surgical specimen ▪

non-neoplastic tissue ▪

fi xation and processing ▪

freezing ▪

identifi cation of samples ▪

conservation of fi xed tissue ▪

conservation of frozen tissue ▪

security measures for frozen tissue. ▪ 17

Data routinely collected by the TBN consortium banks are: Identifi cation data (hospital of collection, local case code, date of birth and

sex); and Pathology Data (date of pathological study, time of sample deposit in the pathology department, anatomical location of neoplastic

process, complete pathological diagnosis, histological grade, stage of tumour, primary or relapse tumour, material available and sample type

(eg biopsy, autopsy material)).17

Researchers accessing samples from the TBN are required to acknowledge the TBN (including the hospitals from which samples were

provided) in any publications resulting from work undertaken using the samples. In addition researcher must provide two copies of the

publications to CNIO. Depending on how much contribution the hospital providing samples has given to the project, researcher may be

asked to include the hospital bank as a collaborator in publications.17

13

Case Study 3: The Canadian Tumour Repository Network (CTRN)

The Canadian Tumour Repository Network (CTRN) was formed in 2004 and operates as a non-profi t consortium of leading biobanks

to aid Canadian health research. CTRN provides researchers with a streamlined process to obtain quality human tissue and human

tissue products from member biobanks. CTRN is governed by a board of representative member bank, responsible for the day to day

management of the consortium.13

The consortium provides standard operating procedures for all aspects of banking for participating banks including:

general institutional requirements ▪

administrative processes ▪

patient recruitment management ▪

recoding and documentation management ▪

facility management and operations ▪

quality assurance procedures ▪

safety and training ▪

material handling; and material release. ▪ 13

In order to access samples from the CTRN, researchers must fi rst register for free membership. The membership provides: ability to

search and apply for tissue samples from Canada’s leading tumour banks in one central location; learning opportunities using online tools;

online collaboration with researchers, epidemiologists, pathologists and other experts across Canada; and invitation to CTRN workshops

and conferences.13

Despite coordinated searching functions and applications, the CTRN still respects individual biobanks status on the supply of samples to

commercial entities and the shipment of samples outside of Canada (i.e. whether or not samples can be provided to commercial entities or

shipped outside of Canada is up to the individual biobanks discretion).13

Tissue samples available include fresh frozen, paraffi n embedded, blood products and saliva. Routinely collected information includes:

clinical information (composition of the tissue, the size and type of tumour, results of clinical tests, treatment type, follow-up and outcome

information); and de-identifi ed personal information relevant to the disease in question.13

4.3 Biobank governance arrangements

Focusing on the non-profi t biobanks, the governance

arrangements of individual biobanks will depend on a variety

of factors, including whether the bank is a stand-alone entity,

a part of a research institute/hospital and/or a part of a larger

network or consortia of biobanks.

Biobanks established under the control of a research

institute or hospital are generally governed by the hospital/

institute board and scientifi c advisory council/committee. If

these banks are also a part of a consortium, then they will

be (partially or fully) governed by the Board of Directors

or Governors of the consortium (which may include

representatives from the hospital/institute). Although the

bank may not be governed by the institute in which it is

housed, it will mostly likely be required to provide regular

reports to the institute as well as the governing board.

Consortia or individual banks that are not associated with

a hospital or institute (aside from sample collection) will be

independently governed.

4.3.1 Governance Boards

The US NBN Blueprint that examined arrangements for

an independent (i.e. non-associated) consortia of biobanks

proposed a three tier governance arrangement. The

organisational structure of the proposed NBN (depicted

Figure 1) focused on day-to-day operations (operations

centre) controlling six business units, and in turn being

governed by a board of governors.8


14

Figure 1 Proposed operating structure for the National Biospecimen Network (NBN)

Likewise, onCore UK is managed by a board of trustees. The

Board is accountable to the members of the company (the

Medical Research Council and Cancer Research UK), and

act as company directors and as charity trustees. The Board

consists of representatives from each of the three funding

bodies (the Department of Health, Cancer Research UK

and the Medical Research Council), a lay-representative and

an independent Chair. Day-to-day running of onCore UK is

conducted by the CEO and a management team (depicted in

Figure 2).9

Similarly, other independent biobank consortia have

established boards of directors or governors to control the

network and their strategic directions, including: UK Biobank,

CHTN (US)10 and the Ontario Tumour Bank.28

4.3.2 Other committees

In addition to the general governing boards and

arrangements, all biobanks require a scientifi c advisory

committee to which all applications for samples will be

submitted. The purpose of the advisory committee is to

approve the research for which the samples are requested

as benefi cial for sample use. This is over and above ethical

approval for research which researchers need to obtain from

their housing institution’s ethical board (or a similar ethical

body e.g. National Health and Medical Research Council in

Australia) prior to biobank application.

4.4 Standard operating procedures

The development of biobank consortia across countries or

regions has led to a global push to develop standardised

operating procedures for biospecimen collection,

preservation, treatment, storage and distribution. The aim of

this is to provide researchers assurance that samples across

multiple banks will have the same integrity and quality. This

would allow researchers to use multiple banks to collect

the number of required specimens, without jeopardising the

quality of the research project.

National Biospecimen Network guidelines, US

In 2002 in the US, the National Cancer Dialogue (now

C-Change) identifi ed an issue in researcher access to

biospecimen samples and established the Tissue Access

Working Group to explore the requirements for a National

Biospecimen Network (NBN). Extensive research was

conducted in 20038 on arrangements for the NBN, including

type of entity, funding arrangements, ethical considerations

and informed consent and best practice guidelines for:

biospecimen collection ▪

biospecimen processing, annotation, storage and ▪distribution

15

Figure 2 Operating structure for onCore UK

Board of Trustees / Directors:funding body representatives, lay-person representative,

independent chair person

CEO

Management Team

day-to-day operations

bioinformatics ▪

consumer/user needs ▪

business plan and operations ▪

privacy, ethical concerns and consent issues ▪

intellectual property and legal issues ▪

public relations, marketing and education. ▪

A summary of the NBN Guidelines is presented at

Appendix C.

National Cancer Institute guidelines, US

Subsequent to this research, in 2007 the National Cancer

Institute, in collaboration with the National Institutes

of Health and the US Department of Health and

Human Services, released best practices guidelines for

biorepositories, summarised in comparison to the NBN

guidelines at Appendix C.

Confederation of Cancer Biobanks guidelines, UK

In the UK, the Confederation of Cancer Biobanks developed

guiding principles for human research tissue banks/resources/

biobanks. The guidelines are summarised comparatively in

Appendix C.

The comparison of the guidelines from these three sources

alone highlights many similar themes for biobanking, especially

regarding informed consent, bioinformatics and appropriate

linkage of samples to clinical information.

Consensus points within these international guidelines

indicate that:

Samples (at least invasive samples) should be collected •

during the process of diagnostic or therapeutic

interventions and the sample assessed by a pathologist

to determine the amount required by diagnostic

pathology prior to the sample being stored in a bank for

research purposes.

Informed consent from donors is mandatory before •

samples can be included in the bank.

SOPs should be developed and staffed trained •

appropriately to promote consistency and quality of

samples. SOPs should be for all aspects of biospecimen

banking and specifi c to each sample type (eg blood,

tissue, DNA) and preservation method.

Samples need to be stored appropriately and with •

suitable back-ups in place should they be required.

Suitable tracking and retrieval methods of samples are •

required, including ‘shipping logs’ for distributed samples.


16

Banks need to be responsive to the needs of researchers •

and develop/implement new technologies as required.

Suitable bioinformatic systems need to be developed/•

implemented to allow privacy of samples to be

maintained, i.e. samples to be de-identifi ed at the

end-user.

4.5 International and Australian biobanking networks

4.5.1 Stakeholder and peak body networks

Stakeholder and peak body networks are formed when

multiple biobanks and/or biobank consortia collaborate to

discuss universal topics in the fi eld such as standard operating

procedures (SOP) for collection, storage, treatment and

shipping of bio-samples, ethics and informed consent

for donors and data/information storage and retrieval.

Although the stakeholder collaborations represent biobanks

and consortia, as an entity they are not biobanks and are

often unincorporated. Examples of stakeholder networks

internationally and within Australia include:

Confederation of Cancer Biobanks (CCB) in the UK. ▪

NCI Offi ce of Biorepositories and Biospecimen Research ▪(OBBR) in the US.

Australasian Biospecimens Network (ABN) in Australia. ▪

The generalised objectives of these collaborations are to:

provide a forum to share information and develop ▪educational materials on technical issues, regulatory

issues, and human subject and confi dentiality issues

develop and review consensus standards and best ▪practice guidelines for biobanks

promote transfer of knowledge and experiences ▪between banks

assist in developing regulations for biorepository ▪activities

develop new technologies/products to meet changing ▪user needs

provide information to users about existing repositories ▪and their collections through searchable databases.31–33

In addition, both the CCB and ABN have also developed

searchable specimen locators which researchers can use to

look for relevant biosamples from member organisations as

discussed below. Technically, the OBBR does not have this

function, however another NCI program, the NCI Specimen

Resource Locator (discussed below) does.

4.5.2 Specimen locator networks

Specimen locator networks enable researchers to search

multiple banks at one time (via a website) to identify if the

samples they require are currently available anywhere. An

example of this is the NCI specimen resource locator, which

enables researchers to search all the NCI affi liated biobanks

for samples by type of tumour, type of sample (eg blood,

DNA, normal matched) by preservation technique (eg fresh-

frozen, formalin fi xed, OCTi fi xed) and by data required

(e.g. demographic data, exposure history, family history and

laboratory data).32

Similar in concept to this is the Confederation of Cancer

Biobanks (CCB) Biosample Search Portal (UK) which enables

researchers to search for samples from the CCB member

banks by tumour type, sample type and diagnosis/broad

morphology. CCB members include:

CamUro-Onc Biorepository. ▪

Candis Cancer Tissue Bank Research Centre. ▪

Glasgow Biobank. ▪

Human Biomaterials Resource Centre. ▪

Northern Ireland Tumour Bank. ▪

onCore UK. ▪

Tayside Tissue Bank. ▪

UK DNA Banking Network. ▪

Wales Cancers Bank. ▪ 33

In Australia the Australasian Biospecimens Network (ABN)

provides a similar function to CCB by allowing researchers

to search ABN member banks for samples using the Tissue

Specimen Locator webpage. The samples can be searched

by primary cancer site, broad morphology and sample type.

ABN member banks include:

OCT fi xation is a type of preservation method used for tissue samples.i.

17

Peter MacCallum Cancer Centre Tissue Bank (Vic). ▪

Kathleen Cuningham Foundation Consortium for ▪research into Familial Breast cancer (kConFab)

(Australasian).

Children’s Hospital at Westmead (NSW). ▪

Westmead Gynaecological Oncology Tissue ▪Bank (NSW).

Queensland Institute of Medical Research (QIMR) Cell ▪Line Bank.

Western Australia Research Tissue Network. ▪ 34

Request for samples from all ABN members (except

kConFab) can now be completed through a standardised

application form (downloadable from the ABN website) and

submitted to the ABN hub for approval.34

The ABN is the main biospecimen locator network in

Australia and is currently funded by an NHMRC Enabling

Grant of $1.75 million over fi ve years (2004 to 2009). The

funding was shared between the seven founding member

banks and is approximately distributed as follows: 80 per cent

personnel, 10 per cent IT infrastructure/maintenance and 10

per cent other running costs. At this stage new members are

not asked to contribute fi nancially.35

This style of networking provides an easy and consistent

entry point for researchers and enables multiple banks to

be searched in one step. In addition, the ABN functions

as a forum to discuss common issues in biobanking, new

technologies, best practices and standard operating

procedures. This type of forum is likely to be invaluable in

the future of biobanking. Other stakeholder networks have

also been established, such as the Australian Prostate Cancer

Collaboration (APCC) which aims to promote collaboration

between all organisations researching prostate cancer. The

APCC has also established its own biobank with collection

nodes across Australia and is in the process of developing a

specimen locator for prostate cancer samples.


18

One of the main hurdles that had to be overcome to establish the consortium was a willingness of all banks to participate.

5 Australian governance arrangements

This chapter describes the Australian standards of

governance which businesses, including biobanks, should

adhere to. It also gives two examples of governance

structures established for biobanks in Victoria and Western

Australia and a data management and linkage system being

used for biobanking in Western Australia. Other types of

governance arrangements established by biobanks with

storage or collection sites in NSW are discussed in Chapter 6, which summarises the fi ndings from the telephone

interviews or email surveys of NSW biobanks.

5.1 Australian standards of governance

Information regarding best practice governance

arrangements can be obtained from the Standards Australia

Good Principles of Governance.36 Governance for biobanks

by a board of directors is in keeping with the Standards

Australia Good Principles of Governance, which state that

organisations (both for-profi t and non-profi t) should include:

defi ned roles, powers and responsibilities for the board

and board members; and defi ned and transparent codes

of conduct and reporting responsibilities. According to

Standards Australia, responsibilities of the board include:

strategic direction of the entity, with clearly documented ▪objectives

approve all major decisions ▪

approval of budgets and other performance indicators ▪

compliance with applicable laws and regulations ▪

appropriate risk identifi cation and mitigation strategies ▪

ensuing appropriate policies are in place and adhered to ▪

appointment and evaluation of performance of a chief ▪executive offi cer (CEO).36

In general, the board should ensure that collectively it has

the appropriate level of skills and experience (operational

and technical) required to fulfi l its responsibilities and board

members should be independent of management to avoid

(where possible) confl icts of interest.36

Standards Australia also comments on non-profi t

organisations, which are generally incorporated associates

or companies limited by guarantee. An important distinction

in this sector is between member-serving and community-

serving organisations. The distinction between the two can

be diffi cult, but generally member-serving organisations

designate the rights of members, e.g. voting rights or rights

to services. However, for community-servicing organisations,

defi ning the groups and/or types of membership can be

more diffi cult and may cover, for example, donors, other

supports, members by application, members by invitation,

governments and service recipients. In this case, each

membership type may enjoy different entitlements.36

5.2 Victorian Cancer Biobank

The Victorian Cancer Biobank (VCB) is a Victorian

State Government (Department of Innovation, Industry

and Regional Development) funded project to improve

coordination between biobanks in Victoria and to improve

researcher access. The VCB has been established as a not for

profi t organisation, hosted by the Cancer Council Victoria.

Table 1 shows the fi nancial status of the VCB for 2006 and

2007, which shows that the majority of the $4m funding over

two years has gone to research grants and associated costs

(over $2.5m). It should also be noted that the VCB spent

$38,000 in 2007 (approximately two per cent of the years

funding) on advertising, printing and promotional activities

to promote the use of the biobank and raise awareness with

researchers.

5.2.1 Organisation and Governance

The VCB is a consortium of the four major biobanks in

Victoria (Peter McCallum Cancer Centre, Melbourne Health,

Austin Health and Southern Health). These four biobanks

had been independently established as formalised biobanks,

each with multiple collection sites but one major storage site

(depicted in Figure 3).

19

Table 1 Financial status of the VCB 2006 and 2007

2007 (Jan to Dec) $’000 2006 (Jan to Dec) $’000

Income

DIIRD Grant 1,800 2,200

Other 1 -

Total 1,801 2,200

Expenditure

Grants and other research costs 1,084 1,583

Payroll and staff expenditure 178 13

Advertising 38 -

Other 83 27

Total 1,383 1,623

Surplus

Net surplus for the year 418 577

Balance of surplus to carry forward 995 577

As a consortium the four individual banks are governed as a

single entity, hosted by the Cancer Council Victoria

(Figure 4).

Each biobank in the consortium has a tissue bank steering

committee and/or management committee responsible for

the day to day operations of the banks, including hiring of

staff, fi nancial management, equipment and infrastructure

management and management of the relationships with

collection sites. Ethics approval for tissue collection and the

consent process has been established by the Hospital Ethics

Committee of the main sites of the four biobanks.

Overall, the consortium is governed by the Consortium

Committee which set the strategic directions for the

consortium. Underneath this is central operations

responsible for oversight of the four biobanks including input

in to strategic directions, setting SOPs, development of a

business plan, budgeting and expenditure and overall fi nances

of the consortium. Alongside is the Tissue Bank Managers

Advisory Group, which is responsible for implementing the

business plan.

Other sub-committees include the Access Committee

responsible for approving tissue sample requests and the

Informatics Committee responsible for data collection/

linkage operations and software development.

5.2.2 Benefi ts and hurdles

There were several hurdles to overcome in order to

establish such a consortium, but the benefi ts are perceived

to outweigh the negatives. By operating as a consortium the

benefi ts to researchers include:

Improved access to tissue samples for researchers ▪because researchers can now apply through one central

application to access the four main biobanks (and the

sub-collection centres) in a standardised process.

Removal of potential bias for biobanks to prioritise ▪internal researchers over external researchers, and

ensuring specimens are available to all researchers in

Victoria, Australia and internationally without bias.

Increase in availability of rare or hard to get samples ▪because researchers now have access to the whole of

the Victorian specimen collection in one application.

An example of this is the collection of fresh tissue

samples which can be diffi cult to obtain and to deliver to

researchers as a fresh sample.

The VCB has been able to give funding to the biobanks ▪for a pathology registrar (one at each bank) through

the grant funding of the consortium to recognise the

demand on pathology services.


20

Figure 3 VCB Biobanks and Collection Sites

21

Figure 4 VCB governance arrangements

‘Previously, access to biospecimens was only from one or two

hospitals involved in the research project. Now, through the

Biobank Consortium, collection is from multiple sites and I

have access to a wider network.’

Cancer Researcher, Peter MacCallum Cancer Centre, from

VCB Newsletter, BioBank Brief, April 2008

One of the main hurdles that had to be overcome to

establish the consortium was establishing a willingness of all

banks to participate based on the benefi ts to the researcher.

Reluctance to participate often stemmed from the

perception of having to ‘give up’ their samples and a loss

of control over their bank. This was overcome by

maintaining the existing management of day-to-day practices

and the inclusion of biobank representatives in higher

management committees.

5.2.3 Standard operating procedures and bioinformatics

In order to establish consistency across the four biobanks,

the VCB has developed standard operating procedures

(SOPs) covering all four banks. The SOPs were based on

ISBER standards. Despite having the SOPs, there is still a

need to monitor the procedures of individual banks from

time to time as there can be drift (eg for minimum

data collection).

Each of the biobanks has their own individual identifying

number system to identify samples and to link to data.

Currently each site has data systems for this purpose, with

a shared minimum data set. However, the VCB are planning

to move to a centralised database system. The system will

collect basic information (minimum data set) on the sample

and patient, and will use the BioGrid Australia Cancer Data

Linkage system43 to link to follow up data and outcomes data.

5.2.4 Researcher access

Currently the VCB advertise the biobank consortium

through: their website, which includes a page for prospective

donors as well as researchers; directed marketing campaigns,

e.g. media reports (television, radio, newspaper); and

quarterly newsletters circulated to all cancer researchers in

Victoria. The VCB also produce an annual report detailing

highlights and future direction, governance arrangements,

milestone progress and funding arrangements.


22

In addition, at least one of the four biobanks (Peter

MacCallum Cancer Centre) is a member of the Australasian

Biospecimen Network (ABN), enabling researchers to search

for specimens on line through the biospecimen locator. VCB

is also in the process of creating their own biospecimen

locator program to enable researchers to search across all

collection sites for all samples housed in one shot. Marketing

appears to be an important component of the consortium

business plan to let researchers know about the banks and

the samples collected to ensure maximum usage of

the system.

5.2.5 Cost recovery

VCB charge a cost recovery fee for samples. This is based

on a three tiered set up. There are two tiers for academic

research, with those organisations providing ‘in kind support’

receiving a bit of a discount and the highest cost being

charged to commercial research.

The service areas of the tissue collection, processing and

storage process have been broken down into modules for

costing units. This enables researchers to purchase different

sections of service and be charged accordingly, for example in

clinical trials where the company may only want/need certain

aspects of service such as collection and processing because

they have obtained their own consent for the study.

Cost recovery only equates to approximately 20 per cent of

the actual cost of the biobanking process.

5.3 Biobanking in Western Australia

5.3.1 Biobanks within pathology departments

A new model of biobanking that has emerged in Western

Australia (WA) is to extend the capacity of pathology

department services. This model has been established by Dr

Nikolajs Zeps at St John of God Pathology, associated with

St John of God Health Care in Western Australia. St John of

God Health Care is a Catholic, non-profi t organisation and is

one of the largest health care and pathology providers

in WA.37,38

Originally, Dr Zeps and his team established the Western

Australian Research Tissue Network (WARTN). WARTN

was established as a biobank consortium for WA through

a translational research collaboration between the School

of Surgery, University WA and Radiation Oncology

Department, Sir Charles Gairdner Hospital, and was the

fi rst statewide biobank consortium established. WARTN

experienced some diffi culties however, including lack of

interest by surgeons in biobanking and lack of pathology

resources to aid in occasional banking activities as required.

The perception of the biobanking activities as an add-on

to traditional pathology services also resulting in large and

unsustainable fi nancial costs.37 Therefore the Zeps team

considered a different approach. Moving away from housing

the biobanking under the research arm, the team established

the biobank within the Pathology Department of St John

of God Pathology (which has 43 collection centres across

Perth and regional WA). This new project is a collaboration

between St John of God Pathology and the St John of God

Colorectal Service.37

This model required a shift in the routine preparation of

samples by pathology to include fresh frozen samples and

some molecular testing, as well routine paraffi n embedding.

There were many benefi ts noted from this model of

biobanking, such as:

(1) Staff attitude:

The perception of pathologists that they were being ▪asked to undertake additional ad hoc procedures was

removed by installing a set of new routine procedures

in pathology.

Increased pathology staff attention and interest through ▪increased role variety and responsibility.

(2) Reduced costs: Costs associated with processing

and storing the samples were reduced as it was no longer an

additional service provided by pathology (and hence charged

at the full rate), but a routine procedure factored into

pathology costs (hence costs were only staff time

and consumables).

(3) Increased sample collection: As all tissue samples

are processed through pathology for diagnostic processes,

housing the biobank within pathology results in all possible

samples being identifi ed by the biobank.ii With this, good

Samples are often missed when the biobank is separate from pathology as the biobank staff are reliant on information from, and hence ii.

good relationships with, the surgeons and pathology staff.

23

relationships with surgeons collecting samples are maintained.

(4) Improved diagnostic results: Improved molecular

test results for diagnostic purposes as fresh frozen samples

rather than paraffi n embedded samples could be used.37

One potential issue arising with this model of biobanking

is that in Australia it has only been tested to date with

high volume tumours (e.g. colorectal, breast and prostate).

Inclusions of other more rare tumours may increase costs.

In addition, the SOP for the freezing of fresh tissue does

not currently require immediate freezing after surgery. If

immediate freezing was required for other tumour types

this would also increase costs of staff time, as someone

would need to collect the sample from the surgery room

immediately after it was removed during the surgery.37

(Note that an alternative approach may be to position liquid

nitrogen canisters in the surgical theatres to ensure that the

specimens are snap frozen without delay. This procedure

is used for specimen collection from private hospitals

associated with the Kolling NeuroEndocrine Tumour Bank

(see Section 7.5.5), where biobank staff are not available

onsite for immediate specimen collection).

Consent processes

Consent for biobanking of tissues removed during surgery for

future research has been included on the standard surgery

form at the St John of God hospitals participating to prevent

duplication of this process (traditionally, biobank personnel

would collect consent from patients post surgery if there was

enough sample remaining post diagnostic testing).37

Standard Operating Procedures and Quality Assurance

Being a part of the pathology department, the SOPs are

a part of a NATA accredited facility and are based on

international quality assurance protocols.39

Cost recovery and measures of success

As a part of the pathology department with only incremental

increases to pathology costs, the biobank has been funded

as a standard protocol within the pathology department.

As such, there is no need for the biobank to request fees

for samples from researchers. Instead, the biobank requires

from researchers, the following as a measure of ‘success’ and

methods of sustainability:

Researchers must include the biobank as an 1.

acknowledgement (at least) or collaborator on any

publication resulting from research with the samples

(there have been three collaborative publications

this year).

The biobank may request that, once published, the 2.

data from the research is to be made available to other

researchers through inclusion in the biobank database.37

Other examples of pathology based biobanking

This model of biobanking through pathology departments

has been used successfully internationally, for example the

Spanish National Cancer Research Centre (CNIO) Tumour

Bank Network (TBN).18

There are also examples of the use of pathology

departments in biobanking within NSW. For example,

the tumour bank at Children’s Hospital in Westmead,

although established through and funded under the research

department, has close collaborations with the pathology

department. In this example, the pathology department

process and store all samples for the biobank. Biobank staff

are then able to collect consent for use of the samples from

the patients/parents and store those consented to in the

biobank for future use. The close relationship with pathology

ensures that all possible samples are examined for use in

biobanking and that good relationships are maintained with

the surgeons who collect the samples.

‘It cannot be more strongly emphasised that tumour banking is

a team effort which is heavily reliant on the surgeons and their

persistence in training their staff (e.g. interns and registrars) to

help the laboratory staff.’

Comment made by biobank head in NSW.

5.3.2 Data management tools and linkages

An important aspect of biobanking is the clinical data that

accompanies samples and the management of the data and

tracking of samples. This becomes particularly important as


24

the biobank grows in size and sample numbers; and merges

or collaborates with other banks.

Traditionally, biobanks have developed internal databases

for the collection of related data and tracking of sample

locations, which are often outgrown by the expansion of the

biobank. In WA however, a new service has been developed

by the Western Australian Genetic Epidemiology Resource

(WAGER) to provide laboratories (including biobanks) with

Laboratory Information Management Systems (LIMS).40,41

The LIMS allow researchers to store and manage clinical

and other information collected for research or biobanking

purposes. If the information is associated with tissue samples,

the location of the samples can also be tracked (to specifi c

freezer boxes within freezers) and monitored for volume

and use. Data can be uploaded into the LIMS via a secure

and encrypted webpage only accessible to members of the

WAGER LIMS once their account is activated (researchers

are sent a program to load onto their computers to allow

access to the webpage). Data is then stored in a highly secure

and reliable, purpose built data bank located at the University

of Western Australia. Data stored through WAGER is still

‘owned’ by the individual researcher and access to the data is

at the discretion of the researchers.41

Other functions of WAGER are data extraction and

analysis tools and study support. WAGER does not charge

researchers to become members for use of LIMS or these

tools, nor to access data through WAGER. Other services

that WAGER are developing, such as statistical help for

research studies, are charged a nominal amount for WAGER

staff time.40,41

WAGER does ask however, that researchers using their

service acknowledge WAGER in any publications resulting

from access to the WAGER informatics resource. To date

there have been more than 230 publications acknowledging

WAGER.40,41

Data linkage

Another benefi t to researchers using WAGER for data

management is the agreement between WAGER and the

Western Australian Data Linkage System (WADLS) of the

WA Health Department.42 WADLS enables linkage of WA

population health data collections and other external data

sets by assigning a unique identifi er to each subject based

on demographic information (e.g. name, sex, date of birth,

address) in each data set to be linked. Information and data

are not stored in WADLS; it is just a mechanism to link

various data sets.

Linkages to other data sets can be facilitated through

WAGER based on the agreement between WAGER and

WADLS. WAGER itself however cannot link data sets,

therefore two studies both using WAGER to manage data

will still need to be linked through WADLS as required. In

relation to biobanking however, biobanks using WAGER to

manage their data could use the subject linkages generated

through WADLS to obtain follow-up and other clinically

relevant data based on WA population health data sets.41

There are many research projects that use WAGER to track

and manage tissue samples and information, but not many

of these are actual biobanks, rather specimen collections.

There is a DNA Biobank that uses WAGER and the St John

of God Pathology biobank (and before that the WARTN)

use WAGER to manage data and also submits information

to WADLS via the Cancer Registry of WA. This process is

facilitated through WAGER.37,41

Other data linkage systems that have been developed

in Australia are BioGrid Australia,43 which is currently

developing the Australia-wide Cancer Grid (funded by

the Department of Innovation, Industry and Regional

Development, Victoria) to allow tracking of patient

information across many tumour types and hospitals across

Australia; and the Centre for Health Records Linkage

(CheReL),44 a NSW initiative that creates links between

health databases based on subjects demographic details

(e.g. name, date of birth and address). Similar to WADLS,

CHeReL does not provide access to the data sources, only

a link between data sources which researchers/clinicians can

then use to match data.

Although no large scale population-based epidemiological

biobanks are established in Australia to date, the use of data

linkage systems, such as those described above, can add

greatly to the depth of epidemiological research that can

be undertaken.

25

6 Biobank locations in New South Wales

Most biobanks relating to cancer research were for specifi c cancer types rather than a generalist approach.

6.1 Biobank locations in New South Wales by geographic hub

The results of identifying biobanks in NSW (Table 2)

showed that:

The existing banks or collection nodes cover a range of ▪cancer/tumour types, such as: breast (x4); lymphoma and

leukaemia (x3); colorectal (x3); skin cancer (x2); neuro-

endocrine and brain (x3); gynaecological (x2); myeloma

(x1); prostate (x1); pancreas (x1); gastro-intestinal (x1);

paediatric (x2); sarcoma (x1).

The majority of banks/collections collected samples from ▪one (30 per cent) or two (30 per cent) geographical

sites. The most collection sites currently for any one

bank was eight (Children’s Cancer Institute Australia

Tissue Bank) and six (Australian Breast Cancer Tissue

Bank). Four banks collected from three sites (17 per

cent) and four were unconfi rmed (17 per cent). Several

commented that they are in the process of seeking ethics

approval from other sites with the aim of expanding the

number of collection centres for the bank.

One bank collected samples from Australian states ▪outside NSW (Australasian Brain Tumour Bank

collects from NSW and Western Australia) and one

bank collected samples from Australia and overseas

(Children’s Cancer Institute Australia Tissue Bank collects

from NSW, Queensland, Victoria, South Australia,

Tasmania and New Zealand).

The majority of the individual banks/collections were ▪identifi ed in the Northern Sydney hub (33 per cent).

Most biobanks relating to cancer research were for specifi c

cancer types rather than a generalist approach (the notable

exceptions to this were banks related to childhood cancers).

Despite several of the banks having multiple collection sites,

there were still some instances of multiple individual banks

covering the same tumour types.

A summary of the biobanks and specimen collections

identifi ed in NSW by geographic hub are presented in

Table 2 and Table 3.


26

Table 2 Biobanks in NSW by geographic hub

# Name of Tissue Repository Tumour type(s) Central Location

Tissue Storage Nodes

Collection Sites

Central Sydney

1 Sydney Melanoma Unit Bio-

Specimen Bank

Any skin cancer, with

majority melanomas

RPAH RPAH

(Anatomical

Pathology)

RPAH; Mater Hospital; Ethics

approval being sought at other

sites

Darlinghurst

2 Australian Prostate Cancer

BioResource, NSW Node

Prostate Garvan Institute

of Medical

Research

Garvan Institute

of Medical

Research

St Vincent’s Hospital

3 South Western Sydney

Colorectal Tissue Bank

Colorectal Garvan Institute

of Medical

Research

Garvan Institute

of Medical

Research

Liverpool and Bankstown

Hospitals 2000 – 2003

4 NSW Pancreatic Cancer

Network Tissue Bank

Pancreas Garvan Institute

of Medical

Research

Garvan Institute

of Medical

Research

Kolling Institute

of Medical

Research

Bankstown Hospital; RNSH

5 Colorectal Cancer Tissue Bank Colorectal Integrated

Cancer

Research,

UNSW

Garvan Institute

of Medical

Research

St. Vincent’s Hospital

Northern Sydney

6 Breast Cancer Tissue Bank,

Kolling Institute(distinct from

storage node for WMI Breast

Cancer Tissue Bank, also at

Kolling Institute)

Breast Kolling Institute

of Medical

Research

Kolling Institute RNSH; RNS Private; Mater

7 Gynaecological Tissue Bank,

Kolling Institute

Gynaecological Kolling Institute

of Medical

Research

Kolling Institute RNSH; RNS Private; Mater

8 Upper GI Tissue Bank (including

pancreatic tissue bank), Kolling

Institute

Upper GI including

pancreas

Kolling Institute

of Medical

Research

Kolling Institute RNSH; RNS Private

9 NeuroEndocrine Tumour Bank,

Kolling Institute

Neuroendocrine including

low grade brain tumours,

pituitary tumours, CNS

tumours, brain metastases

Kolling Institute

of Medical

Research

Kolling Institute RNSH; RNS Private

10 Australasian Brain Tumour Bank High grade brain tumours Kolling Institute Kolling Institute RNSH; RNS Private; WA

collection partner in 2008 with

planned roll-out to other sites

27

Table 2 Biobanks in NSW by geographic hub (cont’d)



Collection Sites

Western Sydney

11 Breast Cancer Tissue Bank Breast Westmead

Millennium

Institute

(management

hub)

Westmead

Millennium

Institute

RPAH

(Anatomical

Pathology)

St Vincent’s

RNSH (Kolling

Institute)

John Hunter

Port Macquarie

(Symbion

Pathology)

Listed Storage nodes; NSW

Breast Cancer Institute

12 Westmead Gynaecological

Tissue Bank

Gynaecological tissue

including ovarian, uterian,

perinatal, cervix, fallopian

tube, appendix (when

thought to be ovarian).

Some colorectal samples

from St Vincent’s Hospital.

Westmead

Millennium

Institute

Westmead

Millennium

Institute

Westmead Hospital; (some

colorectal samples from St

Vincent’s Hospital)

13 Children’s Hospital Westmead

Tumour Bank

57 types of paediatric

tumour specimens.

Children’s

Hospital

Westmead

Children’s

Hospital

Westmead

Children’s Hospital Westmead

Randwick

14 Children’s Cancer Institute

Australia Tissue Bank

Acute leukaemia (for

specifi c trials); other

childhood cancers including

neuroblastoma, solid

tumour of varying types,

NHL and acute myeloid

leukaemia.

Children’s

Cancer Institute

Australia

Children’s

Cancer Institute

Australia

Westmead; Sydney Children’s

Hospital; Royal Children’s,

Melbourne; Royal Children’s,

Brisbane; Women and

Children’s, Adelaide; John

Hunter Hospital; Royal

Hospital, Hobart; Starship,

Auckland; Wellington Hospital;

Christchurch Hospital

15 Brain Tumour Bank Brain tumours Prince of Wales

Private Hospital

Prince of Wales

Private Hospital

Prince of Wales Private

Hospital

16 Surgical Oncology Group

Sarcoma Tumour Bank

Sarcoma Prince of Wales

Hospital

Prince of Wales

Hospital

Prince of Wales Hospital;

Canberra Hospital


28

Table 3 Specimen Collections in NSW by geographic hub

# Formal Bank or Specifi c Collection(s)

Tumour type(s) Central Location Tissue Storage Nodes Collection Sites

Central Sydney

18 In planning Lymphoma and

leukaemia

RPAH - planned Planned storage site

at Centenary Institute

adjacent to RPAH

RPAH - planned

19 Specimen collection(s) Mostly multiple myeloma RPAH RPAH Haematology

Laboratory

RPAH

20 In planning Bladder Concord Hospital Concord Hospital

(Anatomical Pathology)

Unconfi rmed

Darlinghurst

21 Specimen collection(s) Breast Garvan Institute of

Medical Research

Garvan Institute of

Medical Research

St Vincent’s Hospital

RPAH

Northern Sydney

22 Specimen collection(s) Breast Mater Hospital Mater Hospital Mater Hospital

Western Sydney

23 Specimen collection Mostly acute leukaemias Westmead Millennium

Institute

Westmead Millennium

Institute

Westmead Hospital

Children’s Hospital

Westmead

Concord Colorectal Tumour Bank and the John Hunter and Calvary Mater hospitals in Newcastle were not able to be surveyed to know if there is a

formal biobank or specimen collection.



Collection Sites

Other NSW

17 The Cancer Council NSW Blood specimens from

individuals with any non-

melanoma skin cancer

(specifi c studies).

Blood specimens related to

other specifi c studies.

The Cancer

Council NSW

The Cancer

Council NSW

Several

Table 2 Biobanks in NSW by geographic hub (cont’d)

29

7 Biobank governance in New South Wales

The biobanks investigated in NSW presented a mix of single and multicentre collection and/or storage sites.

This chapter discusses the fi ndings of the governance survey

of formal biobanks. Table 9.3 at Appendix D presents a

summary of the fi ndings for each of the formal

biobanks interviewed.

7.1 Biobank general characteristics

Table 4 outlines general characteristics of biobanks surveyed

in Phase 1 and/or Phase 2 of the study, including their year

of establishment, specimen source site(s) and total numbers,

donor numbers and researcher access. The table highlights

the following characteristics of existing tumour banks

in NSW:

Almost all biobanks surveyed in NSW were established 1.

in the last decade, with the majority of these started in

the past two–fi ve years.

Funding for the biobanks is generally from grants, and 2.

ranges from less than $100,000 to over $2,000,000.

Further details regarding tissue bank funding sources and

entity status are discussed in Section 7.3.

Sites from which tumours are collected are dependent 3.

on the nature of the tumour collection or the source

population. For example, biobanks may collect site

specifi c tumours such as breast or prostate, may collect

tissue from various tumour sites due to the nature of

the cancer such as sarcoma, or collect from multiple

tumour sites due to the nature of the population such as

paediatric biobanks.

Numbers of specimens and contributing donors to date 4.

and by month varies greatly and is dependent on tumour

type and incidence, as well as whether the bank collects

from single or multiple sites. Donors per month ranges

from 1.5 in the Surgical Oncology Group Sarcoma

Tumour Bank at Prince of Wales (POW) Private

Hospital to 65 in the Breast Cancer Tissue Bank based

at Westmead Millennium Institute, which has several

collection and storage nodes.

The APCC BioResource, Breast Cancer Tissue Bank 5.

(Westmead), Westmead Gynaecological Tissue Bank

and the CHW Tumour Bank are all formalised banks

with specimens available to all Australian researchers

based on appropriate approvals and some priority

access policies (see Section 7.6.1). Other banks have

historically only provided specimens to local researchers

or their collaborators, and do not have formalised

researcher access policies. Other banks, such as the

NSW Pancreatic Cancer Network Tumour Bank, have

restricted access to members of the NSW Pancreatic

Cancer Network, as there are insuffi cient specimens and

staff to allow requests beyond this.

Several banks indicated that they have rare specimens in

limited supply. These are listed in Table 5.

Some biobanks have developed collaborations to facilitate

the collection of rare specimens. For example, the Kolling

Institute NeuroEndocrine Tumour Bank has developed

collaborations both with internal professorial medical/

surgical staff and staff at other institutions in Australia and

New Zealand to collect and store rare specimens within the

Kolling biobank.


30

Tab

le 4

Curr

ent

Stat

us

of N

SW

Bio

ban

ks (

Oct

ober

2008)

Bio

bank

Nam

eYe

ar

esta

b.Fu

ndin

g si

nce

ince

ptio

nFu

ndin

g so

urce

s (p

revi

ous

and

curr

ent)

Spec

imen

sou

rce

site

(s)

Tota

l no.

sp

ecim

ens

Tota

l co

ntri

butin

g do

nors

App

rox.

no.

of

don

ors

/ m

onth

Gen

eral

a or

rest

rict

ed

rese

arch

er a

cces

s

Sydney

Mela

no

ma

Unit B

io-S

peci

men

Ban

k

2007

Par

t of gr

ant

fundin

g fo

r

multip

le p

roje

cts

CI N

SW

Tra

nsl

atio

nal

Pro

gram

Gra

nt;

NH

MR

C P

rogr

am

Gra

nt

Pri

mar

y m

ela

no

ma;

meta

stat

ic

mela

nom

a; n

on-m

ela

nom

a sk

in

lesi

ons

213

b658 (

those

donat

ing

blo

od

sam

ple

)

60-8

0 b

lood

20-3

0 t

issu

e

Pri

ori

ty a

ccess

to

those

ass

oci

ated

with S

MU

or

colla

bora

tors

Aust

ralia

n

Pro

stat

e C

ance

r

Bio

Reso

urc

e (4

Aust

nodes

incl

Gar

van)

2005

Ove

r $2.5

MPro

stat

e C

ance

r

Foundat

ion

Aust

ralia

;

Cm

mo

nw

eal

th

Ban

k; A

ndro

logy

Aust

ralia

;

NH

MR

C E

nab

ling

Gra

nt

Pro

stat

e4,2

72

c1,

487

45-5

0G

enera

l

South

West

ern

Sydney

Colo

rect

al

Tum

our

Ban

k

2000

Unkn

ow

n

(his

tori

cal

speci

mens

only

)

CI N

SW

Car

eer

Deve

lopm

ent

Fello

wsh

ip

Colo

rect

al~

1,200

d403

n/a

Rest

rict

ed

NSW

Pan

creat

ic

Can

cer

Netw

ork

Tum

our

Ban

k

2002

Ove

r $500K

Var

ious

(not

liste

d)

Pan

creas

2,3

00

e 300

(pro

spect

ive,

non-a

rchiv

al

speci

mens)

40-4

5R

est

rict

ed t

o

mem

bers

of

NSW

Pan

creat

ic

Can

cer

Netw

ork

Inte

grat

ed

Can

cer

Rese

arch

Colo

rect

al C

ance

r

Tis

sue

Ban

kf

1993

Genera

l

labora

tory

fundin

g

Genera

l

labora

tory

fundin

g

Colo

rect

alR

est

rict

ed

Genera

l acc

ess

refe

rs t

o s

peci

mens

bein

g av

aila

ble

to a

ll A

ust

ralia

n r

ese

arch

ers

, with s

om

e ban

ks t

hen h

avin

g pri

ori

ty a

ccess

sch

em

es

(i.e

. pri

ori

ty a

ccess

for

those

invo

lved

a.

in s

peci

men c

olle

ctio

n o

r th

eir c

olla

bora

tors

).

Exc

ludin

g blo

od a

nd b

lood p

roduct

s. T

ota

l speci

mens

incl

udin

g blo

od a

nd b

lood p

roduct

s is 8

71.

b.

Exc

ludin

g blo

od a

nd b

lood p

roduct

s. T

ota

l speci

mens

incl

udin

g blo

od a

nd b

lood p

roduct

s is 4

8,6

91.

c.

H

isto

rica

l speci

mens

only

, curr

ently

no p

rosp

ect

ive

colle

ctio

n.

d.

In

cludin

g 2000 a

rchiv

al s

peci

mens.

e.

C

onduct

ed P

has

e 1 s

urv

ey o

nly

so d

ata

rega

rdin

g sp

eci

men a

nd d

onor

num

bers

not

avai

lable

.f.

Tota

l for

3 K

olli

ng

Inst

itute

Tum

our

Ban

ks in

cludin

g B

reas

t C

ance

r, U

pper

GI an

d G

ynae

colo

gica

l.g.

D

eta

ils for

this b

ank

refe

r to

the

Neuro

co

mponent

of th

e Kolli

ng

Neuro

Endocr

ine

Tum

our

Ban

k w

hic

h in

corp

ora

tes

the

Aust

rala

sian

Bra

in T

um

our

Ban

k.h.

31

Bio

bank

Nam

eYe

ar

esta

b.Fu

ndin

g si

nce

ince

ptio

nFu

ndin

g so

urce

s (p

revi

ous

and

curr

ent)

Spec

imen

sou

rce

site

(s)

Tota

l no.

sp

ecim

ens

Tota

l co

ntri

butin

g do

nors

App

rox.

no.

of

don

ors

/ m

onth

Gen

eral

a or

rest

rict

ed

rese

arch

er a

cces

s

Kolli

ng

Bre

ast

Can

cer

Tum

our

Ban

k

2003

~$700K

g

CI N

SW

; Can

cer

Counci

l (ST

REP);

NBC

F; N

HM

RC

;

RN

SH

Key

Can

cer

Are

ac

Bre

ast

Not

pro

vided

162

40-5

0

Has

only

been

loca

l rese

arch

ers

and c

olla

bora

tors

to d

ate

Kolli

ng

Upper

GI

Tum

our

Ban

k

Mid

1990s

Pan

creas

; liv

er;

bile

duct

/

chola

ngi

o; g

astr

ic; o

eso

phag

us

Not

pro

vided

297

Kolli

ng

Gyn

aeco

logi

cal

Tum

our

Ban

k

2003

Ova

ries; e

ndo

metr

ium

; cerv

ix;

vulv

a

Not

pro

vided

153

Kolli

ng

Neuro

Endocr

ine

Tum

our

Ban

k

1992

$30K+

Andre

w O

lle

Mem

ori

al T

rust

;

Sydney

Neuro

-

Onco

logy

Gro

up; C

INSW

est

ablis

hm

ent

gran

t

Adre

nal

; par

athyr

oid

; thyr

oid

;

mis

cella

neo

us

endo

crin

e

2,3

07

1,990

13-2

2

Aust

rala

sian

Bra

in

Tum

our

Ban

kk

2004

Bra

in a

nd C

NS: g

liom

as;

menin

gio

mas

; meta

stas

es;

pituitar

y ad

eno

mas

; oth

er

tum

ours

of C

NS

885

841

20-2

5

Bre

ast

Can

cer

Tis

sue

Ban

k

2006

Ove

r $2.5

MN

HM

RC

; NBC

F;

CI N

SW

Bre

ast

20,5

00

1,270

65

Genera

l

West

mead

Gyn

aeco

logi

cal

Tis

sue

Ban

k

1992/3

$100-5

00K

NH

MR

CO

vari

es; p

eri

toneum

; fal

lopia

n

tube; u

teru

s; c

erv

ix; c

olo

rect

al;

unkn

ow

n

518

507

8-1

0G

enera

l

Tab

le 4

Curr

ent

Stat

us

of N

SW

Bio

ban

ks (

Oct

ober

2008)

(cont’d)


32

Bio

bank

Nam

eYe

ar

esta

b.Fu

ndin

g si

nce

ince

ptio

nFu

ndin

g so

urce

s (p

revi

ous

and

curr

ent)

Spec

imen

sou

rce

site

(s)

Tota

l no.

sp

ecim

ens

Tota

l co

ntri

butin

g do

nors

App

rox.

no.

of

don

ors

/ m

onth

Gen

eral

a or

rest

rict

ed

rese

arch

er a

cces

s

Child

ren’s H

osp

ital

West

mead

Pae

dia

tric

Tum

our

Ban

k

1998

Ove

r $500K

Benevo

lent

benefa

cto

rs;

Dept

of H

eal

th;

NH

MR

C E

nab

ling

Gra

nt; C

I

NSW

Rese

arch

Infr

astr

uct

ure

Gra

nt; O

nco

logy

Child

ren’s

Foundat

ion

ALL; A

ML; C

ML; a

cute

leuka

em

ia o

ther;

car

cino

ma

vari

ous; a

dre

nal

tum

our

(oth

er)

;

bra

in t

um

our;

rar

e benig

n

tum

our;

Ew

ing’

s sa

rco

ma;

sarc

om

a oth

er;

neuro

bla

sto

ma

and v

aria

nts

; germ

cell

tum

our;

hae

mat

olo

gica

l oth

er;

hepat

obla

sto

ma;

lym

pho

ma;

his

tiocy

tosi

s; r

enal

; sch

wan

nom

a;

ost

eosa

rco

ma;

peri

phera

l

neuro

ect

oderm

al t

um

our;

retino

bla

sto

ma;

rhab

dom

yosa

rcom

a

Not

pro

vided

2,4

70

10G

enera

l

Child

ren’s C

ance

r

Inst

itute

Aust

ralia

Tum

our

Ban

k

2000

2 x

$10

0-5

00K

Inte

rnal

Bone

mar

row

; peri

phera

l blo

od

~77,

000

~5,0

00

50

So

me

rest

rict

ed

to c

linic

al t

rial

s

Bra

in T

um

our

Ban

k

Pri

nce

of W

ales

Pri

vate

2002

Unkn

ow

n

Char

itab

le fundin

gB

rain

tum

ours

100

100

Not

report

ed

Unkn

ow

n

Surg

ical

Onco

logy

Gro

up S

arco

ma

Tum

our

Ban

k,

Pri

nce

of W

ales

Pri

vate

2000

n/a

(in

tern

al

fundin

g)

Inte

rnal

fundin

gSar

com

a80

80

1.5

Unkn

ow

n

Can

cer

Counci

l

NSW

2006

n/a

(in

tern

al

fundin

g)

Inte

rnal

fundin

gB

lood fro

m p

atie

nts

with a

ll

cance

r ty

pes

plu

s co

ntr

ols

~900

~900

50

Rest

rict

ed

Tab

le 4

Curr

ent

Stat

us

of N

SW

Bio

ban

ks (

Oct

ober

2008)

(cont’d)

33

Table 5 Specimens in rare supply

Biobank Name Rare specimens in limited supply

Sydney Melanoma Unit Bio-Specimen Bank Primary melanomas.

NSW Pancreatic Cancer Network Tumour Bank All; plus some rare non-ductal neoplasms.

South Western Sydney Colorectal Tumour Bank All rare.

Kolling Endocrine Tumour Bank Medullary thyroid carcinomas; phaeochromocytomas;

adrenocortical carcinomas.

Kolling Neuro Tumour Bank (incl ABTB) Low grade gliomas (grade II astrocytomas, grade II

oligodendrogliomas); anaplastic astrocytomas; pituitary adenomas and

carcinomas.

Breast Cancer Tissue Bank Some specifi c subtypes of breast cancer in proportion to their

incidence in the patient population.

Westmead Gynaecological Tissue Bank Primary fallopian tube serous adenocarcinoma; primary ovarian

mucinous adenocarcinoma, granulose cell tumour, malignant mixed

mullerian tumour, immature teratoma; primary uterus placental site

trophoblastic tumour; primary cervical melanoma.

Children’s Hospital Westmead Paediatric Tumour Bank All rare.

Children’s Cancer Institute Australia Tumour Bank Stage 4 neuroblastoma.

Surgical Oncology Group Sarcoma Tumour Bank,

Prince of Wales Private

All rare.

7.2 Biobank design

7.2.1 Patient consent and types of specimens collected

Each of the formal biobanks reported that they gain patient

consent for broad, as yet unspecifi ed future research.

Specimens at most biobanks can also be collected for specifi c

research projects on request, given appropriate approvals.

This means that as long as collection/processing/storage

procedures are comparable between institutions and over

time, researchers should be able to utilise tissue from several

repositories in research projects without having to seek

additional patient consent for each project.

Some banks consist partly or solely of historical specimens

(e.g. South Western Sydney Colorectal Tumour Bank

contains historical samples only, and Sydney Melanoma Unit

(SMU) contains archival samples from the previously named

MASCRI bank). These specimens may or may not have been

originally collected with broad consent, so require additional

ethics approval to access.

At almost all biobanks, specimens collected include tumour

tissue, matched normal tissue, blood and blood products,

with some variation particularly on blood products. There

are some tumour-specifi c exceptions to this, for example

matched normal tissue is not collected for brain tumours. At

some biobanks including the SMU Bio-Specimen Bank, many

more patients consent and donate blood than those who

eventually donate cancer tissue. This is due to the nature

of the tumour and process of removal. Melanomas are

routinely removed by general practitioners, skin clinics and a

dermatologist prior to the patient attending SMU, and tissue

is either not retained for banking or there is insuffi cient tissue

for banking following diagnostic procedures.

The Cancer Council NSW biobank currently comprises

blood derivatives rather than tumour tissue from patients

with all cancer types except non-melanoma skin cancer. This

bank was established as a result of specimen collection for

specifi c studies (one with broad patient consent) although a

decision regarding future use of these specimens has not yet

been made.


34

7.2.2 Specimen processing and storage

Almost all biobanks routinely store fresh frozen tissue and

the majority of banks also routinely store blood and blood

products, which variously include whole blood, plasma,

serum, buffy coat, clotted blood and EDTA blood. Fresh

frozen matched normal tissue is collected and stored where

possible (i.e. not for brain tumours or melanomas). Several

banks also routinely store paraffi n embedded specimens

(APCC BioResource, NSW Pancreatic Network Tissue Bank,

Breast Cancer Tissue Bank, CHW Tumour Bank, Westmead

Gynaecological Tissue Bank, and glioma samples at the Kolling

NeuroEndocrine Bank).

DNA and RNA are not routinely extracted at most banks,

although most are able to undertake this on request from

researchers. Routine H&E staining is only undertaken at

the Breast Cancer Tissue Bank, with three additional banks

indicating that they are able to undertake this on request.

Other processes undertaken at one or more banks on

request from researchers include tissue microarrays, cutting

and mounting of paraffi n specimens, and

tumour cryosections.

Specimens are routinely stored in -80C freezers, which are

often shared with other biobanks existing at the same site.

Several banks also own or have access to liquid nitrogen

tanks or dewars for tissue storage, and centrifuges

for processing.

7.2.3 Single or multicentre collection and storage sites

The biobanks investigated in NSW presented a mix of

single and multicentre collection and/or storage sites. Four

biobanks have single or local-only (including onsite Public and

Private Hospitals) collection and storage sites. These are the

Children’s Hospital Westmead Paediatric Tumour Bank, the

Gynaecological Oncology Tumour Bank at the Westmead

Millennium Institute, the Brain Tumour Bank at Prince of

Wales Private Hospital and the Neuroendocrine Tumour

Bank (excluding the Australasian Brain Tumour Bank) at the

Kolling Institute for Medical Research.

Eight of the banks interviewed have multiple collection sites

with a single storage site. These include the Australasian

Brain Tumour Bank (although blood will be stored at the

WA DNA Bank as part of a collaboration in the future),

Breast Cancer Tissue Bank, Upper GI Tissue Bank and

Gynaecological Tissue Bank all located at the Kolling Institute,

the Sydney Melanoma Unit Biospecimen Bank, the Children’s

Cancer Institute Australia Tumour Bank and the Surgical

Oncology Group Sarcoma Tumour Bank. Collection sites

range from local geographical area to nationwide. Some

banks rely on biobank staff to physically collect specimens

and transport to the central location for storage, while

others rely on external transport arrangements.

Four of the banks have multiple collection sites and storage

nodes and two of these banks link sites via a specimen

locator network. These include the Australian Breast Cancer

Tissue Bank managed from the Westmead Millennium

Institute, which currently has six storage nodes located in

NSW, and the Australian Prostate Cancer BioResource

managed from the Royal Adelaide Hospital which has four

storage nodes in four Australian states including NSW. The

NSW Pancreatic Research Network collects and stores

data at two sites and the Australasian Brain Tumour Bank

has recently established a collaboration with the WA DNA

Bank to store blood associated with high-grade brain tumour

specimens stored at the Kolling Institute.

In addition, several of the collection and storage sites not

only collect specimens for affi liated NSW biobanks, but

are also collection points for other large national trials

such as the Australian Ovarian Cancer Study, which has 20

collection sites around Australia, or the Kathleen Cuningham

Foundation Consortium for research into Familial Breast

cancer (kConFab) which collects samples from all over

Australia and New Zealand. In both of these examples, the

samples are not banked locally but are sent to a central

storage site, both located at the Peter MacCallum Cancer

Centre in Melbourne.

The design of the biobank in terms of single or multiple

collection and/or storage sites is in large part dictated by

the tumour or patient type and the cancer incidence. For

example, for more commonly occurring cancers such as

breast cancer, several institutions house biobanks with

dedicated full or part-time staff. These may or may not be

linked to multiple collection sites or larger consortia. Similarly,

all paediatric tumours can be collected and housed in one

facility such as the Children’s Hospital Westmead Paediatric

35

Tumour Bank. In contrast, for less common cancers such

as melanomas or gliomas, full or even part-time staff at

institutions may not be viable, so consolidation occurs by

having multiple collection sites but a single storage facility.

In large institutions, this may also be overcome by housing

several biobanks in the one facility.

The design of current biobanks is also dependent on

the original intent of the bank. Some facilities have been

established with the intent of developing a bank of

biospecimens for future research (e.g. Breast Cancer Tissue

Bank at Westmead). Others such as the CCIA Tumour Bank

have collected the majority of samples as part of a clinical

trial involving a range of hospitals, but are now collecting

other non-trial samples on a more ad-hoc basis.

‘Tumour banks need to rationalise what they collect in order

balance possible future research needs with storage space and

staffi ng requirements’.

Comment made by a biobank head.

One advantage of specimen storage at the site of collection

may be that it helps to establish local expertise in collection

and preservation of specimens and data, and minimise

additional handling and data entry required with movement

of biospecimens.

Additionally, an issue arising from multiple collection sites

with a central storage facility is the question of who ‘owns’

the biospecimens and associated data. Several comments

were made suggesting a reluctance to send specimens to a

common storage facility separate to the collecting institution,

if the specimen and associated data is perceived to be ‘lost’

to that institution and its associated researchers.

7.2.4 Specimen locator network

Several of the NSW biobanks have specimen locators

designed for researchers to search for specimen availability

within a specifi c biobank, regardless of whether the samples

are all housed at one site or not. These include the Breast

Cancer Tissue Bank based at the Westmead Millennium

Institute and the APCC BioResource.

In addition, three biobanks are members of the ABN

(Breast Cancer Tissue Bank, WMI; Gynaecological Oncology

Tissue Bank, WMI; CHW Paediatric Tumour Bank) where

researchers are able to search for specimen availability

across all member biobanks via a biospecimen locator

network. This enables researchers to gain basic information

about sample availability from multiple banks at one time.

It should be noted though that currently not all available

specimens at these member banks are necessarily listed on

the ABN biospecimen locator. For example, the Westmead

Gynaecological Oncology Tissue Bank has listed specimens

collected subsequent to NHMRC grant funding from ABN

on the ABN tissue specimen locator, but is still in the process

of expanding this to cover specimens collected prior to

this time.

‘It is very time consuming being part of a physical network

where you collect from others or send to other sites. Putting

funding into the establishment of virtual networks though

would improve things enormously, where specimens are

collected and stored locally, with information stored on a

network for researcher access.’


7.3 Entity status and funding sources

7.3.1 Entity status

All the biobanks consulted exist as not for profi t

organisations or as departments (or units within

departments) within hospitals or research institutions.

7.3.2 Current funding

Funding sources

While some biobanks are supported by NSW Department

of Health or institutional funding, all but fi ve rely to some

extent on grant funding for their operation. The CCIA

Tumour Bank, the Surgical Oncology Group Sarcoma

Tumour Bank, the Integrated Cancer Research Colorectal

Tumour Bank and the Cancer Council NSW biobank are

entirely internally funded. The Brain Tumour Bank at Prince

of Wales Private is funded by charitable donations. Grant

funding for other banks includes, but is not restricted to,

NHMRC enabling grants, Cancer Council NSW strategic


36

partnership grants and Cancer Institute NSW infrastructure

grants. For biobanks relying on grant funding, governance

arrangements and focus of the biobank are determined to

some extent by the terms of the grant. Several comments

were made regarding the diffi culty in establishing or

implementing long-term plans for biobanks when funding

arrangements are fi nite. Rather than decisions being made

based on long-term strategic plans, some major decisions

regarding bank expansion were reported as being more

opportunistic based on grant funding received.

‘It is very diffi cult to set up tissue banks in real time when you

don’t know your future funding arrangements.’


Funding allocation

For most banks, 85–90 per cent of grant funding is allocated

to staff, including some allocation to staff involved in clinical

data collection. For larger banks such as the Breast Cancer

Tissue Bank, staff at collection sites are employed by the local

institution, so a greater proportion of funds for this bank

(20 per cent) can be allocated to equipment. Most banks

allocate a small percentage of funds to equipment, IT, general

maintenance and/or other items such as consumables if not

available internally.

7.3.3 Future funding

Current grant funding for all biobanks expires variously

between 2008 and 2012.

Most biobanks relying on grant funding have applied or plan

to apply for ongoing funding from bodies such as the Cancer

Institute NSW and National Health and Medical Research

Council, including collaborative grants for multicentre banking

initiatives. In addition to this, some banks are also planning

to seek funds from fundraising agencies or via involvement in

clinical trials.

Comments regarding formalised long-term strategic funding

plans were not provided or not available for most banks.

An exception to this was the Breast Cancer Tissue Bank

(BCTB), which developed a long-term funding plan after

consideration of biobank funding models, both in Australia

and internationally. The BCTB is aiming for grant funding for

its fi rst two fi ve-year terms, then aiming for long-term stable

funding through a combination of not-for-profi t sources,

including Federal and State Government health funding,

granting agencies and breast cancer foundations. It may

also explore private sponsorship and partial cost recovery.

Funding models considered by the BCTB included those

for broad tissue inventories, which are generally funded by

granting agencies, specialised mechanisms, multi-institution

funding (e.g. from NCI) or by government (e.g. onCore

UK, Victorian Cancer Biobank), and disease-specifi c tissue

inventories which can also receive funding from disease-

focussed foundations.

Regardless of whether long-term plans are in place for

sustenance of the biobank, many banks made comments

regarding the diffi culties around fi nite funding arrangements

when relying on grant funding.

‘Securing future funding is an ongoing major diffi culty.’

‘Funding for tissue bank personnel is very limited and unless

funding comes from other sources, the future is very bleak.’

Comments made by biobank heads.

7.4 Organisational structure and governance arrangements

7.4.1 Biobank governance

All biobanks collecting from multiple non-local geographical

sites are governed in some capacity by executive or

management committees or ‘arms-length’ advisory groups,

independent of the housing institution. These committees are

responsible for the strategic direction and major decisions

of the bank, and generally comprise chief investigators or

professorial heads from various participating institutions

and/or research groups. The large biobanks with multiple

storage nodes (APCC BioResource and the Breast Cancer

Tissue Bank, WMI) also have other committees under this

governing committee who are variously responsible for

policies and procedures and operational issues. In addition,

these large networked biobanks either have or are in the

process of establishing Scientifi c Advisory Groups as part of

a formal review process for assessment of scientifi c merit and

feasibility of research applications.

37

Local-only: for example, tissue banks at the Kolling Institute for Medical Research collecting from on-site or local public and iii.

private hospitals only.

Biobanks with either single or local-onlyiii collection and

storage sites are generally governed by a biobank committee,

which is not independent of the housing institution, although

may have outside representation to provide expertise in

clinical or non-clinical areas. These biobank committees are

generally responsible for all aspects of biobank governance

including strategic direction (within the confi nes of the

grant(s)), policies and procedures, operational issues, review

of scientifi c merit and feasibility of researcher applications,

and decisions regarding specimen distribution. Expert advice

is sought by these committees as required.

Where more than one biobank exists at an institution,

storage facilities are often shared, but each has its own

biobank committee responsible for operational issues and in

most cases, researcher requests and specimen distribution.

Only the Kolling Institute for Medical Research has dedicated

staff to manage the operations of all four biobanks housed at

the institution (rather than separate staff for each biobank),

and a separate biobank committee, in addition to individual

biobank committees, which oversees and sets the strategic

directions of all biobanks at the institution.

Some institutions house biobanks not only for their own

tissue collections but also act as storage nodes for other

biobanks. For example, the Kolling Institute of Medical

Research has its own breast cancer biobank containing

specimens collected from three sites, but is also a storage

node for the Australian Breast Cancer Tissue Bank managed

from the Westmead Millennium Institute. Specimens for

the latter biobank are also collected from other institutions

such as the Sydney Adventist Hospital. These biospecimen

collections, whilst managed by local staff, fall under the

governance of the biobank for which specimens are collected.

Ethics approval for all biobanks is provided by human

research ethics committees at each of the collecting and

housing institutions.

7.4.2 Personnel

The number of FTE staff employed by the biobanks varies

from zero to 10. For example, the Surgical Oncology

Sarcoma Tumour Bank is essentially managed by two

professorial staff employed by Prince of Wales Private

Hospital and therefore does not have any additional

dedicated biobank staff. The Breast Cancer Tissue Bank

employs 9.6 FTE staff in positions including a project manager,

tumour bank offi cers and assistants, database manager and

administrative/data entry position.

Staff are most commonly employed in positions including

biobank or project managers or coordinators, tissue bank

offi cers, technical assistants or clinical data managers.

7.4.3 Biobank performance measures

For most biobanks where the primary focus is banking for

future research purposes, the performance of the bank is

measured by the number of donors and specimens collected;

the number of specimens accessed by researchers; and the

number of publications arising. For some of the newer banks

that are still being established, researchers may not yet

have accessed specimens or published papers, but these are

planned future measures of success. Some banks also include

the number of PhD student project completions arising from

access to the biobank as a measure of performance. One

bank, the CHW Tumour Bank, stipulates that publications

arising must be in internationally peer review journals to be

considered a measure of successful performance.

Whilst most banks reported using similar general measures

of success, information was not gathered on actual indicators

of the successful number of donors, specimens collected,

specimens accessed or publications arising, or the time

frame for each of these measures. Thus, although biobanks

may have their own target performance indicators in these

areas, bank performance against these indicators was not

conducted in this report. It is likely that performance targets

may vary considerably by biobank size and rarity of tumours.

Also, fundamental differences between the banks and

variability in defi nitions relating to specimens collected

and stored means that at this stage comparative analysis

of biobank performance cannot be conducted. Several

options for future internal or comparative analysis of biobank

performance were considered in the preparation of this

report and are presented below. Issues relating to these

options are also discussed.


38

Indicators using specimen or donor numbers

As specimen numbers and donor numbers are dependent on

tumour type (i.e. rare versus common tumours) and biobank

size (i.e. multiple collection sites versus single site), an analysis

of total specimens accessed as a proportion of total specimens

collected, or total publications arising as a proportion of total

specimens collected, were considered to be more useful

performance measures than specimen or donor numbers

themselves. These could then indicate for example, the

number of specimens accessed per 1000 specimens collected or

the number of publications arising per 1000 specimens collected

for each biobank. These were not presented in the current

project as the number of specimens was variously defi ned by

different biobanks to include: total fresh frozen tumour tissue

only; total fresh frozen tumour and matched normal tissue;

total tissue including fresh frozen and paraffi n embedded;

both tissue and blood products and/or other specimens;

the number of donors contributing one or more specimens,

which may or may not equate to the number of specimens

per se; historical or archival specimens as well as prospective

collections; or specimens collected for clinical trials but

also stored by the biobank. Similarly, the number of donors

was variously defi ned to include or exclude those donating

blood samples only, so these fi gures could also not be used

in a comparative analysis. In addition, comparisons between

biobanks using measures such as these must be used carefully

as newly operating banks may still be in their establishment

phase where specimens are being collected but are either

not yet available to researchers or have not yet resulted in

publications. Also, common defi nitions of ‘publications’ must

be used in any comparative analysis (i.e. the CHW Biobank

stipulates that publications must be in international peer

review journals).

Average number of publications per year

The number of publications per year will depend on various

factors including size of bank, how long established, tumour

incidence and specimens available. Number of specimens

available cannot currently be used in comparative analyses

for the reasons described above. An analysis of number of

publications per year per 1000 donors was considered as a

more informative measure of success once banks are well

established. At this stage however, comparative analysis

using this measure may be misleading due to the following

differences in defi nitions of terms between banks:

Total donor numbers ▪ . Defi nitions of donor may vary

across biobanks to variously include those donating only

tumour tissue, tissue and blood, or only blood.

Total number of publications arising ▪ . Publications arising are

variously defi ned as a measure of success by biobanks.

For example, the Kolling Institute biobanks not only

measure publications arising, but also number of PhD

project completions as a measure of success. The CHW

defi nes successful publications as those occurring only in

international peer review journals, so fi gures for CHW

may underestimate the comparative publication rate per

1000 donors.

Average publications per year per 1000 donors ▪ .

Comparison of these fi gures must be done with caution.

Newer banks may show low publication rates per donor

for several years until established. Banks collecting

multiple tumour types may also take several years

to build up suffi cient specimens relating to particular

tumour types for research purposes, so while donor

numbers may be high, numbers relating to specifi c

tumour types may be low.

Donor numbers and collection site numbers

Number of donors per year per collection site was

also considered as a possible internal or comparative

performance measure. Again though, use of donor numbers

per year will be infl uenced by defi nition of donor, rarity of

cancer or tumour type, the purpose for which the bank

was established and presence of other biobanks at one or

more collection sites. In addition, referral patterns for each

collection site may vary and infl uence donor numbers (i.e.

the catchment area for referrals to a particular hospital may

be statewide for a particular cancer type or restricted to a

regional or local area).

39

7.5 Standard operating procedures (SOP)

7.5.1 Development of SOPs

All biobanks surveyed indicated they had standard operating

procedures for the main aspects of the banking procedure

including patient consent, specimen collection and storage,

and bio-informatics.

Operating procedures for specimen collection and storage

tend to have been developed internally at each bank,

although some banks have based their procedures on

external sources such as international standards (e.g. the

International Society for Biological and Environmental

Repositories (ISBER) Best Practices for Repositories,45 the

National Cancer Institute Best Practices for Biospecimen

Resources46), other Australian biobanks (including the

Breast Cancer Tissue Bank at WMI, Peter MacCallum

Cancer Centre Tissue Bank (now a part of the Victorian

Cancer Biobank which has standardised procedures across

Victoria, based on ISBER procedures)) or the Australasian

Biospecimen Network Biorepository Protocols.47 Many banks

also review their procedures routinely to keep them up-to-

date with the latest techniques.

‘Collection of standardised data is really important for any

network of tissue banks – minimum data sets provided by

Cancer Institute NSW and Cancer Council NSW have been

very helpful.’

Comment from a tissue bank head.

Whether standard operating procedures were guided by

external sources or developed internally only, they have been

adapted at each institution to suit tumour specifi c, institution

specifi c and/or researcher group specifi c requirements. In

some instances this is based primarily on historical practices

of particular pathology laboratories and staff.

Although there are some variances across the NSW

biobanks, standard operating procedures are similar and/or

based on the same source (with the exception of procedures

specifi c to a certain type of tumour or specimen not

routinely collected).

7.5.2 Patient consent

Patient information and consent forms were kept broad by

all banks surveyed to ensure that the samples collected have

the potential to be used for any scientifi cally valid research

request. The consent forms and patient information provided

varies across banks, depending on size, number of collection

sites, type of biospecimens to be collected and intended use.

In general however, all forms/information included:

that the research undertaken on the samples provided ▪could be in one of a variety of areas and may not yet be

defi ned but will be subject to approval of scientifi c merit

that research may take many years and any information ▪gained will not benefi t the patient or their family

personally or fi nancially

a list of the biospecimen samples to be included in the ▪bank and the option to select which ones to be included

options to withdraw samples from the bank at any time. ▪

Broad consent enables increased fl exibility of research with

the sample collected, but it must be obtained in a way

that the patient has fully understood the implications of

‘donating’ their samples, and the patient should have the

option to agree to elected parts of the consent as they

feel appropriate. Patients must also be given the option to

withdraw their samples at any time. For further discussion on

the ethical issues regarding consent see Chapter 7.

The process for obtaining patient consent at each of the

biobanks surveyed is included under Standard operating

procedures in Table 9.3 in Appendix D. Patients are generally

consented using a Biobank Patient Consent Form by biobank

staff, surgeon or nurse pre-operatively, or if this does not

occur, post-operatively. Most banks report a success rate

of more than 90 per cent using this procedure, with several

reporting 99–100 per cent for recruitment of donors. The

Surgical Oncology Group Sarcoma Tumour Bank at POW

Private, rather than having a separate patient consent form

and process for tumour banking, includes this in the hospital

admission form. Success rates for this procedure were not

provided.

The Breast Cancer Tissue Bank is currently conducting a

small pilot study at one of the collection sites on donor


40

attitudes to tissue banking and patients’ preferred method

of recruitment.

7.5.3 Data collection

Biobanks showed considerable variation in the types and

extent of data collected for each patient. These data may

be considered in the following categories: identifi cation

data; pathology data; clinical data including demographic

information; and clinical follow-up data.

Identifi cation data. Patient identifi cation information,

including name, DOB, and/or medical record number, is

generally recorded with specimen storage numbers or

identifi ers in a secure database. Information may also include

such things as name of surgeon and date of surgery. This

information can then be de-identifi ed for researchers.

Pathology data. This is generally stored with identifi cation

data in the biobank database (see below). Respondents

in this project were not asked to report on the types of

pathology data collected.

Clinical data. Biobanks vary widely in the extent of clinical

information collected and recorded. Some collect no clinical

data and go through a time-consuming manual process of

linking pathology and clinical data if required for subsequent

research. For those banks collecting clinical data, this may

include one or more of the following: past medical history;

family history; diagnosis; diagnosis date; hospital; referring

doctor; surgeon; type of surgery (biopsy or resection);

treatment (radiotherapy, chemotherapy); outcomes;

subsequent surgeries and treatment; survival outcomes.

‘Clinical information collection is a very frustrating exercise and

to date, there is no Clinical Data Collection Form. In addition,

according to our tumour bank ethics approval, the clinical

database must be kept separate from the tumour

bank database.’

Comment from a biobank head

Clinical follow-up data. Again, biobanks vary widely in

the extent to which clinical follow-up data are collected.

Two banks reported data linkage with Clinical Cancer

Registries (CCR) for notifi cation of date and cause of

death. The Breast Cancer Tissue Bank reported collecting

treatment information (radiotherapy and chemotherapy)

from the Cancer Institute NSW minimum dataset, however,

commented that this information is only available for patients

treated in public facilities and is not a straightforward

exercise. The Cancer Council NSW reports that clinical

follow-up data will be done via linkage through the Centre

for Health Record Linkage (CHeReL).

7.5.4 Data storage

All tissue banks had established a database to register basic

client information and link this to the physical sample through

a coded system. Each bank had developed a database, often

in Microsoft Excel or Microsoft Access. All tissue banks

(except one), restricted researcher access to de-identifi ed

data. Only tissue bank staff are able to re-identify patient

information as required.

‘If clinical information linked to specimen information is

required for research, it is a “scratching and scrounging”

exercise to retrieve, although not impossible.’

Comment from a biobank head.

Clinical information and follow-up data were often kept

separately from the tissue bank database, with manual

searches required to include this information with samples

for researchers. Some tissue bank managers had heard

of or considered using specifi c data linkage platforms to

facilitate this process (e.g. the Centre for Health Record

Linkage (CHeReL) in NSW or BioGrid Australiaiv), but were

concerned about the quality of data collected and the use (or

lack) of standardised data sets.

‘Collecting follow up data for samples that are accessed for

projects is time consuming – there are always differences

across hospitals and tumour bank databases in the way data is

collected and stored. Data linkage platforms like CheReL and

BioGrid could be useful in theory but there would probably

need to be more standardised data collection methods for

them to be useful.’


There are currently few well-established data linkage

networks between pathology and clinical databases in NSW

biobanks. Most biobanks surveyed are aiming to establish

more sophisticated networks, but are constrained by fi nancial

and human resources including lack of technical expertise.

CHeReL and BioGrid are data linkage platforms able to link de-identifi ed data from multiple data sets. For more information see their iv.

respective websites: http://www.cherel.org.au/; http://www.biogrid.org.au/pages/index.php.

41

7.5.5 Quality control measures

All but one of the biobanks reported that they had

mechanisms in place to ensure specimen integrity. In all these

banks freezers are locked, alarmed and/or electronically

monitored with 24 hour temperature monitoring and

recording. The CHW Tumour Bank also commented that

they have a liquid CO2 injection system for back-up and

freezer failure. Three banks (APCC BioResource, SMU Bio-

Specimen Bank and Breast Cancer Tissue Bank) reported

that specimens are divided and housed separately in case

of freezer failure. The Breast Cancer Tissue Bank reported

SOPs to ensure that samples shipped between collection

centres are temperature monitored during shipment.

The Kolling NeuroEndocrine Bank made the following

comments in relation to quality control measures for

ensuring specimen integrity:

‘It essentially comes down to routine. A liquid nitrogen canister

is positioned on the wall of the surgical theatre in the private

hospital which ensures that the specimen is snap frozen with

minimal delay. All surgical staff are trained by the researchers

to correctly label and freeze the specimen. In the case of the

public hospital, the tumour bank offi cer is called prior to the

removal of the tumour and is present in the theatre at the

time of tumour removal. The tumours are brought back to

the laboratory and logged in to the data book and stored at

–80°C. The tumour Bank freezer is monitored daily.

‘When the tumour is used for scientifi c purposes, a technique

has been developed to maintain tumour integrity during

processing. The tumour sections are cut on a plastic petri dish

which is pre-frozen at –80°C and then laid out on a bed of dry

ice. The tumour is never exposed to ambient temperature. All

dissection tools are autoclaved prior to use and treated with

a solution called RNAse Zap to ensure inhibition of RNAses

which can cause specimen deterioration.’

While most biobanks require researchers to return unused

specimens to the bank, the Kolling NeuroEndocrine Bank

and the Breast Cancer Tissue Bank made specifi c comment

that this was not a requirement, as the biobank could not

guarantee specimen integrity once it had been removed from

the bank.

7.6 Researcher access

7.6.1 Key themes from biobank governance surveys

Researcher access policies

Almost all biobanks interviewed have a formal researcher

access policy. These are available from biobank websites

(where they exist) or can be sent to researchers on request.

The tissue access policy for the APCC BioResource was

developed using the guidelines provided by the NHMRC

for biobanks funded via the Enabling Grant initiative. Most

biobanks have an associated standard Researcher Access

Form which they send to researchers via email on request.

Researchers are able to access some biobanks (e.g. CHW

Paediatric Tumour Bank) via the website.

Researcher access to biospecimens generally involves:

Initial researcher contact with biobank to determine ▪availability of specimens. This may be done via a web-

based search (i.e. ABN Tissue Specimen Locator) or via

telephone or email contact.

Mandatory Human Research Ethics Committee ▪(HREC) approval for the research, usually from

researcher institution.

Submission of Researcher Access Form to Biobank with ▪appropriate HREC approval documented as required.

Review of submission by a Scientifi c Advisory Group ▪or Biobank Management Committee to determine

the scientifi c merit of the application and whether it is

practical, feasible and a high priority use of the specimens

requested. If applications have been peer reviewed by

major scientifi c bodies (i.e. NHMRC, CI NSW) there

may be no additional requirement for scientifi c review by

the Biobank.

Provision of requested material to researcher upon ▪receipt of signed agreements.

All biobanks with multiple collection/storage sites stipulate

priority access for participating institutions or their affi liates

or collaborators. Similarly, the NSW Pancreatic Research

Network Tissue Bank restricts access to members of the

NSW Pancreatic Research Network, as it currently has


42

insuffi cient tissue and staff resources to allow access beyond

this. Several biobanks stipulate that access will not be

provided to commercial organisations, although the Breast

Cancer Tissue Bank WMI for example states that ‘meritorious

cases may be referred to the BCTB Advisory Panel for

further consideration’.

BREAST CANCER TISSUE BANK ACCESS POLICY

The following factors will be taken into consideration:

Review of the scientifi c merit of the project by the BCTB ▪Scientifi c Review Panel/BCTB Management Group. This

will be based on scientifi c validity; study design; technical

parameters (e.g. reproducibility, sensitivity, specifi city);

clinical or scientifi c impact; project balance within the

BCTB; practicality and feasibility (e.g. amount of tissue,

number and type of samples required).

First priority will be given to peer-reviewed, funded ▪research projects.

Second priority will be given to developmental projects ▪and new researchers developing projects in academic

centres.

Investigators directly involved in the operation of ▪collection centres will be given an agreed priority access

in proportion to the number of specimens collected.

Researchers making large requests or requests for very ▪rare tissue may have their applications further reviewed

by the BCTB Advisory Panel who will consider the

application in light of the interests of the bank.

Applications made by commercial organisations will not ▪in general be supported; however meritorious case may

be referred to the BCTB Advisory Panel for further

consideration.

Excerpt from BCTB Access Policy (Version 2.4).

Almost all biobanks require researchers to acknowledge the

biobank in any publications arising from use of specimens,

and most require researchers to send copies of publications

to the bank. Most banks also require researchers to report

back to the bank regarding integrity and quality of

samples supplied.

It would be ideal to allow access to biospecimens for all

Australian academic researchers (or possibly international

researchers in the case of rare tumours) following mandatory

Human Research Ethics Committee approval and review

of scientifi c merit and feasibility of project (including sample

availability). However, most biobanks have a priority access

system to ensure priority is given to collecting institutions,

or their collaborators or affi liated research groups, and

to ensure that suffi cient tissue and human resources are

available to meet requests. This type of priority system

would need to be reviewed if banks were to become a part

of a consortium as there will be many collections sites across

the state.

Researcher awareness of biobanks

In all cases, the primary method of making researchers

aware of the biobank was via word of mouth. For biobanks

primarily used by local or affi liated researchers, this was

sometimes also done via presentations given to interested

parties. For biobanks with broader researcher access,

word of mouth recommendations included those from

other researchers or via direct contact with biobank staff,

particularly at conferences. One biobank head routinely

initiates contact with researchers to inform them of the

biobank, based on knowledge obtained from conference

presentations about the researcher’s interests. Other

methods by which researchers become aware of biobanks

are via biobank publications or, less commonly, via the ABN

or the specifi c biobank website.

Two well-established biobanks heads (from the APCC

BioResource and the CHW Paediatric Tumour Bank)

commented that one of the most important future needs

of established banks was to maintain or increase researcher

utilisation of biospecimens.

‘The defi nition of a tissue or tumour bank should be where

specimens go in as well as get withdrawn. One of the issues for

large banks is getting withdrawals.’


Costs to Researchers

Most biobanks charge researchers either nothing or freight

costs only. The APCC BioResource previously had a partial

cost recovery system in place, but found that this limited

researcher requests so this requirement was lifted in 2007.

Since removing this system the APCC BioResource has had

fourteen requests for specimens, all approved. The Breast

Cancer Tissue Bank, WMI, charges an additional cost for

43

DNA and is planning to introduce a partial cost recovery

scheme in the future. The Gynaecological Oncology Tissue

Bank, WMI, generally charges only for freight costs, but also

has some project dependent cost recovery charges (i.e. if

the research project has grant funding for biobanking). The

CHW Paediatric Tumour Bank charges freight costs only as

its ‘current philosophy is that the bank has been established to

facilitate genuine research resulting in published papers rather

than as a business where full cost recovery may be important.

The more genuine research papers that are published, the more

likely that these can be used to leverage ongoing funding’.

‘If provisions of the funding grant for the tumour bank include

the provision of samples to researchers, then cost recovery

would appear to be double-dipping. If, however, the tumour

bank has not been set up with grant or other funding to cover

the costs of collecting, processing, storing, shipping etc, then

cost recovery would seem appropriate.’

Comment from a researcher.

Researcher requests, access and publications arising

Requests from researchers to established biobanks for

biospecimen access over the past 12 months ranges from

four to 20. All but one of these were approved. Numbers

of specimens accessed in the last year in relation to these

researcher requests ranges from fi ve to more than 200 and

is dependent on the nature of the research, the size of the

bank and the rarity of the specimens requested. Some banks

do not record numbers of publications arising. Where this

information is known, it ranges from nil for newly established

banks to 39 since 1995 for the Kolling Institute Banks.

Number of requests, specimens accessed and publications

arising for each of the biobanks surveyed can be seen at

Appendix D.

7.6.2 Key themes from researcher surveys

Barriers to access for researchers

These can be summarised as:

The dispersed nature of the biobanks and ▪specimen locations.

No central register of biobanks allowing researchers to ▪locate specimens.

No single scientifi c advisory committee for submission of ▪applications if needing samples from multiple sites.

Application to researcher institutional HREC requires ▪details of ethics approvals of biobanks to which the

researcher is applying. If this includes multiple banks, this

is extremely time consuming.

Generally there is insuffi cient research funding to cover ▪any costs associated with biospecimen access other than

freight.

Facilitators of access for researchers

These can be summarised as:

A central register of specimen locations, ideally grouped ▪by cancer type.

More streamlined approval process for ethics approval ▪at researcher institution and for scientifi c advisory

committee approval and access to specimens at housing

institutions.

Minimal costs associated with access to biospecimens, ▪unless these are covered by the research grant.


44

The opportunities presented are not mutually exclusive and many can be built upon over time to incrementally work towards system change.

8 Future options for New South Wales biobanking

As previously stated, the ultimate purpose of this

comprehensive review was to assist in the facilitation of

the following:

improve researcher access to tissues collected in a range ▪of cancers

improve effi ciency and reduce duplication of ▪administrative processes

build capacity that is cost-effective and sustainable ▪

identify the current investment in biobanking and ▪strategies to optimise value for money.

This Chapter draws together fi ndings from the interviews

with biobanks in NSW and international arrangements, to

present several governance arrangement models observed

and the benefi ts and issues associated with each governance

model. In addition, other aspects of opportunity for

biobanking in NSW will be discussed.

8.1 Summary of New South Wales formalised biobank governance

The majority of biobanks in NSW identifi ed in the project

have been established as formalised biobanks with single

or multiple collection sites and centralised storage of

biospecimens at the main site. The majority of banks were

clinical biobanks rather than epidemiological biobanks. Some

of the biobanks identifi ed were also a part of specimen

locator networks such as the ABN (e.g. Children’s Hospital at

Westmead Tumour Bank), but many were not. The majority

of banks provide access to all academic researchers subject

to approval based on scientifi c merit (and assuming ethics

approval for the research is granted). However, depending on

the size of the biobank and the availability of samples, many

banks prioritise research conducted by staff in the institution

the bank is located over external researchers, and prioritise

academic research over commercial research. Some banks

do not provide samples outside of their own institution and

others do not provide samples to commercial research. Most

banks do not charge researchers for the samples provided

(other than the cost of freight to deliver the sample), but

a few of the larger banks have established cost recovery

procedures. The nature of the cost recovery varies

between banks.

In addition to formalised biobanks, there are a number of

specimen collections throughout NSW (only a few were

identifi ed in this project, most likely due to the limitations

of the methodology in contacting appropriate staff/

researchers). The intent of these collections is generally for

use solely within the host laboratory and as such do not

have formalised or structured governance arrangements in

place. Therefore, this type of tissue collection has not been

considered in the discussion below.

8.2 Future opportunities for governance models for biobanks

As a result of this review, several options and opportunities

were identifi ed for Biobanking in NSW.

Level A – Minimal Change: no changes to local governance

of banks or physical structures required:

stakeholder network ▪

specimen locator network ▪

accreditation. ▪

Level B - Consortia Approach: changes to local governance

arrangements required, possible changes to physical set up

required depending on type of existing setup:

consortia by tumour type in NSW ▪

consortia by tumour type Australia-wide ▪

consortium of all biobanks in NSW. ▪

45

Other opportunities for consideration:

extension of pathology services ▪

data management and tracking infrastructure ▪

data linkage and extending epidemiological ▪research capacity.

The opportunities presented are not mutually exclusive and

many can be built upon over time to incrementally work

towards system change. Figure 5 diagrammatically represents

future opportunities for biobanking in NSW and how they

relate to each other.

8.2.1 Stakeholder Network

A stakeholder network would comprise biobank managers

and other stakeholders meeting on a regular basis to enable

formal discussions on topics common to all biobanking such

as standard operating procedures, ethical issues, consent

and application processes and committee member make up,

with the intent of developing consensus views and guidelines

to promote consistency across biobanking practices. Such

Figure 5 Opportunities for biobanking in NSW

S takeholder Network

AccreditationS pecimen

Locator Network

Level A:No governance or physical changes

NS W consortia by

Tumour

Consortia all NS W

Australian consortia by

Tumour

Level B:Governance changes, possible physical changes,

•

Extension of Pathology services

•

Population Studiesa network would enable biobanks to remain up-to-date on

various aspects of banking and to discuss banking issues in a

structured and meaningful environment.

Stakeholder networks are unlikely to attract funding or

sponsorship themselves and would rely highly on the good

will and donations of time of interested members. The

further development of accreditation processes and/or

specimen locator networks in association with a stakeholder

network would probably require some additional funding

for resources.

These types of stakeholder networks are common

internationally (e.g. the Confederation of Cancer Biobanks in

the UK and the Offi ce of Biorepositories and Biospecimen

Research in the US). In Australia, the formation of the

Australasian Biospecimen Network (ABN) included

development of a stakeholder network comprising biobank

managers and stakeholders from the founding member

biobanks. To date the ABN has developed recommended

SOPs for biobanking, guideline consent forms and

standardised application forms for members.


46

8.2.2 Accreditation

Extending on the development of the SOPs for biobanking in

NSW (and/or Australia), the stakeholder networks could be

charged with the development of an accreditation process

for biobanks. This could include the mandatory use of

agreed SOPs for tissue collection, preparation/manipulation

and storage, as well as standards for businesses such as the

International Organization for Standards quality management

standards (e.g. ISO 9000) or National Association of Testing

Authorities (NATA) accreditation.

NATA assess technical competence through standard

testing and accreditation of businesses in terms of: people

excellence; technical excellence; innovative and fl exible

service delivery; superior value and service; networking and

organisation; organisational growth; and public interest. In

Australia, St John of God Pathology and hence the biobank

are NATA accredited.

The ISO 9000 standards cover aspects such as procedures

regarding all key processes in the business; monitoring

processes to ensure they are effective; keeping adequate

records; checking output for defects, with appropriate and

corrective action where necessary; regularly reviewing

individual processes and the quality system itself for

effectiveness; and facilitating continual improvement.

Internationally banks such as UK Biobank and the CNIO TBN

have or are planning to obtain ISO 9000 certifi cation.

Accreditation would enable a consistency in procedures and

policies across multiple biobanks without the need to change

governance or funding arrangements. Conforming to the

agreed accreditation process may require some additional

resources for biobanks (namely in staffi ng) and there may be

costs associated with accreditation, e.g. for administration

and review processes and costs associated with recognised

bodies such as NATA and ISO.

8.2.3 Specimen Locator Network

Further extension of SOPs and/or accreditations processes,

would be the development of a specimen locator network(s).

Specimen locator networks, made available to researchers

through a centralised website, would enable researchers

to search many biobanks for required samples at once,

although application for specimens may still require individual

application procedures for each bank.

In this model, each member biobank would maintain their

existing governance arrangements, including committees

and committee members, SOPs, and sample ‘ownership’.

The biobanks would then be able to choose whether or not

to use the advice and guidelines developed by the virtual

network of stakeholders to modify/improve their practices

(to which they would have contributed to the development).

This type of model would work as a general resource for

all tumour types (e.g. ABN) or a tumour-specifi c resource

(e.g. the APCC). The benefi ts of a general (all tumour types)

network are that all biobanks (including those of rare tumour

types) could benefi t and that researchers would only have

one network to consider in looking for samples. Conversely

however, there may be issues specifi c to particular tumour

types where a tumour-specifi c network may be more

appropriate. As clinical researchers typically have a narrow

research focus, it is likely their bio-specimen needs would still

fall under one tumour type.

The specimen locator network could be limited to banks in

NSW only or it could be expanded to cover all of Australia

and even Australasia (both APCC and ABN are Australia

wide). The model has been established in small scale already

and has proven to work well both for general cancer (ABN)

and tumour specifi c (APCC). Funding arrangements for such

a network could be established in one of three ways:

In the two examples of a specimen locator network, ▪to date, both have received funding to establish the

network, which has been distributed amongst the

member biobanks. This model of funding could be

pursued in establishing other networks. The issue with

this is that as the membership increases the required

funding may also increase and may

become unsustainable.

Biobanks could maintain their current funding ▪arrangements and the specimen locator network could

apply for small funding grants for maintenance and

ongoing costs (e.g. website, specimen locator, organised

meetings, development of guidelines).

47

Biobanks could maintain their current funding ▪arrangements and apply for individual grants. Each

member may then be asked to contribute a small

amount to the running costs of the network.

This model presents a fl exible and relatively low cost

option to improve coordination, consistency, marketing

and awareness across biobanks in NSW. Options such

as specimen locators and standardised application forms/

processes would increase the ease of application

by researchers.

8.2.4 Consortia by tumour type in NSW

A tumour-specifi c consortium of biobanks across NSW

could encompass all existing biobanks collecting samples of

a particular tumour group, similar in nature to the Australian

Breast Cancer Tissue Bank. In this model, all biobanks

and collection sites would be rolled into a single entity

representing a tumour-specifi c biobank consortium with

multiple collection and multiple storage sites across NSW.

The establishment of such a consortium would require

new governance arrangements for the banks under a

central governance committee. This committee should

include representatives from all collection/storage sites,

which contribute to the setting of strategic directions for

the consortium. Similarly, other sub-committees, such as

scientifi c advisory committees, would need to be centralised,

but still maintain appropriate representation from experts

in the fi eld and representation from all collection/storage

sites. It will also be necessary to nominate the lead agency

for the consortium (or establish a new lead entity), which

would be responsible for ethical approval for tissue collection

through the Human Research Ethics Committee (note,

other participating institutions may still require internal ethics

approval for collection and storage).

Importantly, this model would enable one application process

for all tumours of the same type in NSW, regardless of the

institution the samples were coming from. The consortia

model would bring consistent operating procedures for

consent, tissue collection, processing and storage across

tissue collection by cancer type in NSW. This would enable

researchers to be confi dent of the same quality of sample,

regardless of which institution the sample was collected at,

and allow a single application process to cover the whole

of NSW for a specifi c tumour type. In addition, marketing

and promotion of the biobanks could be centralised and

coordinated, and specimen locator software on a centralised

website would facilitate researcher awareness of

available samples.

Another benefi t of the consortia model is increased

economies of scale based on shared resources and

centralised administration processes, which would enable

greater resource to be used for centralised applications

processes, advertising and marketing of the biobanks and

quality assurance measures across banks.

One potential issue with this model, however, is that as a

single entity ‘ownership’ of tissue samples may no longer

belong to the individual banks, but to the new biobank

consortium. Subsequently, individual banks would not be able

to prioritise internal researchers (from their institution) over

external researchers. This in itself would benefi t researchers,

especially those at organisations that do not have biobanks,

but may cause anxiety among biobank managers and result in

an unwillingness to participate. In addition, some banks have

strong policies on whether to allow commercial research to

access samples, while others do not. Merging of the biobanks

into a single consortium would require a consensus stand on

issues such as this, hence the importance to have adequate

representation from individual biobanks on the governance

committee. Such representation may also help ease the

anxiety of biobanks regarding sample ‘ownership’.

A compromise to complete consensus of governance

arrangements (as described above) would be to have

consensus for the essential issues, but allow fl exibility on

issues such as whether samples can be sent to commercial

agencies or not. Internationally, the Canadian Tumour

Repository Network (CTRN) has such fl exibility within the

governance arrangements of their consortium. The CTRN

has SOPs for all biobanking aspects, a centralised website and

specimen locator network, but allows individual banks to be

fl exible regarding supply of samples to commercial entities or

not and shipment of samples outside of Canada or not.13


48

The funding arrangements for a NSW tumour specifi c

biobank consortium are likely to depend on the existing

arrangements of each individual bank and may be a

combination of:

External grant funding, with single/joint funding ▪applications submitted (rather than individual banks each

submitting an application).

Contributions from host institutions, especially in relation ▪to space, equipment (which may be shared), and

other infrastructure.

Cost recovery models, as a larger network there are ▪likely to be the resources to develop and maintain cost

recovery models for samples.

Other issues to be considered include database management

and data linkage systems. Most biobank databases have

been developed internally and vary across all banks. As

a consortium, it may be possible to streamline these

processes and develop standardised databases with standard

procedures to link samples to follow up data. Past experience

of other biobank consortia, such as the Victorian Cancer

Biobank and other linkage systems (the WAGER / WADLS

arrangements) should be considered to avoid unnecessary

re-invention/duplication of processes and software.

A consortium of NSW tumour-specifi c biobanks could also

be a part of a stakeholder network to discuss and share

new information and issues and a specimen locator network

(possibly external to their own), providing researchers with

another point of access to samples.

8.2.5 Consortia by tumour type Australia-wide

An extension of the consortia of biobanks across NSW

model is to include biobanks from other Australian states/

territories and/or other Australasian countries as well, based

on tumour type. Some biobanks in NSW already do have

collection sites outside NSW, such as the Australian Brain

Tumour Bank being established at the Kolling Institute which

will have collection sites in NSW and WA, and kConFab and

the Children’s Cancer Institute Australia biobanks which both

have collection sites across Australian and New Zealand.

As banks will be merged into a single entity, this model will

present similar issues around governance (centralised) and

appropriate committee membership, ‘ownership’ of samples,

storage and collection sites, prioritisation of researcher

access and funding arrangements. Similar researcher benefi ts

will be generated through increased awareness, centralised

application processes, specimen locator functions and

increased access from de-prioritisation based on

research institute.

This model of governance may also be benefi cial for biobanks

of rare tumour types which may have diffi culty forming a

biobank network in NSW alone due to lack of samples

available. By extending to all of Australia/Australasia, rare

tumour bank networks will be able to increase the sample

range and provide coordinated access to researchers

across Australia/Australasia. It is for these reasons that the

Australian Sarcomav Study Group is being developed and the

sarcoma specimen collection at Prince of Wales Hospital is

becoming a member of this consortium.

8.2.6 Consortium of all NSW Biobanks

In order to establish ultimate consistency and coordination

across biobanks in NSW, a consortium of all NSW biobanks

could be established, similar in principle to the Victorian

Cancer Biobank (VCB). This model represents a single

biobank entity for all of NSW and as such would also present

the same issues to be considered regarding governance,

funding, ‘ownership’, collection and storage and prioritisation

as the cancer-specifi c network models (NSW or Australia/

Australasia wide). Similarly, the researcher benefi ts would

be increased awareness; coordination and consistency of

applications and other processes; and specimen

locator capability.

Additional benefi ts of a consortium model would be

increased marketing potential at the statewide level through

pooled resources, roll out of best-practice procedures/policy

to the whole state and ability to establish consistent database

technology for all biobanks in NSW, with the potential to

develop data linkage procedures with WADLS, CHeReL or

BioGrid Australia (similar to the VCB model).

An additional hurdle to the consortium model in NSW is the

tumour-specifi c nature of existing biobanks. In NSW, many

biobanks focus on a specifi c type or group of tumours. While

Sarcomas are rare tumours and it is diffi cult to obtain suffi cient numbers of samples from one hospital and indeed one state/territory alone.v.

49

there are general biobanking issues/policies that hold true

for any bank, there are also tumour-specifi c concerns, which

may hinder processes such as setting strategic directions,

if all biobanks are to be under a single entity. It would be

necessary to examine these issues in more detail if this model

was to be considered.

8.2.7 Extension of pathology services

In addition to the type of entity status biobanks are

established with in the future, consideration should be given

to the location of the biobank within the health system.

There are examples of successful biobanks which have been

established within the pathology departments of hospitals

(e.g. Spanish National Cancer Research Centre Tissue Bank

Network and the St John of God Pathology Biobank in WA).

As described in Section 5.3.1 there are several benefi ts

to establishing biobanks within pathology departments,

namely reduced costs, established infrastructure including

accreditation and SOPs, and good relationships with

surgeons to ensure appropriate sample collection.

One of the concerns raised by a biobank head was that the

introduction of large biobank consortia may negatively impact

on the relationships with surgeons as the personal aspects

of smaller or institutional only biobanks are lost. Introducing

biobank consortia through the pathology departments may

be a way to counter this based on the need for all samples

to go to pathology fi rst for diagnostic purposes and hence

reinforce the strong relationship between pathology staff

and surgeons.

Issues relating to the use of pathology departments to house

biobanks include:

The issue of sample ‘ownership’: moving from the ▪existing set up on separate biobanks to inclusion in

pathology departments may present problems with

ownership and perceptions of ‘giving up’ samples.

Possible lack of pathology resources: although the staff ▪time required for many of the biobanking processes

is minimal on top of existing pathology duties, some

pathology departments are already under resourced.

In addition, the expansion of samples storage may

require additional storage facilities and increase IT/data

management capacity.

8.2.8 Data management and data linkage

The growth of biobanks over the past fi ve to 10 years has

already yielded a need for more sophisticated bioinformatic

processes and systems to be used. If future growth through

development of biobank consortia is to be realised, then

the need for improved data management and data linkage

systems will increase. In redeveloping databases and data

management, biobanks and biobank consortia could, for

example, through the use of tools such as the LIMS at

WAGER and data linkage systems (such as WADLS, CHeReL

or BioGrid Australia), systematically track follow-up and

outcomes data for donors and enable new uses for biobank

specimen data in terms of population studies.

It is also worth noting that a variety of free software tools

are available to biobanks (such as CaBig, Caisis, CTRNet’s

ATiM) to facilitate operations. There are also important data

standardisation initiatives in the United States, Canada and

Europe as well as Australia. Biobanks in NSW could benefi t

tremendously from leveraging off existing resources in

these areas.

8.2.9 Epidemiological research opportunities

Internationally, there are studies being established to collect

biological samples (e.g. blood and urine) along with clinical

information on subjects for future epidemiological studies

of defi ned cohorts. This will provide powerful new tools for

the research into familial diseases, including cancers. There

is some participation in these collections within NSW (such

as with kConFab researching familial breast cancer), although

most biobanking activity in NSW is more clinically focussed.

8.2.10 Comparison of models

A brief comparison of the governance and other

arrangements for the potential biobanking models is provided

in Table 6.


50

Table 6 Comparison of biobanking models – indication of the changes from current practice

Category Level A: Minimal Change Level B: Consortia Approach

Stakeholder Network

Accreditation Specimen Locator Network

NSW Consortia – Tumour Specifi c

Australia Consortia – Tumour Specifi c

NSW Consortia General

Entity status for current biobanks

No change No change No change Single entity Single entity Single entity

Governance No change No change No change Central

committees

– appropriate

representation

Central

committees

– appropriate

representation

Central

committees

– appropriate

representation

Sample storage No change Possible changes

depending on

accreditation

recommendations

No change No change –

possibility of

central storage as

appropriate

No change –

possibility of

central storage as

appropriate

No change

Samples ‘ownership’

No change No change No change Centrally ‘owned’ Centrally ‘owned’ Centrally ‘owned’

SOPs Development of

consensus SOPs–

non-compulsory

Modifi ed to

consensus –

compulsory

Promotion of

consensus SOPs–

non-compulsory

Modifi ed to

consensus –

compulsory

Modifi ed to

consensus –

compulsory

Modifi ed to

consensus –

compulsory

Consent Development of

consensus – non-

compulsory

Modifi ed to

consensus –

compulsory

Promotion of

consensus SOPs–

non-compulsory

Modifi ed to

consensus –

compulsory

Modifi ed to

consensus –

compulsory

Modifi ed to

consensus –

compulsory

Researcher awareness

No direct change No direct change Increased through

communal

website

Increased through

central website

Increased through

central website

Increased through

central website,

other marketing

campaigns

Researcher access

Apply to individual

banks

Apply to individual

banks

Apply to individual

banks

Single application,

centralised per

consortia

Single application,

centralised per

consortia

Single application,

centralised for all

NSW

Application processes

Development of

consensus – non-

compulsory

Modifi ed to

consensus –

compulsory

Promotion of

consensus SOPs–

non-compulsory

Modifi ed to

consensus –

compulsory

Modifi ed to

consensus –

compulsory

Modifi ed to

consensus –

compulsory

Funding No additional

funding – reliant

on good will of

members

Individual bank

funds required

for accreditation

processes

Joint or

institutional

funding to set up

/ maintain website

and specimen

locator software

Joint funding

plus institutional

funding and

possible cost

recovery

Joint funding

plus institutional

funding and

possible cost

recovery

Joint funding

plus institutional

funding and

possible cost

recovery

Marketing No direct change Increased through

implementation of

SOPs

In creased

opportunity

through

communal

website

Increased through

central website,

other marketing

campaigns

Increased through

central website,

other marketing

campaigns

Increased through

central website,

other marketing

campaigns

Region NSW or Australia

/ Australasia

NSW or Australia

/ Australasia

NSW or Australia

/ Australasia

NSW Australia /

Australasia

NSW

51

8.2.11 Infrastructure and resources required

Level A

Minimal change approach: infrastructure and resources required

Level A options would require little governance or physical

changes to existing biobanking arrangements. As such,

there would be a lower level of infrastructure or resourcing

requirements and costs associated with these options.

It is expected that the stakeholder networks would develop

from good will of existing managers/staff and other interested

parties and as such would not require any additional staffi ng

to be formed. Resources that may be required would include

staffi ng for coordination activities, conference facilities such

as teleconferencing, web-conferencing and face to face as

required. It may also be necessary to produce reports of the

developments and promote this through a website.

Additional resources required for the accreditation

opportunity would depend largely on the type of

accreditation and the existing structure of the biobank. All

biobanks would need to fund the accreditation process,

which could range from several $100 to $3,000–$4,000.

Depending on the biobank, it may also be necessary to

employ extra staff (e.g. 0.5 FTE) to manage the accreditation

processes and some investment in upgrading or changing

processes may be required to adhere to requirements.

Development of a specimen locator network would require

IT infrastructure to establish and maintain a website and

specimen locator software. It may also be necessary to

employ staff (e.g. 0.5–1.0 FTE) to manage the processes and

ensure the network is up-to-date with all member biobank

information. Expansion of existing specimen locator networks

where possible could reduce costs and resources required.

Therefore, Level A opportunities provide relatively low

cost strategies that are implementable in the short term to

improve biobanking arrangements and improve research

access in NSW.

Level B

Consortia approach: infrastructure and resources required

In pursuing the opportunities represented in Level B, as well

as the changes to governance arrangements described above,

more signifi cant infrastructure and other resources would

be required.

All biobank consortia would require the following

infrastructure and resources. However, much of this will

already be established or available at the existing biobanks:

Staff1. : all biobank consortia should have at least 0.5 – 1.0

FTE to manage the bank, process samples, data entry

and follow up data collection, coordinate consent and

application processes and shipment of samples. The

number of staff FTE required would depend largely

on the number of donors/samples and the number of

collection/storage sites. Banks collecting samples for

common cancers are likely to have large volumes and

multiple collection sites, hence the need for additional

staff. It may be diffi cult for banks for rarer tumours to

be able to afford staffi ng alone based on the volume of

work required. In these cases, sharing of infrastructure

and staff can be benefi cial to increase the economies

of scale. This is the case at the Kolling Institute where

at least three tumour-specifi c banks share staffi ng

and infrastructure. It is not possible to specify a

benchmarked number of staffed based on sample or

donor number, but the types of staffi ng roles typically

employed (especially in larger biobanks) include: manager,

coordinator, offi cer, technical assistant, data manager

and administration assistance. Staffi ng and staff time

contribute to approximately 70 per cent to 90 per cent

of biobank running costs (based on survey responses).

Freezers and liquid nitrogen2. : all biobanks will require

at least access to a –80˚C freezer and possibly liquid

nitrogen tanks, as well depending on the types and

numbers of samples being stored. Responses to the

survey suggest that most biobanks share freezer space

and liquid nitrogen tanks with other laboratories.

Average freezer usage by biobanks was between 80 and


52

2,500 donors per freezer. Considering freezers can hold

between 14,000 and 50,000 plus samples (depending

on sample size and freezer size), even if banks were to

store multiple samples per donor, they are unlikely to

require individual freezers at this stage. In addition, banks

with multiple storage sites will have samples spread

across all sites (e.g. the Australian Breast Cancer Tissue

Bank has samples across fi ve freezers at fi ve storage

sites and four liquid nitrogen tanks at four of the fi ve

collection sites). Products requiring storage at –80˚C

or in liquid nitrogen: 93 per cent of biobanks surveyed

routinely stored fresh frozen samples (for tumour tissue

and approximately 47 per cent stored fresh frozen

matched normal tissue as well) and approximately 67

per cent routinely stored blood and blood products.

Approximately 20 per cent and 13 per cent of biobanks

routinely stored DNA and RNA, respectively and a

further 47 per cent would prepare DNA and RNA

upon request. Of the biobanks surveyed, most indicated

that an average of fi ve per cent to 10 per cent of funds

was spent on equipment and a further 10 to15 per

cent on maintenance. Twenty-seven per cent of banks

did not attribute a cost to equipment and 40 per cent

of banks did not attribute a cost to maintenance. Two

banks (13 per cent) indicated higher equipment costs of

approximately 20 per cent of funds, with an additional 5

per cent on maintenance for one of these banks). Both

of these banks had large number of donors (1,000 plus

and 2,000 plus). One of the banks had fi ve collection/

storage sites, likely to increase the equipment costs for

this bank, the other had additional equipment not listed

by other biobanks including a virtual microscope slide

scanner, a manual tissue arrayer and a high-throughput

immunohistochemistry staining station.

Room temperature storage3. : in addition to access

to storage at –80˚C or in liquid nitrogen, biobanks

will require room temperature storage space if they

routinely store paraffi n embedded tissue samples and/

or H&E stained samples. Of the biobanks surveyed,

approximately 40 per cent routinely stored paraffi n

embedded samples and only one biobank (seven per

cent) routinely stored H&E stained tissue. A further 27

per cent of banks would process H&E staining

upon request.

Other equipment and consumables4. : in addition to

storage facilities, other large equipment that biobanks

may require (or require access to) are a centrifuge (for

processing of blood) and a microtome for sectioning

of paraffi n embedded tissues for staining. Biobanks

will also require consumables (e.g. chemicals, cryo-

tubes, stationary) for the processing and storage of

samples. Other miscellaneous costs for biobank included

conferences and travel. Biobanks indicated an average

of four per cent–10 per cent of funds are contributed

towards consumables and miscellaneous items.

Computing and databases5. : biobanks require IT

infrastructure to: track and monitor sample locations;

manage clinical information about donors including

de- and re-identifi cation of samples as required; and

monitor follow-up and outcomes data of donors. Of

the banks surveyed, 60 per cent did attribute costs to

IT infrastructure, 27 per cent attributed one per cent

of funding to IT and another 13 per cent attributed

5–8 per cent of funds to IT. Considering the essential

role of IT in data management, the survey suggested

relatively little to no money was actively invested in

this area of biobanking. Twenty per cent of biobanks

surveyed did not yet have any computing hardware

attributable to the biobank, and the remaining banks had

internally developed databases located on institutional

servers. The number of computers per biobank ranged

from zero to fi ve (one at each of the storage sites). As

biobanks grow, it will be important that they invest

into their IT and data management systems. Tools such

as the laboratory information management system

from WAGER could be used to help biobanks with

data management issues and lessons from other well

established biobanks (e.g. Victorian Cancer Biobank)

could be taken in regards to appropriate software and

database systems for biobanking needs. Eighty per cent

of biobanks surveyed collected follow-up information

on donors (either systematically every six to 12 months

or in an ad hoc as required fashion). Ninety-two per

cent of these banks collected the information manually.

Increased usage of data linkage systems (as discussed in

Section 8.2.8) could greatly facilitate these processes and

reduce the staff time required for this important task.

53

8.3 Other observations to consider in the future of biobanking

8.3.1 Governance committee(s)

Regardless of the model of governance established, all

biobanks will need to have a governance committee and

several sub-committees with appropriate representation.

In line with the Australian Standards of Governance,36 the

overarching governance committee should be responsible

for: setting the strategic directions of the bank with clearly

documented objectives; approval of major decisions; budgets

and performance indicators; risk management; policy/

procedure development and adherence; and adherence to

appropriate laws and regulations.

As such, the committee should consist of appropriate

representatives from participating institutions (both

collection and storage sites), clinicians, researchers, pathology

and ethical committees. Governance committees could also

consider patient/donor and/or general public representation

to ensure strategic directions are in line with views of the

public. Other committees essential for a biobank include a

Human Research Ethics Committee (HREC) and a Scientifi c Advisory Committee.

Most host institutions/hospitals have an established HREC,

which biobanks are required to seek approval for specimen

collection and consent procedures. When multiple

institutions are involved, ethical approval for collection and

consent may be required from all HRECs of participating

institutions. Models such as the statewide consortium model

of biobanking, could present an opportunity to develop

statewide policies around biobanking ethics so that in

future approval from one HREC will carry over all HRECs

in the state, to avoid administrative duplication. HRECs

are required by law to have representation of the general

public (lay representation), thus providing one avenue for

the general public and donors/patients to have input into

the collection procedures and consent process. Currently

all research for which specimen samples are requested

must have ethical approval for the research. This is generally

provided by the institution or affi liated university at which

the research is being conducted. These ethical approval

processes for research should remain in line with NHMRC

ethics polices and guidelines.

In addition to HREC approval for consent and collection

processes (responsibility of the bank) and for research

(responsibility of the researchers), biobanks should establish

or have access to a Scientifi c Advisory Committee,

responsible for assessing the scientifi c merit of a research

request. Scientifi c committees should have representation

from clinical and academic experts in the fi eld of interest.

In models such as the consortium, where there are many

tumour types, it may be necessary to have different scientifi c

advisory committees for each tumour group to maintain a

suffi cient level of knowledge in the committee.

8.3.2 Funding arrangements

At present, the funding arrangements for biobanks varies

across NSW, but the majority of banks rely on government

funding grants, such as the NHMRC enabling grant,

institute/department funding and good will (e.g. space, staff,

equipment sharing, infrastructure), and other philanthropic

donations. The issue for many banks is that fi nite funding

grants limit the strategic directions that can be set, and the

ability to gain additional investment, as there is no certainty

of ongoing funding for the future. Similarly, institutional/

departmental funding relies on the good will and wealth of

the host institute and cannot be guaranteed indefi nitely.

Clearly then, it is important for biobanks to be able to

measure their ‘success’ in order to apply for ongoing funding.

Currently this appears only to be based on publications

generated from research that used specimens, highlighting

the importance for biobanks to follow up the research to

which they have supplied samples. Some banks are able to

overcome this by collaborating with researchers in projects

they supply samples to, thus guaranteeing acknowledgement

on publications.

Other performance indicators and measures of ‘success’

could include the number of samples deposited compared

to the number of samples withdrawn from the bank in a

specifi ed time period. To maximise this type of performance

indicator however, marketing plans would need to be

incorporated to the business plan of all banks to ensure

researchers are aware of the bank and the samples provided.

Aside from websites (which themselves appeared to be ad

hoc for biobanks in NSW), the VCB was the only biobank


54

surveyed that actively marketed themselves to researchers

through various media campaigns and provision of

newsletters/updates circulated to all research institutions in

Victoria. This style of marketing, which is more cost-effective

for large networks or consortia, may be useful for biobanks in

NSW as well.

Another method of ‘funding’ is that of cost recovery for

samples. Many banks currently do not charge researchers

for samples, or only charge for freight costs to deliver the

samples. Some larger banks have established cost recovery

procedures to, in part; recover the costs associated with

collecting, processing and storing the samples. There are two

main concerns with cost recovery:

One is the resources required to follow up payments, ▪especially if there are tiers to cost recovery (e.g. based

on type of researcher – academic or commercial – and/

or types of samples and level of processing required) or

if requests are sent in batches based on tissue availability.

Another concern is that researchers will not be able ▪to afford to pay for tissue samples as these costs are

generally not budgeted for in the research grants. For

cost recovery processes to work optimally in future

it may require a shift in the way researchers apply for

funding (i.e. to allow for costs of tissue sample) when

proposing future research projects.

One advantage of adopting the consortium of biobanks

governance model is that funding applications would be

for one unifi ed group, therefore eliminating competition

between individual banks. The combined infrastructure is

also likely to make following up of publications easier to

manage. Another advantage is that innovative cost recovery

models can be generated (e.g. the modular cost recovery

model of VCB) to enable partial cost recovery of samples.

8.3.3 Sample ‘ownership’

The idea of sample or specimen ‘ownership’ is important

for biobanks. Some researchers are reluctant to the idea of

consortiums for fear of losing control of ‘their’ samples and

having less say in which research the samples will go to. This

also impacts on collection versus storage sites, with many

banks reluctant to send their samples to centralised site for

storage for similar reasons.

8.3.4 Sharing of resources

There are currently small biobanks for rare cancers, which by

themselves could not afford the infrastructure of a biobank.

These banks therefore tend to share facilities and even

staff with larger banks at the institution in which they are

housed. This is an economical solution for these small banks.

This type of infrastructure sharing however, could present

complication regarding funding arrangements in a cancer

specifi c network model.

8.3.5 Good will and relationships

Biobanks rely on good relationships and communication

between surgeons, pathology, biobanks and researchers.

One of the concerns regarding a large biobank network

or consortium raised was that a lack of human interaction

(especially important to maintain the good will of surgeon

and pathology laboratories), could dissolve the relationships

established resulting in a breakdown of communication.

Therefore, if a network or consortium were to be

considered, specifi c provisions regarding the maintenance of

relationships at each participating hospital would be essential.

8.3.6 Other types of collections

Other types of tissue collections not discussed in this chapter

which could be explored in future include:

Collections located in anatomical pathology laboratories ▪in hospitals, which store unused specimens for up to 20

years. Consent, collection and storage protocols may

vary from formalised biobanks, but introduction of SOPs

could increase the ‘usability’ of these specimens in future.

Specifi c collections in individual laboratories collected ▪specifi cally for one research study. Unused samples

could potentially be used for other research if consent

for tissue use was broad or re-collected. In this case,

it would probably be necessary for a researcher to

donate their unused samples to formalised biobanks,

which would require the good will of the researcher and

assume there was no reluctance to share samples.

55

8.3.7 Bio-ethical Issues and considerations

When discussing biobanks, there are certain bio-ethical issues

that need to be considered, such as ‘ownership’ of donated

samples and the ethics of making a profi t from human tissue

(e.g. what are the consequence of supplying samples for

commercial research?); the inclusion of lay persons (patient/

donor) as representatives on biobank committees such

as HREC (mandatory) or scientifi c advisory committees;

issues around consent, what is broad consent, what are the

limitations of this consent, can there be staged choice for

consent (i.e. a donor consents to certain aspects, but not all)

and can the donor withdraw consent at any time?vi While

several of these issues have been considered by biobanks

(for example, broad consent for all banks includes the ability

to withdraw samples at any time, many banks have staged

consent were donors select the level(s) of research they will

consent to and the Australian Breast Cancer Tissue Bank

has a lay representative in their governance committee), the

issues will need further exploration as different models of

biobank governance arise.

At a minimum, biobanks (including consortia if established)

should adhere to the NHMRC guidelines regarding consent

for tissue collection and data linkage/re-identifi cation.

NHMRC states that in relation to collection of tissue in

research consent may be:

specifi c ▪ : limited to the specifi c project tin consideration

extended ▪ : for the use of data or tissue in future research

projects (that are an extension of the original or closely

related to the original project)

unspecifi ed ▪ : for the use in future research.48

The limited information on the type of research to be

conducted for extended or unspecifi ed consent must still

give suffi cient and adequate information for the donor to

make an informed decision, and may also include permission

to enter data or tissue into a bank. Patients do not need to

give a reason if they choose not to consent or to withdraw

consent and should not be disadvantage because of their

decision. Participants are able to withdraw consent at

any time.50

The NHMRC Guidelines also state that data collected for the

purposes of biobanking must be re-identifi able (i.e. identifi ers

removed and replaced by code, but retain the ability to be

re-identifi ed as required). While most data are collected,

aggregated and stored for a single purpose or activity,

permission can be sought from participants to ‘bank’ their

data for possible use in future research projects.49

8.4 Conclusion

There are currently various models of governance

arrangements for biobanks located in NSW, ranging from

small biobanks with one collection site, to larger banks

with several collection sites and storage sites across NSW

and in some cases Australia. The complexities of biobank

governance arise when considering ‘ownership’ of samples,

SOPs, cost recovery and prioritisation.

In future there is much to be gained by increasing

coordination and consistency across biobanks and increasing

access by researchers. One relatively simple method to do

this is to develop stakeholder networks, which allow formal

discussion among stakeholders regarding these issues and

can allow for development of specimen locators to facilitate

searches for specifi c samples across multiple banks at one

time. Building on this, banks could become accredited

to ensure adherence to agreed SOPs and consistency of

samples across biobanks. The simplicity of these models is

that they do not require any changes to existing governance

arrangements.

In addition to this, formalised biobanks could develop

consortia across NSW or Australia based on tumour groups.

The increased resources from this model would enhance

consistency across biobanks, but the required governance

changes to a single entity could generate anxiety amongst

existing biobanks.

A fi nal model for consideration is to develop a statewide

consortium of biobanks across NSW, which will allow

enhanced resource sharing and generate consistency

statewide. This model may have advantages relating to

funding options and generation of cost recovery models.

The bioethical issues and considerations for future research on tissue banks were raised from discussions with the Centre for Values, Ethics vi.

& the Law in Medicine (VELiM) (Associate Professor Ian Kerridge, Emeritus Professor Miles Little, Dr Wendy Lipworth and Bronwen

Morrell) University of Sydney, 17 July 2008.


56

However, it would still require governance under a single

entity which may not be welcome by existing biobanks.

Other important issues to be considered in any model

for biobanks include: the role of pathology departments

and providers; supporting key infrastructure such as data

management and data linkage; the distinction between clinical

and epidemiological biobanks; recommended committee

memberships; consistency of SOPs; funding model options;

maintaining relationships between biobanks, surgeons and

pathology; and bio-ethical considerations, especially relating

to consent from donors.

In order to assess the best approach to maximise the

future of biobanking in NSW, it will be important for all

stakeholders to actively contribute to the discussion of

options and arising issues. This may include biobank heads,

researchers, specimen donors, bio-ethicists, clinicians

and pathologists.

57

9 Appendixes

9.1.1 Formalised Biobank Governance Arrangements: telephone questionnaire

Background Information

Date of survey. ▪

Name of biobank. ▪

Name of person interviewed. ▪

Position of person interviewed. ▪

Contact email/telephone/address. ▪

Website, if available. ▪

General Information

Purpose of tissue/tumour collection: Does the bank 1.

collect general samples for future (as yet unspecifi ed)

research and/or samples for specifi c research proposals

for researchers?

Broad types of tumour samples collected (e.g. Breast, 2.

Prostate, Melanoma, Multiple, etc)?

Broad types of specimens collected (e.g. blood and blood 3.

products, tissue (normal and/or tumour, DNA/RNA)?

Single or multiple collection sites: does the bank collect 4.

only from the one site, or multiple sites? If multiple

collection sites – are samples stored at the other

collection sites, or are all samples transported to the

main site? At each collection site, are samples collected

from the site itself and/or transported to the site from

other hospitals/institutions? If other hospitals/institutions,

what are their names?

Are there other biobanks located at the institution? Do 5.

you share facilities/staff with other biobanks?

How the samples and data are linked (e.g. barcode 6.

system, identifying number/code)?

How is the data for the samples de-identifi ed and re-7.

identifi ed as required?

Entity status and funding sources

What is the entity status of your biobank (e.g. 8.

department within a hospital/institution, not for profi t

organisation with government funding, not for profi t

organisation without government funding, for profi t

organisation)?

What was the funding source for the establishment 9.

of the biobank (hospital/institutional, government e.g.

NHMRC grant, philanthropic, etc)?

What is the current funding source for the biobank?10.

Does the biobank charge researchers (e.g. cost recovery 11.

or administration fees) for access to samples? What are

the fee arrangements (eg is there a different fee for

internal researchers compared to external researchers

or pharmaceutical companies? Is there a different fee

depending on the amount of processing/manipulation

required for the sample type?).

Organisational Structure and Governance Arrangements

What are the internal management arrangements of the 12.

biobanks, i.e. to whom does the bank report (eg biobank

board or management committee, hospital board)?

If there are multiple collection/storage sites, to whom 13.

do the individual sites report (eg biobank board

or management committee, hospital board)? If the

collection is for banking for future research, who

provides ethics approval for this collection?

Who/what body is responsible for setting the strategic 14.

directions of the biobank?

What other committees/groups are involved with the 15.

biobank (e.g. scientifi c advisory group)?

Is the biobank a part of or affi liated with broader 16.

network/consortium of biobanks? In what capacity?

APPENDIX A EXAMPLE QUESTIONNAIRES


58

Standard Operating Procedures (SOP)

Does the biobanks have SOPs for:17.

Consent. ▪

Specimen collection. ▪

Preservation. ▪

Manipulation (i.e. making tissue arrays). ▪

Storage. ▪

Distribution (i.e. to researchers). ▪

De-identifi cation and re-identifi cation of data. ▪

Bioinformatics (i.e. data storage). ▪

Data collection (demographic, clinical, outcomes). ▪

Researcher access. ▪

Were these internally developed or based on external 18.

sources (e.g. other biobanks procedures)?

Can you provide HMA with a copy of the SOPs?19.

Researcher access

How would researchers fi nd out about your biobank and 20.

the types of samples you have (eg webpage and sample

search facilities, telephone, other researchers)?

How many requests have you had for tissue samples 21.

(either normal or tumour) in the last 12 months?

How many of these were approved by the banks?22.

9.1.2 Specifi c Tissue Collections: email questionnaire

What is the broad cancer category of the tissue ▪collected (i.e. breast, colorectal etc)?

What type of specimens were collected (ie tissue – ▪normal/tumour, blood and blood products, DNA,

other etc)?

Was the study for which the specimens were collected ▪part of a specifi c research project or clinical trial? If yes,

which one(s)?

Was consent for the collection and use of samples ▪restricted to the study(s) in question, or was broad

consent given by the donor so that the samples can also

be used in future research projects?

9.1.3 Follow-up survey for Formalised Biobanks

General Information

Name of Tissue Bank:

Central Location of Tissue Bank:

Could you please provide us the information on the 1.

current size of your collection and categorise by tumour

site if possible.

Tumour Site No. of specimens

Total number of specimens:

To date, how many donors have contributed to your 2.

tumour bank?

What is the average (approximate) number of donors 3.

per week/month (as appropriate)?

From each donor, what are the types of samples 4.

routinely stored? (i.e. paraffi n embedded samples, fresh

frozen samples, fresh samples, blood, DNA, RNA etc.)?

What additional processes can be undertaken by your 5.

tissue bank on request from a researcher (i.e. DNA or

RNA extraction, H&E staining etc.)?

Does your tissue bank have any rare samples in limited 6.

supply? If yes, what is/are the tumour type(s), tumour

location(s) and number of specimens?

What infrastructure currently exists at your tissue bank 7.

in terms of IT (i.e. computers, databases etc.) or other

(i.e. large equipment such as freezers etc.)?

59

Entity Status and Funding Sources

How much funding has the tissue bank received since 8.

its inception, and from which funding agency/agencies?

Please complete whatever information you are able

to provide on the table below, plus the total funding

received by the tissue banks and the year the bank

began operation.

Year(s) of funding(i.e. 2004–2009)

Funding agency Amount funded by category:

<$1,000$1,000 - $50,000

$50,001 - $100,000$100,001 - $500,000

>$500,000

Total funding since inception (by funding category above):

Year tissue bank began operation:

In broad terms, what percentage of funds has been 9.

allocated to each of the following categories:

Personnel ▪

IT resources ▪

Equipment ▪

General maintenance ▪

Other (please list if possible) ▪

When does your current funding expire?10.

What plans or strategies are in place for securing future 11.

funding and for the long term sustenance of the bank?

Organisational Structure and Governance Arrangements

How many personnel are employed by the tissue bank 12.

(full time equivalents), and what are their positions?

Do you measure the performance of your tissue bank? 13.

If yes, how? (i.e. number of specimens stored, number of

specimens accessed by researchers, number of research

publications resulting from specimen use etc)?

Standard Operating Procedures (SOP)

What is the routine procedure for obtaining patient 14.

consent, and the approximate success rate for obtaining

patient consent? If possible, please provide HMA a copy

of your standard Patient Consent Form if you have not

already done so?

What clinical information is routinely collected from each 15.

donor? If possible, please provide HMA a copy of your

standard Clinical Data Collection Form(s) if you have not

already done so?

Do you collect any additional clinical follow-up data from 16.

donors? If so, how is this done (i.e. via a data linkage

system such as CHeReL or manually)?

What quality control measures are in place for ensuring 17.

specimen integrity (i.e. systems for storage, monitoring,

security etc)?

Researcher Access

Would the researchers accessing specimens from the 18.

tumour bank be expected to :

Acknowledge the tumour bank in their publication? ▪

Provide the tumour bank with copies of the ▪accepted publication?

Return unused specimens to tumour bank? ▪

Provide additional information on the specimens they ▪have studied?

Other? ▪


60

Could you please provide us information on the number 19.

of specimens accessed by researchers over the following

time periods:

Over the past 12 months. ▪

Since tissue bank inception. ▪

Could you please provide us information on the number 20.

of publications arising from researcher access to your

tissue bank since its inception if known and if not

already provided?

9.1.4 Researchers: telephone questionnaire

Date:

Name of Person Interviewed:

Institute:

Contact email:

Contact phone:

Which tumour/biobank have you accessed?1.

How did you fi nd out about the biobank?2.

How did you access the biobank? For example, was it 3.

online via the web, did you download a form and post/

email back, etc.

If you obtained specimens from multiple banks, how 4.

were the different banks accessed? Were there any

diffi culties with this process?

Were you able to easily fi nd out if the bank had the 5.

specimens you required?

How long did it take to acquire specimens? Was this 6.

within your expected time frame?

What are the reporting requirements to the biobank 7.

for using their samples? Do these requirements create a

burden to the research?

Were there any costs associated with obtaining the 8.

samples? If so, were the costs acceptable or a deterrent

to obtaining samples?

What do you see as the barriers to access for 9.

researchers in retrieving specimens from biobanks?

What do you see as the facilitators to access for 10.

researchers in retrieving specimens from biobanks?

61

APPENDIX B GOVERNANCE ARRANGEMENTS OF INTERNATIONAL BIOBANKS

Country Bank Name Entity Status Governed by Funders Sample Collection

UK onCore UK Non-profi t and charity Board of trustees Department of Health

England;

Medical Research

Council; and

Cancer Research UK

Scotland Generation Scotland Non-profi t Scientifi c committee;

Advisory board

Scottish University

Medical Schools,

Biomedical Research

Institutes,

NHS in Scotland

UK UK Biobank* Registered charity Wellcome Trust

Medical Research

Council

Dept of Health

Scottish Executive

Northwest Regional

Development Agency

EU Tubafrost (The

European Human

Tumor Frozen Tissue

Bank)

Group of pathology and

research depts across

Europe all involved

in cancer care and/or

research

Cordis: Community

Research and Dev

Information Service

Organisation of

European Cancer

Institutes

Tissues collected

internationally but

stored at local sites

EU Genome Austria Tissue

Bank

Non-profi t Medical University of

Graz

Primarily the Genome

Research in Austria

project

Tissues and blood

collected internationally

but stored on site

Spain Spanish National

Cancer Research

Centre Tumour Bank

Network

Non-profi t Spanish National Cancer

Research Centre,

Molecular Pathology

Programme

Ministry of Health Tumour and matched

normal tissue collected

and stored at

participating hospitals

in Spain.

Sweden Swedish National

Biobank Program

Wallenberg Consortium

North (joint funder)

governed by Advisory

Group consisting of

Vice Chancellors of

participating universities,

then a Coordinating

Group as Executive

Mgt.

Swegene Consortium

Wallenberg Consortium

North

10 participating

biobanks

Table 9.1 Governance arrangements of international biobanks


62

Country Bank Name Entity Status Governed by Funders Sample Collection

Canada Ontario Tumour Bank Non-profi t Board of directors;

Scientifi c Advisory

Board

Government of Ontario More than 5 hospital

sites in Ontario

Canada Alberta Research

Tumor Bank

Provincial Executive

Committee;

Academic partners

(university); and

Health authority

partners

Canadian Breast Cancer

Foundation – Prairies/

NWT Chapter

Alberta Cancer Board

Canadian Tumour

Repository Network

3 treatment facilities

Canada Canadian Tumour

Repository Network

Non-profi t Institutes of Health

Research under

direction of the

Canadian Association

of Provincial Cancer

Agencies

6 charter members

(bio-banks) across

Canada

US Cooperative Human

Tissue Network

Non-profi t Coordinating

Committee including

Principal Investigator

and audit member from

each division

National Cancer

Institute

6 Divisions

US Mayo Clinic Scottsdale Multiple Myeloma

Research Consortium

14 contributing sites in

US and Canada

US Early Detection

Research Network

Non-profi t National Cancer

Institute

US Cooperative Breast

Cancer Tissue Resource

Non-profi t National Cancer

Institute

More than 4

participating hospitals /

organisations

US National Biospecimen

Network: Prostate

SPORE Pilot

Non-profi t Board of Governors;

Operations Centre;

Business Units

National Cancer

Institute

US Bioserve For-profi t Samples from four

continents

US/UK Asterand For-profi t Board of Directors Investors/stockholders 36 donor institutions

world-wide

*UK Biobank currently stores baseline information from blood and urine, not tissue, samples and is not solely focussed on cancer research

(from www.ukbiobank.ac.uk).

Table 9.1 Governance arrangements of international biobanks (cont’d)

63

APPENDIX C COMPARISON OF INTERNATIONAL BIOBANK GUIDELINES

Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB

NBN52 NCI53 CCB54

Best Practices for Biospecimen Collection

Collection priority based on defi ned purpose

of each biospecimen resource

Collect from ethnically and geographically

diverse populations of all ages.

Biospecimens collected from populations with

demographic characteristics and diversity

appropriate to the research

Draw from large network of academic and

community medical centres.

Collection can be from a variety of context

including surgical procedures, organ donation,

transplantation...

Relevant data including collection and

processing protocols and time elapsed

during collection and processing recorded by

biospecimen resource.

Pathologist determines proportion of

specimen needed for diagnosis.

Pathologist to determine specimen portions

necessary for pathologic diagnosis, to ensure

patient care is not compromised.

Samples collected during the course of

diagnostic or therapeutic interventions.

Standardized, monitored shipping procedures

with a tracking system.

Specimen quality assurance through ‘H and

E’ analysis, pathologist review, and integrity

check.

Scannable bar codes to track specimens. Each storage vessel to have a unique identifi er

or combination of identifi ers fi rmly affi xed to

the container.

Standard operating procedures for specimen

collection.

Train collection personnel using standard

protocols. and

Ensure personnel are trained and qualifi ed to

ensure high quality samples. Use of SOP for

consistency.

Close contact with collection site personnel

to ensure standards.

Best Practices for Biospecimen Processing and Annotation

Procure and process specimens for storage

within one hour post-excision using detailed,

standardised protocols.

Minimise time for collection for solid tumours

and reduce temperature ASAP. Rapid

processing may not be as critical for other

specimen types e.g. blood


64

NBN52 NCI53 CCB54

Best Practices for Biospecimen Processing and Annotation (cont’d)

Processing should use the method that

preserves the most analytes unless the aim

of a particular study specifi cally required an

alternative.

Use pathologists to verify and evaluate

biospecimens.

Link all assay/test results and relevant

annotation to specimens and provide

information to researchers.

All relevant information should be tied to the

unique identifi er.

Provide information/annotation obtained

during quality control of specimen in a

database for researchers to access.

Uniform non-redundant vocabulary for data

collection e.g. caBIGTM).

Use common data elements for standardised

data collection.

Collect complete data on all elements of a

minimal data set to meet user needs.

Track researcher request for data to review

and modify minimal data set as required.

Collect and store longitudinal data. Collect longitudinal data as required for study

purposes which may include demographic

data, lifestyle factors, environmental and

occupational exposures, cancer history,

diagnostic studies, treatment data and

outcomes data. Data to be stored and

collected according to SOP and privacy

regulations.

Ensure the accuracy of data entry through

the use of standardised terminology and

computer data-entry forms. and

Implement independent checks of data. Employ techniques to validate data accuracy.

Best Practices for Biospecimen Storage and Distribution:

Samples to be stored in specifi cally designed

facilities to maintain quality and security.

Collect non-diseased matching adjacent tissue

(normal tissue) and blood/serum specimens.

Develop standards for storage depending on

tissue type and storage condition.

Individual specimen types (e.g. frozen tissue,

paraffi n embedded tissue, glass slides, blood,

serum, urine, RNA and DNA) should have

individual SOP for preservation and storage

developed.

Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB (cont’d)

65

NBN52 NCI53 CCB54

Best Practices for Biospecimen Storage and Distribution (cont’d):

SOPs to include storage temperatures

such as: paraffi n blocks stored below 27˚C;

liquids (blood, urine) specimen components

separated before storage; tissues stored in

the vapour phase of liquid nitrogen freezers

kept below -140˚C.

Storage personnel to record storage

information especially deviations from SOP

and freeze/thaw episodes.

Specimens should be stored in a stabilised

state with minimal unnecessary freeze/

thawing.

Storage vessels to be appropriate for

conditions of storage and volumes of samples.

Monitor specimens around the clock,

perform, weekly maintenance and annual

quality checks of freezers, and use freezer

backup procedures.

Automated security systems to continuously

monitor the function of storage equipment,

with automatically activated back up

equipment (e.g. power supply).

Retrieve samples according to SOP to

safeguard specimen quality.

Use multiple storage sites (on or off site).

And periodically audit, inventory, and certify

location, identity, and quality of specimens.

Ship samples at as constant a temperature

as possible with appropriate temperature

control packs for the distance of travel e.g.

freezer packs cooled to -20˚C for frozen

samples, dry ice for samples stored at -70˚C

and freezer packs cooled to -15˚C to maintain

fridge temperatures.

Recipients to be notifi ed when samples are

shipped and repository notifi ed when samples

received. Tracking method/shipping log to

be implemented (either computerised or

written).

Best Practices for Bioinformatics:

Maintain close relationship with system

developers, researchers, data managers, and

repository managers.

Systems should be able to link with local

systems.



66

NBN52 NCI53 CCB54

Best Practices for Bioinformatics (cont’d):

Use automated data extraction or

multiple checks/standardised language in

bioinformatics system.

Bioinformatics system to track all aspects

of biospecimen collection, processing and

distribution to support annotation. Must

comply with privacy regulations.

Feed research results back into system for

access by researchers.

Employ a searchable and minable Web-based

system. and

Provide extensive network security and

access control.

System to be secure and to be able to

provide audit logs of all access to protected

health information

Include tools to extract free text from e.g.

pathology reports.

Best Practices for Consumer/User Needs

End-users should only request samples that

are going to be used.

Transparent and open communication

between research and community (donors or

potential donors)

Give priority to researchers at collecting

institutions.

Samples given on basis of best use.

Base prioritisation on merit review using

tissue utilisation committee and standardised

criteria.

Have policies to prevent last sample

distribution and researcher monopolisation of

samples.

Separate provision polices may be required

for samples which are close to depletion.

Directly solicit researcher feedback on

particular samples/shipment.

Feedback questionnaire on the quality of

samples received should be standard practice.

Evaluate repository performance through

committees/review groups.

Regularly assess and change in response to

researcher needs.

Develop policies around data sharing

of results keeping in mind the need for

researcher to protect publication rights of

research.


67


NBN52 NCI53 CCB54

Best Practices for Business Plan and Operations

Establish a written quality management

system or adheres to a published system.

Quality management should be integral to the

management of any biosample resource.

Develop a SOP manual for all aspects from

collection to distribution.

Establish and maintain close relationships with

all relevant staff at collection sites.

Current SOPs available for all staff at all times

Ensure standard biohazard regulations and

general laboratory safety is in place.

Combine banking and prospective tissue

collection.

Accurately determine costs of all stages of

repository operation to fi nancially sustain

repository.

Samples should be assigned a monetary value;

rather fees should be levied to recover costs

towards collection and storage of samples

and/or in exchange for services that add utility

to the samples.

Continually assess and incorporate new

technologies. and

Review all SOPs every 2 years and whenever

signifi cant changes in practices, procedures,

technologies or law/regulation are made.

Require acknowledgment of repository in

publications and provide specifi c language

with which to do so.

Best Practices for Privacy, Ethical Concerns, and Consent Issues

Comply with applicable privacy statutes and

regulations.

Limit access of medical information to only

those required.

Responsible custodianship of samples. Repositories are only custodians of samples.

Limit access to codes that link patient

identifying information to their tissue

specimens through physical and/or cyber

procedures.

Privacy protection according to federal

regulations of privacy.

Use institutional review board oversight of

repository practices.

Require institutional review board review of

research for researchers requesting samples.

Use bioethics advisory board or other

governance and oversight board/committee

to oversee privacy/confi dentiality procedures.

Access decision guided by set of general

principles.

Samples used (where possible) on the basis

of the likelihood of being put to a good

and benefi cial use in a timely fashion after

donation


68

NBN52 NCI53 CCB54

Best Practices for Privacy, Ethical Concerns, and Consent Issues (cont’d)

Obtain specimens obtained from fully

consented tissue sources.

Informed consent according to NCI

regulations.

Informed consent for use of samples, including

reciprocal policies internationally and across

cultural differences where necessary.

Use tiered consent process.

Best Practices for Intellectual Property and

Legal Issues

Develop and adhere to specifi c IP policy. Develop IP and resource sharing policy.

Allow tissue sources to withdraw samples if

they are not de-identifi ed.

Use a formal agreement with researchers that

specifi es appropriate sample use.

Specify responsibility for assuming risks for

use of biospecimens in tissue use agreements.

and

Carefully review researcher submissions and

credentials.

Best Practices for Public Relations, Marketing,

and Education

Market the tissue resource, using word of

mouth, journal advertisements, and exhibits

at scientifi c meetings.

Provide information about generalised

research fi ndings to tissue sources, physicians,

and researchers.

Categories are based on those from NBN. NCI and CCB themes were organised to align with these themes for comparison purposes.


69

AP

PE

ND

IX D

S

UM

MA

RY

OF

DE

SIG

N A

ND

GO

VE

RN

AN

CE

FIN

DIN

GS

FO

R E

AC

H B

IOB

AN

K

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Sydney

Mela

no

ma

Unit

Bio

-Speci

men B

ank

(succ

ess

or

to M

ela

no

ma

and S

kin C

ance

r R

ese

arch

Inst

itute

Tum

our

Ban

k

whic

h n

o lo

nge

r exis

ts –

MA

SCR

I sp

eci

mens

now

under

SM

U c

ura

tion)

Est

ablis

hed in

2007.

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

and

speci

fi c

pro

ject

s.C

urr

ently

multip

le c

olle

ctio

n s

ites

and o

ne

stora

ge s

ite.

Shar

ed s

tora

ge fac

ilities

with B

reas

t C

ance

r T

issu

e

Ban

k (R

PAH

node)

.

Routinely

sto

re fre

sh

froze

n t

issu

e, w

hole

blo

od,

pla

sma,

seru

m, b

uff

y co

at.

Additio

nal

pro

cess

es

on

request

incl

ude D

NA

or

RN

A e

xtr

action, H

&E

stai

nin

g. 2

x -

80C

fre

eze

rs.

1x c

entr

ifuge

.

Depar

tment

within

inst

itution (

Univ

ers

ity

of Sy

dney

Facu

lty

of

Medic

ine)

.

Funded b

y pro

gram

gra

nts

(CI N

SW

and N

HM

RC

).

Curr

ent

fundin

g expir

atio

n

201

0.

Bio

speci

men B

ank

Co

mm

itte

e se

par

ate

fro

m h

ousi

ng

inst

itution

resp

onsi

ble

for

polic

y,

pro

gress

, rese

arch

feedbac

k an

d r

evi

ew

of

applic

atio

ns

for

use

of

speci

mens.

3.5

FT

E s

taff.

Ban

k perf

orm

ance

meas

ure

d b

y num

ber

of

speci

mens

store

d.

SOPs

for

pat

ient

conse

nt

and s

peci

men

colle

ctio

n, p

roce

ssin

g an

d

stora

ge. T

he

SM

U t

eam

endeav

ours

to c

onse

nt

all n

ew

SM

U p

atie

nts

with ~

90%

succ

ess

. Most

then p

rovi

de

a blo

od

sam

ple

and s

om

e ar

e

subse

quently

suitab

le for

tiss

ue

colle

ctio

n. B

ioban

k

dat

a st

ore

d o

n E

XC

EL

spre

adsh

eet

usi

ng

dat

a

entr

y gu

idelin

es,

with

pap

er

note

of sp

eci

men

loca

tion. T

reat

ment,

follo

w-u

p a

nd p

atholo

gy

deta

ils a

re e

nte

red in

to

a re

sear

ch d

atab

ase.

Deve

lopin

g lin

k to

SM

U

clin

ical

dat

abas

e. S

OPs

deve

loped u

sing

guid

ance

fro

m: B

CT

B; d

ocu

ments

sourc

ed fro

m A

BN

incl

udin

g IS

BER

Best

Pra

ctic

e G

uid

elin

es,

WA

Rese

arch

Lab

ora

tori

es,

Pete

r M

cCal

lum

tis

sue

and

blo

od b

anki

ng

pro

cess

es.

Freeze

rs a

larm

ed a

nd

reco

rd t

em

pera

ture

devi

atio

ns.

Speci

mens

div

ided a

nd s

tore

d in

separ

ate

freeze

rs.

Open t

o a

ll re

sear

chers

with p

riori

ty a

ccess

giv

en

to r

ese

arch

ers

ass

oci

ated

with o

r co

llabora

ting

with

SM

U. R

ese

arch

ers

will

be

char

ged fre

ight

cost

s only

.

Hav

e h

ad n

o r

ese

arch

er

request

s to

dat

e fo

r SM

U

speci

mens

(ban

k only

initia

ted in

Oct

ober

2007),

but

120 h

isto

rica

l MA

SCR

I

speci

mens

acce

ssed

by

rese

arch

ers

in p

ast

year

. Unkn

ow

n n

um

ber

public

atio

ns

aris

ing

fro

m

speci

men a

ccess

.


70

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Aust

ralia

n P

rost

ate

Can

cer

Colla

bora

tion (

APC

C)

Bio

Reso

urc

e

Est

ablis

hed in

2005.

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

pro

ject

s.

Multip

le c

olle

ctio

n s

ites

and four

stora

ge n

odes

in four

Aust

ralia

n s

tate

s,

linke

d v

ia a

web-b

ased

dat

abas

e. A

t G

arva

n

node, f

acili

ties

shar

ed w

ith

bre

ast

and p

ancr

eat

ic

cance

r re

sear

ch g

roups.

Affi li

ated w

ith A

BN

but

not

a m

em

ber.

Routinely

store

fre

sh fro

zen n

orm

al

and c

ance

r tiss

ue, p

araf

fi n

em

bedded t

issu

e, f

roze

n

pla

sma,

seru

m, b

uff

y co

at,

ambie

nt

tem

pera

ture

whole

blo

od G

uth

rie

blo

ts. A

dditio

nal

pro

cess

es

on r

equest

incl

ude D

NA

and R

NA

extr

action. 1

x

-80C

fre

eze

r per

node.

So

me

acce

ss t

o li

quid

nitro

gen s

tora

ge.

Not

for

pro

fi t

org

anis

atio

n

curr

ently

funded b

y

NH

MR

C e

nab

ling

gran

t.

Fundin

g so

urc

es

hav

e

incl

uded P

rost

ate

Can

cer

Foundat

ion A

ust

ralia

,

Co

mm

onw

eal

th B

ank,

Andro

logy

Aust

ralia

,

NH

MR

C. 8

5%

funds

allo

cate

d t

o p

ers

onnel,

with r

em

ainder

to

equip

ment, m

ainte

nan

ce,

IT. C

urr

ent

fundin

g

expir

atio

n 2

009.

Gove

rned n

atio

nal

ly b

y

Exe

cutive

Co

mm

itte

e

consi

stin

g of Pro

fess

ori

al

Head

s of Pro

stat

e

Can

cer

Rese

arch

Gro

ups

at e

ach n

ode, w

ith

resp

onsi

bili

ty for

stra

tegi

c

dir

ect

ion. M

anag

ed b

y

nat

ional

Bio

Reso

urc

e

Man

agem

ent

Co

mm

itte

e

resp

onsi

ble

for

polic

ies

and p

roce

dure

s. A

nat

ional

Tis

sue

Ban

k C

oord

inat

ors

Co

mm

itte

e an

d lo

cal

tiss

ue

ban

k co

mm

itte

es

are

resp

onsi

ble

for

opera

tional

issu

es.

A

nat

ional

Bio

Reso

urc

e

Tis

sue

Acc

ess

Co

mm

itte

e

dete

rmin

es

scie

ntifi c

meri

t

and feas

ibili

ty o

f re

sear

ch

applic

atio

ns.

5 F

TE s

taff

(one

Stat

e C

oord

inat

or

at G

arva

n n

ode)

. Ban

k

perf

orm

ance

meas

ure

d

by

num

ber

of par

tici

pan

ts,

pro

port

ion d

onat

ing,

speci

mens

rele

ased t

o

rese

arch

ers

.

SOPs

for

pat

ient

conse

nt,

speci

men/d

ata

colle

ctio

n,

pro

cess

ing

and s

tora

ge.

Uro

logi

st a

ppro

aches

pat

ient

re t

issu

e

donat

ion. I

f ag

reed, S

tate

Coord

inat

or

pro

vides

info

rmat

ion a

nd c

onse

nts

pat

ient. 9

9%

succ

ess

rat

e.

Min

imum

pat

holo

gy a

nd

clin

ical

dat

a se

ts r

outinely

colle

cted a

nd s

tore

d

on w

eb-b

ased c

entr

al

dat

abas

e. A

dditio

nal

clin

ical

dat

a co

llect

ed

man

ual

ly. S

OPs

bas

ed

on e

xte

rnal

sourc

es

incl

udin

g IS

BER

, NC

I 2nd

genera

tion, O

EC

D T

issu

e

Ban

king

Best

Pra

ctic

e

Guid

elin

es.

Fre

eze

r units

alar

med a

nd m

onitore

d.

Speci

mens

div

ided a

nd

house

d s

epar

ately

. Tis

sues

his

tolo

gica

lly r

evi

ew

ed

pri

or

to r

ele

ase.

Rese

arch

er

Acc

ess

Polic

y

deve

loped u

sing

NH

MR

C

guid

elin

es

for

Tis

sue

Ban

ks

under

enab

ling

gran

ts.

Pri

ori

ty o

f ac

cess

to lo

cal

site

rese

arch

ers

, and n

o

acce

ss t

o c

om

merc

ial

org

anis

atio

ns.

Rese

arch

ers

requir

ed t

o a

cknow

ledge

ban

k in

public

atio

ns,

pro

vide

ban

k w

ith c

opie

s

of public

atio

ns,

pro

vide

dat

a on s

peci

men

inte

grity,

retu

rn u

nuse

d

speci

mens

to b

ank.

The

need t

o “

mar

ket”

the

bio

reso

urc

e to

pote

ntial

rese

arch

ers

has

been

reco

gnis

ed t

o e

nsu

re u

se

of bio

speci

mens.

Only

50%

of st

ore

d m

ateri

al

fro

m a

ny

pat

ient

rele

ased

ove

r fi rs

t 5 y

ear

s. H

ad

a par

tial

cost

reco

very

syst

em

in p

lace

but

this

limited r

ese

arch

er

use

so

ceas

ed t

his in

2007.

Hav

e

since

had

14 r

equest

s,

all a

ppro

ved. S

peci

mens

acce

ssed: 1

2 m

icro

arra

ys

and 8

5 fro

zen t

issu

es.

No

public

atio

ns

aris

ing

fro

m

speci

men a

ccess

to d

ate.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)

71

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

NSW

Pan

creat

ic C

ance

r

Netw

ork

Tis

sue

Ban

k

Est

ablis

hed in

2002.

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

and

speci

fi c

pro

ject

s. T

wo

colle

ctio

n a

nd s

tora

ge

site

s. S

om

e st

ora

ge

faci

litie

s sh

ared w

ith

oth

er

bio

ban

ks a

t G

arva

n.

Routinely

sto

re fre

sh

tiss

ue, p

araf

fi n b

lock

s,

extr

acte

d D

NA

and R

NA

.

Additio

nal

pro

cess

es

on r

equest

incl

ude d

ata

QA

, tis

sue

mic

roar

ray,

H&

E s

tain

s, IH

C. S

eve

ral

freeze

rs.

Not

for

pro

fi t

org

anis

atio

n.

Curr

ently

funded v

ia

Stra

tegi

c R

ese

arch

Par

tners

hip

Gra

nt

fro

m

Can

cer

Counci

l NSW

.

Inte

rnal

support

als

o.

Curr

ent

fundin

g expir

atio

n

201

0.

Gove

rned b

y Exe

cutive

Co

mm

itte

e of th

e

NSW

Pan

creat

ic

Can

cer

Netw

ork

whic

h

is in

dependent

of th

e

housi

ng

inst

itution. T

his

Co

mm

itte

e co

mpri

ses

Chie

f In

vest

igat

ors

fro

m

fi ve

Netw

ork

sites

plu

s

two o

ther

Netw

ork

staf

f, an

d is

resp

onsi

ble

for

stra

tegi

c dir

ect

ions

and s

cientifi c

revi

ew

of

rese

arch

er

applic

atio

ns.

10 F

TE s

taff (

inte

rnal

and e

xte

rnal

). B

ank

perf

orm

ance

meas

ure

d

by

speci

men n

um

bers

,

public

atio

ns

and

pre

senta

tions

aris

ing,

regu

lar

audits

of tiss

ue

request

s an

d a

ccess

.

SOPs

for

pat

ient

conse

nt,

speci

men a

nd d

ata

colle

ctio

n, p

roce

ssin

g

and s

tora

ge. P

atie

nts

conse

nte

d b

y N

SW

Pan

creat

ic C

ance

r

Netw

ork

sta

ff o

n s

ite.

Genera

l clin

ic-p

atholo

gica

l

info

rmat

ion c

olle

cted

incl

udin

g m

anag

em

ent,

medic

al h

isto

ry, o

utc

om

es.

Dat

abas

e lin

king

pat

holo

gy

and c

linic

al d

ata

desi

gned

in-h

ouse

. Dat

a lin

kage

with C

CR

for

notifi ca

tion

and c

ause

of deat

h. S

OPs

deve

loped in

tern

ally

to

meet

with in

stitution

and r

ese

arch

gro

up

speci

fi c

requir

em

ents

,

with s

om

e re

view

of N

CI

best

pra

ctic

e gu

idelin

es.

Freeze

rs a

larm

ed a

nd

monitore

d.

Form

al R

ese

arch

er

Acc

ess

Polic

y, w

ith a

ccess

rest

rict

ed t

o r

ese

arch

ers

who a

re p

art

of th

e N

SW

Pan

creat

ic R

ese

arch

Netw

ork

as

there

are

insu

ffi c

ient

tiss

ue

and s

taff

reso

urc

es

to a

llow

acc

ess

beyo

nd t

his

. Rese

arch

ers

requir

ed t

o a

cknow

ledge

ban

k in

public

atio

ns,

pro

vided c

opie

s of

public

atio

ns

to b

ank,

retu

rn u

nuse

d s

peci

mens

to b

ank.

No c

har

ge t

o

rese

arch

ers

. Aro

und 6

request

s fo

r fr

esh

tis

sue

and 2

0 for

arch

ival

tis

sue

in la

st y

ear

, all

appro

ved. 6

public

atio

ns

aris

ing

in la

st

2 y

ear

s.

South

West

ern

Syd

ney

Colo

rect

al T

um

our

Ban

k,

Gar

van

Bega

n o

pera

tion in

2000.

Curr

ently

his

tori

cal

speci

mens

only

with n

o

furt

her

colle

ctio

n. E

thic

s

appro

val o

bta

ined for

speci

fi c

rese

arch

pro

ject

s

usi

ng

these

his

tori

cal

speci

mens.

All

speci

mens

were

fre

sh fro

zen a

nd

incl

ude n

orm

al a

nd c

ance

r

tiss

ue, b

lood. A

dditio

nal

pro

cess

es

on r

equest

incl

ude

RN

A. -

70C

fre

eze

r.

Curr

ently

funded

by

CI N

SW

Car

eer

Deve

lopm

ent

Fello

wsh

ip.

85%

funds

allo

cate

d t

o

pers

onnel a

nd 1

5%

to

genera

l mai

nte

nan

ce.

Curr

ent

fundin

g expir

atio

n

201

1.

No s

taff e

mplo

yed

by

the

ban

k. N

o b

ank

perf

orm

ance

meas

ure

s

(his

tori

cal s

peci

mens

only

).

Pat

ient

clin

ical

deta

ils

store

d in

Exc

el d

atab

ase

in p

assw

ord

pro

tect

ed

serv

er.

Stan

dar

d p

atholo

gy

dat

a is c

olle

cted, a

nd

surv

ival

dat

a co

llect

ed b

y

CC

R. E

thic

s ap

pro

val t

o

acce

ss t

his in

form

atio

n for

this c

ohort

of pat

ients

. No

additio

nal

follo

wup d

ata

colle

cted. F

reeze

r lo

cked

and a

larm

ed.

Rest

rict

ed r

ese

arch

er

acce

ss t

o c

olla

bora

tors

,

with jo

int

auth

ors

hip

in p

apers

. Rese

arch

ers

requir

ed t

o a

cknow

ledge

ban

k in

public

atio

ns,

pro

vide

ban

k co

pie

s of

public

atio

ns,

retu

rn u

nuse

d

speci

mens

to b

ank.

No

speci

mens

acce

ssed in

last

12 m

onth

s w

ith u

nkn

ow

n

num

ber

pri

or

to t

his

. 2

public

atio

ns

aris

ing.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)


72

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Kolli

ng

Inst

itute

Tis

sue

Ban

ks:

Bre

ast

Can

cer

Tis

sue

Ban

k

Neuro

-endocr

ine

Tis

sue

Ban

k

Upper

GI T

issu

e B

ank

Gyn

aeco

logy

Tis

sue

Ban

k

Bre

ast

and G

ynae

colo

gica

l

ban

ks e

stab

lished 2

003,

Endocr

ine

ban

k 19

92 a

nd

Upper

GI ban

k m

id 1

990s.

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

and

speci

fi c

pro

ject

s. M

ultip

le

colle

ctio

n (

mai

nly

loca

l

public

and p

riva

te

hosp

ital

s) a

nd s

ingl

e

stora

ge s

ite. F

our

bio

ban

ks

shar

e s

tora

ge fac

ilities

and

3 b

ioban

k st

aff.

Bre

ast,

Gyn

aec

and U

pper

GI

ban

ks r

outinely

sto

re

tum

our

and n

orm

al t

issu

e,

clott

ed b

lood, E

DTA

blo

od (

Bre

ast

& G

yn

only

). N

euro

-endocr

ine

routinely

sto

res

froze

n

tiss

ue

with m

atch

ed

blo

od s

ample

. Par

affi n

em

bedded g

liom

a sa

mple

s

also

sto

red. N

euro

ban

k

will

extr

act

DN

A a

nd

RN

A, a

nd c

ut

and m

ount

par

affi n s

peci

mens

on

request

. 2 -

80C

fre

eze

rs.

3 c

om

pute

rs.

Depar

tment

within

an in

stitution w

ith n

o

gove

rnm

ent

fundin

g. G

rant

fundin

g fo

r 3 b

ioban

k

staf

f fr

om

CI N

SW

(infr

astr

uct

ure

gra

nt)

,

Can

cer

Counci

l NSW

(Str

ategi

c par

tners

hip

gran

t) a

nd S

tate

Bre

ast

Can

cer

money.

90%

funds

allo

cate

d t

o p

ers

onnel,w

ith

rem

ainder

to e

quip

ment,

consu

mab

les

and IT.

Curr

ent

fundin

g expir

atio

n

201

1/12

.

Ban

ks a

re g

ove

rned b

y a

Tis

sue

Ban

k C

om

mit

tee

consi

stin

g of Pro

fess

ori

al

Head

or

repre

senta

tive

of eac

h T

issu

e B

ank.

Resp

onsi

ble

for

stra

tegi

c

deci

sio

ns.

Indiv

idual

Tis

sue

Ban

k co

mm

itte

es

are

resp

onsi

ble

for

scie

ntifi c

meri

t an

d for

deci

sions

rega

rdin

g sp

eci

mens,

with

expert

advi

ce s

ough

t as

requir

ed. 3

FT

E s

taff. B

ank

perf

orm

ance

meas

ure

d

by

num

ber

speci

mens

store

d, n

um

ber

speci

mens

acce

ssed, n

um

ber

of

public

atio

ns

and P

hD

student

com

ple

tions.

SOPs

for

pat

ient

conse

nt

slig

htly

diffe

rent

acro

ss

the

four

ban

ks. S

OPs

exis

t

for

speci

men c

olle

ctio

n,

pro

cess

ing

and s

tora

ge.

Pat

ients

conse

nte

d p

rior

to s

urg

ery

by

ban

k st

aff

or

surg

eon. P

atholo

gy

dat

a st

ore

d in

AC

CESS

dat

abas

e. N

o form

al li

nks

to c

linic

al d

atab

ase

yet

est

ablis

hed. S

OPs

for

eac

h b

ioban

k hav

e b

een

adva

nce

d s

epar

ately

but

movi

ng

tow

ards

an

ove

rall

stan

dar

d. I

nte

rnal

ly

deve

loped b

ut

usi

ng

exte

rnal

sourc

es

as a

guid

e

(i.e

. fro

m P

ete

r M

cCal

lum

).

Freeze

rs a

larm

ed a

nd

monitore

d.

Var

iations

in R

ese

arch

er

Acc

ess

Polic

y ac

ross

bio

ban

ks. S

om

e hav

e

form

al A

ccess

Form

s,

oth

ers

still

bas

ed o

n v

erb

al

request

(w

ith a

ppro

pri

ate

HR

EC

and s

cientifi c

appro

val). P

rio

rity

of

acce

ss t

o lo

cal r

ese

arch

ers

or

affi lia

tes

– n

o e

xte

rnal

no

n-a

ffi li

ated r

ese

arch

ers

hav

e re

quest

ed a

ccess

to

dat

e. R

ese

arch

ers

requir

ed

to a

cknow

ledge

ban

k

in p

ublic

atio

ns,

retu

rn

unuse

d s

peci

mens

to b

ank,

pro

vide

info

rmat

ion o

n

sam

ple

qual

ity.

No c

har

ge

to r

ese

arch

ers

. A c

opy

of an

y re

sultin

g ab

stra

cts

or

public

atio

ns

must

be

forw

arded t

o T

issu

e B

ank.

5-1

0 r

equest

s in

the

last

year

, all

appro

ved. O

ver

200 s

peci

mens

acce

ssed

ove

r la

st y

ear

, plu

s 10

7

Endocr

ine

speci

mens.

39 p

ublic

atio

ns

aris

ing

since

1995 (

excl

udin

g

Neuro

Endocr

ine)

, plu

s

appro

x 40 fro

m E

ndocr

ine

ban

k plu

s 15

PhD

com

ple

tions.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)

73

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Aust

rala

sian

Bra

in T

um

our

Ban

k (K

olli

ng

Inst

itute

)

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

and

speci

fi c

pro

ject

s.

Expan

din

g to

multip

le

Aust

ralia

n c

olle

ctio

n s

ites

with s

ingl

e tiss

ue

stora

ge

site

(Kolli

ng

Inst

itute

) an

d

singl

e blo

od s

tora

ge s

ite

(WA

DN

A B

ank)

. Bio

ban

k

staf

f an

d fac

ilities

shar

ed

with four

bio

ban

ks a

t th

e

Kolli

ng

Inst

itute

. Affi li

atio

n

with A

GO

G a

nd W

AIM

R

to e

stab

lish n

atio

nal

bra

in

tum

our

bio

reso

urc

e.

Pla

nnin

g to

routinely

sto

re

fresh

fro

zen o

r par

affi n

blo

ck t

um

our

tiss

ue

and

whole

blo

od. A

dditio

nal

pro

cess

es

incl

ude

DN

A

and R

NA

extr

action,

par

affi n s

peci

men c

utt

ing

and m

ounting.

-80C

freeze

r. Liq

uid

nitro

gen

dew

ars.

Unit w

ithin

Neuro

-

endocr

ine

Tis

sue

Ban

k

at t

he

Kolli

ng

Inst

itute

.

Gra

nt

fundin

g fo

r bio

ban

k

staf

f (s

ee

oth

er

Kolli

ng

Tis

sue

Ban

ks a

bove

). P

lus

a co

llabora

tive

gra

nt

fro

m

Can

cer

Counci

l NSW

to

est

ablis

h n

atio

nal

bra

in

tum

our

bio

reso

urc

e

with W

AIM

R. 9

0%

funds

allo

cate

d t

o p

ers

onnel

and 1

0%

to m

ainte

nan

ce.

Curr

ent

fundin

g expir

atio

n

201

2.

No in

dependent

man

agem

ent

com

mit

tee

– fal

ls u

nder

the

Neuro

-

endocr

ine

Tis

sue

Ban

k

Co

mm

itte

e at

the

Kolli

ng

Inst

itute

. 0.2

FT

E p

lus

acce

ss t

o 0

.1 F

TE. B

ank

perf

orm

ance

meas

ure

d

by

num

bers

of sp

eci

mens,

public

atio

ns

aris

ing,

and

PhD

pro

ject

co

mple

tion.

SOPs

exis

t fo

r pat

ient

conse

nt

and s

peci

men

colle

ctio

n, p

roce

ssin

g

and s

tora

ge. P

atie

nts

are

conse

nte

d w

ith a

75%

succ

ess

rat

e by

neuro

surg

ical

nurs

e pri

or

to s

urg

ery

. Rem

ainin

g

25%

conse

nte

d p

ost

opera

tion p

rior

to

dis

char

ge. P

atholo

gy

dat

a st

ore

d in

AC

CESS

dat

abas

e on K

olli

ng

serv

er.

Tum

our

ban

k eth

ics

appro

val r

equir

es

that

clin

ical

dat

abas

e be

kept

separ

ate

fro

m p

atholo

gy

dat

abas

e. C

linic

al d

atab

ase

in d

eve

lopm

ent. T

he n

eed

for

a m

ore

sophis

tica

ted

syst

em

linki

ng

pat

holo

gy

and c

linic

al d

ata

has

been

reco

gnis

ed (

i.e. W

AIM

R

syst

em

). F

reeze

r al

arm

ed

and m

onitore

d. S

OPs

to m

ainta

in s

peci

men

inte

grity

duri

ng

pro

cess

ing

(ie s

o n

eve

r expose

d t

o

ambie

nt

tem

pera

ture

).

Hav

e e

ndeav

oure

d t

o u

se

NA

EF

fro

m N

SW

Heal

th

to fac

ilita

te r

ese

arch

er

acce

ss b

ut

hav

e had

diffi cu

lty

usi

ng

in W

A a

nd

hav

e had

co

mpla

ints

fro

m

rese

arch

ers

rega

rdin

g its

use

. Rese

arch

ers

requir

ed

to a

cknow

ledge

ban

k

in p

ublic

atio

n, p

rovi

de

public

atio

n c

opie

s to

ban

k, a

dvi

se o

n a

ny

sam

ple

unsu

itab

ility

. Only

requir

ed a

mount

give

n

to r

ese

arch

ers

as

unuse

d

speci

mens

may

bre

ach

SOPs

(ie

re s

peci

men

inte

grity

and s

tora

ge). N

o

char

ge t

o r

ese

arch

ers

.

Pla

nnin

g to

run lo

cal

info

rmat

ion s

ess

ions

to

rais

e b

ank

awar

eness

. 7

request

s fo

r sp

eci

mens

in la

st y

ear

, all

appro

ved.

Appro

x. 1

500 N

euro

speci

mens

acce

ssed fro

m

Neuro

Endocr

ine

Ban

k

(incl

udin

g A

BT

B)

in la

st

year

. 8 p

ublic

atio

ns

aris

ing

since

ince

ption.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)


74

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Bre

ast

Can

cer

Tis

sue

Ban

k

(BC

TB), b

ased a

t W

MI

Est

ablis

hed 2

006.

Mem

ber

of A

BN

. Ban

king

for

unsp

eci

fi ed futu

re

rese

arch

pro

ject

s. M

ultip

le

colle

ctio

n a

nd s

tora

ge

site

s. A

t eac

h s

tora

ge

node, f

acili

ties

are s

har

ed

with o

ther

bio

ban

ks a

s

requir

ed (

i.e. s

har

ed

liquid

nitro

gen t

anks

).

Routine

stora

ge o

f FF

PE

with m

atch

ing

H&

E s

lide,

fresh

fro

zen c

ance

r an

d

adja

cent

no

rmal

tis

sue,

whole

blo

od, p

lasm

a,

seru

m, b

uff

y co

at, D

NA

,

dig

ital

imag

e of H

&E

tum

our

sect

ion. O

n

request

can

pro

vide

DN

A a

nd R

NA

isola

tion,

par

affi n e

mbedded

tum

our

sect

ions,

tum

our

cryo

sect

ions,

tis

sue

mic

roar

rays

. 5x

-80C

freeze

rs (

5 s

ites)

, 4x

vapour

phas

e nitro

gen

tanks

plu

s tr

ansp

ort

ship

pers

, refr

igera

ted

centr

ifuge

s, r

obotic

DN

A

extr

actio

n in

stru

ment.

Not

for

pro

fi t

org

anis

atio

n

with n

o g

ove

rnm

ent

fundin

g. F

unded v

ia

gran

ts c

urr

ently

fro

m

NH

MR

C, C

I N

SW

(fo

r

dat

a m

anag

em

ent

and

colle

ctio

n) a

nd N

BC

F.

Staf

f at

colle

ctio

n s

ites

em

plo

yed b

y lo

cal

inst

itution. 6

5%

funds

allo

cate

d t

o p

ers

onnel,

20%

equip

ment,

rem

ainder

to c

onsu

mab

les,

IT, o

ther.

Curr

ent

fundin

g

expir

atio

n 2

008/0

9.

Gove

rned b

y M

anag

em

ent

Gro

up c

onsi

stin

g of C

hie

f

Inve

stig

ators

of eac

h

pro

ject

. Under

this g

roup

is E

xecu

tive

Co

mm

itte

e

resp

onsi

ble

for

day

-

to-d

ay o

pera

tions

and

feas

ibili

ty o

f re

sear

cher

request

s. “

Arm

s-le

ngth

”

Advi

sory

Gro

up c

onsi

stin

g

of A

ust

ralia

n e

xpert

s in

fi eld

of bio

ban

king

and

rese

arch

pro

vides

advi

ce

on s

trat

egi

c dir

ect

ion

(within

conte

xt

of fu

ndin

g

agre

em

ents

), d

ispute

reso

lution, b

ioeth

ics

and

com

pla

ints

. Est

ablis

hin

g

a fo

rmal

sci

entifi c

revi

ew

pro

cess

for

rese

arch

ers

– c

urr

ently

seek

expert

advi

ce a

s re

quir

ed t

o

revi

ew

sci

entifi c

meri

t

of ap

plic

atio

ns.

9.6

FT

E

staf

f. B

ank

perf

orm

ance

meas

ure

d b

y sp

eci

mens

colle

cted a

nd a

ccess

ed,

speci

men q

ual

ity,

rese

arch

er

applic

atio

ns.

SOPs

for

pat

ient

conse

nt

bas

ed o

n in

div

idual

HR

EC

requir

em

ents

at

eac

h

hosp

ital

. Oth

er

SOPs

are

stan

dar

d a

cross

the

six

site

s an

d a

re a

dap

table

for

use

by

oth

er

Bio

ban

ks.

Pat

ients

are

usu

ally

conse

nte

d b

y nurs

e or

phys

icia

n e

ither

pre

or

post

opera

tive

ly, w

ith 9

9%

succ

ess

. SO

Ps

exis

t fo

r

speci

men a

nd c

linic

al d

ata

colle

ctio

n, p

roce

ssin

g an

d

stora

ge. C

linic

al h

isto

ry,

pat

holo

gy a

nd t

reat

ment

info

rmat

ion is

colle

cted

and e

nte

red in

to B

CT

B

dat

abas

e (s

ituat

ed o

n

serv

er

at m

anag

em

ent

hub, w

ith s

ite-s

peci

fi c

acce

ss). P

C a

nd d

ocu

ment

scan

ners

at

eac

h c

olle

ctio

n

site

. SO

Ps

were

deve

loped

bas

ed o

n N

CI,

OB

BR

Best

Pra

ctic

e G

uid

elin

es,

and ISB

ER

Best

Pra

ctic

e

Guid

elin

es.

Qual

ity

guid

elin

es

follo

win

g IS

BER

Best

Pra

ctic

es

adhere

d

to. A

ll st

ora

ge e

quip

ment

lock

ed, t

em

pera

ture

monitore

d a

nd a

larm

ed.

Tem

pera

ture

monitori

ng

of sh

ipped s

ample

s.

Speci

mens

div

ided a

nd

store

d s

epar

ately

. Uniq

ue

labelli

ng.

RN

A s

ample

s

qual

ity

test

ed p

rior

to

rele

ase.

Rese

arch

er

Acc

ess

Polic

y

avai

lable

fro

m w

ebsi

te.

Applic

atio

ns

acce

pte

d

fro

m a

ll A

ust

ralia

n

rese

arch

ers

with p

riori

ty

give

n t

o p

eer

revi

ew

ed

pro

ject

s an

d in

vest

igat

ors

asso

ciat

ed w

ith c

olle

ctio

n

centr

es

in p

roport

ion

to t

he

num

ber

of

speci

mens

colle

cted.

Co

mm

erc

ial a

pplic

ants

will

be

consi

dere

d o

nly

if

meri

tori

ous.

Rese

arch

ers

requir

ed t

o a

cknow

ledge

ban

k in

public

atio

ns,

pro

vide

public

atio

ns

or

deta

ils t

o b

ank,

pro

vide

qual

ity

report

on s

ample

s.

Unuse

d s

peci

mens

not

retu

rned a

s sp

eci

men

inte

grity

cannot

be

guar

ante

ed. S

peci

men

avai

labili

ty c

an b

e se

arch

ed

via

web. R

ese

arch

ers

are

char

ged fre

ight

cost

s an

d

som

e ad

ditio

nal

char

ge

for

DN

A. P

lannin

g to

intr

oduce

additio

nal

cost

reco

very

fee

stru

cture

late

r th

is y

ear

. 5 s

peci

mens

supplie

d t

o r

ese

arch

ers

in p

ast

year

, with 6

5 in

pro

gress

. No p

ublic

atio

ns

aris

ing

to d

ate, a

s ban

k is

rela

tive

ly n

ew

.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)

75

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

West

mead

Gyn

ae-

colo

gica

l Tis

sue

Ban

k

Est

ablis

hed 1

992/9

3.

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

pro

ject

s.

Sin

gle

colle

ctio

n a

nd

stora

ge s

ite. S

har

e

som

e st

ora

ge fac

ilities

with B

CT

B. N

o form

al

arra

nge

ment

to d

ate

to

shar

e s

taff d

ue

to d

iffe

rent

fundin

g so

urc

es.

Affi li

ated

with A

BN

. Routine

stora

ge o

f fr

esh

fro

zen

and p

araf

fi n e

mbedded

sam

ple

s. A

dditio

nal

pro

cess

es

on r

equest

incl

ude D

NA

and R

NA

extr

action, H

&E s

tain

ing.

Shar

ed -

80C

fre

eze

r.

2x

liquid

nitro

gen t

anks

,

shar

ed v

apour

phas

e

isoth

erm

al s

tora

ge.

Depar

tment

within

West

mead

Hosp

ital

,

Gyn

aeco

logi

c O

nco

logy

Gro

up. C

urr

ently

funded

by

NH

MR

C e

nab

ling

gran

t as

par

t of A

BN

, and

by

West

mead

Hosp

ital

Gyn

aeco

logi

c O

nco

logy

Dept. 9

0%

funds

allo

cate

d

to p

ers

onnel,

10%

to

equip

ment. C

urr

ent

fundin

g expir

atio

n 2

009.

Gove

rned b

y T

issu

e

Ban

k C

om

mit

tee

whic

h

com

pri

ses

clin

icia

ns,

surg

eons,

sci

entist

s an

d

consu

mer

repre

senta

tive

s.

This c

om

mit

tee

is

resp

onsi

ble

for

the

stra

tegi

c dir

ect

ion o

f

the

ban

k an

d p

rovi

des

scie

ntifi c

advi

ce o

n p

roje

ct

applic

atio

ns,

with o

ther

expert

advi

ce s

ough

t

as r

equir

ed. 1

x 0.6

FT

E

staf

f. B

ank

perf

orm

ance

meas

ure

d b

y num

ber

speci

mens

store

d,

speci

mens

acce

ssed b

y

rese

arch

ers

, clin

ical

follo

w-

ups

and p

aths

revi

ew

ed,

tiss

ues

pro

cess

ed,

public

atio

ns

resu

ltin

g,

clin

ical

tri

als

support

ed

and s

ample

s co

llect

ed for

clin

ical

tri

als.

SOPs

for

pat

ient

conse

nt,

speci

men a

nd d

ata

colle

ctio

n, p

roce

ssin

g an

d

stora

ge a

nd r

ese

arch

er

acce

ss. P

atie

nt

conse

nte

d

pri

or

to s

urg

ery

then p

ost

surg

ery

for

“Mole

cula

r

Bio

logy

of G

ynae

colo

gic

Dis

eas

e”, w

ith 1

00%

succ

ess

. Speci

mens

colle

cted p

ost

NH

MR

C

gran

t fu

ndin

g fr

om

AB

N

are

store

d o

nsi

te in

AB

N s

peci

men lo

cato

r

dat

abas

e. A

imin

g to

hav

e

all s

peci

mens

put

on A

BN

speci

men lo

cato

r dat

abas

e

in futu

re (

incl

udin

g th

ose

colle

cted p

rior

to g

rant)

. A

more

sophis

tica

ted s

yste

m

for

linki

ng

pat

holo

gy a

nd

clin

ical

follo

w-u

p d

atab

ases

would

be

welc

om

ed.

Curr

ently

clin

ical

follo

w-u

p

dat

a co

llect

ed m

anual

ly

fro

m D

epar

tmenta

l

and H

osp

ital

Medic

al

Reco

rds.

SO

Ps

were

inte

rnal

ly d

eve

loped a

nd

are

regu

larl

y as

sess

ed a

nd

updat

ed. L

oca

l SO

Ps

were

use

d t

o d

eve

lop S

OPs

for

AB

N. F

reeze

r an

d

isoth

erm

al lo

cked, a

larm

ed

and m

onitore

d. L

iquid

nitro

gen d

ew

ars

in lo

cked,

alar

med la

bora

tory

and

leve

ls c

heck

ed.

Acc

ess

ava

ilable

to A

ust

ralia

n a

nd

inte

rnat

ional

rese

arch

ers

,

who o

ften c

olla

bora

te

loca

lly. R

ese

arch

ers

requir

ed t

o a

cknow

ledge

ban

k in

public

atio

ns,

and p

rovi

de

copie

s or

refe

rence

deta

ils t

o

ban

k. U

nuse

d s

peci

mens

are

not

retu

rned t

o

ban

k. R

ese

arch

ers

genera

lly fi n

d o

ut

about

ban

k th

rough

word

of

mouth

, confe

rence

s an

d

public

atio

ns.

Rese

arch

ers

are

char

ged fre

ight

cost

s,

with o

ther

cost

reco

very

char

ges

bein

g pro

ject

dependent. F

or

exam

ple

,

if th

e pro

ject

has

gra

nt

fundin

g fo

r bio

ban

king,

will

char

ge r

ese

arch

er

acco

rdin

gly.

2 n

ew

and

2 o

ngo

ing

request

s th

is

year

, all

appro

ved. O

ver

the

pas

t 12

month

s, 5

04

sam

ple

s ac

cess

ed b

y

rese

arch

ers

(in

cludin

g

sect

ions

froze

n, fi

xed,

RN

A, D

NA

). 1

,094

sam

ple

s ac

cess

ed s

ince

tiss

ue

ban

k in

ception.

Appro

xim

ately

23

public

atio

ns

aris

ing.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)


76

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Child

ren’s H

osp

ital

West

mead

Pae

dia

tric

Tum

our

Ban

k

Est

ablis

hed 1

998. F

oundin

g

and c

urr

ent

mem

ber

of A

BN

. Ban

king

for

unsp

eci

fi ed futu

re r

ese

arch

and s

peci

fi c

pro

ject

s.

Has

als

o e

stab

lished

a Pat

holo

gy S

upport

Lab

ora

tory

pro

vidin

g

rese

arch

ori

ente

d t

issu

e

han

dlin

g expert

ise

to

scie

ntist

s as

soci

ated w

ith

the

bio

ban

k. Info

rmal

rese

arch

netw

ork

s w

ith

nat

ional

and in

tern

atio

nal

rese

arch

gro

ups.

Sin

gle

colle

ctio

n a

nd s

tora

ge

site

. Routine

stora

ge o

f

peri

phera

l blo

od (

froze

n

whole

), b

one

mar

row

aspir

ates

(fro

zen)

and

slid

es,

solid

tum

our

bio

psi

es

fresh

fro

zen a

nd

FFPE. A

dditio

nal

pro

cess

es

on r

equest

incl

ude D

NA

and R

NA

extr

action,

tiss

ue

em

beddin

g an

d

mounting,

mic

roar

rays

.

-80C

fre

eze

r, m

anual

tiss

ue

arra

yer,

stai

nin

g

stat

ion.

Par

t of th

e O

nco

logy

Depar

tment

within

hosp

ital

. Curr

ently

funded

by

Depar

tment

of H

eal

th,

benefa

cto

r fu

ndin

g, a

nd

gran

t fu

ndin

g (C

I N

SW

infr

astr

uct

ure

gra

nt

and

NH

MR

C e

nab

ling

gran

t

via

AB

N). 7

0%

fundin

g

allo

cate

d t

o p

ers

onnel,

20%

equip

ment

and r

est

to IT

and m

ainte

nan

ce.

Curr

ent

fundin

g expir

atio

n

2009.

Man

aged b

y B

ioban

k

Co

mm

itte

e w

hic

h is

under

the

gove

rnan

ce o

f th

e

Onco

logy

Rese

arch

Unit,

Onco

logy

Depar

tment

and R

ese

arch

Div

isio

n o

f

the

hosp

ital

. The

Bio

ban

k

Co

mm

itte

e co

mpri

ses

clin

ical

and r

ese

arch

expert

s an

d a

long

with

the

Onco

logy

Rese

arch

Unit a

nd O

nco

logy

Depar

tment, is

resp

onsi

ble

for

the

stra

tegi

c dir

ect

ion

of th

e ban

k. 4

.5 F

TE

staf

f. B

ank

perf

orm

ance

meas

ure

d b

y publis

hed

pap

ers

in in

tern

atio

nal

ly

peer

revi

ew

journ

als.

Deve

loped in

stitute

speci

fi c

SOPs

in li

ne

with t

hose

for

AB

N

(ava

ilable

to d

ow

nlo

ad

fro

m A

BN

websi

te).

These

hav

e d

eve

loped

ove

r tim

e an

d a

re

curr

ently

bein

g updat

ed.

Pat

ients

conse

nte

d v

ia

dir

ect

consu

ltat

ion w

ith

par

ents

/guar

dia

n follo

win

g

colle

ctio

n o

f bio

psy

, blo

od

or

bone

mar

row

asp

irat

e

for

dia

gnost

ic p

urp

ose

s.

Clin

ical

, pat

holo

gy a

nd

long

term

follo

w-u

p d

ata

colle

cted b

y O

nco

logy

Dept, a

nd a

vaila

ble

to

tum

our

ban

k on r

equest

.

Bio

ban

k dat

abas

e co

nta

ins

bas

ic d

em

ogr

aphic

info

rmat

ion b

ut

is n

ot

linke

d t

o c

linic

al d

atab

ase

store

d in

Onco

logy

Depar

tment. A

more

sophis

tica

ted s

yste

m t

o

link

dat

abas

es

would

be

welc

om

ed for

rese

arch

,

alth

ough

may

need t

o b

e

tailo

red t

o p

aedia

tric

s /

multip

le t

um

our

types.

One

com

pute

r house

s th

e

tum

our

ban

k dat

abas

e.

Freeze

r m

onitore

d a

nd

alar

med, w

ith p

ager

carr

ied a

t al

l tim

es.

Liq

uid

CO

2 in

ject

ion s

yste

m for

bac

k up a

nd fre

eze

r fa

ilure

.

Rese

arch

er

Acc

ess

Applic

atio

n v

ia t

he

CH

W

Tum

our

Ban

k w

ebsi

te.

Open t

o a

ll nat

ional

and

inte

rnat

ional

rese

arch

ers

with a

ppro

pri

ate

eth

ics

appro

val a

nd

dem

onst

rate

d s

cientifi c

valid

ity.

Rese

arch

ers

requir

ed t

o a

cknow

ledge

tum

our

ban

k an

d

auth

ors

hip

in p

ublic

atio

n,

pro

vide

ban

k co

pie

s of

public

atio

n, r

etu

rn u

nuse

d

speci

mens

to b

ank.

Bio

ban

k ac

tive

ly p

rom

ote

s

itse

lf to

rese

arch

ers

by

conta

ctin

g dir

ect

ly.

Occ

asio

nal

ly r

ese

arch

ers

fi nd s

peci

mens

via

AB

N

or

CH

W T

um

our

Ban

k

websi

te. C

urr

ently

only

char

ges

rese

arch

ers

fre

ight

cost

s. A

round 1

0 r

equest

s

in la

st y

ear

, all

but

one

appro

ved. 7

15 s

peci

mens

acce

ssed in

pas

t ye

ar,

and 1

,500 s

ince

tis

sue

ban

k in

ception. O

ver

24

public

atio

ns

aris

ing

in

inte

rnat

ional

ly p

eer

revi

ew

journ

als.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)

77

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Child

ren’s C

ance

r In

stitute

Aust

ralia

(C

CIA

) Tum

our

Ban

k

Est

ablis

hed 2

000.

Ban

king

for

unsp

eci

fi ed

rese

arch

and fro

m

seve

ral h

osp

ital

s as

par

t

of a

clin

ical

tri

al (

sam

ple

s

kept

afte

r pro

cess

ing

and a

nal

ysin

g fo

r m

inim

al

resi

dual

dis

eas

e). M

ultip

le

colle

ctio

n a

nd s

ingl

e

stora

ge s

ite. R

outinely

sto

re fi c

olle

d b

one

mar

row

or

whole

blo

od.

On r

equest

can

undert

ake

DN

A e

xtr

action. 2

x -8

0C

freeze

rs, 2

x cr

yoplu

s 3,

besp

oke

dat

abas

e an

d 3

com

pute

rs.

Unit w

ithin

a n

ot

for

pro

fi t

org

anis

atio

n

without

gove

rnm

ent

fundin

g. F

unded b

y C

CIA

.

90%

fundin

g al

loca

ted

to p

ers

onnel,

10%

consu

mab

les.

Bio

ban

k M

anag

em

ent

Co

mm

itte

e co

mpri

sed

of se

nio

r C

CIA

sci

entist

s

(clin

icia

ns

and n

on-

clin

icia

ns)

resp

onsi

ble

for

ban

k go

vern

ance

incl

udin

g

sett

ing

stra

tegi

c dir

ect

ion.

2.6

FT

E s

taff. B

ank

perf

orm

ance

is m

eas

ure

d

by

staf

f ap

pra

isal

aga

inst

posi

tions

desc

riptions

and

goal

s fo

r ye

ar.

SOPs

for

pat

ient

conse

nt

and s

peci

men c

olle

ctio

n,

pro

cess

ing

and s

tora

ge.

Most

pat

ients

conse

nte

d

as p

art

of cl

inic

al t

rial

s.

Non-t

rial

pat

ients

conse

nte

d b

y doct

or

with

~70%

succ

ess

. Routine

clin

ical

info

rmat

ion s

tore

d

incl

udes

fi rs

t an

d s

urn

ame,

sex, D

OB

, dia

gnosi

s dat

e,

hosp

ital

, refe

rrin

g doct

or,

dia

gnosi

s an

d p

rim

ary

site

.

Lim

ited c

linic

al follo

w-u

p

dat

a co

llect

ed a

nd e

nte

red

man

ual

ly (

ie d

ate

and s

ite

of re

lapse

, dat

e of deat

h).

SOPs

inte

rnal

ly d

eve

loped.

Freeze

r lo

cked w

ith

secu

rity

acc

ess

. Dat

abas

e

secu

re a

nd r

egu

larl

y

check

ed v

s sa

mple

s in

freeze

r.

Rese

arch

er

Acc

ess

Polic

y,

with a

ccess

rest

rict

ed

acco

rdin

g to

pat

ient

conse

nt

(i.e

. rest

rict

ed t

o

use

in c

hild

ren’s c

ance

r

rese

arch

). R

ese

arch

ers

requir

ed t

o a

cknow

ledge

ban

k in

public

atio

ns,

pro

vide

copie

s to

ban

k,

retu

rn u

nuse

d s

peci

mens

to b

ank.

Rese

arch

ers

lear

n o

f bio

ban

k by

word

of m

outh

or

experi

ence

with C

CIA

. No c

har

ge t

o

rese

arch

ers

. 5 r

equest

s

in la

st y

ear

outs

ide

clin

ical

tri

als,

all

appro

ved.

Public

atio

ns

aris

ing

not

reco

rded, b

ut

star

ting

to

captu

re t

his in

form

atio

n.

Surg

ical

Onco

logy

Gro

up

Sar

com

a Tum

our

Ban

k,

Pri

nce

of W

ales

Hosp

ital

Est

ablis

hed 2

000.

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

and

speci

fi c

pro

ject

s. M

ultip

le

colle

ctio

n a

nd s

ingl

e

stora

ge s

ite. R

outine

stora

ge o

f fr

esh

tum

our

tiss

ue. L

arge

fre

eze

r

in O

nco

logy

Rese

arch

Centr

e.

Depar

tment

within

a

hosp

ital

, with n

o e

xte

rnal

fundin

g.

Man

aged b

y tw

o

pro

fess

ori

al s

taff

resp

onsi

ble

for

the

Onco

logy

Depar

tment

fro

m w

hic

h a

lmost

all

sam

ple

s ar

e co

llect

ed.

Eth

ics

appro

val f

or

ban

k

pro

vided b

y SESIH

S Eth

ics

Co

mm

itte

e.

Deve

lopin

g

a nat

ional

netw

ork

via

the

Aust

ralia

n S

arco

ma

Study

Gro

up. N

o s

taff e

mplo

yed

by

the

ban

k.

SOPs

for

pat

ient

conse

nt

and s

peci

men c

olle

ctio

n,

pro

cess

ing

and s

tora

ge.

Pat

ient

conse

nt

form

s

incl

uded in

Adm

issi

on

Form

. Routine c

linic

al

info

rmat

ion in

cludes

dem

ogr

aphic

, tum

our

and

treat

ment

char

acte

rist

ics,

outc

om

es.

Sam

ple

s an

d

dat

a lin

ked v

ia M

RN

and s

urn

ame. D

atab

ase

updat

ed a

fter

pat

ient

visi

ts w

ith a

nnual

revi

ew

of outc

om

es.

SO

Ps

deve

loped in

tern

ally

usi

ng

som

e exte

rnal

sta

ndar

ds.

No q

ual

ity

contr

ol

meas

ure

s cu

rrently

in

pla

ce t

o e

nsu

re s

peci

men

inte

grity.

Sar

com

a re

sear

chers

know

n w

ithin

Aust

ralia

.

Rese

arch

ers

are

not

requir

ed t

o a

cknow

ledge

ban

k in

public

atio

n b

ut

are

requir

ed t

o p

rovi

de

copie

s

to b

ank.

One

request

for

sam

ple

s in

last

12 m

onth

s,

appro

ved. 8

speci

mens

acce

ssed in

pas

t ye

ar, a

nd

15 s

ince

ban

k in

ception. 3

public

atio

ns

aris

ing

(ow

n

work

).

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)


78

Bio

bank

Nam

eB

ioba

nk D

esig

nEn

tity

Sta

tus

and

Fund

ing

Sour

ces

Org

anis

atio

nal S

truc

ture

Stan

dard

Ope

ratin

g Pr

oced

ures

Res

earc

her

Acc

ess

Colo

rect

al C

ance

r T

issu

e

Ban

k, Inte

grat

ed C

ance

r

Rese

arch

UN

SW

Est

ablis

hed 1

993.

Est

ablis

hed for

labora

tory

rese

arch

purp

ose

s, w

ith

bro

ad c

onse

nt

obta

ined

for

futu

re u

nsp

eci

fi ed

rese

arch

pro

ject

s. S

ingl

e

colle

ctio

n a

nd s

tora

ge s

ite.

Routine

stora

ge o

f ca

nce

r

and n

orm

al t

issu

e an

d

blo

od p

roduct

s. A

dditio

nal

pro

cess

es

incl

ude

DN

A

and R

NA

extr

action.

Genera

l lab

ora

tory

fundin

g, n

o e

xte

rnal

fundin

g.

Eth

ics

appro

val f

or

ban

king

and s

tudie

s vi

a St

Vin

cent’s

Hosp

ital

Eth

ics

Co

mm

itte

e (c

olle

ctio

n

site

). L

abora

tory

Head

resp

onsi

ble

for

stra

tegi

c

dir

ect

ion o

f ban

k. F

orm

al

agre

em

ent

with A

BN

to

send e

xcess

sam

ple

s to

West

mead

Gyn

aeco

logi

cal

Tis

sue

Ban

k.

SOPs

for

pat

ient

conse

nt

and s

peci

men c

olle

ctio

n,

pro

cess

ing

and s

tora

ge.

Pat

ients

conse

nte

d b

y

clin

ical

nurs

e w

ho a

lso

colle

cts

speci

mens

and

ente

rs d

atab

ase

deta

ils.

SOPs

inte

rnal

ly d

eve

loped

ove

r la

st 1

5 y

ear

s of ban

k

opera

tio

n. I

nte

rnal

ly

deve

loped d

atab

ase

to

link

speci

mens

to d

ata.

In t

he

pro

cess

of lin

king

with B

ioG

rid d

ata

linka

ge

syst

em

.

Rest

rict

ed a

ccess

to

loca

l rese

arch

ers

or

colla

bora

tors

.

Bra

in T

um

our

Ban

k, P

rince

of W

ales

Pri

vate

Hosp

ital

Ban

king

for

unsp

eci

fi ed

futu

re r

ese

arch

. Sin

gle

colle

ctio

n a

nd s

tora

ge

site

. Routinely

sto

re fre

sh

froze

n t

issu

e. A

dditio

nal

speci

mens

can in

clude

peri

phera

l blo

od. -

80C

freeze

r.

Depar

tment

within

hosp

ital

. So

me

char

itab

le

funds

(for

purc

has

e of

freeze

r).

Eth

ics

appro

val f

or

ban

k

via

Pri

nce

of W

ales

Pri

vate

Eth

ics

Co

mm

itte

e. N

o

FT

E s

taff e

mplo

yed b

y th

e

ban

k.

Pat

ients

conse

nte

d u

sing

stan

dar

d h

osp

ital

conse

nt

form

. Clin

ical

dem

ogr

aphic

dat

a o

nly

obta

ined.

Freeze

rs a

larm

ed a

nd

monitore

d.

No m

arke

ting

of ban

k or

rese

arch

er

request

s to

dat

e, a

lthough

acc

ess

is

not

rest

rict

ed.

The C

ance

r C

ounci

l NSW

Tis

sue

Ban

k*

Ban

king

for

speci

fi ed

rese

arch

pro

ject

s, b

ut

with c

onse

nt

to c

onduct

unsp

eci

fi ed futu

re

rese

arch

fro

m p

artici

pan

ts

in o

ne

study.

Routinely

store

blo

od d

eri

vative

s

incl

udin

g pla

sma,

seru

m,

buff

y co

at. A

dditio

nal

pro

cess

es

on r

equest

not

yet

dete

rmin

ed. 2

x -8

0C

freeze

rs.

Inte

rnal

fundin

g only

.

50%

fundin

g al

loca

ted t

o

pers

onnel,

40%

equip

ment

and 1

0%

IT

reso

urc

es.

Sin

gle-s

ite

multi-ce

ntr

e

eth

ics

appro

val f

rom

St V

ince

nt’s

Hosp

ital

,

plu

s eth

ics

appro

vals a

t

par

tici

pat

ing

site

s. 0

.5 F

TE

staf

f. B

ank

perf

orm

ance

curr

ently

meas

ure

d b

y

num

ber

of sp

eci

mens

sto

red (

curr

ently

colle

cted

only

as

par

t of ongo

ing

studie

s).

Pat

ients

conse

nte

d in

vari

ous

way

s in

cludin

g

hosp

ital

sett

ings

, Can

cer

Counci

l Netw

ork

s, C

linic

al

Can

cer

Regi

stri

es.

Clin

ical

dat

a co

llect

ed v

ia p

atie

nt

quest

ionnai

re. L

inks

to

oth

er

sourc

es

pla

nned

for

late

r in

the

study.

Additio

nal

dat

a lin

kage

via

CH

eR

eL. Q

ual

ity

contr

ol

as p

er

Dept

Medic

al

Onco

logy

, St

Vin

cent’s

Hosp

ital

.

Speci

mens

are n

ot

yet

avai

lable

for

exte

rnal

rese

arch

er

acce

ss.

*T

he

Can

cer

Counci

l NSW

undert

oo

k th

e s

peci

men s

urv

ey

and P

has

e 2

Exte

nded s

urv

ey

only

, so s

om

e dat

a ar

e u

nav

aila

ble

.

Tab

le 9

.3

Design

and G

ove

rnan

ce F

indin

gs for

Eac

h B

ioban

k In

terv

iew

ed a

nd/o

r Surv

eyed (

cont’d)

79

Abbreviations

ABN Australasian Biospecimens Network (Aus)

AGOG Australian Genomics and Clinical Outcomes of High Grade Glioma

APCC Australian Prostate Cancer Collaboration

BCTB Breast Cancer Tissue Bank (Westmead Millennium Institute)

CAPCA Canadian Association of Provincial Cancer Agencies

CBCTR Cooperative Breast Cancer Tissue Resource (US)

CCB Confederation of Cancer Biobanks (UK)

CCIA Children’s Cancer Institute Australia for Medical Research

CCR Clinical Cancer Registry

CEO Chief Executive Offi cer

CHeReL Centre for Health Record Linkage

CHTN Cooperative Human Tissue Network (US)

CHW Children’s Hospital Westmead

CIHR Canadian Institutes of Health Research

CI NSW Cancer Institute NSW

CSO Chief Scientist Offi ce (Scotland)

CTRN Canadian Tumour Repository Network

EDRN Early Detection Research Network (US)

FFPE Fresh Frozen Paraffi n Embedded

FTE Full Time Equivalent

H&E Haematoxylin and Eosin staining

HMA Healthcare Management Advisors

ISBER International Society for Biological and Environmental Repositories

kConFab Kathleen Cuningham Foundation Consortium for research into Familial Breast Cancer


80

MASCRI Melanoma and Skin Cancer Research Institute

NBCF National Breast Cancer Foundation

NBN National Biospecimen Network (US)

NCI National Cancer Institute (US)

NCRI National Cancer Research Institute (UK)

NEAF National Ethics Application Form

NHMRC National Health and Medical Research Council

OBBR Offi ce of Biorepositories and Biospecimen Research (US)

OECD Organisation for Economic Cooperation and Development

QIMR Queensland Institute of Medical Research

RNSH Royal North Shore Hospital

RNS Private Royal North Shore Private Hospital

RPAH Royal Prince Alfred Hospital

SMU Sydney Melanoma Unit

SOP Standard Operating Procedures

SPORE Specialise Program of Research Excellence

UNSW University of New South Wales

USMCI BSN US Military Cancer Institute Biospecimen Network

VCB Victorian Cancer Biobank

WAIMR West Australian Institute for Medical Research

WMI Westmead Millennium Institute for Medical Research

81

References

Personal Correspondence – Peter Geary, CEO 1.

Canadian Tumour Repository Network (Jan 2009).

http://gemstudy.org/main/index.html (accessed Feb 2.

2009).

Mann et. al. (2006) Analysis of cancer risk and BRCA1 3.

and BRCA2 mutation prevalence in the kConFab familial

breast cancer resource. Breast Cancer Research 8(1):

R12.

The Human Genome Project http://www.ornl.gov/sci/4.

techresources/Human_Genome/home.shtml accessed

(accessed Feb 2009).

Welberry H, Edwards C, Weston A, Harvey C, Wilson 5.

CS, Böll SK, Lo M and Bishop JF. Cancer Research in NSW

2001–2006. Sydney: Cancer Institute NSW, March 2008.

Beishon M. 6. How Europe is taking on the big biobank

challenge. Cancer World: Drug Watch. May/June 2008:

20–26.

Catchpoole D, deFazio A, Devereux L, Fleming M, Hof 7.

M, Schmidt C, Thourne H, Zeps N. The importance

of biorepository networks: the Australian Biospecimen

Network – Oncology. Australian Journal of Medical

Science, Feb 2007. 28(1): 16–20.

National Biospecimen Network Blueprint, Andrew 8.

Friede, Ruth Grossman, Rachel Hunt, Rose Maria Li, and

Susan Stern, eds. (Constella Group, Inc., Durham, NC)

2003.

OnCore UK website, http://www.oncoreuk.org/index.9.

html (accessed May 2008).

Cooperative Human Tissue Network website, http://10.

chtn.nci.nih.gov/ (accessed May 2008).

Early Detection Research Network website, http://edrn.11.

nci.nih.gov/ (accessed May 2008).

Cooperative Breast Cancer Tissue Resource website, 12.

http://cbctr.nci.nih.gov/ (accessed May 2008).

Canadian Tumour Repository Network website, https://13.

www.ctrnet.ca/ (accessed May 2008).

Generation Scotland website, http://129.215.140.49/gs/14.

index.html (accessed May 2008).

Generation Scotland website, Projects page. 15.

http://129.215.140.49/gs/21cgh.htm (accessed May 2008).

Generation Scotland website, Projects page 16.

http://129.215.140.49/gs/SFHS.htm (accessed May 2008).

Spanish National Cancer Research Centre website, 17.

National Health System Support Services: Tumour Bank

page: http://www.cnio.es/ing/programas/progTumor01.

asp (accessed September 2008).

Spanish National Cancer Research Centre website, 18.

About the CNIO page, http://www.cnio.es/ing/about/

antecedentes.asp (accessed September 2008).

BioResource-Med webpage, Genome Austria Tissue 19.

Bank (GATiB) page: http://bioresource-med.at/

(accessed September 2008).

Genome Research in Austria website, the programme 20.

page: http://www.gen-au.at/content_index.

jsp?base=foerdern&lang=en (accessed September 2008).

Bioserve website, http://www.bioserve.com/company/21.

companyOverview.cfm (accessed May 2008).

Asterand website, http://www.asterand.com/Asterand/22.

index.htm (accessed May 2008).

HealthCare IT website http://www.ardais.com/index.23.

html (accessed September 2008).

Prostate SPORE National Biospecimen Network Pilot 24.

website, http://prostatenbnpilot.nci.nih.gov/default.asp

(accessed May 2008).

National Cancer Institute, Offi ce of Biorepositories 25.

and Biospecimen Research website: Frequently asked

questions: http://biospecimens.cancer.gov/basics/faqs/


Biobank Ireland Trust website: http://biobankireland.com/26.

default.aspx (accessed September 2008).

UK Biobank website: http://www.ukbiobank.ac.uk/ 27.



82

Ontario Tumour Bank website, http://www.28.

ontariotumourbank.ca/?gclid=CNDn48aJuZMCFRGYggo

dIUdZBg (accessed September 2008).

The Confederation of Cancer Biobanks website, http://29.

www.ncri.org.uk/ccb/index.html (accessed May 2008).

National Cancer Institute website, Offi ce of 30.

Biorepositories and Biospecimen Research page, http://

biospecimens.cancer.gov/ (accessed May 2008).

The Australasian Biospecimens Network website, http://31.

www.abrn.net/default.htm (accessed May 2008).

NCI Specimen Resource Locator website, http://pluto3.32.

nci.nih.gov/tissue/default.cfm (accessed May 2008).

Confederation of Cancer Biobanks website, Biosample 33.

Search Portal page, http://www.walescancerbank.com/

explorer/ccb.php (accessed May 2008).

Australasian Biospecimens Network website, Tissue 34.

Specimen Locator page, http://www.abrn.net/AbnWeb/

OncologySearchPage.aspx (accessed May 2008).

Dan Catchpoole, Tissue Bank Manager, Children’s 35.

Hospital at Westmead. Personal Correspondence,

October 2008.

Standards Australia AS 8000-2003, Australian 36.

StandardTM Good Governance Principles. Prepared

by Committee MB-004, Business Governance for the

Council of Standards Australia, June 2003.

Dr Nikolajs Zeps, Researcher: St John of God Pathology: 37.

Radiation Oncology, Sir Charles Gairdner Hospital;

School of Surgery, University of Western Australia; and

Notre Dame medical school. Personal Correspondence,

October 2008.

St John of God Pathology website: http://www.sjog.38.

org.au/portal/page?_pageid=454,1&_dad=portal&_

schema=PORTAL&p_division= (accessed September

2008).

Grizzle W, Sexton K and Bell W. Quality Assurance in 39.

Tissue Resourcing supporting Biomedical Research. Cell

Preservation Technology. 2008. 6: 113–118.

Western Australian Genetic Epidemiology Resource 40.

webpage: http://www.wager.org.au/home.html (accessed

September 2008).

Paul White, Manager WAGER. Personal 41.

Correspondence, October 2008.

Western Australian Data Linkage Information website, 42.

Facts and Questions page: http://www.datalinkage-

wa.org/go/data-linkage/facts-and-questions (accessed

September 2008).

BioGrid Australia webpage: http://www.biogrid.org.au/43.

pages/index.php (accessed May 2008).

Centre for Health Record Linkage (CHeReL) website: 44.

http://www.cherel.org.au/about_Us.html (accessed

May 2008).

http://www.isber.org/Pubs/BestPractices2008.pdf 45.


http://biospecimens.cancer.gov/global/pdfs/NCI_Best_46.

Practices_060507.pdf (accessed May 2008).

http://www.abrn.net/pdf/ABN_SOPs_Review_Mar07_47.

fi nal.pdf (accessed May 2008).

National Health and Medical Research Council 48.

(NHMRC), the Australian Research Council and the

Australian Vice-Chancellors’ Committee. National

Statement on Ethical Conduct in Human Research.

Australian Government. 2007. Section 2.2.14.

National Health and Medical Research Council 49.

(NHMRC), the Australian Research Council and the

Australian Vice-Chancellors’ Committee. National

Statement on Ethical Conduct in Human Research.

Australian Government. 2007. Section 3.2.

Eisman, Bloom, Brower et al, Case Studies of Existing 50.

Human Tissue Repositories, ‘Best Practices’ for a

biospecimen resource for the genomic and proteomic

era. Prepared for the National Cancer Institute National

Dialogue on Cancer. Published by Rand, 2003.

Confederation of Cancer Biobanks, Human Research 51.

Tissue Banks/ Resources / Biobanks Guiding Principles.

http://www.ncri.org.uk/includes/What_We_Do/facilities/

CCBDocs/Principles.pdf (accessed May 2008).

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