Medical College of Wisconsin
CTSICores SearchResearch InformaticsREDCap

More than cheating: deception, IRB shopping, and the normative legitimacy of IRBs. J Law Med Ethics 2012;40(4):990-6



Pubmed ID




Scopus ID

2-s2.0-84872161649 (requires institutional sign-in at Scopus site)   6 Citations


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 T


Ryan Spellecy PhD Assistant Provost, Director, Professor in the Institute for Health and Equity department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Consent Forms
Efficiency, Organizational
Ethics Committees, Research
Government Regulation
Guideline Adherence
Professional Role
Research Design
Research Personnel
United States