The current status of ethical review of protocols concerning human participants in research in Canada

Since the 1987 Medical Research Council of Canada (MRC) guidelines on research involving human subjects were issued, there has been a steady evolution of the process of ethical review. The National Council on Bioethics in Human Research (NCBHR), a council of volunteer experts, was established to provide assistance to Research Ethics Boards (REBs) in Canada in interpreting and applying the guidelines. A survey by NCBHR of REBs dealing with health issues demonstrated that, whilst a satisfactory process was in place, guidelines were only partially observed with considerable variation in the process of ethical review of protocols. Recently, the three major granting councils the MRC, the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC) - have established a Tri-Council Working Group and are now writing a Code of Ethical Conduct to guide researchers and REBs. It will be more prescriptive than previous guidelines. The change from guidelines to a code may signal the need for closer attention by researchers and REBs to concerns for protection of research participants.