How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

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?

Making researchers moral: Why trustworthiness requires more than ethics guidelines and review

“…130-3). The present case seems to be no different: Already voices are heard asking how RECs are to be monitored (Coleman and Bouesseau, 2008). If one assumes the moral integrity of researchers to be compromised, such anxiety is understandable.…”

“…According to one study, informed consent was the most frequent cause for discussion between researchers and RECs . Some RECs spend much time on the wording of informed consent documents because such issues seem particularly susceptible to objective resolution (Coleman and Bouesseau, 2008) or because they find that there is little else about a project that they can control (Hoeyer et al, 2005a). In qualitative research, the requirements imposed by ethics review have been claimed to distract researchers from more pressing moral problems (Bosk and de Vries, 2004).…”

“…(World Medical Association, 2008) General principles have partly given way to enumerations of concrete rules, for instance with regard to what pieces of information should be disclosed to research participants. In some contexts, ethics review has increasingly become a matter of scrutinising informed consent forms , Coleman and Bouesseau, 2008, Hoeyer et al, 2005a.…”

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

“…Several publications are now not only questioning the knowledge component of an REB member but many varied aspects pertaining to the functioning and accountability of the REB members and boards with some of those even questioning the potential for fully regulating REBs in both Canada and the United States 67,68,69,70,71,72,73,74 .…”

Research Ethics in Accessing Hospital Staff and Securing Informed Consent

“…Critics also question the ability of RECs to "judge" qualitative research (see for example Coleman, 2008;Dixon-Woods, Angell, Ashcroft, & Bryman, 2007;Halse & Honey, 2005;Howard, 2004;Murphy & Dingwall, 2007), and their authority. Even though critics acknowledge the importance of some "form of monitoring" (Howard, 2007) and "the presence and importance of organizational processes, structures and constraints" (Kyarimpa & GarciaZamor, 2006), the current procedures are often perceived to be "intimidating" and "intrusive", "an obligation that delays the "real" work of research, and "infamous for their rejection of research proposals" (Halse & Honey, 2005;Howard, 2007).…”