About ethics

Establishment

The Human Research Ethics Committee (HREC) acts by way of delegated authority of the Board of Directors and has executive authority conferred upon it to fulfil the roles and carry out the functions detailed in these Terms of Reference.

The HREC is established pursuant to the bylaws of the Royal Melbourne Hospital (RMH) as a sub-committee of the Research Advisory Council (“RAC”) and operates within the guidelines of the National Health and Medical Research Council (NHMRC). The HREC reports to the Melbourne Health Board through the RAC.

Scope of responsibility

The HREC has been established to conduct scientific and ethical reviews of proposals for human research:

• to be undertaken at or under the auspices of the RMH
• received by the HREC in the exercise of its function as an accredited HREC within the streamlined ethical review of clinical trials programme of the Department of Health Victoria
• received by the HREC in the exercise of review processes accepted, accredited or certified for the purposes of any other system designed to eliminate unnecessary duplication of ethics review of human research, including the Interstate Mutual Acceptance program operating in Victoria, Queensland and New South Wales

Roles

The roles of the HREC are to:

• ensure that the design and conduct of any human research that it reviews within the scope of its responsibilities conforms with the National Statement on Ethical Conduct in Human Research (NHMRC, ARC, UA, 2007) (National Statement) and other relevant national codes of human research ethics and also with the ethical standards to which RMH is committed
• ensure that participants in any human research that the HREC reviews and approves are accorded the respect and protection that is due to them
• facilitate and foster human research that is of benefit to Australian communities
• ensure that any decision it makes complies with relevant Victorian and Australian laws

Functions

In fulfilling these roles, the HREC will:

• Receive and review proposals for human research projects to determine whether they meet all relevant ethical standards.
• Ensure that it is sufficiently informed on all aspects of a research proposal, including its scientific and statistical validity, before deciding whether a proposal is both acceptable on ethical grounds and conforms with the National Statement.
• Decide whether participants in all reviewed and approved human research projects will be accorded the protection and respect that is due to them.
• Advise the RMH and researcher applicants whether or not reviewed research proposals meet relevant ethical standards and have or have not been approved and provide reasons, linked to the National Statement, for those decisions.
• Determine, in relation to each reviewed and approved research project, that there will be mechanisms to monitor the conduct of the research and that the frequency and type of those mechanisms reflect the degree of risk to participants.
• Offer relevant advice and assistance to other institutions without formally constituted HRECs
• Implement systems adopted by the RMH to promote the efficient ethical review of multicentre research projects in order to minimise unnecessary duplication of ethical review of human research.
• Have the authority to delegate to a subcommittee any of its powers and functions that are capable of being delegated in order to assist in the expeditious and effective ethical review of research proposals. The HREC will remain responsible and accountable for the activities and recommendations of any subcommittees.
• Consider issues referred by the RAC and/or Board of Directors of RMH and, where appropriate, provide advice to the RAC and/or Board of Directors especially on policy issues with ethical implications.
• Provide a forum in which staff, patient, carer or student concerns regarding ethical issues in research can be considered and investigated.
• Promote a deeper understanding of ethical issues related to research within Melbourne Health through educational activities.

Membership

The RMH HREC will be constituted in conformity with the National Statement and will have at least eight (8) members, both men and women, namely:

• a chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement;
• at least two members who are lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work, and who are preferably from the community in which the institution is located;
• at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example a nurse, medical practitioner, or allied health professional;
• at least one member who performs a pastoral care role in a community, for example, an Aboriginal elder or a minister of religion;
• at least one member who is a practising lawyer, but where possible one who is not engaged to advise the institution;
• at least two members with current research experience that is relevant to research proposals to be considered at the meetings they attend; and
• additional members as required from time to time to assist with scientific review and ethical decision making.