Yale University

Legal and ethical values in the resolution of research-related disputes: how can IRBS respond to participant complaints?

TitleLegal and ethical values in the resolution of research-related disputes: how can IRBS respond to participant complaints?
Publication TypeJournal Article
Year of Publication2014
AuthorsUnderhill, Kristen
JournalJournal of empirical research on human research ethics : JERHRE
Volume9
Issue1
Pagination71-82
Date Published2014 Feb
ISSN1556-2654
KeywordsBiomedical Research, Dissent and Disputes, Ethics Committees, Research, Ethics, Research, HIV Infections, Humans, Informed Consent, Questionnaires, Social Responsibility, United States
AbstractUnder 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.
DOI10.1525/jer.2014.9.1.71
Alternate JournalJ Empir Res Hum Res Ethics

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