Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.

Background: Despite potential benefits of the return of research results to research participants, the TriCouncil Policy Statement , which reflects Canadian regulatory ethical requirements, does not require this. The policies of Canadian research ethics boards are unknown.Objectives: To examine the policies of Canadian university based REBs regarding returning results to research participants, and to ascertain if the presence/absence of a policy may be influenced by REB member composition.Design: Email survey of the coordinators of Canadian university based REBs to determine the (...) presence/absence of a policy on return of research results to research participants both during an ongoing study and at conclusion. REB coordinators were asked to return a copy of the policy or guidelines and to describe the member composition of their REB.Findings: Of 50 REBs that were contacted 34 responded and 22 met the inclusion criteria. Two had a policy that governed the return of research results while on a study, and seven following the completion of a study. Presence of an ethicist or a lawyer on the REB did not influence the presence/absence of such policies. No REBs had specific guidelines describing how participants should be informed of results.Conclusions: Most REBs did not require researchers to disclose study results to research participants either during or following a study. Thus this study identifies an ethical shortcoming in the conduct of human research in Canada. It has also demonstrated that there are no clear recommendations by REBs to facilitate the return of results to participants following research projects. (shrink)

This paper was delivered at the 2009 annual conference of the National Council on Ethics in Human Research. It is a reflective piece based on many years of experience with human research ethics and the role of Research Ethics Boards in human participant research.

It has become almost a truism to describe the interaction between research ethics committees and researchers as being marred by distrust and conflict. The ethical conduct of researchers is increasingly a matter of institutional concern because of the degree to which non-compliance with national standards can expose the entire institution to risk. This has transformed research ethics into what some have described as a research ethics industry. In an operational sense, there is considerable focus on modifying research behaviour through a (...) combination of education and sanctions. The assessment of whether a researcher is ethical is too often based on whether they submit their work for review by an ethics committee. However, is such an approach making a useful contribution to the actual ethical conduct of research and the protection of the interests of participants? Does a focus on ethical review minimise institutional risk? Instead it has been suggested that ethics committees may be distorting or frustrating useful research and are promoting a culture of either mindless rule following or frustrated resistance. An alternative governance approach is required. There is a need for a strong institutional focus on promoting and supporting the reflective practice of researchers through every stage of their work. By situating research ethics within the broader framework of institutional governance, this paper suggests it is possible to establish arrangements that actually facilitate excellent and ethical research. (shrink)

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, advisor to student researchers and a 3-year term (...) as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation. (shrink)

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of (...) time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects. (shrink)