Note: This paper does not cover committee working procedures or the process of ethical review of a research protocol.
1. The HSE Research Ethics Committee should be constituted to ensure competent review and evaluation of all ethical aspects of the research projects they receive, and to ensure that their tasks can be executed free from bias and influence that could affect their independence in reaching their decision.
2. The Chair shall be directly appointed by the Executive.
3. The Executive of the HSE is responsible for the appointment of REC members.
4. The Vice-Chair shall be an appointed member elected by the membership or, in their absence, a member nominated by the Chair.
5. An appointed member must be prepared to have published his/her name, profession and affiliation. When making appointments conflicts of interest should be avoided if at all possible. Where unavoidable there should be transparency with regard to such interests.
6. Normally an appointed member shall be required to attend in full at least three of four scheduled REC meetings in each year.
7. An appointed member shall be expected to maintain confidentiality regarding meeting deliberations, applications, information on research participants, and related matters.
8. The appointed member shall be informed in writing of the terms of the appointment, including its duration, the policy for renewal, the disqualification procedure and the resignation procedure, the policy concerning declaration of interests, and the details of allowable expenses.
9. Members should be appointed for fixed terms, normally two years. Terms of appointment may be renewed, but not normally more than five consecutive terms should be served.
10. The HSE shall ensure that a rotation system for membership is in place that allows for continuity, the development and maintenance of expertise within the REC, and the regular input of fresh ideas.
11. The REC should have sufficient members to guarantee the presence of a quorum (vide infra) at each meeting. The maximum should be 12 members (plus Chair and secretariat). This should allow for a sufficiently broad range of experience and expertise, so that the scientific and methodological aspects of a research proposal can be reconciled with the welfare of research participants, and with broader ethical implications.
12. The REC should be constituted to contain a mixture of ‘expert’ and ‘lay’ members and have a balanced age and gender distribution. At least half of the membership should be independent of the HSE.
13. Appointment of independent members shall be by an open process, compatible with the Nolan standards. Vacancies should be filled following advertisement via the press, local professional and/or other networks as most appropriate to the vacancy to be filled.
14. HSE, including HSL, members shall be appointed by the Executive following internal advertisement and taking into account the experience required by the committee.
15. The ‘expert’ members of the committee shall be chosen to ensure that the REC has the following expertise:
Relevant methodological and ethical expertise in:
Relevant experience in Health and Safety Practice
Statistics and/or epidemiology relevant to research
Legislation (preferably relevant to Health and Safety) and/or Bioethics
16. At least two members of the committee shall be ‘lay’ members who are independent of the HSE either as employees or in a non-executive role and whose primary personal or professional interest is not in a research area. Consideration should be given to workplace employee representatives.
17. Despite being drawn from groups identified with particular interests or responsibilities in connection with research or health and safety issues, REC members are not in any way the representatives of those groups. They are appointed in their own right, to participate in the work of the REC as equal individuals of sound judgement, relevant experience and adequate training in ethical review.
18. The Chair and Medical Secretariat may seek the advice of specialist referees on any relevant aspects of a specific research proposal that lie beyond the expertise of the members. These referees may be specialists in ethical aspects, specific health and safety issues or methodologies, or they may be representatives of workers or special interest groups. Such referees should not be involved in the business of the Committee other than that related to the specific research proposal in question and their advice should be recorded in the minutes.
19. A meeting quorum shall consist of six members. It shall include the Chair and/or Vice-Chair, at least one ‘expert’ member with relevant research and/or methodological expertise, one ‘lay’ member, and at least one other member who is independent of the HSE.
20. Observers, who shall play no part in the Committee’s deliberations, may be invited subject to the minuted agreement of the REC, and subject to written invitation giving the terms under which observer status is permitted. Such observers should have no vested interest in any applications being considered. Observers should be allowed only if they accept in writing the same duty of confidentiality as REC members.
21. The HSE will, within Government guidelines, take responsibility for all the actions of a member in the course of their performance of his or her duties as a member of the REC other than those involving bad faith, wilful default or gross negligence. A member should, however, notify the HSE if any action or claim is threatened or made, and in such an event be ready to assist the HSE as required.