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)

Background: The offer of aggregate study results to research participants following study completion is increasingly accepted as a means of demonstrating greater respect for participants. The attitudes of research ethics board chairs towards this practice, although integral to policy development, are unknown.Objectives: To determine the attitudes of REB chairs and the practices of REBs with respect to disclosure of results to research participants.Design: A postal questionnaire was distributed to the chairs of English-language university-based REBs in Canada. In total, 88 REB (...) chairs were eligible. The questionnaire examined respondents’ attitudes towards offering participants completed study results, methods for delivering this information, and barriers to disclosing results.Findings: The response rate was 89.8%. Chairs were highly supportive of offering results to research participants. Only 19.5% of chairs responded that a policy or guideline that governed the return of research results to participants existed at their institution. Most chairs supported the idea of their REB instituting a set of guidelines recommending that researchers offer results to participants in a lay format. Chairs identified the major impediments to the implementation of programmes offering to return results to participants as being financial cost and retaining contact with research participants .Conclusions: University-based REB chairs overwhelmingly support the offer of research results to participants. This is incongruent with the frequent lack of existing REB guidelines recommending this practice. REBs should support guidelines that diminish identified barriers and promote consistency in offering to return results. (shrink)

While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration. In regard to a concrete research (...) setting—the one of clinico-genomic research—we discuss what kinds of difficulties have to be faced when returning individual research results to trial participants. In a last step, we elaborate on a stepwise model to trigger the individual feedback process. Hence, this paper gives guidance on how to feedback individual research results in a specific research setting and responds at the same time to new challenges in the debate on the duty to return individual research findings. (shrink)