• Section 1 - Establishment
• Section 2 - Membership
• Term of Office
• Appointment of Members
• Pool of Inducted Alternate Members
• External Expertise
• Executive Officer
• Section 3 - Terms of Reference
• Section 4 - Review and Approval of Research Proposals
• Applications Requiring Urgent Approval
• Section 5 - Quorum
• Section 6 - Confidentiality of Proceedings

Section 1 - Establishment

(1) Established in 1991.

(2) The Human Research Ethics Committee (the Committee) reports to the Deputy Vice-Chancellor (Research, Development and Industry) and, through the Deputy Vice-Chancellor (Research, Development and Industry), to the Finance, Audit and Risk Committee of the University Council.

(3) The Committee is established in accordance with the provisions of the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research.

(4) Charles Sturt University (the University) applies a two-tiered system of review for all applications for research involving human participants. The two-tiered structure provides for an approval process wherein:

1. research that is considered as more than 'low risk'* is reviewed by the Human Research Ethics Committee (the first tier), and
2. research that is considered as 'low risk'* is reviewed at the Faculty level, by Faculty Human Ethics Committees, and monitored by the Human Research Ethics Committee (the second tier).

(5) Note: *According to the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research 'low risk' research is research in which the only foreseeable risk is one of discomfort.

Section 2 - Membership

(6) The membership of the Human Research Ethics Committee comprises:

1. Nominee of the Deputy Vice-Chancellor (Research, Development and Industry) as Presiding Officer;
2. One representative from each Faculty, appointed by the Deputy Vice-Chancellor (Research, Development and Industry) in consultation with the Executive Deans of Faculty;
3. Lawyer*;
4. Layman*;
5. Laywoman*;
6. Minister of Religion*;
7. Indigenous Representative;
8. One Charles Sturt University academic staff member from the Faculty of Science (from the Health Discipline);
9. One Charles Sturt University academic staff member from the Social Research discipline area;
10. One Charles Sturt University academic staff member from the Exercise Science discipline area.

(7) Note: * These positions are required under guidelines issued by the National Health and Medical Research Council.

(8) Note: ** External members may claim a Meeting Allowance; refer Policy on Allowances for External Members of Compliance Committees.

Term of Office

(9) Members of the Committee will be appointed for a period of three years. Members can serve consecutive periods of membership at the discretion of the Human Research Ethics Committee.

Appointment of Members

(10) Members will be appointed by an open and transparent process; where possible it will be via consultation with current members, Head of Schools, Executive Deans and Deputy Vice-Chancellor (Research, Development and Industry) seeking expressions of interest; if necessary this process may be extended to include advertisement externally.

Pool of Inducted Alternate Members

(11) The Executive Officer of the Committee shall establish and maintain a pool of inducted alternate members in each of the membership categories required under the guidelines issued by the NHMRC.

(12) If one of the substantive members of the Committee (in the same category) cannot attend a meeting then one of the alternate members may attend the meeting in their place and participate in the meeting with the same rights of membership as the substantive member.

External Expertise

(13) The Executive Officer of the Committee shall establish and maintain a panel of experts that may be called upon to offer advice or clarification of specific ethical dimensions of an issue relevant to the ethical review of a proposal.

Executive Officer

(14) The Executive Officer shall be an officer appointed by the University Secretary. The Executive Officer shall have the right of audience and debate at meetings of the Committee.

Section 3 - Terms of Reference

(15) The Human Research Ethics Committee shall:

1. consider ethical implications of all proposed human research projects which involve more than 'low risk' conducted by University staff and postgraduate students (including honours students) and non-affiliated researchers seeking HREC review under the Harmonisation of Multi-Centre Ethical Review (HoMER) process and to determine whether or not they are acceptable on ethical grounds;
2. monitor 'low risk' research proposals approved by Faculty Human Ethics Committees;
3. receive and respond to complaints and issues of non-compliance raised by any person in relation to research that has been considered and approved by the Committee;
4. submit, each quarter, a written report on its activities to the Finance, Audit and Risk Committee of the University Council;
5. report annually to the National Health and Medical Research Council:
   1. provide for surveillance of human research projects until completion so that the Committee may be satisfied that the conduct of the research continues to conform with the approved proposal;
6. preserve the protocols of research approvals in the form in which they are approved and maintain a record of all proposed human research projects, so that the following items of information are readily available:
   1. project identification number;
   2. principal investigator(s);
   3. short title of project;
   4. ethical approval or non-approval with date;
   5. date(s) designated for review;
7. establish and maintain communication with the National Health and Medical Research Council's Medical Research Ethics Committee and provide access, upon request, to information in the University Committee's records; and

(16) In carrying out these functions, the Committee shall:

1. conform with the National Health and Medical Research Council Statement on Human Experimentation and Supplementary notes on research in particular fields that may be published from time to time;
2. take account of local culture and social attitudes in making decisions;
3. ensure that procedures relating to obtaining consent are observed;
4. ensure that no members of the committee adjudicate on proposals in which they may be personally involved; and
5. ensure that while accepting that there is a duty to advance knowledge by research, the rights of individual patients, or subjects of research, take precedence over the expected benefits to human knowledge to the Community.

Section 4 - Review and Approval of Research Proposals

(17) When reviewing and approving research proposals, the Committee shall base all of its comments, requests for clarification or further information, on the National Statement on Ethical Conduct in Research Involving Humans, issued by the National Health and Medical Research Council (NHMRC).

(18) The Committee shall review each research proposal according to the following issues:

1. Research Merit and Integrity;
2. Justice;
3. Beneficence;
4. Respect for human beings.

(19) The Committee shall meet each month (February to December) to review and approve all research proposals that have been received.

Applications Requiring Urgent Approval

(20) The Executive Officer of the Committee shall convene, on behalf of the Presiding Officer, an extraordinary meeting of the Committee to review and approve any research proposals that are received and which require urgent approval before the next scheduled meeting of the Committee.

(21) In those cases where an extraordinary meeting of the Committee cannot be convened, due to a lack of a quorum, the Executive Officer shall circulate the research proposal(s) that require urgent approval to the members of the Committee who shall, in writing, indicate their approval or otherwise of the proposal.

Section 5 - Quorum

(22) At any meeting of the Committee a quorum shall be a majority of the current membership of the Committee.

(23) Members unable to attend shall be encouraged to submit their views prior to the meeting for consideration during the meeting.

Section 6 - Confidentiality of Proceedings

(24) Matters which are discussed and papers which are considered during a meeting shall be confidential to the Committee.