More than cheating: deception, IRB shopping, and the normative legitimacy of IRBs. J Law Med Ethics 2012;40(4):990-6
Date
01/08/2013Pubmed ID
23289700DOI
10.1111/j.1748-720X.2012.00726.xScopus ID
2-s2.0-84872161649 (requires institutional sign-in at Scopus site) 7 CitationsAbstract
Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban "IRB shopping" (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. To the extent that these practices are common, or represent an IRB system that places unreasonable burdens on those seeking IRB approval, we should consider whether non-compliance reflects problems of normative legitimacy for the IRB system itself.
Author List
Spellecy R, May TAuthor
Ryan Spellecy PhD Assistant Provost, Director, Professor in the Institute for Health and Equity department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Consent FormsDeception
Efficiency, Organizational
Ethics Committees, Research
Government Regulation
Guideline Adherence
Humans
Professional Role
Research Design
Research Personnel
United States
