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The St Vincent's Hospital Melbourne (SVHM) Human Research Ethics Committee (HREC) is fully constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research 2023. 

SVHM uses St Vincent's Hospital Application for Governance and Ethics (SAGE) , as a one-stop portal for all High and Low Risk Ethics/Governance application submission and post-approval management of research projects.

Quick reference guides and video tutorials on how to navigate SAGE is available here .

Important Notices

New ethics applications, process of review of a high-risk ethics application.

Ethics Submission Guide  - This guide can also be used for any questions regarding the necessity and role of the required documents.  High-Risk Ethics Application closing dates here  (not applicable to Low-Risk Ethics Application).

Required Documents for Ethics Application

Legal documents:  please make sure to send through a PDF version of any legal documents required as part of the submission. These can be signed:

• In wet ink - please submit a scanned copy of the wet ink signature
• DocuSign/Adobe Sign - please make sure that a  Contract Submission Form  is submitted.

All documents can be found under 'Forms' in the right hand side bar. Please click  here  to be redirected. Missing documents in the submission will result in ineligible application and review delays.

Reviewing HREC Approving this Research and HREC Executive Officer Details

* Please note: these details must appear exactly as it is shown below

7. Patient-Facing Materials  –  if participants are enrolled in the study

Such as surveys, brochures, advertisements or questionnaires. All documents must have a footer that includes document name, version number and date.

8. Medical Physicist Letter  –   if Ionising Radiation is involved

• Radiation - Notification to the Reviewing HREC  – for all studies involving ionising radiation
• Medical Physicist Report  – for studies involving ionising radiation that is additional to standard care. The report MUST be conducted by a medical physicist. One report must be submitted for each site seeking ethical approval.

9. Investigator Brochure (IB)  –  for studies involving drugs and/or devices 

10.  Form of Indemnity - HREC Review Only  –  f or all commercially sponsored clinical trials where SVHM is providing premises for the conduct of HREC review

SVHM Indemnified Party Details

St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755

1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

12.  Clinical Trial Notification Form (CTN)  –  for use of unapproved therapeutic goods under the CTN scheme

SVHM Details For Use When Completing the Form

13.  Certificate of Insurance  –  f or all commercially sponsored clinical trials

What is Required? -  Insurance for Clinical Trials Information and Guide (2020)

14. Investigator Clinical Practice (GCP) Certificates –  Mandatory

Provide a current and valid GCP Certificates for the following study personnel:

• For Multi-site study - Coordinating Principal Investigator
• For Single-site study - Principal Investigator

15. Investigator Curriculum Vitae (CVs)  –  Mandatory

Provide a Curriculum Vitae for the following study personnel:

• For Multi-site study - Coordinating Principal Investigator and Principal Investigators of each site

New Governance Applications

Process of review.

Ethics Submission Guide  - This guide can also be used for any questions regarding the necessity and role of the required documents .

After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at St Vincent's Hospital Melbourne . Research must not commence until governance authorisation has been granted. 

• There is no closing date for Governance Applications. Applications must be complete at the time of submission.
• Please adhere to SVHM Site Specific Guidelines.
• We will endeavour to provide a response within 10 working days once all necessary paperwork has been submitted.
• Submission must be received within 3 months of ethical approval (if SVHM reviewing HREC) or fee will be required.

Required Governance Documents

• DocuSign/Adobe Sign - please make sure that a  Contract Submission Form  is submitted 

Local HREC Office Contact

* Please note: these details must appear exactly as it is shown below Please refer to the site-specific guidelines for acceptable Catholic wording on the site-specific PICF.

10. Patient-Facing Materials  –  if participants are enrolled in the study

Such as surveys, brochures, advertisements or questionnaires. All documents must have a footer that includes document name, version number and date.

11. Medical Physicist Letter  –  if ionising radiation is involved

• Radiation - Notification to the Reviewing HREC  – for all studies involving ionising radiation.
• Medical Physicist Report  – for studies involving ionising radiation that is additional to standard care. The report MUST be conducted by a medical physicist at SVHM.

12. Investigator Brochure (IB)  –  for studies involving drugs and/or device

Submit the original Investigator Brochure approved by the reviewing HREC. 

13. Budget  –  as per sponsor or institution guidelines

14.  Form of Indemnity - Standard  –  for all commercially sponsored trials where  SVHM is providing premises for the conduct of the study

1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

15. Clinical Trial Research Agreement (CTRA)  –  for commercially sponsored, multi-site clinical trials

16.  Research Collaboration Agreement (RCA) –  for investigator initiated, multi-site clinical trials

SVHM Details for RCA:

• Name of Institution: St Vincent's Hospital (Melbourne) Limited
• Address: 41 Victoria Parade, Fitzroy VIC 3065
• ABN: 22 052 110 755

Research Collaboration Agreement (RCA) with SVHM details inserted can be found on our 'Forms' Page  here .

Please note that only the Director of Research and the Executive Officer can sign off on behalf of the institution, the principal investigator does not have the authority to sign off on behalf of the institution.

17. Contract Submission Form   –  for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign Please consult the  SVHM Digital Signature Guidelines  for further information. 

18.  Clinical Trial Notification Form (CTN)  –  for use of unapproved therapeutic goods under the CTN scheme

SVHM Details for Use When Completing the Form:

19. Certificate of Insurance  –  for all commercially sponsored trials

Submit the original Certificate of Insurance approved by the reviewing HREC.  

20. Investigator Good Clinical Practice (GCP) Certificates  – Mandatory

• SVHM Principal Investigator
• SVHM Associate Investigators

21. Investigator Curriculum Vitae (CVs)  –  Mandatory

Post Approval Amendment – HREC Review (SVHM is the reviewing HREC)

Process of amendment review.

After ethics approval has been obtained from an accredited HREC for your project, you may be required to submit an amendment if changes are required to your study. All amendments must be reviewed and approved by a HREC before they are undertaken. Amendments include any changes to the protocol, PICFs, IBs, research personnel, patient-facing documents or sites involved.

• There is  no closing date for amendment submissions. 
• Please adhere to SVHM Site Specific Guidelines. 
• We will endeavour to have a response within 10 working days once all necessary paperwork has been submitted. 

Required Documents for Different Amendment Types

Change of principal investigator (permanent), general amendment: change of principal investigator (temporary - less than 6 months), general amendment: updated protocol and/or investigator's brochure (ib) , general amendment: updated participant information and consent form (picf) , general amendment: updated participant facing documents, addition of a full site, addition of satellite site.

Please click  here  to view guideline document for what qualifies under this category of site addition.

Addition of Recruitment Site

Addition of service site, all other changes (administrative), post approval amendment – governance review (svhm is a participating site).

After ethics approval has been obtained from an accredited HREC for your project, you may be required to submit an amendment if changes are required to your study. All amendments must be reviewed and approved by a HREC before they are undertaken. Amendments include any changes to the protocol, PICFs, IBs, research personnel, patient-facing documents or sites involved.

• There is no closing date for amendment submissions. 
• Please adhere to SVHM Site Specific Guidelines
• We will endeavour to have a response within 10 working days once all necessary paperwork has been submitted

All documents can be found under 'Forms' in the right hand side bar. Please click  here  to be redirected.

Change of SVHM Principal Investigator (Permanent)

Change of svhm principal investigator (temporary - less than 6 months), changing members of a research team (associate investigator or research coordinator), updated protocol and/or investigator's brochure (ib), updated participant information and consent form (picf) , updated participant facing documents, annual reporting requirements, annual safety reports, due on the anniversary of study approval.

• For clinical trials involving an investigational medicinal product or investigational medical device
• The completion and submission of an annual safety report is part of the conditions of ethical approval for all projects.
• For further information, please contact Reception on 03 9231 6970 or email  [email protected]

Annual Reports Should Generally Include

• A brief description and analysis of new and relevant findings
• IMPs not on the TGA Register - a brief analysis of the safety profile of the IMP and its implications for participants taking into account all safety data
• A brief discussion of the implications of the safety data to the trial’s risk-benefit ratio
• A description of any measures taken or proposed to minimise risks

Submitting Annual Safety Reports (ASR)

• Please submit Annual Safety Reports (ASR) via SAGE. See  How to submit an Annual Safety Report (ASR)
• The sponsor is responsible for reporting to the reviewing HREC, in accordance with Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016). ONLY the Sponsor or CPI can sign-off and submit the ASR Form.
• DSURs may serve as the annual safety report, but are not required. They can be uploaded to the Annual Safety Report Form on SAGE.

Annual Project/Progress Reports

Due 01 May - Annual Reports for projects that have been approved in January to April in any year do not need to be submitted until 01 May the following year.

Failure to submit progress reports within 45 days following the 01 May submission deadline may lead to a suspension of the ethical approval for the study.

• The completion and submission of an annual report is part of the conditions of ethical approval for all projects.
• Acknowledgement of a submitted annual progress report will generally be provided within 2 months of submission - this timeline may be extended due to the significant volume of reports received. 
• For further information, please contact Research Integrity and Compliance Assistance on 03 9231 6987 or email:  [email protected]

Submitting Annual Reports

All Annual Reports and Final Reports are to be submitted under the relevant projects on SAGE. Different report forms are required depending on the project types (Summary below). For more information regarding how to submit an annual report on SAGE, please refer to these  Annual Report Submission Guides .

Safety Reporting (SAEs, SSIs, USMs)

*Annual Safety Report Information in Header above, under "Annual Reporting Requirements"

For more details on safety reporting please view the  " NHMRC Guide on Safety monitoring and reporting in clinical trials involving therapeutic goods" on our Resources page .

This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.

Submitting Safety Reports

• Please submit Safety Reports via SAGE. See SAGE Resource Pack for instructions.
• All safety reports for St. Vincent's Hospital Melbourne RGU must be signed by the Chief Investigator or the Sponsor.

IMPORTANT: Please note a serious breach report must be submitted to HREC for all safety reports that were not reported within the required timeframe, as they may pose a risk to the study participant.

Definitions

Serious adverse events (saes).

• In the event of a Serious Adverse Event (SAE) Investigators are required to report to Sponsor within 24 hours of becoming aware of the SAE.
• The sponsor, on becoming aware of the reported SAE made by Investigators, will be required to notify HREC and TGA based on the type of SAE and the associated timeline as described below:

*If St Vincent’s Hospital Melbourne is nominated as the trial sponsor, St Vincent’s Hospital Melbourne will assume the Sponsor responsibility and abide by the above SAE reporting timeline.

Frequently Asked Safety Reporting Questions

1. Who is now responsible for submitting Safety Report?

The Sponsor is responsible for reporting a safety event to the reviewing HREC in accordance to with the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC 2016). The Site PI needs to provide a copy to the site RGO as required if it involves the site participant.

2. Do I need to submit AEs and SAEs that are unrelated?

It is not a requirement to report and submit AES and SAEs that are unrelated to St. Vincent's Hospital Melbourne (SVHM).

3. Do I need to submit AEs and SAEs that are related?

AEs and SAEs that are listed on the investigator’s brochure will not need to be submitted to the HREC.

4. For related SAEs that do not fall under the definitions of USM, SSI in the NHMRC guidelines, do they need to be submitted? And what’s the reporting timeframe?

For related SAEs that do not fall under the definitions of USM and SSI in the NHMRC guidelines, they do not have to report to the SVHM HREC committee. Site will need to inform Sponsor about the SAE and have the communication documented in the study folder.

5. Who is now responsible for submitting SUSARs and USADEs?

The Sponsor is required to report all SUSARs to the Therapeutic Goods Australia. The HREC will not require the Sponsor to submit the SUSARs except for participants that involves St Vincent's Hospital, Melbourne participants.

6. Do I need to submit SUSARs and Six monthly line listings to HREC?

SVHM HREC will not require SUSARs and six monthly line listings to be submitted for sites other than St. Vincent's Hopsital Melbourne (SVHM).

7. What if Sponsor is required by their global policies mandating the reporting of individual case of SUSARSs and six monthly line listing to HREC?

St Vincent’s Hospital, Melbourne HREC will accept and acknowledge the individual case of SUSARS and six monthly line listing if it mandated in the Sponsor global policies.

Serious and Non-Serious Breaches

Nhmrc 2018 update.

The NHMRC has introduced a new document called “Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018”. 

The European Union (EU) Clinical Trials Regulation (536) introduced the term ‘serious breach’ to describe the sub-set of deviations that should be reported to review bodies and the Integrated Addendum to ICH E6 R1: Guidelines for Good Clinical Practice (ICH E6 R2) requires the sponsor to perform a root cause analysis for ‘noncompliance [deviations] that significantly affect or has the potential to significantly affect human subject protection or reliability of trial results.

Although GCP requires all deviations to be reported to the trial sponsor, not all deviations need to be reported to the reviewing bodies.

HRECs only need to be made aware of the small sub-set of deviations that have a significant impact on the continued safety or rights of participants, or the reliability and robustness of the data generated in the clinical trial (hereinafter referred to as serious breaches).

Serious breaches occurring at a site should also be reported by the investigator to their institution, as they may impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.

Serious Breaches vs. Non-Serious Breaches

Please see our document " Breach Report Guidelines " for more information as to what needs to be reported to the RGO/HREC here.

For additional information, please view the NHMRC "Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018"

Reporting Serious Breaches

• Please submit serious breach reports to the reviewing HREC and the RGO site at which the breach occurred
• From October 2023 onwards, all breach reports are submitted via SAGE - see SAGE Resource Pack for instructions on how to submit
• ONLY E-COPIES are required for breaches
• Contact:: [email protected]

Reporting Non-Serious Breaches

• Please submit non-serious breach reports ONLY to the RGO site at which the breach occurred
• see  SAGE Resource Pack  for instructions on how to report a non-serious breach

If you have any queries please contact the Research Governance Unit on 9231 6970 or e-mail  [email protected]

Authorised Prescriber Scheme

After HREC Approval has been granted, you will need to submit an application to the TGA for evaluation. This submission should include:

• A completed  Authorised Prescriber Scheme application form   (Obtained from the TGA Website). Ensure the indication listed on this form is the indication. 
• HREC letter of approval or a letter of endorsement from a specialist college, including a declaration that all necessary documentation has been reviewed
• Please visit the TGA Website for more guidance regarding the application process

Please email Authorised Prescriber Applications to: [email protected].

New Authorised Prescriber Applications

1x hard copy

5. Monitoring Information

*Please include:

• How the medical practitioner will determine if the use is effective
• How the medical practitioner will determine whether an adverse event has occurred
• What monitoring is required
• How it will be done
• Interval and duration of monitoring

1x signed original hard copy

6. Efficacy and Safety

• The unapproved good’s efficacy and expected benefits
• Any known/expected adverse effects,
• Risks and safety issues
• Related toxicology

7. Evidence

*The application should contain appropriate sources of evidence to support the use of the unapproved good. The sources of evidence for data, with the highest level of significance first, in decreasing order are:

• Product information documents (of equivalent) (if the good is approved by an overseas regulator)
• Randomised controlled trials
• Nnon-randomised controlled trials
• Individual case studies
• Consensus opinion of specialist colleges and societies

8. Global Regulatory Status – if available

*The global regulatory status of the unapproved good may affect the level of evidence required in the application.

9. Informed Consent

*The use of unapproved goods is considered experimental. The Authorised Prescriber must obtain the informed consent of each patient for whom they prescribe the unapproved good.

The Authorised Prescriber must advise patients in the Informed Consent of the following:

• TGA has not have evaluated the unapproved good’s safety, quality and efficacy
• Possible benefits and risks of its use
• Possibility that there may be unknown side effects
• Any alternative approved goods

It is best practice to obtain informed consent in writing using a standard form.

If the unapproved good is, however, derived from biological tissues including blood or plasma, the medical practitioner must obtain informed consent using the form available on the TGA website.

10. Current Prescriber CV

After HREC Approval had been granted 

You will need to submit an application to the TGA for evaluation. This submission should include:

• a completed  Authorised Prescriber Scheme application form  (Obtained from the TGA Website) . Ensure the indication listed on this form is the indication.

Reporting Requirements of an Authorised Prescriber

SVHM Radiation Safety Licence Number: 300042061

SVHM TGA Sponsor Reference Number: 28204

SVHM CTN Code: 30514

SVHM HREC Code: EC00343

For more information visit the Research Governance Unit Contact page

Making submissions to the Department of Health HREC

On this page, key messages, general information regarding submissions to department of health and department families, fairness and housing - human research ethics committee (hrec), research requiring access to data held by the dh, research requiring the department program area approval, ethical considerations in quality assurance and evaluation activities, privacy legislation, medical research involving patients under a legal incapacity, submission and meeting dates for the human research ethics committee.

• Applications must be presented using the Human Research Ethics Application (HREA) along with the Victorian Specific Module.
• Proposals are to be submitted to the executive officer at least 2 weeks before the scheduled date of the meeting.
• Discuss your application with the committee executive officer [email protected] prior to lodgement.

Researchers should consider the Criteria for referral of research to the committee - to determine whether their project should be submitted for ethical review. Those seeking to lodge an application must discuss their application with the committee executive officer [email protected] .

Researchers should note the following in preparing and submitting their application to the HREC:

1. Completing the HREC application form

The Human Research Ethics Application (HREA) is a standard form developed by the National Health and Medical Research Council (NHMRC). The Victorian Specific Module (VSM) addresses Victorian legislative requirements; it must be submitted as part of an ethics application when the HREA is used. For a low and negligible risk (LNR) research project taking place in Victoria only, the LNR VIC application form may be used instead of the HREA. The applicant must discuss the project with the HREC Executive Officer [email protected] before completing the LNR VIC. A Victorian Specific Module is not required for projects using the LNR VIC.

2. Submitting the ethics application

Your application must include:

• a cover letter stating the meeting at which review is sought
• a completed HREA or LNR VIC
• a completed Victorian specific Module (not required with LNR VIC)
• any other relevant attachments, such as protocol, survey instruments, copies of questions, data variables sought from databases, recruitment materials, plain language statements of the project, consent forms
• a curriculum vitae. Researchers are asked to please provide no more than a brief 2 page CV of the lead investigator and primary person doing the work of the project (if not the lead investigator).

These application documents should be itemised in the cover letter in the order in which they appear in the application so it is apparent that the submission is complete.

The HREC considers proposals for approval at its monthly meetings. In cases of extreme urgency, for instance a proposal addressing a current epidemic, it will consider a proposal out of session.

In some instances, the HREC finds it useful to talk to the researcher/s in person and will make arrangements to do so at a monthly meeting. The result of the review process is communicated to researchers as soon as possible after the meeting at which the proposal was considered. In those instances where the HREC requests clarifications, modifications or additional information, responses to these requests are considered either out of session or at the earliest available meeting - the mode depends upon the deliberations of the meeting at which the proposal was considered.

The HREC does not consider draft, 'in principle' or otherwise incomplete proposals. It does, however, consider proposals in respect to studies to be completed in stages, provided the proposal in relation to the first stage is complete.

For guidance on data linkage projects please contact the Centre for Victorian Data Linkage External Link .

As a general rule, if the proposed research involves personnel, resources, data or clients of a particular program area within the Department, researchers should seek program area management support for their project before submitting it to the HREC for ethical review.

Although support within the relevant program area may be conditional upon receiving HREC approval, program managers may refuse permission to carry out a project on grounds unrelated to ethical issues.

The granting of approval by the HREC does not take precedence over the authority of program managers to determine the priority of activities within their area and researchers should be aware that HREC approval does not guarantee program support for their project.

Ethical considerations in Quality Assurance and Evaluation Activities External Link

In addition, chapters from the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) External Link that are relevant when determining whether or not an activity ought be characterised as one of research or quality assurance are: Chapter 2.1 Low risk and negligible risk research and:

• Oversight and review of ethical procedures (5.1.10 - 5.1.17)
• Research involving no more than low risk (5.1.18 - 5.1.21)
• Research that can be exempted from ethical review (5.122 - 5.1.23)

Researchers must ensure that proposals conform to all relevant privacy legislation, including the Privacy Act 198 8 (Commonwealth), the Privacy and Data Protection Act 2014 (Vic) and the Health Records Act 2001 (Vic). Where researchers are seeking to obtain information from Commonwealth agencies or from private health service providers, they should consult the Guidelines Under Section 95 of the Privacy Act 1988 and/or the Guidelines Approved Under Section 95A of the Privacy Act 1988. The Privacy and Data Protection Act 2014 (Vic) regulates the responsible collection and handling of personal information (excluding health information) by organisations in the Victorian public sector and replaces the Information Privacy Act 2000 (Vic). The Health Records Act 2001 (Vic) applies to all health information held in Victoria in the public or private sectors. The Health Privacy Principles became legally binding on 1 July 2002. Victoria has statutory guidelines for the purposes of Health Privacy Principles 1.1 (e) paragraph (iii) and 2.2 (g) paragraph (iii). The guidelines can be obtained from the Office of the Health Complaints Commissioner. Researchers are responsible for providing sufficient information in the HREA to enable the HREC to determine whether the research represents any breach of the various Privacy Principles and, if so, whether the public interest in the research substantially outweighs the public interest in respecting privacy.

Researchers wishing to conduct medical research involving patients under a legal incapacity to consent must consult the relevant provisions of the Victorian Guardianship and Administration Act 1986 especially Division Six ss(42)P-ss(42)Z. There are certain preconditions that must be met before a HREC can approve such research.

There are 8 meetings of the Committee scheduled for 2024. A limit of 5 applications per meeting applies. It is imperative that those seeking to lodge an application for ethical review discuss their application with the ethics committee executive officer, prior to lodgement via email [email protected] .

Applications to the committee are lodged via the ERM (Ethics Review Manager) online portal External Link . Researchers will need to set up an account on ERM in order to lodge their submissions, see the ERM Register External Link .

Further information on how to make a HREC application and ERM can be found on the Clinical trial research website External Link .

The committee meets the first Wednesday of the month in the second two months of each quarter. Submissions should be submitted by 2:00pm the day they are due.

HREC submission and meeting dates

Meetings are held on the first Wednesday of the month (note: there are no meetings in January, April, July, or October). Submissions for the upcoming HREC meeting close on the Wednesday 5 weeks ahead of the meeting.

Reviewed 10 April 2024

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• Human Research Ethics

Our research ethics committees review cancer research projects to ensure ethical standards are met and that the confidentiality of participants' information is protected.

(See our glossary of medical and professional acronyms for details of qualifications).

Membership of the Human Research and Ethics Committee

Professor Jeffrey Szer :  BMedSc MB BS FRACP Chair

Prof Marilyn Pittard: LLB (Hons), BEc (Hons), Barrister and Solicitor of the Supreme Court of Victoria  Lawyer, Deputy Chair

Ms Tarishi Desai:  BComm, BA(Hons), JD  Lawyer

Mr Dominik Kucera:  B.Bus (Acc), CPA Communtiy member

Dr Maia Sauren:  BE, Electrical and Computing (biomedical major) PhD (Electrical and Computer Engineering)   Community member

Dr John Hannon: BSc(Hons), BTh, PhD, DipEd

Pastoral Care

Ms Grace Butson: BPhty, MCncrSc

Professional Care

Ms Rishni Perera : BBiomed, MSpeechPath

Dr Rebecca Bergin: BA&Sc, Biochemistry and Molecular Biology (Hons), PhD (Department of General Practice)  

Dr Fiona Bruinsma: BSc, Grad Dip App Psych, MA App Sc (Epidemiology), DPH

A/Prof Allison Hodge:  BAgSc (Hons), BSc, Grad Dip Diet, MEnvSc, Grad Dip Epi Biostats, PhD

Dr Sibel Saya:  BS, MC-GENCOUN, PhD (Centre for Cancer Research & Department of General Practice)  Researcher

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Human ethics

The Human Research Ethics (HRE) team at UVic manages the review of research activity that involves human participants and human biological materials.

We provide:

• research ethics advice
• up-to-date regulatory information

We also give presentations to classes and can offer guidance to you and your students.

Useful resources:

• do I need human research ethics approval?
• how do I apply for human research ethics approval?
• human ethics resources
• Research Ethics BC harmonized review guidelines
• human research ethics FAQ

If you're not sure your project requires ethical approval,  email us or call  250-472-4545  as soon as possible. Graduate students should note that  failing to get research ethics approval could affect your ability to graduate. 

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The following are COVID-specific guidelines to support in-person research with human participants, on campus and in the community.

Please review this information if you are planning to resume in-person research that has been halted or are planning to apply for a new study.

• Conducting research virtually with participants
• UVic COVID-19 health & safety information
• UVic human research ethics COVID-19 Bulletin #7

UVic is committed to supporting our researchers in their intellectual pursuits. We also recognize the need to protect the rights and interests of the public and individuals who take part in UVic research.

UVic policies and procedures that govern human-related research uphold the highest ethical standards. They act in accordance with Canada's tri-council policy statement on the ethical conduct for research involving humans (TCPS2) .

UVic researchers must understand their responsibilities to UVic and the public. Familiarize yourself with the following before you start your research.

• Board of Governors (BOG) research policy (policy RH8100) - sets out the manner in which research is conducted, supported and communicated at UVic.
• BOG university regulations for research involving humans (policy RH8105) - delegates ethical review management and administration to the Office of Vice-President Research and the Human Research Ethics office. Procedures for conducting human research start on page 4. These procedures include detailed information about the administration of human research ethics at UVic.
• internal guidelines for quality assessment of services and programs  - these guidelines apply to internal quality assurance, performance review or testing within UVic.  Note that these are guidelines, not a policy.

Federal policies

• Federal research ethics policy -  tri-council policy statement on the ethical conduct for research involving humans (TCPS2)
• Memorandum of Understanding (MOU) on roles and responsibilities in the management of federal grants and awards

Human research ethics board

The Human Research Ethics Board (HREB) oversees UVic research activities that involve human participants or human biological materials. They ensure that these research activities meet the required ethical standards. This includes research taking place in academic courses.

UVic Human Research Ethics Board 2022-2023

If you have questions or if you are new to research, email us before you begin your study, or call us at  250-472-4545 .

contact by subject area

• general inquiries, ethics approval, ethics exemptions, external researchers
• new applications, RAIS ethics module, BC harmonized review
• RAIS renewals, amendments, completions

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Human Ethics Committee

The University's Human Ethics Committee and subcommittees are responsible for the assessment of human ethics applications.

If you have queries about your ethics application, please contact the Research Office ethics team .

Human Ethics Committee membership

• AProf Rhonda Shaw ,  School of Social and Cultural Studies (Convenor)
• Prof Stephen Marshall , Centre for Academic Development (Deputy Convenor)
• Dr Catherine Caudwell , School of Design Innovation (Deputy Convenor)
• AProf Jonathan Barrett , School of Accounting and Commercial Law
• Dr Peter Wood , Wellington School of Architecture
• Dr Aliitasi Su'a-Tavila , School of Health
• Dr Arini Loader , School of History, Philosophy, Political Science & International Relations
• Dr Ali Glasgow , School of Education
• Prof Paul Jose , School of Psychology
• Dr Marcela Palomino-Schalscha , School of Geography, Environment and Earth Sciences
• Dr Amarie Carnett , School of Education
• Dr Jesse Pirini , Wellington School of Business and Government
• Dr Linda Bonne , School of Education
• Dr Maree Hunt , School of Psychology
• Dr Stephen Skalicky . School of Linguistics and Applied Languages
• Dr Liam Martin , School of Social and Cultural Studies
• Dr Amanda Reilly , School of Accounting and Commercial Law
• Dr Chloe Parton , School of Health
• Dr Corinna Howland , School of Social and Cultural Studies
• Dr Danica McGovern , Faculty of Law
• Prof Karen Salmon , School of Psychology
• Dr Kim van Wissen , School of Nursing, Midwifery and Health Practice
• Dr Nadia Pantidi , School of Design Innovation
• Dr Rachel Low , School of Psychology
• Dr Sadat Muaiava , School of Languages and Cultures
• Assoc Prof Spencer Lilley , School of Information Management
• Richman Wee, external member with expertise in bioethics
• Jane Blaikie, external community member
• Kate Kolich, external community member
• Ben Classen, School of English, Film, Theatre, Media and Communication, and Art History (student member)
• Arama Tairea, School of Social and Cultural Studies (student member)

Discuss Human Ethics applications

To talk to someone about an application, contact:

Dr Rhonda Shaw

Associate Professor School of Social and Cultural Studies

• [email protected]
• MY 1007, Murphy Building, 21D Kelburn Parade

Isobel Cairns

Manager, Research Ethics, Integrity and Policy Research Office

• [email protected]
• +64 4 463 9451
• RB 905, Rankine Brown, Gate 3, Kelburn Parade

Dr Tatjana Schaefer

Manager, Research Ethics and Integrity Research Office

• [email protected]
• 04 463 6802

Dr Victoria Coldham-Fussell

Research Ethics Adviser Research Office

• [email protected]

Valentine Ibeka

Research Ethics Adviser

Research Office

• [email protected]

Welcome to the Human Research Ethics Application (HREA)

Hrea has been updated to reflect the revise d national statement on ethical conduct in human research (2023) ..

Submissions of applications for ethics review from public hospital Human Research Ethics Committees may need to be made using ERM , REGIS or Research GEMS (external links). For further information, please see NHMRC's website .

For FAQs , a How-to Guide and technical assistance on the HREA system, please consult the HREA resources page .

Ethics resources, national statement on the ethical conduct in human research (2023), australian code for the responsible conduct of research (2018).

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