Abstract
BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?
Highlights
Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are improving the protection of human research participants
Despite the emphasis on quality assessment in other areas of health care, "there has been near silence on the possibility of applying quality assessment techniques to ethics practices [1]." While the need for quality assessment in research ethics is beginning to receive greater attention [2], the focus has largely been on evaluating the quality of the deliberations that take place in research ethics committees" (RECs)' meetings, as opposed to the impact of those deliberations on the research process itself
We look beyond auditing and accreditation to consider other mechanisms for assessing and improving the quality of RECs' work
Summary
The Increasing Role of REC Review REC review is a cornerstone of international guidelines on research with human participants. A non-profit organization in the United States called Public Responsibility in Medicine and Research (PRIMR) offers a certification program for IRB members and staff, which "evaluates and validates individuals' knowledge of ethical principles, historical events, regulatory requirements, and operational and functional issues relating to IRBs and other human subjects protection programs [30]." Persons who pass the certification test are authorized to include the acronym CIP ("certified IRB professional") in their professional titles. All of these mechanisms can make important contributions to the quality of the ethics review process. In addition to disseminating information among REC members, it is important to share findings about REC practices with external audiences like administrative authorities and community leaders
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