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UNDERSTANDING & MANAGING THE HUMAN RESEARCH ETHICS APPLICATION PROCESS

A practical guide to the ethics application process

Presented by: Anthony Benka Manager, Research Ethics and Biosafety

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Topics• Human Research Ethics

• The basics • Guidelines for Researchers

• Research Code & National Statement• The Review of Ethics Applications• Planning • Ethics Review Process• Reporting on Progress • Resources

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Human Research Ethics

The basics

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What is human research?

Human research is:1. research conducted with people2. research conducted about people 3. research dealing in their data or tissue

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Values and principles of human research ethicsA robust foundation for researchers. • Research merit and integrity: research must be worthwhile, have value

to the community. • Respect for human beings: recognises that each human being has

value in him/herself.• Beneficence: the obligation to maximise

possible benefits and minimise possible harms • Justice: addressing the resolution of the

question of who ought to receive the benefits of research and bear its burdens

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Participants: Who are they?

Defining participants

• People who are the principal focus of the research • Whom the research impacts (concurrently or retrospectively).

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Participants in human research

• taking part in surveys, interviews, or focus groups;

• undergoing psychological, physiological or medical testing or treatment

• being observed by researchers• researchers having access to

personal documents or other materials

• the collection and use of body organs, tissues or fluids or exhaled breath

• access to information (individually identifiable, re-identifiable of non-identifiable form) as part of an existing published or unpublished source or database.

Human research is broad and involves participants in a wide range of manners:

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Before You Start

What you need to know

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The Australian Code for the Responsible Conduct of Research

The only research worth performing is that which is conducted with integrity.

• All researchers are required to comply with The Australian Code for the Responsible Conduct of Research

• Part A - The principles & practices of responsible research conduct of research- Responsibilities , Managing research data, Supervision, Publication &

dissemination of findings, Authorship, Peer review, CoI & Collaborative research. • Part B – Breaches, research misconduct and resolving allegations • Researchers should obtain a copy of the Code of Conduct for Research

and familiarise themselves its requirements.• Obtain a copy at: http://research.vu.edu.au/rcc.php

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The National Statement on Ethical Conduct in Human Research

To promote ethically good research• This requires:

• respect and protection to be accorded to participants• foster research that is beneficial to the community

• To clarify the responsibilities of:• institutions & researchers for the ethical design, conduct and dissemination

of results of human research• review bodies in the ethical review of research

• Researchers must be familiar with the NS requirements if:• researcher conducting research with human participants;

• Obtain a copy at:• http://www.nhmrc.gov.au/publications/synopses/e72syn.htm

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The Big Picture

Who will deal with my application?

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Ethics & Biosafety Administration Group – Our Services• Administer the policies and procedures

established by the Committees and those established by Commonwealth and State legislation, relevant codes.

• Report to Commonwealth and State authorities, regulatory agencies.

• Resource reviews and inspections of facilities, and ensure currency of scientific establishment licenses.

• Provide specialist information and advice to committee members, staff and research students regarding human research ethics, animal experimentation and animal welfare, and gene technology and biosafety.

• Promulgate the requirements of Codes of Conduct for Research and the National Statement to facilitate improvements to research at VU

• Administer all ethics applications for AEEC, IBC & HRECs (central & faculty based)

• Conduct initial review of all applications.• Service committees and develop agendas• Notify researchers of committee outcomes• Monitor compliance with ethics and

regulatory requirements (projects, facilities/infrastructure.)

• Manage allegations of ethical breaches• Receive all requests (eg amendments,

extensions) to approved projects

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Who Reviews Ethics Applications?

Human Research Ethics Committees• Victoria University Human Research Ethics Committee

(VUHREC) • Review:

• non-minimal risk applications• applications from other institutions

• Faculty based sub-committees• Review:

• minimal risk applications– risks of discomfort

• negligible risk– inconvenience

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Committee Structure

Deals with ‘non-minimal’ risk

applications. Eg. projects involving children, special groups, intrusive

techniques or very sensitive

material is reviewed at this

level.Ratifies Faculty HREC decisions,

manages membership, implements

procedure and formulates

responses to NHMRC.

Reviews resolutions from minutes and anomalies

that may arise from VUHREC.

Review ‘Minimal Risk’ applications, amendments &

extensions requested. Other

applications forwarded to

VUHREC. Faculty HRECs

make recommendations on procedures to

VUHREC

Develops policy and procedure for existing and emerging issues.

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Planning your Research Project

Planning your research

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Managing Research Projects & Ethics

• Manage your time carefully• Project Management

• Projects are unique, complex and have connected activities

• Understand a) time b) resources c) quality• Factor in the ‘ethics application process’ into

your research project• Committee meetings are deadline driven • Submission deadlines are crucial• Addressing amendments may take more time

than expected

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Ethics Review Process

Process

Preparation

Submission

Notification

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Ethics Application Process• Application Submission

• Risk Assessment

• Minimal or Non Minimal Risk

• Faculty or University HREC

• HREC Assessment

• Approved

• Minor Amendments

• Withheld

• Referred

• Ethics Notification

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Preparation

• Carefully read the instructions in the Application Form • Complete the Ethics Application Checklist• Familiarise yourself with the Guidelines for Applications before submitting

the application• Ensure all questions in your application are appropriately answered• Ensure the Declaration Form page is completed by all relevant parties

• Principal Investigator should be satisfied that the application is in a suitable form for submission

• Late submission is simply not acceptable; Committees will not assess proposals that have not been circulated with the meeting papers.

• Proposals finished in a mad scramble tend to be poorly developed and in consequence often need resubmission.

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Submission

What must I submit?• An electronic application to the EBG (Faculty Ethics Officer) • One approved original application (authorised by all parties to research) and twelve

duplicate applications to the EBG.• Applications will not be processed without the appropriate authorisation!

• Information to Participant form/s • Participant Consent form/s• Copies or concise descriptions of surveys/tests/questions/certified translations• Supporting Documentation

• Eg. Ethics approvals and/or letters of approval from other organisations, etc.What happens to my application?• Initial review of submission by the Ethics Officer.

• The Officer then liaise with the Chair, Faculty HREC and/or with Ethics & Biosafety Manager to decide on the proposal’s level of risk

• Details entered into the HRE Dbase (HRETH # is generated for individual applications) • Application is placed on the following HREC Agenda

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How & When Will I Be Notified?

Following the HREC meeting:• The HREC Secretary will notify the PI within 14 days of the HREC

meeting • E-mail notification to PI (usually 4 – 6 working days)• Hard copy Ethics Notification letter will be posted to the PI, signed by the

Chair of the HREC (project may only commence if approval granted)If I do not hear from the HREC?1. Check with the project’s Principal Investigator 2. Contact the relevant Ethics Officer3. Quote your HRETH Number (allocated upon submission)

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The Committee’s Decision Defined

Approved • HREC has granted ‘Ethics Clearance.’ Your project has been Approved and

you may commence your research. Conditional Approval with Minor Amendments • Your application requires amendments as stipulated in the Ethics Notification letter

(forwarded to PI). • You will be required to address the amendments and resubmit the application:

1. a response to the items listed in the Ethics Notification2. one original signed copy of the resubmitted application 3. one resubmitted application with changes highlighted (tracked changes)4. soft copy of the amended application with all relevant attachments

• The resubmitted application is to be forwarded to the HREC Chair via the relevant Ethics Officer.

• Specific changes to the submission must be clear. • You Cannot Commence Research Project

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The Committee’s Decision DefinedWithheld • The Committee has expressed concern regarding the research project. • You will need to address the amendments outlined in the Ethics Notification letter • You will need to contact the nominated liaison person to discuss the HREC’s concerns.• You will need to revise the application addressing the issues raised and resubmit the

application: 1. response to the items listed in the Ethics Notification (12 copies)2. one original signed copy of the resubmitted application 3. ten (12) resubmitted applications with changes highlighted (tracked changes)4. soft copy of the amended application with all relevant attachments

• RE DO the Declaration Form with all the necessary signatures prior to resubmitting the application to the Ethics Officer who will place it on the Agenda for the next Ethics Committee meeting.

• Ensure that you have amended all relevant dates, as it is likely that the dates on your original submission are no longer valid.

• You Cannot Commence Research Project

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The Committee’s Decision Defined

Referred • The Committee has deemed the nature of the application not suitable for that

Committee’s review. The application has been sent another HREC for assessment (eg. Victoria University Human Research Ethics Committee to assess Non-Minimal Risk issues that were not apparent in the original submission).

• All correspondence should be referred to that HREC.

Rejected• The Committee deems the research project as ethically flawed. It has very serious

concerns and regards the project unacceptable.• The HREC will issue an Ethics Notification letter outlining its concerns and the

applicable section of the National Statement that it has based its decision.• A liaison person (normally the Chair) will be nominated as a contact. • You Cannot Commence Research Project

You may only commence your research project when you have received Ethics Approval

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Responding to the Committee

• When do I need to respond following amendments?• The Committee would normally expect that a revised application

would be submitted within two months of the date of notification. • If you are unable to submit your amended application within this

timeframe, please notify the Ethics Officer in writing.

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Afterwards

Reporting on progress, changes and adverse events

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Annual/Final Reports

• Researchers are obligated to submit an annual report outlining the progress of the research project.

• Continued approval is contingent upon submission of the report.• Upon completion of the research project, researchers must submit a

Final Report to the approving HREC.

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Amendments to Applications

• Approval and extensions to my research • Approval normally granted for max. 2 years• Extension requests to be forwarded to the original HREC that granted approval• Submit letter outlining reason for extension, quoting HRETH number, Project Title,

and progress to date.• Extension will be contingent upon you submitting the required annual/progress

report. • Changes to my Research Project (Minor Amendments to approved projects)

• Minor amendment requests to be forwarded to the HREC that originally granted approval

• Submit letter outlining nature and reason for change, quoting HRETH number, Project Title, and progress to date.

• Submit updated application form including approved clean copy (by PI) and a tracked changes copy highlighting all changes.

• Send through an e-copy to the EBG• Approval will be contingent upon you submitting the required annual report and

meeting ethical standards

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Resources

EBG

Website

Guidelines

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Human Research Ethics Web Page

http://research.vu.edu.au/hrec.php• Application Kit

• Application Guidelines, Application form, Participant Information form, Participant Consent form and Review questions

• Committee & Dates • University & Faculty contact details• Submission and meeting dates• Membership• HREC Terms of Reference

• Approved Projects• Changes and Extensions to approved projects• Annual project and Final reports

• Useful Links

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Ethics & Biosafety Administration Group

Mr Anthony BenkaManager, Research Ethics and Biosafety. Phone: 9919 4148 (Mondays, Wednesdays & Thursdays)• VUHREC, AEEC, IBC, Feedback, Complaints, Adverse Events. Ms Lilian TanEthics Officer (Phone: 9919 4461)• VUHREC • Health, Engineering and Science HREC, • AEEC. Ms Lauren Donley Ethics Officer (Phone: 9919 4781)• Arts, Education and Human Development HREC • Business and Law HREC • IBC

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Useful Links & Resources

• Human Research Ethics Web pagehttp://research.vu.edu.au/hrec.php

• New Research in a New Era Training Program (Ethics Training Module)http://research.vu.edu.au/nrne/NRNE/ethics/web/index.html

• National Statement on Ethical Conduct in Research Involving Humans http://www7.health.gov.au/nhmrc/publications/synopses/e35syn.htm

• Human Research Ethics Handbook http://www.nhmrc.gov.au/publications/synopses/e42syn.htm

• National Health and Medical Research Council http://www7.health.gov.au/nhmrc/

• Office of the Privacy Commissioner (National Privacy Principles) http://www.privacy.gov.au/policy/index.html

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Ethics Application form

Tips for researchers

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The Ethics Application Form

What is expected?• Read the instructions carefully• Answer all questions• Ensure language is clear and simple (avoid jargon)• Proof read application and attachments• Ensure you have all supporting documents (information forms, approvals,

etc…)• Time – dedicate ample time to understanding & developing the application• Quality – approach the ethics process with the intent of submitting a high

quality application (utilise all options & cover all items) • Resources – seek out those who can assist (PI, Co-investigators, Experts

and HREC members)• Plan ahead.

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The Ethics Application FormResponsibility• Principal Investigator (PI)

• has overall responsibility for the research project • Responsible for the preparation of the proposal. • PI should not sign off on the proposal until he/she is satisfied that it is of suitable standard

must sign off approving the application.• Research Student

• It is normal for the student undertaking research for a higher degree to write the proposal with the guidance of their supervisor (normally the PI).

• Head of School/Department• Responsible for final sign off - approving the project at the School/Dept level.

While acknowledging that many proposals are completed

only just in time to meet committee deadlines, the HREC has very little sympathy for poorly written proposals.

It’s the Researcher’s responsibility to get it right. Poorly written applications will be withheld and/or withheld

Delays generally result from poorly planned, poorly constructed applications.

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What to remember

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Why do I need approval?

• Ethics approval is essential• Moral and legal requirement• Professional practice

• Ethics review: an obstacle or an ‘insurance policy’?• Experts from a variety of backgrounds review research applications • Critical feedback• Risk minimisation• VU protects you

• Adverse events & complaints• Delay or refinement?

• Addressing critical gaps in the project• Respecting the rights of participants• Identifying legal oversights• Highlighting the obligations of a researcher• Identify issues of safety (eg. researcher and participants)

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Conduct & human research

Human research ethics values and principles help guide researchers to develop and conduct research in a way that is:

• Safe• Respectful• Responsible• High quality

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Questions?

40WWW.VU.EDU.AU

UNDERSTANDING & MANAGING THE HUMAN RESEARCH ETHICS APPLICATION PROCESS

A practical guide to the ethics application process

Developed by: Anthony Benka Manager, Research Ethics and BiosafetyVU Research Office