Terms of Reference

Purpose and objectives

• To fulfil the role of a Human Research Ethics Committee (HREC) as required by the National Statement on Ethical Conduct in Human Research (the National Statement).
• To protect the rights and welfare of research participants and to minimise the risk of harm arising from research studies involving humans ¹.
• To ensure all research projects involving human participants are designed in accordance with the following values:
  • research merit and integrity
  • justice
  • beneficence
  • respect
• To ethically review and monitor research projects in accordance with the National Statement.
• To facilitate ethically good research through efficient and thorough review processes developed in accordance with the National Statement.
• To promote good communication between the HREC, researchers, and the institution.

Functions

• Review proposed projects, and amendments to approved projects, involving human participants to determine whether they are ethically acceptable and in accordance with the National Statement and other relevant policies and legislation, and approve, defer, or reject proposals as required.
• Monitor the progress and completion of approved projects through inspections, audits, annual and final reports, including follow-up reviews of approved projects and activities, and only permit the continued approval for those projects and activities that are ethically acceptable and conform to the requirements of the National Statement.
• Withdraw or suspend approval for any project that may be deemed to be unethical or non-compliant with the National Statement, the Australian Code for the Responsible Conduct of Research (the Code), or other relevant policies and legislation.
• Comment on institutional plans and policies that may affect the welfare and rights of human participants in research.
• Take appropriate action regarding unexpected adverse events and non-compliance.
• Provide advice to the Deputy Vice-Chancellor (Research and Innovation) on measures needed to ensure that the requirements and standards of the National Statement, the Code, and relevant USC policies and procedures are met and maintained.
• Provide advice to the Deputy Vice-Chancellor (Research and Innovation) on strategies to promote awareness and understanding of the ethical conduct of human research within USC and the broader community.
• Receive complaints from research participants, researchers, or others regarding the conduct of human research projects or the conduct of the HREC and to deal with these promptly in accordance with the National Statement, the Code, and USC policies and procedures.
• Bring to the attention of the Deputy Vice-Chancellor (Research and Innovation) issues of significant concern.

Membership

• The minimum membership of the HREC is eight and must at least comprise:
  • 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 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
  • at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people, for example, a nurse or allied health professional
  • at least one person who performs a pastoral care role in the community, for example, an Aboriginal elder or a minister of religion
  • at least one lawyer, where possible one who is not engaged to advise the institution, and 
  • at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise.
• No member may be appointed in more than one of the above categories, but the university may recruit more than the minimum membership to suit the needs of the institution.
• Membership may include a deputy chairperson who will act as the chairperson, as required.
• As far as possible, at least one third of the members should be from outside the university, and there should be equal numbers of men and women.
• Where possible, additional members may be appointed to assist the HREC.
• The HREC may invite people with specific expertise to provide advice to the committee, as required.

Appointment of members

• Members are recruited by direct approach, nomination or by advertisement through an open and transparent selection process.
• Members must accept these terms of reference and declare any conflicts of interest before appointment.
• Members are appointed by the Deputy Vice-Chancellor (Research and Innovation) and will be provided with a formal notice of appointment.
• Members are provided with appropriate induction, support, and training and are expected to engage in training provided.
• The HREC chair may receive remuneration to compensate for the additional time required to both chair the meetings and perform executive duties as determined by the Deputy Vice-Chancellor (Research and Innovation).
• The term of office of a newly appointed member will be three years, with the option of reappointment for subsequent terms by approval of the Deputy Vice-Chancellor (Research and Innovation).
• The appointment of a member may be terminated if the Deputy Vice-Chancellor (Research and Innovation) determines that:
  • it is in the best interest of the HREC and the university  
  • the member is not fit to serve on a HREC, or 
  • the member has failed to carry out their HREC duties.
• Members may resign from the HREC at any time throughout their tenure.

Delegations

• In accordance with the National Statement, the university may establish other non-HREC levels of ethical review, which will be described in relevant USC policy and procedures.
  Depending on the level of risk and the specific ethical review pathway, certain research proposals can be approved by one of the following:
  • the HREC chair
  • a HREC panel or HREC executive
  • a university sub-committee established for ethical review, or
  • the Office of Research.
• On the recommendation of the HREC, the institution may establish subcommittees to assist the HREC in its work.
• The HREC may delegate authority to an agent or suitably qualified persons to inspect and monitor remote sites.

Quorum and voting protocols

• Where there is less than full attendance at a meeting, the chair should be satisfied, before reaching a decision, that the views of those absent who belong to the minimum membership have been received and considered.
• The minimum number of attendees at any HREC meeting shall be no less than three.
• The committee will endeavour to make its decisions by consensus, but where consensus is not achieved then assent by two-thirds of members is required.
• When required, members may attend a meeting using videoconferencing, web-conferencing or teleconferencing.
• Members with a conflict of interest must withdraw from the meeting and remaining members must meet minimum requirements as defined above.

Meetings

• The committee shall determine the frequency of its meetings ensuring that the timing and frequency of meetings effectively support the university's research activity.
• As far as possible, meetings will be arranged to enable at least one member in each category to attend.
• The chairperson must preside at the HREC meetings. If the chairperson is absent, the deputy chairperson may preside in their absence.
• The committee may invite non-voting participation of people with expertise or experience who can assist with the deliberations of a particular matter.

Accountability and reporting

• The HREC is directly accountable to the Deputy Vice-Chancellor (Research and Innovation).
• The HREC will conduct a self-assessment exercise very two years with the results being presented to the Deputy Vice-Chancellor (Research and Innovation), the Research Committee and Academic Board.
• The HREC reports annually to:
  • the National Health and Medical Research Council (NHMRC)
  • USC’s Research Committee (more regular reports to be provided if determined in Research Committee’s terms of reference)
  • USC's Academic Board
  • USC's Audit and Risk Committee
  • the Deputy Vice-Chancellor (Research and Innovation).
• The HREC Chair and the Deputy Vice-Chancellor (Research and Innovation) meet annually to discuss the HREC annual report and any other issues that may impact on compliance with the National Statement.

Related documents

• Human Research Ethics - Governing Policy
• Human Research Ethics - Procedures
• Enterprise Risk Management - Governing Policy
• Higher Degrees by Research - Academic Policy
• Responsible Research Conduct - Governing Policy
• Managing and Investigating Breaches of Responsible Research Conduct - Procedures
• Staff Code of Conduct - Governing Policy
• Student Conduct - Governing Policy

Related legislation / standards

• Australian Code for the Responsible Conduct of Research
• National Statement on Ethical Conduct in Human Research
• Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders

1 Research projects involving human participants is research conducted with or about people, their data or tissue.

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