HUMAN RESEARCH ETHICS COMMITTEE (TQEH/LMH/MH)
TERMS OF REFERENCE
Purpose of the Committee
The Human Research Ethics Committee (TQEH/LMH/MH) primarily reviews research
protocols involving human participants on behalf of The Queen Elizabeth Hospital, Lyell
McEwin Hospital and Modbury Hospital and other institutions in line with the National
Mutual Acceptance guidelines.
The Committee is responsible for ensuring research activity complies with the National
Statement on Ethical Conduct in in Human Research (2007) and incorporating all updates
to protect the welfare and the rights of participants.
The Committee promotes public interest to ensure that research is conducted using
systems that facilitate, encourage and support ethically informed research on humans.
The Committee is responsible for ensuring research will not expose participants to
unacceptable risks and practices; and that the potential participants can evaluate the
expected consequences of their involvement and make an informed decision to participate.
Under the National Mutual Acceptance guidelines, the institution will give due regard to
institutional objectives and responsibility to participants and researchers when considering
the ethical review of another HREC.
Roles and Responsibilities of the Committee
The roles and responsibilities of the Committee are to:
 Safeguard the rights, safety and well being of all research participants and to ensure
that any research involving human participants is underpinned by the basic ethical
principles of respect, beneficence and justice.
 Encourage research to the extent that it is judged to be both scientifically valid and
ethically satisfactory.
 Ensure that the proposed research will not expose participants to unacceptable risks and
practices; and that the potential participants can evaluate the expected consequences of
their involvement and make an informed decision to participate.
 Receive and respond to adverse event reports.
 Monitor and review, at least annually, the progress of research to maintain satisfaction
regarding compliance with contemporary ethical standards and requirements.
 Maintain a register of all proposed research projects, including:
Institution name, project number, discussion dates, principal investigator, short
title of project, amendments to protocols, reasons for ethical approval/non
approval, date of ethical approval, company protocol number, funding source(s),
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details of surveillance, approval date, review date, conditions imposed and current
status.
 Establish and maintain communication with the National Health and Medical Research
Council and provide access on request (without revealing the personal details of any
patient or responder) to information in the Ethics Committee’s Register, held at TQEH.
 Undertake an educational role within the research community in relation to matters
specific to research ethics.
 Consider recommendations from the Scientific Review Subcommittee when making
decisions.
 Minimise duplication of ethical review National Statement, Section 5.3, giving
consideration to the SA Health Single Ethics Review Model and the National Approach
to Single Ethical Review.
In undertaking the consideration of research proposals, the Human Research Ethics
Committee (TQEH/LMH/MH) will:
 Consider:
- Risk Benefit Assessment
- Informed Consent
- Selection of Participants
- Privacy and Confidentiality
- Safeguards and Incentives for participation
- Data Storage
- Monitoring
- Research Design
- Resource Allocation
 Be guided by the principles outlined in the Declaration of Helsinki, International Conference on
Harmonisation of Good Clinical Practice and relevant National Health and Medical Research
Council (NHMRC) guidelines.
 Be available as the primary site (lead committee) for ethical review for multi-centre proposals
under the HoMER process.
 Facilitate research proposals that are to be conducted at multiple sites including The Queen
Elizabeth Hospital, Lyell McEwin Hospital, or the Modbury Hospital, but whose ethical review
has been conducted by another institution (lead committee) under the HoMER process.
 Take into account local, social and cultural attitudes.
 Ensure that while accepting that health professionals have a duty to advance knowledge by
research, the rights of individual patients, or participants of research, are paramount.
Relationship to non-affiliated researchers
 Research proposals from non-affiliated researchers will be undertaken unless:
1. The HREC Chairperson determines there is insufficient expertise on or available to the
HREC to permit an adequate scientific and ethics review of the proposal; or
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2. The HREC is not able to review the proposal in a timely manner (e.g. the meeting agenda
for the next HREC meeting has reached capacity).
Accountability
The Committee is accountable to the Executive Director, Medical Services of the Central Adelaide
Local Health Network. Reporting will occur via formal meetings between the Chairman,
Executive Officer, and the Executive Director, Medical Services on a quarterly basis. These
meetings will be formally minuted.
All approved research will be monitored in accordance with SOP 5.13 Monitoring Approved
Research and the SA Health Ethics Operational Policy.
Mechanisms of Reporting
The reporting obligations of the Committee are to:

Provide a ratified copy of the Minutes of each meeting to the Executive Director, Medical
Services of the Central Adelaide Local Health Network.



Provide a ratified copy of the Minutes of each meeting to Chief Operating Officer of the
Northern Adelaide Local Health Network.

Provide information from aggregated records as requested from time to time by the NHMRC.

Report annually, or as required, to the NHMRC in a format specified by NHMRC.
Membership
The minimum membership of the HREC is eight and as far as possible, there shall be equal
numbers of men and women, with at least one third of the members being from outside of the
institution for which the HREC is reviewing research (National Statement 5.1.29).
Membership is in accordance with National Statement 5.1.30 and will consist of:
(a) a chairperson, with suitable experience, whose other responsibilities will not impair the
HREC’s capacity to carry out its obligations under this National Statement;
(b) 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;
(c) 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;
(d) at least one person who performs a pastoral care role in a community, for example, an
Aboriginal elder, a minister of religion;
(e) at least one lawyer, where possible one who is not engaged to advise the institution; and
(f)
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.
Remuneration for Members

Remuneration of $25.00 per hour of attendance is provided for community (lay) members of
the Human Research Ethics Committee (TQEH/LMH/MH). Members who are an apology
will not receiving this reimbursement.
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
Remuneration of $50 ($25.00 x 2 hours) for pre-meeting reading is provided for community
(lay) members of the Human Research Ethics Committee (TQEH/LMH/MH).

Transportation vouchers and car parking reimbursements are supplied for community (lay)
members wishing to utilise them to attend, and return from scheduled meetings.
These Terms of Reference have been reviewed and approved by the NHMRC as part of the
National Certification Scheme.
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