RMIT University Human Research Ethics Committee

Terms of reference

1. Introduction

The purpose of this document is to set out the terms of reference of the RMIT University Human Research Ethics Committee (HREC).

2. Purpose

The HREC has been established to ensure that human research is conducted ethically, and protects the welfare and rights of participants and researchers, in accordance with the National Statement on Ethical Conduct in Human Research 2007 (National Statement) and the Australian Code for the Responsible Conduct of Research (Code).

The RMIT University Human Research Ethics Procedure outlines the processes and structures for the administration of human research ethics at RMIT University.

3. Governing Body

The HREC reports to the National Health and Medical Research Council (NHMRC). The HREC also reports to the Deputy Vice-Chancellor (Research and Innovation) (DVC R&I), through the RMIT Research Committee.

4. Responsibilities

The HREC shall:

4.1 Consider ethical dimensions of proposed research projects involving humans and determine whether or not they are acceptable on ethical grounds, consistent with the values of research merit and integrity, respect for human beings, justice and beneficence and meet relevant requirements of the National Statement and any other appropriate requirements

4.2 In conducting reviews, acknowledge and take into account any prior peer review which has judged that a project has research merit

4.3 Ensure that any unnecessary duplication of ethical review is minimized

4.4 Maintain a record of all research projects involving humans that are considered in accordance with the requirements of the National Statement

4.5 Provide for monitoring of human research projects until completion, so that the HREC may be satisfied that such projects continue to conform with approved protocols and ethical standards

4.6 Review and approve any proposed minor or major amendments to approved projects

4.7 Receive, review and accept annual and final reports of approved projects

4.8 Receive and investigate adverse event reports for projects approved by the HREC and CHEAN

4.9 Receive and investigate complaints regarding human research conducted by RMIT University researchers under an approval provided by the HREC or CHEAN in alignment with the RMIT Research Misconduct Procedure and in consultation with the ‘Designated Person’ under the Code

4.10 Maintain communication with internal and external stakeholders and promote ethically good human research at RMIT University

4.11 Provide assistance to RMIT University in the preparation of reports, relating to HREC operations and human research ethics, as required

4.12 Provide input to RMIT University policies and procedures, which relate to human research ethics, as required

4.13 Manage appropriately any conflicts of interest (actual or potential) involving the HREC, its members or advisors

In discharging its responsibilities, the HREC may seek assistance of such experts, or regulatory and advisory bodies, as it chooses.

5. Composition

Membership

5.1 The membership of the HREC is prescribed by the National Statement. Members are appointed for their knowledge, qualities and experience

5.2 As per the National Statement, the HREC will maintain a minimum membership of:

  • A chairperson (Category A);
  • At least two lay people, one man and one woman, who have no affiliation with the institution and who do not currently engage in medical, scientific, legal or academic work (Category B);
  • At least one person with knowledge of, and current experience in, the professional care, counseling and treatment of people (Category C);
  • A member of a community who performs a pastoral care role (Category D);
  • A lawyer, where possible one who is not engaged to advise the institution (Category E); and
  • At least two people with current research experience that is relevant to research proposals to be considered at meetings (Category F).

5.3 Normally, a Category F member of the HREC will be as appointed Deputy Chairperson to assist with the operation of the HREC

5.4 HREC may invite any person to attend a meeting, to either provide expertise/advice, or act as an observer

5.5 Members are expected to maintain regular attendance at meetings, and communicate their apologies if they are unable to do so

5.6 Members who are non-RMIT staff or students shall receive an honorarium for each meeting attended.

Term of appointment

5.7 All members of HREC shall be appointed for a period of three years, and may be eligible for reappointment for a further three year period.

Indemnification

5.8 RMIT will provide all members with legal protection in respect of liabilities that may arise in the course of bona fide conduct of their duties.

6. Procedural Items

Meetings

6.1 The HREC shall meet regularly, normally monthly from February to December

6.2 In the absence of both the Chair and the Deputy Chair another member of the committee shall preside

6.3 The quorum for a meeting shall normally be the minimum membership of the HREC as specified in 5.2. Where there is less than full attendance of the minimum membership at a meeting, the meeting may proceed provided the chairperson is satisfied, before a decision is reached, that the views of those absent who belong to the minimum membership have been received and considered

6.4 Under exceptional circumstances the Chair of the HREC together with two other members may grant provisional approval, out-of-session, for general business of the committee under a standing delegation from the HREC, subject to ratification at the following full committee meeting.

Administration

6.5 Administrative support shall be provided to the HREC by the Research Office, which shall be responsible for:

  • compiling and distributing meeting papers, agendas and minutes;
  • keeping and storing of committee records; and
  • maintaining records of all applications.

Confidentiality

6.6 HREC documentation and proceedings shall be treated as confidential, although the HREC may disclose information, to appropriate internal or external bodies/ persons, at its discretion

Reports

6.7 The HREC will assist RMIT University in submission of an annual report to the NHMRC

6.8 The HREC will report to the RMIT Research Committee, at least quarterly, on matters including the number of applications, approval process and any matters concerning the administration of human research ethics that should be brought to the attention of the Research Committee. The HREC will also submit an annual report to the RMIT Research Committee about developments in human research ethics at RMIT during the preceding year.

Evaluation and Review

6.9 The HREC shall evaluate its performance annually, with an emphasis upon continuous improvement in processes and operations, and report externally to the NHMRC and internally to the Deputy Vice-Chancellor (Research and Innovation) (DVC R&I), through the RMIT University Research Committee.

7. Approval

The HREC’s Terms of Reference were last approved by the DVC R&I on 28 August 2015.