1.0 research and development policy · the study team on the delegation log have a current gcp...

Research & Development Policy Version 9.0 – April 2018 1

Policy No: OP95 Version: 1.0

Name of Policy: Research and Development Policy

Effective From: 30/07/2018

Date Ratified: 10/04/2018

Ratified By: R&D Council

Review Date: 01/04/2020

Sponsor: Director of Nursing, Midwifery & Quality

Expiry Date: 09/04/2021

Withdrawn Date:

Unless this copy has been taken directly from Pandora (the Trust’s Sharepoint document management system) there is no assurance that this is the most up to date version This policy supersedes all previous issues


Version Control

Version Release Author/Reviewer Ratified

by/Authorised by Date

Changes (Please

identify page no.)

1.0

30/07/2018 Mrs Alison Harvey R&D Council 10/04/2018


Contents

1. Introduction .................................................................................................................. 5

1.1 National context and key policy drivers ................................................................... 5

2. Policy scope ................................................................................................................. 5

2.1 The target audience ................................................................................................ 5

2.2 Related Trust Policies ............................................................................................. 5

3. Aim of policy ................................................................................................................ 6

3.1 Statement of purpose .............................................................................................. 6

4. Duties (Roles and Responsibilities) ........................................................................... 6

4.1 The Trust Board ...................................................................................................... 6

4.2 The Medical Director and Director of Nursing and Midwifery ................................... 6

4.3 Quality Governance Committee .............................................................................. 6

4.4 The Research & Development (R&D) Council ......................................................... 6

4.5 The R&D Council Chair/Vice Chair ......................................................................... 6

4.6 The Associate Medical Director for Research & Development, Head of Nursing

Research, and the Research and Development Manager ................................................. 6

4.7 The Chief and Principal Investigators (CI & PI) ....................................................... 6

4.8 Good Clinical Practice (GCP) Training .................................................................... 7

4.9 Business Unit Clinical Leads / SafeCare Leads / Clinical Research Teams are

responsible for: .................................................................................................................. 7

4.10 The Research & Development Department ............................................................. 7

5. Definitions .................................................................................................................... 8

5.1 Locally accepted definition ...................................................................................... 8

5.2 Other processes similar to and related to Research and Development (not covered

by this policy) ..................................................................................................................... 8

5.3 Improvement and Assurance .................................................................................. 9

6. Research and Development ........................................................................................ 9

6.1 Commitment to research engagement, collaboration and partnership ..................... 9

6.2 Balancing Priorities ............................................................................................... 10

6.3 Governance of Research and Development.......................................................... 11

6.4 Reporting and Dissemination of Results ............................................................... 13

6.5 Research and Development Annual Report .......................................................... 13

6.6 Monitoring Effectiveness ....................................................................................... 13

7. Training and Development ........................................................................................ 14

7.1 Provision of Research Training ............................................................................. 14

7.2 Employment and Development of Research and Development Staff .................... 14


8. Finance ....................................................................................................................... 14

9. Deferred Income ......................................................................................................... 15

10. Equality and Diversity ................................................................................................ 15

11. Monitoring Compliance with the Policy .................................................................... 15

12. Consultation and Review .......................................................................................... 16

13. Policy Implementation (including awareness raising) ............................................ 16

14. References ................................................................................................................. 16

15. Associated Documentation ....................................................................................... 16

Appendices

Appendix 1 CI/PI Responsibilities Document

Appendix 2 R&D Council – Terms of Reference


Research & Development Policy

1. Introduction

1.1 National context and key policy drivers

The expectation is for all healthcare professionals to participate in research and is

a central tenant of the NHS Constitution, which states that ‘research is everyone’s

business’ (reference). This has been reinforced and extended by a succession of

key national publications, including: The Research Governance Framework for

Health and Social Care: Second Edition 2005; Health and Social Care Act 2008;

Medicines for Human Use (Clinical Trials) Regulations 2004, Statutory Instrument

2004/103; Medicines for Human Use (Clinical Trials) Amendment Regulations

2006, Statutory Instrument 2006/1928; Medicines for Human Use (Clinical Trials)

Amendment (No.2) Regulations 2006, Statutory Instrument 2006/2984; The

Human Tissue Act 2004; The EU Clinical Trials Directives 2001/20/EC; The Good

Clinical Practice Directive 2005/28/EC; The Data Protection Act 1998; and the

Declaration of Helsinki.

2. Policy scope

2.1 The target audience

This policy applies to any individual engaged in the research and development

process in the organisation (Gateshead Health NHS Foundation Trust; “the Trust”)

and includes students, volunteers, patients and staff. This policy applies to all

research and development activity, including both commercial and non-commercial

research involving the Trust.

2.2 Related Trust Policies

Key Trust policies relevant to research and development include, but are not

limited to:

Incident Reporting and Investigation Policy (RM04)

Confidentiality and Data Protection Policy (IG06)

Hand Hygiene Policy (IC04)

Infection Prevention and Control Policy (IC01)

Procurement Management and Use of Medicinal Devices Policy (RM30)

Overview of the Ordering, Storage, Prescribing and Administration of

Medicines (MM01)

Risk Management Policy (RM01)

Research Related Adverse Events Reporting Policy

Trust Appearance Policy for all Staff

External Agency Visits, Inspections, Accreditations and Reports Policy

Service Evaluation Policy

Clinical Audit Policy


3. Aim of policy

3.1 Statement of purpose

The purpose of this Research and Development Policy is to maintain and support a

culture of best practice in the management and delivery of research activity within

the Trust and provides guidance for all staff participating in any research and

development activity.

4. Duties (Roles and Responsibilities)

4.1 The Trust Board is ultimately responsible for research and development activity

throughout the Trust which contributes to our drive to deliver an evidence based

service. The Board has a responsibility to seek assurance that research activity

follows the governance arrangements set out in this policy.

4.2 The Medical Director and Director of Nursing and Midwifery, as leads for

clinical governance, have delegated responsibility from the Chief Executive for

ensuring there are effective research governance arrangements in place.

4.3 Quality Governance Committee is responsible for assessing the implications of

any areas of concern or potential risk identified through research activity that have

been escalated for their attention and making decisions on whether any course of

action should be taken.

4.4 The Research & Development (R&D) Council is the council tasked with

overseeing the Trust’s research activity. It has a responsibility to inform and advise

the board via the Quality Governance Committee whether research activity is

meeting the Research Governance Framework, Second Edition 2005. The R&D

Council will also ensure that the Capacity and Capability Assessment has been

carried out and that all Clinical Support Teams have been involved. The R&D

Council Terms of Reference are detailed in Appendix 2.

4.5 The R&D Council Chair/Vice Chair will be elected at the same time following a

voting process by the R&D Council for a three year term. The Vice Chair will

succeed the Chair following this three year term.

4.6 The Associate Medical Director for Research & Development, Head of

Nursing Research, and the Research and Development Manager have shared

responsibility as corporate operational leads for research and development activity.

4.7 The Chief and Principal Investigators (CI & PI) within each Business Unit are

responsible for undertaking projects in accordance with this policy and adherence

to the Research Governance Framework, Second Edition 2005 to ensure that

research is integrated into clinical practice in a safe and effective way. Chief

Investigator (CI) refers to the person who takes overall responsibility for all aspects

of a study. Principal Investigator (PI) refers to the person who takes responsibility

for research staff and activities at a particular site. (Appendix 1)


4.8 Good Clinical Practice (GCP) Training

It is the responsibility of all PI’s/CI’s/Research Nurses/CTO’s/Data Managers/R&D

Staff to undertake GCP Training on a 3 yearly basis. GCP Training is a mandatory

requirement for this Trust. No research study will commence until all members of

the study team on the Delegation Log have a current GCP Certificate.

4.9 Business Unit Clinical Leads / SafeCare Leads / Clinical Research Teams are

responsible for:

Ensuring specialty structures provide an effective research and development

programme and ensuring that patients have access to clinical trial information

as appropriate.

Providing adequate information about research to patients, for example, using

the National Institute for Health Research (NIHR) ‘It’s OK to Ask’ leaflets.

Providing regular updates at Safecare meetings on existing research and

development activity, and horizon scanning alongside the North of England

Research Network for future studies.

Reporting research and development activity for inclusion into the Trust Annual

Research and Development Report.

4.10 The Research & Development Department are responsible for maintaining an up

to date database of research & development activity, managing study oversight by

audit and progress reporting throughout the life of a research study, to completion,

receiving the final study report, publications and archiving. They will provide the

R&D Council with a quarterly report on the progress of research activity within the

Trust.. The Research & Development Department are also responsible for

providing support, education and training, (as and when required), for all research

staff within the Trust. Trust staff are individually accountable for ensuring that their

research conduct is in line with National Policies and Procedures. When involved

with research activity they are responsible for carrying out this activity in line with

this Policy.


5. Definitions

5.1 Locally accepted definition

“Research is essential to the successful promotion and protection of health and

well-being, and also to modern, effective health and social care services. At the

same time, research can involve an element of risk, in both terms of return on

investment and sometimes for the safety and well-being of research participants.

Proper governance of research is essential to ensure that the public can have

confidence in, and benefit from, quality research in health and social care. The

public has a right to expect high scientific, ethical and financial standards,

transparent decision-making processes, clear allocation of responsibilities and

robust monitoring arrangements. Research can be defined as – the attempt to

derive generalisable new knowledge by addressing clearly defined questions with

systematic and rigorous methods.”

Research Governance Framework for Health and Social Care,

Second Edition (2005)

5.2 Other processes similar to and related to Research and Development (not

covered by this policy)

5.2.1 Case/Peer Review

This usually involves a group of clinicians reviewing a random sample of

patients’ care and reviewing if best possible care was provided or whether

things could have been done differently.

5.2.2 Patient Outcome or Clinical Performance Indicators

This involves the continuous collection of data in order to monitor indicators of

patient outcomes or service delivery, which provides trends of performance

over time.

5.2.3 Patient Experience Surveys/Focus Groups

Are methods used to obtain service users’ views about the care they have

received? Patient experience surveys may be undertaken to determine what

actually happens in order to improve services, thus differing from patient

satisfaction surveys which ask whether the patients like what happened.

5.2.4 Patient Satisfaction Surveys

This involves asking patients how satisfied they are/were with an aspect or

multiple aspects of their care and treatment. Patient satisfaction surveys

supplement patient outcome review programmes.

5.2.5 Service Evaluation/Monitoring

This is designed and conducted principally to define or judge current care,

measuring the service without reference to a standard, defined system or

approach. It usually involves analysis of existing data, but may include the

administration of a simple interview and/or questionnaire. Elements of service

evaluation often appear as part of a clinical audit.


5.2.6 Clinical Audit

Clinical audit differs from research as it ascertains whether we are doing what

we should be doing and how well we are doing it “Does this service reach a

predetermined standard ?” rather than seeking to obtain new knowledge and

finding out what treatments are most effective i.e. what we should be doing as

with research.

5.3 Improvement and Assurance

The Trust supports the research and development activity within the Trust, and the

Board are assured about the governance through the rigorous reporting structure

both to the Clinical Research Network and to the Department of Health.

The Trust Board will receive an annual report prepared by the R & D Department

for information and assurance.

6. Research and Development

6.1 Commitment to research engagement, collaboration and partnership

6.1.1 Involving patients and the public

The Trust promotes the commitment to the principle of involving patients /

carers at all stages of the research process, either directly through the use of

patient research champions which are in early stage of development

(reference) or through patient forums and membership of project steering

groups.

6.1.2 Multi-disciplinary and multi-professional research, and partnership

working with other organisations

Collaborative working is the hallmark of good research practice. Partnership

working with the NIHR Clinical Research Network (CRN) is pivotal for the

delivery of research within the Trust. However, working alongside other

research active clinicians and teams in other NHS Trusts is encouraged as is

our partnership working with Industry sponsored research.

6.1.3 Working with Funding Bodies and Commissioners

The Trust has high expectations of Chief and Principal Investigators and their

collaborative working with research sponsors and funding bodies, in that

research projects are delivered in a timely manner and to a high standard of

research governance and practice. The evolving research framework also

demands that we work increasingly closely with our commissioners regarding

funding excess treatment costs.


6.2 Balancing Priorities

The Trust needs to maintain a strategic overview of how research and

development resources are being used to deliver the management and

governance requirements for NIHR portfolio trials. The Trust research and

development activity attempts to bring together national priorities for research,

priorities for the Trust, the potential to improve health outcomes for patient care, as

well as educational requirements in the interests of staff and users of our services.

It is very difficult to predict the annual number of new portfolio research projects,

however all Chief and Principal Investigators are encouraged to work alongside the

Research and Development Department as well as the specialty groups of the

CRN so that we can proactively identify studies which the Trust and clinicians

would like to be involved with.

The research and development activity within the Trust will be constantly evolving

and must be owned by clinical services; however, the research activity must meet

the Trust corporate requirements for assurance.

6.2.1 Choosing and prioritising National Research Projects

The NIHR’s vision - to improve the health and wealth of the nation through

research, will be met by providing a health research system in which the NHS

supports outstanding individuals working in world-class facilities, conducting

leading-edge research focused on the needs of patients and public.

National Research Priorities include all Industry Research involving major

Pharmaceutical Companies, both in the UK and internationally. National

Priorities also include the Dementia Challenge called for by the Prime Minister

and Antimicrobial Resistance identified by the Chief Medical Officer.

6.2.2 Local Research Projects

The Trust is a Partner Organisation (PO) of the North East & North Cumbria

Clinical Research Network (NE & NC CRN). The Network’s Vision is to make

the North East and North Cumbria the best place to take part in research: for

patients and for staff. The Network will do this by ensuring that they are

aligned to the key principals of the biggest stakeholders: Patients, NHS, NIHR,

and the Life Sciences Industry.

Local Research Projects include all Industry, Portfolio, Non Portfolio and

Student studies.


6.3 Governance of Research and Development

6.3.1 HRA Approval - Assess, Arrange & Confirm

HRA Approval is the new process for the NHS in England that brings together

the assessment of governance and legal compliance, undertaken by dedicated

HRA staff, with the independent REC opinion provided through the UK Health

Departments’ Research Ethics Service. It replaces the need for local checks of

legal compliance and related matters by each participating organisation in

England. This allows participating organisations to focus their resources on

assessing, arranging and confirming their capacity and capability to deliver the

study.

The new system simplifies the approvals process for research, making it easier

for research studies to be set up. The elimination of duplicate application routes

means that research questions about how to improve patient care or about new

treatments will be answered quicker. Patients will benefit from research funding

being dedicated to delivery of research rather than being wasted in navigating

complex systems. By removing duplication of reviews of research by NHS

support teams, the NHS will be freed up to focus on delivering research.

Medicines and Healthcare products Regulatory Agency (MHRA) Approval for

studies is also included in this new process.

HRA Approval does not cover studies from Northern Ireland, Scotland and

Wales. These studies will continue to be reviewed by the National Research

Ethics Committee. Separate MHRA Approval will also need to be sought for

Northern Ireland, Scotland and Wales.

6.3.2 Information Governance: collection, storage and retention of data and

confidentiality

Information Governance refers to the collection, storage and retention of data,

ensuring that information is held securely and confidentially, according to the

codes, standards and laws as outlined below:

Data Protection Act 1998

Freedom of Information Act 2001

The Caldicott Principles Security policy framework

Data Quality and Records Management (NHS Code of Practice 2006 Parts

1 and 2)

The HRA will carry out the Information Governance Review for English studies.

Studies led from Northern Ireland, Scotland and Wales will carry out a shared

review with the HRA in accordance with their country’s research approval

process.

The Storage and retention of research data is outlined in the Trust Local

Records Management Policy.


6.3.3 Escalation to External Panel Review

Escalation to external review will occur if a decision cannot be reached by the

R&D Council. This will be managed on a case by case basis. A Datix Report

will be submitted to formally record the identified risk and escalation to external

review.

6.3.4 Escalation to the Quality Governance Committee

Escalation to the Quality Governance Committee will occur if patient safety or

quality issues are highlighted at the R&D Council / Interim R&D Council

Meeting, for their further discussion and decision.

6.3.5 Risk Assessment

The Risk Assessment SOP 031 details the Risk Assessment undertaken prior

to the R&D Council Meeting in order to highlight any patient safety, quality

issues or impact the research may have on the Trust.

6.3.6 Informed Consent - Competency Framework for Nurses, Midwives and

Allied Health Professionals - CTIMP Studies

The CI or PI may delegate responsibility of the informed consent process to a

research nurse for low risk CTIMPs (if stated in the Protocol), on a trial by trial

basis, having received favourable ethical opinion and supported by the study

Sponsor. The R&D Council will also need to assess the capacity and capability

for the study before confirmation can be given to the Sponsor

Research Nurses who are willing to undertake informed consent for CTIMPs

will undertake the Consent Competency Framework for Nurses. The

Competency Framework will assess their competency to obtain informed

consent for low risk CTIMPs. The Framework will be completed prior to the

start of any study and a copy of the framework will be placed in the Site File for

reference.

6.3.7 Sponsorship of Studies

The Trust is currently in transition with regards to undertaking the Sponsorship

of any research study/clinical trial/CTIMP. Any requests for Sponsorship will be

deferred to the Central Management Team (CMT). Once the consultation has

been completed, a final decision will be made by the CMT.

The Trust will not sponsor student studies as this is the responsibility of the

University / Educational Institute where the student is registered.


6.3.8 Letters of Access/Honorary Research Contracts

Letters of Access and Honorary Research Contracts will be issued for external

members of staff wishing to undertake research activities within the Trust

following a rigorous process as outlined in the regional Research Passport

Process.

6.4 Reporting and Dissemination of Results

6.4.1 Reporting

The R&D Council will receive reports on the progress of research studies at key

milestones and will be updated with any amendments when appropriate.

6.4.2 Dissemination

The R&D Department will disseminate the results of the completed research

studies via an annual Dissemination Event, where the PIs/CIs/Study Teams

can showcase their studies and discuss the results in greater depth.

Dissemination will also occur at Regional Clinical Research Network Events.

The R&D Website will also disseminate research results for review by the wider

population.

6.5 Research and Development Annual Report

An annual research and development report will be produced by the research and

development department. The report will provide information on research and

development activity undertaken within the financial year including key outcomes,

recommendations and any practice development. The report will be approved by

the R&D Council and disseminated to Trust staff via the business unit Safecare

lead and made available in the R&D section of the Trust intranet.

The annual report will be received by the Quality Governance Committee and Trust

Board for information and assurance against corporate objectives.

6.6 Monitoring Effectiveness through an annual audit programme

6.6.1 Monitoring the effectiveness of Research Activity

The effectiveness of research studies will be ultimately monitored by the

accrual status for each study. The NE & NC CRN records all accrual for all

research studies carried out in the region. The R&D Department will provide an

activity report on a quarterly basis to the R&D Council.


The Research Audit Plan sets out the timetable for the Audits to be carried out

within the Trust on active research studies. Please see the Percentage Plan

below –

2016/2017 2% Audit Sample (random)



A 10% random sample of active research studies will be the Gold Standard

with Research & Development.

7. Training and Development

7.1 Provision of Research Training

The R&D Department will provide training that can be accessed by all healthcare

professionals who are involved in the development or delivery of research within

the Trust. This will include access to either face-to-face or e-learning training for

Good Clinical Practice (GCP). GCP Training for all medical, nursing and allied

health professional staff must be undertaken prior to commencing any research

activity with the Trust. GCP training must be refreshed at least every 3 years for all

staff who are actively involved in research. GCP certificates and dates of

completion will be checked and verified by the R&D Department during the study

set-up for all research activities in the Trust.

Regular communication and awareness raising sessions via leaflets, information

resources and up to date contacts on the R&D intranet site. Bespoke training for

groups and individuals will be available as required.

7.2 Employment and Development of Research and Development Staff

The Trust will employ research staff who are suitably skilled and experienced to

support its portfolio of NIHR trials. The Trust will also ensure that we work

collaboratively with our CRN colleagues to ensure staff have access to further

relevant training in order to maintain and develop their knowledge and skills.

8. Finance

The Research & Development Council will receive a quarterly Finance Report from the

R&D Manager giving an overview on the financial position for the preceding quarter.

This will ensure that the R&D Council will have oversight on the financial aspects of

the R&D Department and be assured that the department has a robust Financial

Framework.

All Research & Development studies (including those studies which have historically

sat within Business Units within the Trust) will come under the full financial control of

the R&D Manager.


9. Deferred Income

The R&D Deferred Income will be managed by the R&D Manager.

10. Equality and Diversity

Research is available to all and is core business in the NHS.

Equality Duty (Equality Act 2010) applies to people with the following protected

characteristics:

Disability

Age

Race – this includes ethnic or national origins, colour or nationality

Sex

Sexual orientation

Religion or belief – this includes lack of belief

Gender reassignment

Pregnancy and Maternity

Marriage and Civil Partnership Staff must ensure that they give due regard to the Equality Duty to eliminate unlawful discrimination. Having due regard means that we must take account of the needs of people with protected characteristics when we design, deliver and evaluate services.

11. Monitoring Compliance with the Policy

Monitoring compliance with this policy will be the responsibility of the R&D Manager.

This will be undertaken by:

Standard/process/issue Monitoring and audit

Method By Committee Frequency

Compliance with GCP

Monitoring of database

R&D Manager

R&D Council

Ongoing

Compliance with Policy

Acknowledged in the R&D Annual Report

R&D Manager

R&D Council

Annually


12. Consultation and Review

Consultation regarding formulation of this Policy has been through the R&D Council.

13. Policy Implementation (including awareness raising)

Implementation of this policy will be led by the R&D Department, Chief and Principal

Investigators within the Trust and their associated business units.

14. References

HRA Website: http://www.hra.nhs.uk/

NIHR Website: http://www.nihr.ac.uk/

NE&NC CRN Website: https://www.crn.nihr.ac.uk/north-east-and-north-cumbria/

DOH Website: https://www.gov.uk/government/organisations/department-of-health

15. Associated Documentation

Appendix 1 CI/PI Responsibilities Document

Appendix 2 R&D Council – Terms of Reference

http://www.hra.nhs.uk/

http://www.nihr.ac.uk/

https://www.crn.nihr.ac.uk/north-east-and-north-cumbria/

https://www.gov.uk/government/organisations/department-of-health


Appendix 1

Roles & Responsibilities

Everyone involved in research with human participants, their organs, tissue or data is

responsible for knowing and following the law and principles of good practice relating to

ethics, science, information, health & safety and finances set out in the Research

Governance Framework.

All those involved in research also have a duty to ensure that they and those they manage

are appropriately qualified, both by education and experience, for the role they play in

relation to any research. They must be aware of, and have ready access to, sources of

information and support in undertaking that role.

Chief Investigator

The Chief Investigator is the person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site, or if the study involves researchers at more than one site, the person who takes primary responsibility for the design, conduct and reporting of the study, whether or not that person is an Investigator at any particular site.

The Chief Investigator takes personal responsibility for the conduct of research involving

participants or organs, tissue or data and agrees to ensure that:

The Research Team will give priority at all times to the dignity, rights, safety and

well-being of participants

The study complies with all legal and ethical requirements

The research is carried out to the standards in the Research Governance Framework

for Health and Social Care (DoH, second edition, 2005)

Each member of the Research Team, including those at collaborating sites, is

qualified by education, training and experience to discharge his/her role in the study,

and their qualifications are documented

Each Investigator in a clinical trial involving medicines is aware of his/her legal duties

Students and new Researchers have adequate supervision, support and training

The Chief Executive of Gateshead Health NHS Foundation Trust and/or any other

individual(s) with responsibilities within this framework are informed that the study

is planned, and their permission is obtained before the research starts


When a study involves participants under the care of a Doctor, Nurse or Social

Worker(s) for the condition to which the study relates, those Care Professionals are

informed that their patients or users are being invited to participate, and agree to

retain overall responsibility for their care

When the research involves a Service User or Carer or a Child, looked after or

receiving services under the auspices of the Local Authority, the Agency Director or

Deputy agrees to the person (and/or their Carer) being invited to participate, and is

fully aware of the arrangements for dealing with any disclosures or other relevant

information

Potential participants and other Service Users and Carers are involved in the design

and management of the study whenever appropriate

The study is submitted for ethics review and it does not start without a favourable

opinion, and the research team acts on any conditions attached to the ethics opinion

Unless participants or the ethics opinion says otherwise, participant’s care

professionals are given any information directly relevant to their care that arises in

the research

Investigators in clinical trials involving medicines have to report serious adverse

events immediately. Unless Urgent Safety Measures are necessary the research

follows the protocol or proposal agreed by the relevant Research Ethics

Committee and by the Sponsor.

For clinical trials involving medicines, it is a legal requirement to follow the protocol

approved by the Licensing Authority (the Medicines and Healthcare products

Regulatory Agency MHRA)

Substantive changes to the protocol or proposal are submitted for ethical

review and the Sponsor’s agreement. These amendments are implemented

only when approved. For Clinical Trials involving medicines this will include

approval from the MHRA

Controlled Trials are registered, and for Clinical Trials involving medicines, the

research follows any conditions imposed by the MHRA

Procedures are in place to ensure collection of high quality, accurate data and

the integrity and confidentiality of data during processing and storage. For

Clinical Trials involving medicines, procedures to comply with legal


requirements concerning Good Clinical Practice (GCP) during the trial, and Good

Manufacturing Practice (GMP) in manufacturing investigational medicinal

products

Arrangements are kept in place for the management of financial and other

resources provided for the study, including for the management of any

Intellectual Property arising

Reports on the progress and outcomes of the work required by the Sponsor,

Funders, or others with a legitimate interest are produced on time and to an

acceptable standard

The finding from the work are opened to critical review through the accepted

scientific and professional channels

The Chief Investigator accepts a key role in detecting and preventing scientific

misconduct by adopting the role of guarantor on published outputs

Once established, findings from the work are disseminated promptly and fed

back as appropriate to participants

There are appropriate arrangements to archive the data when the research has

finished and to make it accessible

All data and documentation associated with the study are available at the

request of the inspection and auditing authorities

Undertake the design, conduct, analyses and reporting of the study to the

standards set out in the Research Governance Framework for Health and Social

Care (DoH, second edition, 2005)

Lead and manage others with delegated responsibility for some aspects

Take on personal responsibility for the design, management and reporting for

the study, coordinating the Investigators who take the lead if the research is at

more than one site


Principal Investigator

The Principal Investigator is the person responsible for a team of individuals conducting a

study at a site.

The Principal Investigator takes responsibility for the day to day conduct of research and will also:

Ensure that any research undertaken follows the current version of the agreed

Protocol or Proposal

Help Health Care Professionals to ensure that participants receive appropriate care

whilst involved in research

Report any adverse drug reactions or other adverse events

Protect the integrity and confidentiality of clinical and other records and data

generated by the research; and reporting any failures in these respects, or suspected

misconduct, through the appropriate systems

The Research Team will give priority at all times to the dignity, rights, safety and

well-being of participants

The study complies with all legal and ethical requirements

The research is carried out to the standards in the Research Governance Framework

for Health and Social Care (DoH, second edition, 2005)

Each member of the Research Team, including those at collaborating sites, is

qualified by education, training and experience to discharge his/her role in the study,

and their qualifications are documented

Each Investigator in a clinical trial involving medicines is aware of his/her legal duties

The Chief Executive of Gateshead Health NHS Foundation Trust and/or any other

individual(s) with responsibilities within this framework are informed that the study

is planned, and their permission is obtained before the research starts

Unless participants or the ethics opinion says otherwise, participant’s care

professionals are given any information directly relevant to their care that arises in

the research

Investigators in clinical trials involving medicines have to report serious adverse

events immediately. Unless Urgent Safety Measures are necessary the research


follows the protocol or proposal agreed by the relevant Research Ethics

Committee and by the Sponsor.

For clinical trials involving medicines, it is a legal requirement to follow the protocol

approved by the Licensing Authority (the Medicines and Healthcare products

Regulatory Agency MHRA)

Procedures are in place to ensure collection of high quality, accurate data and

the integrity and confidentiality of data during processing and storage. For

Clinical Trials involving medicines, procedures to comply with legal

requirements concerning Good Clinical Practice (GCP) during the trial, and Good

Manufacturing Practice (GMP) in manufacturing investigational medicinal

products

PI will have a current GCP Certificate prior to undertaking their role.

Arrangements are kept in place in accordance with Trust policy for the

management of financial and other resources provided for the study, including

for the management of any Intellectual Property arising

Reports on the progress and outcomes of the work required by the Sponsor,

Funders, or others with a legitimate interest are produced on time and to an

acceptable standard

Once established, findings from the work are disseminated promptly and fed

back as appropriate to participants

There are appropriate arrangements to archive the data when the research has

finished and to make it accessible

All data and documentation associated with the study are available at the

request of the inspection and auditing authorities


RESEARCH & DEVELOPMENT COUNCIL Terms of Reference

1. Constitution The Research & Development (R&D) Council will be a meeting of likeminded individuals who either have an active role in research or who have an interest in research. The R&D Council will be responsible for supporting research delivery and research training, ensuring appropriate levels of recruitment to National Institute of Health Research (NIHR) Portfolio studies, ensuring the Trust complies with the Research Governance Framework and Good Clinical Practice and approving Standard Operating Procedures and Policies relevant to research and development. The R&D Council will assess and confirm the Trust’s capacity and capability to take part in proposed research projects using Trust facilities, patients and staff. A risk assessment of all proposed research studies will be undertaken prior to the R&D Council meeting in order to highlight any patient safety, quality issues or impact the research may have on the Trust. The R&D Council will escalate any concerns or issues identified to the Quality Governance Committee in accordance with the R&D Policy. The minutes of the R&D Council will be submitted to the Quality Governance Committee.

2. Purpose of the R&D Council

The purpose of the R&D Council will be to ensure, on behalf of the Trust, that its research management and governance responsibilities are properly discharged. An Annual Report will be submitted to the Trust Board through the Quality Governance Committee, in order to provide this assurance.

The R&D Council will:

Promote and support all research delivery and research training within the Trust

Assess Trust capacity and capability for all research applications

Receive periodic reports from the North East and North Cumbria Clinical Research Network (CRN) with regard to NIHR portfolio studies and patient accrual

Receive periodic reports from the R&D Department regarding research within the Trust, research staff employment and other matters


Endorse compliance with Good Clinical Practice (GCP) and the Research Governance Framework and support the Trust’s efforts to provide robust Research Governance.

Support the Trust in developing its research capacity and capability and actively promote participation in NIHR portfolio research

Ratify Standard Operating Procedures relevant to research, R&D Policy & Terms of Reference

3. Membership/Attendance & Quorum

Chair Dr Salman Razvi (Consultant Endocrinologist) Vice Chair Vacant Post Dr Anne Dale (Consultant Paediatrician) Mrs Alison Harvey (R&D Manager) Secretary Mrs Yvonne Marriott (R&D Coordinator) Mrs Marie Greener (R&D Coordinator)

Members Research Active PIs Research & Development Team

Representatives from Trust Support Services (Pharmacy / Radiology / Pathology) will

also attend the R&D Council.

The R&D Council may co-opt additional members as appropriate to enable it to undertake its role. To be quorate there should be a minimum of 6 R&D Council Members in attendance.

The Medical Director and Director of Nursing, Midwifery & Quality have delegated their authority to the R&D Chair and therefore will not attend the R&D Council or Interim R&D Council Meetings. 3.1 The R&D Council Chair

The R&D Council Chair shall be chosen by the whole R&D Council membership from

among their number. Candidates for the position shall be proposed and seconded

by any two other existing members of the R&D Council.

A person duly proposed and seconded for the position of Chair, shall be appointed if

the appointment is supported by a quorate majority of the other R&D Council

members and if the appointee accepts the appointment. The term of the Chair is

three years.

3.2 The R&D Council Vice Chair

The R&D Council may appoint a Vice Chair to assist the Chair and act in the Chair’s absence. The appointment should be made in the same manner as the appointment of the Chair.


In the event of absence of the Chair and / or the Vice Chair or if there is a conflict of

interest an experienced member of the R&D Council (an R&D Council member for

over two years) who is willing to be an Alternate Chair may chair the meeting or a

part of the meeting providing the is quorate.

3.3 Attendance

Attendance will be monitored and measured against the agreed expected standard and reviewed each January. The standard shall be that all R&D Council members should attend at least four of the meetings scheduled to take place throughout the year. Members may resign at any time by letter or email to the Chair, giving one months’ notice. If R&D Council Members are unable to attend meetings, they may arrange for a representative to attend and exercise full membership rights on their behalf. Non-Members may be invited to attend and observe R&D Council meetings in whole or in part. Persons attending meetings by invitation will not be regarded as members and will have no voting rights.

4. Interim R&D Council

The Interim R&D Council will be chaired by the R&D Council Vice Chair and will meet

on a monthly basis.

The purpose of the Interim R&D Council will be to assess NIHR Portfolio Studies

coming to the Trust in order to comply with Department of Health and NIHR Time to

Target.

5. Meetings

The R&D Council will meet on a monthly basis, although additional meetings may be

convened as necessary in order to deal with urgent business.

The R&D Council will be administered by the R&D Coordinators and minutes will be

taken at every meeting.

Where no agenda items exist, the meeting will be postponed until the next available

R&D Council meeting. Members will be notified by email.

The agenda, minutes of the last meeting and the following documents for each

research project to be assessed, will be uploaded onto the Pandora SharePoint

system at least one week prior to the R&D Council Meeting:-


IRAS Form Protocol HRA Initial Assessment Letter (if available) HRA Approval Letter

The link to the Pandora SharePoint system will be emailed to R&D Council members

when the documents are available to view:-

http://pandora/docs/ResearchAndDevelopment/Committee%20Meetings/Forms/AllIt

ems.aspx

5.1 The R&D Council Agenda Standard Template

1. Apologies

Details of attendance and absences are recorded in order to confirm members

compliance with the attendance requirements of the constitution.

2. Declarations of Interest

R&D Council members are asked to declare their involvement in any agenda

items, in particular any potential conflict of interest in project proposals.

Where a potential or actual conflict of interest is declared, the R&D Council

member is asked to leave the room whilst the relevant agenda item is

discussed.

3. Minutes of the last meeting

Minutes of the previous meeting are checked for accuracy and completeness

before being agreed as a true record and signed and dated by the Chair.

4. Matters Arising

Items from the previous meeting listed for update and/or discussion.

5. Assessment of Trust Capacity & Capability

All research projects undertaken by the Trust must be assessed for capacity

and capability by the R&D Council before they can commence.

6. Research Governance

The R&D Council will be notified of any risk issues, including potential serious

breaches that occur on research studies taking place within the Trust.

http://pandora/docs/ResearchAndDevelopment/Committee%20Meetings/Forms/AllItems.aspx

http://pandora/docs/ResearchAndDevelopment/Committee%20Meetings/Forms/AllItems.aspx


7. Finance

A financial update report will be submitted to the R&D Council on a quarterly

basis

8. Any Other Business

All members will have the opportunity to raise any additional items that they

wish to be discussed by the R&D Council.

9. Date and Time of Next Meeting

Copies of the approved R&D Council minutes will be submitted to the Quality

Governance Committee.

6. Decision Making & Voting Procedures

All members will have equal decision making and voting rights.

It will be open to any member to require a vote to be taken to determine any issue

in the event that a decision cannot be reached by consensus.

Members will have the right to abstain from voting in all ballots. The Chair or Vice

Chair presiding at the meeting shall have the casting vote in determining hung

ballots.

7. Conflicts of Interest

Members have the right and duty to exclude themselves on the grounds of a conflict

of interest from any aspect of the R&D Council’s business. Where members are

aware before the meeting that there may be a conflict of interest, they have a duty

to inform the Chair.

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