PROCEDURES
Working procedures:
Meetings will be conducted once every month. Meetings of the REC would be so arranged as to allow, wherever possible, all members to be fully informed by receipt of all relevant papers and the opportunity to attend. REC may approve, require amendment of, or reject a research proposal on ethical grounds. The REC must record decisions in writing and should include reasons for rejection. REC should inform researchers in writing of decisions and, in the event of rejections or recommended amendments, the reasons for those decisions.
The agenda, including copies of research proposals, would be distributed to all members prior to the meeting, allowing sufficient time for reading.
When there is less than full attendance at a meeting, the Chairperson must be satisfied, before a decision is reached, that the minimum of 5 members, including a member who is independent of the Faculty where the research is to take place, an “expert” member and a “lay” member have received all papers and have had an opportunity to contribute their views and that these have been recorded and considered.
Members who are unable to attend a particular meeting can contribute, prior to those meeting, views on each protocol to be considered. Written comments may be communicated by any convenient method, including email or facsimile. The Chairperson is responsible for ensuring that these views are recorded and considered at the meeting. A quorum of 5 members serves the important purpose of ensuring a degree of discussion, but needs to be realistic.
The REC endeavors to reach decisions by general agreement. This need not involve unanimity, but failure to agree may require an extension of time to reconsider the research protocol and its possible amendment, especially when any member is not satisfied that the welfare and rights of participants are protected.
Committees are encouraged to respect the expression of a diversity of views and to allow the time necessary to review all concerns. Full consideration of all relevant perspectives fosters greater confidence in the committee’s decisions and the advice it offers.
An REC may invite the researcher(s) to be present for discussions of the research and may request amendments to the research protocol. REC need to be sufficiently informed about each research protocol. Interviewing researchers is one means to this end.
REC would invite researcher for interviews to proposals involving contentious ethical issues, invasive or potentially risky procedures, or the need for clarification. Interviews provide opportunities for detailed assessment of the proposed research, for provision of information about its conduct, for clarifying the capacity of the researchers to fulfill their responsibilities and for negotiating possible amendments to research proposals. Interviews can contribute to a cooperative working relationship. Communication between individual REC members and researchers should be in accordance with procedures established by the REC.