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
WWW.VU.EDU.AU
1
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 people
2. research conducted about people
3. research dealing in their data or tissue
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Values and principles of human
research ethics
A 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
Human research is broad and involves participants in a wide
range of manners:
• taking part in surveys, interviews, • the collection and use of body
or focus groups;
organs, tissues or fluids or
exhaled breath
• undergoing psychological,
physiological or medical testing or • access to information (individually
treatment
identifiable, re-identifiable of nonidentifiable form) as part of an existing
• being observed by researchers
published or unpublished source or
• researchers having access to
database.
personal documents or other
materials
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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
•
•
•
•
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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
•
•
•
•
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•
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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
Reviews resolutions from
minutes and anomalies that
may arise from VUHREC.
Deals with ‘nonminimal’ risk
applications.
Eg.
Review ‘Minimal
projects
involving
Risk’
applications,
children,
special
amendments
&
groups,
intrusive
extensions
techniques
very
requested. or
Other
sensiti
ve material is
applications
reviewed
at to
this
forwarded
level.
VUHREC.
Ratifies
Faculty Faculty
HRECs
HRECmake
decisions,
manages
recommendations
onmembership,
procedures to
implements
VUHREC
procedure and
formulates
responses to
NHMRC.
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
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•
•
•
•
•
•
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!
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•
•
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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 Officer
3. 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.
2.
3.
4.
•
•
•
a response to the items listed in the Ethics Notification
one original signed copy of the resubmitted application
one resubmitted application with changes highlighted (tracked changes)
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 Defined
Withheld
• 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
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•
•
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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 Benka
Manager, Research Ethics and Biosafety.
Phone: 9919 4148 (Mondays, Wednesdays & Thursdays)
• VUHREC, AEEC, IBC, Feedback, Complaints, Adverse Events.
Ms Lilian Tan
Ethics 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
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Human Research Ethics Web page
http://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 Form
Responsibility
• 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
•
Head of School/Department
• 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).
• 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?
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•
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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:
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Safe
Respectful
Responsible
High quality
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Questions?
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UNDERSTANDING &
MANAGING THE
HUMAN RESEARCH
ETHICS APPLICATION
PROCESS
A practical guide to the ethics
application process
Developed by:
Anthony Benka
Manager, Research Ethics and Biosafety
VU Research Office
WWW.VU.EDU.AU
40
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Understanding and Managing the Human Research Ethics