HREC - Membership and Terms of Reference

Background

The Melbourne Health Human Research Ethics Committees (HRECs) are established pursuant to the bylaws of Melbourne Health (“MH”) as sub-committees of MH’s Research Advisory Council (“RAC”) and operate within the guidelines of the NHMRC, as amended from time to time. The HRECs act by way of delegated authority of the Board of Directors of Melbourne Health to carry out the functions detailed in these Terms of Reference and report to the Board through the RAC. The number of Melbourne Health HRECs that will exist within Melbourne Health shall be determined by the Board upon advice by the RAC from time to time. At present, Melbourne Health has two HRECs:

• Melbourne Health Human Research Ethics Committee.
• Melbourne Health Mental Health Research and Ethics Committee.

Each Melbourne Health HREC is distinguished from the other by the areas of research reviewed by it.  But as such areas may not be mutually exclusive, the Manager, Office for Research shall determine the allocation of research proposals to each HREC as required.

With the endorsement of the Board of Directors, the RAC may recommend and implement changes to the structure and operations of the HRECs including establishment, composition, streamlining, re-configuration and dissolution, as deemed appropriate from time to time.

Any duly constituted Melbourne Health HREC shall operate in accordance with these Terms of Reference.

Role and Functions of a Melbourne Health HREC

The HRECs are responsible for ensuring that Melbourne Health and the researchers who work under its auspices, fulfil their ethical and legal responsibilities to the people who volunteer to take part in research, in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007) (as amended from time to time) (“National Statement”). These responsibilities reflect the core ethical values of respect for human beings, research merit and integrity, justice and beneficence

In fulfilling these responsibilities, the role of an HREC will be to:

• conduct ethical and scientific review of research projects in a timely fashion and ensure that each proposed research project protects the rights and well being of research participants and facilitates ethically good research;
• operate and act at all times in accordance with the National Statement and other relevant guidelines, regulations and legislation as amended from time to time; and
• ensure that any decision it makes complies with Victorian and Australian laws.

The functions of an HREC will be to:

• receive and consider for approval research projects involving humans undertaken by staff of Melbourne or Western Health and other affiliated personnel within Melbourne or Western Health, including associated University of Melbourne departments, the Walter and Eliza Hall Institute of Medical Research, the Ludwig Institute for Cancer Research and the Howard Florey Institute as necessary; or involving patients of Melbourne or Western Health, and also to consider research projects on behalf of other institutions without their own human research ethics committee. The HRECs will review both the scientific and ethical aspects of research projects;
• 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;
• protect the welfare and the rights of participants in research, with the primary responsibility of each member being to decide independently whether, in his or her opinion, a proposal submitted meets the requirements of the National Statement;
• offer relevant advice and assistance to other institutions without formally constituted HRECs;
• submit a report of its activities on an annual basis to the Research Advisory Council of Melbourne Health; and
• implement systems to promote the efficient ethical review of research projects, including mutual acceptance of ethical review for multi-centre research and streamlined ethical review for approval of multi-site clinical trials, in order to minimise any unnecessary duplication in the review of that research.

  Membership - (follow this link to HREC membership lists)

   An HREC shall be constituted as prescribed by the National Statement and shall include at least eight (8) members, as follows:

1. a chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement;
2. 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;
3. 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;
4. at least one member who performs a pastoral care role in a community, for example, an Aboriginal elder or a minister of religion;
5. at least one member who is a practising lawyer, but where possible one who is not engaged to advise the institution;
6. at least two members with current research experience that is relevant to research proposals to be considered at the meetings they attend; and
7. additional members as required from time to time to assist with scientific review and ethical decision making.

The RAC may appoint HREC members for such a period and on such terms and conditions as it determines consistent with these Terms of Reference, however in ordinary circumstances:

• members are appointed for terms, each of three years, and are eligible for reappointment at the end of each three-year term.
• all nominations to the HRECs will be made by the RAC to, and ratified by, the Chief Executive.  In practice such nominations will be facilitated by the recommendation of the Executive Director of Research and Manager Office for Research;
• HREC members will be nominated and appointed personally for their expertise and not in a representative capacity.

The quorum at each HREC meeting shall be 8 members, including at least one member from each of categories (a), (c), (d) and (e) and two members from categories (b) and (f) above, present either in person or via electronic/technical means.

Responsibilities

General
The general responsibilities of the HRECs will be to:

• promote ethically good human research by:
  1. ensuring participants are accorded the respect and protection that is due to them; and
  2. fostering research that is of benefit to the community;
• consider and advise the RAC, the Executive Management Team and the Board on all ethical matters arising from research activity which require determination. The HREC shall have particular regard to the importance of obtaining informed consent of patients and volunteers and to the maintenance of the best interests of research participants;
• comply with the National Statement and all other applicable guidelines and legislation;  
• advise the RAC and/or the Board as required, on matters concerning medical research;
• consult experts in any field when the HREC considers such action appropriate;
• ensure the requirements of the Commonwealth Department of Health and Ageing are met in the use of any imported therapeutic agents;
• provide advice and advocacy to students and members of staff on current or proposed projects and to encourage research in areas where it considers appropriate;
• consider questions of medical ethics in research without suppressing the natural urge for knowledge amongst members of staff, to act as a method of control on projects which are not properly planned and which cannot be expected to come to fruition;
• ensure that research projects are adequately funded to ensure they can achieve their aims and be completed as proposed and that MH is appropriately reimbursed for services to research; and
• fulfil, as requested or necessary, any or all of the above terms of reference on behalf of the RAC or the Board.

Review of External Research Projects
Given the level of expertise available at MH and the breadth of research projects considered by the HRECs, it is appropriate for HRECs to offer assistance when requested to researchers from other institutions or organisations that do not have their own formally constituted HREC (“external project review”). In undertaking an external project review, an HREC will consider the following matters:

• it may provide ethical approval for projects from other organisations;
• all matters involving research governance will be the responsibility of the organisation conducting the research, and not MH or a MH HREC;
• a HREC may accept and review an external research project proposal , in accordance with the National Statement;
• a researcher external to Melbourne Health (“the external researcher”) is to submit the research proposal using the relevant HREC application form and must comply with all requests from the HREC. The external researcher is not exempt from any requirements applicable to MH researchers;
• the HREC may offer advice to the management of another institution or its researcher regarding the scientific and ethical aspects of a particular project.  The HREC should take care that any advice is drafted in the same terms as those applicable to a Melbourne Health researcher. The advice should be offered wherever possible to the research governance officer of the organisation or institution, as it is the management of that organisation or institution which will have responsibility for research governance and monitoring the project;
• advice provided by a Melbourne Health HREC in relation to an external research project will be scientific and ethical advice offered in accordance with the National Statement.  Such advice is offered to both the external researcher and the institution’s or organisation’s management, and the ongoing responsibility for actually approving the proposal rests with the management of the other institution or organisation; and
• in the case of commercially sponsored pharmaceutical trials, it is necessary that the sponsor provides to Melbourne Health an “HREC Review Only” Form of Indemnity using the current Medicines Australia template. This indemnity must refer to Melbourne Health only providing its HREC and in no other capacity.

Streamlined Ethical Review of Multi-Centre Research
The HRECs shall establish and conduct processes of streamlined ethical review and mutual acceptance with organisations for multi-centre research, as considered appropriate from time to time by the Manager Office for Research, and Executive Director of Research. This includes the Streamlined Ethical Review System for Multi-Site Clinical Trials implemented in Victoria by the Consultative Council for Human Research Ethics.

Operational Matters

The Melbourne Health HRECs act by way of delegated authority of the Board of Directors of Melbourne Health and have executive authority conferred upon them to carry out the functions detailed in these Terms of Reference. Each HREC may require its HREC Secretariat or an HREC subcommittee to undertake any task within it’s the HREC’s powers and functions in order to assist in the expeditious ethical review of a research proposal. 

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