Making submissions to the Department of Health HREC

General information regarding submissions to Department of Health and Department Families, Fairness and Housing - Human Research Ethics Committee (HREC)

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 research.ethics@health.vic.gov.au.

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 research.ethics@health.vic.gov.au 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.

Research requiring access to data held by the DH

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

Research requiring the department program area approval

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

Ethical considerations in Quality Assurance and Evaluation Activities

In addition, chapters from the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) 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)

Privacy legislation

Researchers must ensure that proposals conform to all relevant privacy legislation, including the Privacy Act 1988 (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.

Medical research involving patients under a legal incapacity

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.

Submission and meeting dates for the Human Research Ethics Committee

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 research.ethics@health.vic.gov.au.

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

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

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.