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dc.contributor.authorBouësseau Marie-Charlotte
dc.contributor.authorColeman Carl H
dc.date.accessioned2019-09-25T11:22:17Z
dc.date.available2019-09-25T11:22:17Z
dc.date.created2017-09-28 23:04
dc.date.issued2008-03-01
dc.identifieroai:doaj.org/article:b069254926c14dd18c3387df097f9e0f
dc.identifier10.1186/1472-6939-9-6
dc.identifier1472-6939
dc.identifierhttps://doaj.org/article/b069254926c14dd18c3387df097f9e0f
dc.identifier.urihttp://hdl.handle.net/20.500.12424/249886
dc.description.abstract<p>Abstract</p> <p>Background</p> <p>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 actually improving the protection of human research participants.</p> <p>Discussion</p> <p>Research 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.</p> <p>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.</p> <p>Conclusion</p> <p>Outcomes 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?</p>
dc.languageEN
dc.publisherBioMed Central
dc.relation.ispartofhttp://www.biomedcentral.com/1472-6939/9/6
dc.relation.ispartofhttps://doaj.org/toc/1472-6939
dc.sourceBMC Medical Ethics, Vol 9, Iss 1, p 6 (2008)
dc.subjectMedicine (General)
dc.subjectR5-920
dc.subjectMedicine
dc.subjectR
dc.subjectDOAJ:Medicine (General)
dc.subjectDOAJ:Health Sciences
dc.subjectEthics
dc.subjectBJ1-1725
dc.subjectPhilosophy. Psychology. Religion
dc.subjectB
dc.subjectDOAJ:Philosophy
dc.subjectDOAJ:Philosophy and Religion
dc.subjectMedical philosophy. Medical ethics
dc.subjectR723-726
dc.titleHow do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review
dc.typeArticle
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ge.identifier.permalinkhttps://www.globethics.net/gel/11518500
ge.lastmodificationdate2017-09-28 23:04
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