Legal and ethical values in the resolution of research-related disputes: how can IRBS respond to participant complaints?
- PMID: 24572085
- PMCID: PMC4041031
- DOI: 10.1525/jer.2014.9.1.71
Legal and ethical values in the resolution of research-related disputes: how can IRBS respond to participant complaints?
Abstract
Under US federal regulations, participants providing informed consent must receive information regarding whom to contact in case of a research-related injury or complaint. Although informed consent processes routinely direct participants to contact institutional review boards (IRBs) with questions or concerns, there has been little empirical study of the ways in which IRBs act to resolve participants' research-related complaints. This article explores available literature on participant complaints, considers the responsibilities of IRBs in dispute resolution, and outlines a research agenda. As a case study, this review considers disputes arising from HIV/AIDS research, focusing on novel issues arising from biomedical HIV prevention trials.
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References
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- Agency for Healthcare Research and Quality. Sample forms: Sample combined informed consent and authorization forms. 2009 from http://www.ahrq.gov/funding/grants/policies/informedconsent/icform3c.html.
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- Association for the Accreditation of Human Research Protection Programs Inc. AAHRPP Accreditation Standards 2009
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- Association for the Accreditation of Human Research Protection Programs Inc. 2011 Metrics on Human Research Protection Program Performance. 2011:21.
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