Melbourne ResearchHuman Ethics

Human Ethics Advisory Groups (HEAGs)

The primary function of a Human Ethics Advisory Group (HEAG) is to provide preliminary assessment of human research projects submitted by staff and students in a department, school or faculty; and to advise the relevant Human Ethics Sub-Committee (HESC) and the central Human Research Ethics Committee (HREC) on issues pertaining to human research ethics in the department, school or faculty.

1. Membership

A HEAG should comprise at least three members of academic staff of a department or centre, including one senior member of staff (e.g. Associate Professor). Where possible a post-graduate student should also be appointed to the HEAG.

In the case of small departments or centres it may be helpful if two or more combine to form a multi-department HEAG for review of research ethics proposals. Alternatively a faculty-based Human Ethics Advisory Group may also be formed.

2. Functions and responsibilities

2.1 To examine proposals which involve the use of humans as participants in the research of staff and students of the department, school or faculty; and to advise the HREC and its Sub-Committees on whether the proposals comply with the ethical guidelines adopted by the University and the Human Research Ethics Committee.

2.2 To make an assessment of the ethical implications and the academic value including methodology and technical aspects of proposals to be conducted by staff and students of the department, school or faculty prior to submission of the proposal to the appropriate Human Ethics Sub-Committee, in accordance with the policy and procedures adopted by the HREC.

2.3 To consider, approve and keep appropriate records of Project-within-Program proposals, which are derived from Program applications of research previously approved by the Human Ethics Sub-Committees. To report Project-within-Program approvals and forward a signed copy to the HREC.

2.4 To consider, approve and keep appropriate records of Minimal Risk proposals. To report Minimal Risk approvals and forward a signed copy to the HREC.

2.5 To assist and advise the HREC and its Sub-Committees as follows:

(a) to ensure that investigators are appropriately qualified to conduct the research including any specific procedures proposed by them in a project;

(b) to ensure that proper arrangements are made in accordance with University and HREC policy for security and disposal of confidential data collected in the course of research;

(c) to monitor research projects conducted by staff and students of the department in accordance with the National Statement on Ethical Conduct in Human Research and University procedures;

2.6 To keep appropriate records for audit and compliance purposes.

2.7 To provide ethics training for department researchers, supervisors, post-graduate students and HEAG members, including information on the policy and procedures of the University’s ethics committees.

2.8 Representatives of HEAGs are to attend information sessions and other training seminars provided by the HREC.

3. Method of operation

3.1 The HEAG is to meet regularly during the year to review projects and to discuss general issues relating to the ethical review of research. Minutes, including decisions regarding project approvals made at the meetings, must be recorded, in particular those regarding Minimal Risk or Project-within-Program proposals.

3.2 Where projects are reviewed by circulation between meetings a cover sheet with some record for comments and signatures must be kept. Minimal risk projects which are submitted for approval by the department must be discussed at a meeting of the HEAG and cannot be approved by circulation. Details of discussions at the meeting are to be recorded.

3.3 Members of the HEAG may not review and approve their own research. In such cases another person must review the project and sign HEAG approval.

3.4 Proposal types

(a) Individual research projects. Proposals for research involving human participants forwarded by students or staff in the department should be assessed by the HEAG and forwarded to the appropriate Sub-Committee for consideration, together with the Advisory Group’s recommendations or comments, where relevant.

(b) Program applications. In the case of applications for ethics approval of a program of research, researchers are to complete the program application form and forward it to the HEAG for consideration. HEAG members are to make an assessment of the program with regard to academic merit and ethical implications and then forward to the Sub-Committee the Advisory Group’s recommendations any other comments, where relevant.

(c) Project-within-program applications. In the case of project-within-program applications HEAG members are to make an assessment of the project with regard to academic merit and ethical implications and then, if appropriate, approve the project.

(d) Minimal Risk projects. In the case of Minimal Risk applications considered eligible for approval by the HEAG, Advisory Group members are to make an assessment of the project with regard to academic merit and ethical implications and then, if appropriate, approve the project. The HEAG may decide that a Minimal Risk application requires a full review by the HREC.

3.5 The HEAG must provide an annual report to the HREC on its activities, including:
3.6 The Chair and/or other HEAG members are to attend at least one meeting of the relevant Human Ethics Sub-Committee to discuss the HEAG annual report and other issues of common interest.

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