Terms of Reference
3. SCOPE OF RESPONSIBILITY
The Executive Ethical Review Panel
3.4 The Executive Ethical Review Panel (EERP) will usually meet at least once per month, but more frequently if required.
The Scientific Sub-committee of the Human Research Ethics Committee
4. STATUS OF THE HUMAN RESERCH ETHICS COMMITTEE (HREC) WITHIN THE LOCAL HEALTH DISTRICT
4.1 The HREC is a committee of the Sydney Local Health District Board (reporting to the Education and Research Committee) with responsibility for granting, withholding, suspending and withdrawing ethical approval.
5. ACCOUNTABILITY OF THE HUMAN RESERCH ETHICS COMMITTEE (HREC)
5.1 The HREC is accountable to the Chief Executive in the conduct of its business. The minutes of each HREC meeting shall be signed by the Chairperson and forwarded to the Chief Executive, following confirmation.
5.2 A copy of the minutes shall be forwarded to the Medical Director, Concord Hospital.
5.3 The HREC shall provide an annual report to the Chief Executive at the end of each calendar year, which will include information on membership and the number of proposals reviewed. A copy of this report shall also be forwarded to the General Manager, Concord Hospital.
5.4 The HREC may from time to time bring to the attention of the Chief Executive issues of significant concern.
5.5 The HREC will provide the following annual reports:
5.6 The HREC Terms of Reference, Standard Operating Procedures and membership will be available upon request to the general public and will be posted on the Concord Hospital Research Office website.
a) A Chairperson with suitable experience whose other responsibilities will not impair the HREC capacity to carry out its obligations under the National Statement;
b) At least two members who are lay people, one man and one woman, with no affiliation with the institution or organisation and not currently involved in medical, scientific, legal or academic work;
c) At least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people;
d) At least one member who performs a pastoral care role in the community, for example, an Aboriginal elder or a minister of religion;
e) At least one member who is a lawyer, where possible one who is not engaged to advise the institution for which the HREC is reviewing research; and
f) At least two members with knowledge of and current research experience that is relevant to the applications to be considered at the meetings they attend.
6.1.2 To ensure the membership will equip the HREC to address all relevant considerations arising from the categories of research likely to be submitted, some or all of the above categories may be represented by more than one person.
6.1.3 No member will be appointed in more than one of the membership categories.
6.2 Appointment to the HREC
6.3 Conditions of appointment
6.4 Education for HREC members
6.6 Liability coverage
7. CONDUCT OF BUISNESS
7.1.1 The HREC conducts its business in accordance with the Terms of Reference and the Standard Operating Procedures.
7.2 Expert reviewers
7.2.1 The HREC and/or its sub-committees will be free to consult any person(s) considered to be qualified to provide advice and assistance in the review of any research proposal submitted to it, subject to that person having no conflict of interest and providing an undertaking of confidentiality. Such person(s) shall not be entitled to vote on any matter.
7.3.1 The HREC meets on a regular basis which normally would be at monthly intervals. No meeting is held in January.
7.4 Conflict of Interest
7.4.1 Any member of the HREC who has a conflict of interest in a proposal or other related matter(s) considered by the HREC, should as soon as practicable declare such interest. Conflict of interest includes financial interests, personal, professional or institutional benefits or advantages that depend significantly on the research outcomes.
7.4.2 If the member is present at a meeting at which the project is the subject of consideration, the member will be asked to withdraw from the meeting until the HREC’s consideration of the relevant matter has been completed. The member will not participate in discussions. If the Chairperson has a potential conflict of interest as described above, the Deputy Chairperson will take over the conduct of the meeting for the proposal in question.
7.4.3 The minutes will record all declarations of interest and the procedures to be followed.
HREC meetings are held in private. The agenda and minutes of meetings, applications, supporting documentation and correspondences are all treated confidentially.
7.6 Decision Making
7.6.1 The HREC, after consideration of an application at a meeting, will make one of the following decisions:
7.6.2 The HREC will endeavour to reach a decision concerning the ethical acceptability of a proposal by unanimous agreement. Members present will be allowed reasonable opportunity to express relevant views on matters on the agenda.
7.7.1 To encourage free and open discussion and to emphasise the collegiate character of the HREC, particular views will not be attributed to particular individuals in the minutes except where a member wishes to have their opinion or objection recorded.
7.8.1 The Executive Officer, or delegate, will prepare and maintain written records of the HREC’s activities including agendas and minutes of all meetings of the Human Research Ethics Committee and the Executive Ethical Review Panel.
7.9.1 A fee will be charged for applications submitted for assessment by the HREC in the case of commercially-sponsored research. These fees will comply with the NSW Health Fee Policy for Review of Commercially Sponsored Research (PD2008_030).
8. MONITORING RESEARCH PROJECTS
8.1 The HREC monitors approved projects to ensure compliance with the conditions of approval and to protect the rights, safety and welfare of participants. In doing so it may request and discuss information on any relevant aspects of the project with the investigators at any time.
8.3 The HREC may adopt any additional appropriate mechanisms for monitoring as deemed necessary, depending on the complexity, design and risk perceived. These include:
8.4 The HREC also has the discretion to recommend in the letter of approval that the site co-ordinates onsite monitoring at recommended intervals or randomly throughout the project.
9. COMPLAINTS AND REVIEW
9.1 Complaints about the conduct of an approved research project
9.1.1 Any concern or complaint from a participant or any other person about the conduct of a project should be directed to the attention of the HREC Executive Officer, or their delegate, who will notify the Chairperson as soon as possible. The Chairperson of the HREC will instigate an investigation of the complaint and make a recommendation on the appropriate course of action. The complainant will receive a written response, if appropriate, from the HREC. If the complainant is not satisfied with the outcome of the Chairperson’s investigation, then he/she can refer the complaint to the Chief Executive or his/her nominee, or request the Chairperson to do so.
9.1.2 A concern or complaint about the conduct of a research project which involves allegations of research misconduct, is managed in accordance with the Sydney Local Health District local procedures (Responding to allegations of Research Misconduct SLHD_PD2012_004).
9.2 Complaints about the HREC’s review process
9.2.1 Any concern or complaint about the HREC’s review process should be directed to the attention of the Chairperson of the HREC, detailing it in writing. Complaints may also be made to the Chief Executive. The Chairperson will notify the Chief Executive of any complaints received by him/her. The Chief Executive will inform the Chairperson of any complaints received by him/her as soon as possible.
9.2.2 The Chairperson will instigate an investigation of the complaint and its validity and make a recommendation to the HREC on the appropriate course of action. The complainant will receive a written response, if appropriate, from the HREC. If the complainant is not satisfied with the outcome of the Chairperson’s investigation, then he/she can refer the complaint to the Chief Executive or his/her nominee or request the Chairperson to do so.
9.3 Complaints about the HREC’s rejection of an application
9.3.1 A person with a complaint about the HREC’s rejection of their application should bring the complaint to the attention of the Chairperson of the HREC detailing the grounds of the complaint. Complaints may also be made to the Chief Executive. The Chairperson will notify the Chief Executive of the complaint. The Chief Executive will notify the Chairperson of any complaints received by him/her as soon as possible.
9.3.2 The Chairperson will instigate an investigation of the complaint and its validity and make a recommendation to the HREC on the appropriate course of action. The complainant will receive a written response, if appropriate, from the HREC. If the complainant is not satisfied with the action taken by the HREC, then he/she can refer the complaint to the Chief Executive or his/her nominee or request the Chairperson to do so.
9.3.3 Should the HREC be requested to review its decision, then the outcome of this review by the HREC will be final.
9.4 Complaints about the HREC’s approval of an application
9.4.1 Where the HREC has given a favourable decision on an application and an ethical or scientific issue is subsequently identified by any party or it has become apparent that the decision was based on inconsistent application of policy and guidelines, a written appeal is lodged with the Chairperson in the first instance.
9.5 Complaints about the conduct of HREC members
9.5.1 Complaints about the conduct of an HREC member are managed by the Chief Executive, or their delegate who informs the Chairperson of the complaint.
10. REVIEW/AMENDMENT TO THE TERMS OF REFERENCE
10.1 These Terms of Reference will be reviewed every three years and may be amended in consultation with the HREC.
10.2 Revised Terms of Reference will be sent to the Chief Executive and the Sydney Local Health District Board for approval.
11. TERMINATION OF HREC RESPONSIBILITY
11.1 Where the HREC is to be merged, closed or has ceased to function, Sydney Local Health District will notify the NHMRC and will determine the appropriate course of action, such as the status of its registration and/or status as a certified institution with the NHMRC and the monitoring of previously approved research. Sydney Local Health District will also notify the NSW Ministry of Health.
For review July 2017