Healthy Skepticism Library item: 17912

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Publication type: Journal Article

Ferris LE.
Industry-sponsored pharmaceutical trials and research ethics boards: are they cloaked in too much secrecy?
CMAJ 2002 May 14; 166:(10):1279-80
http://www.cmaj.ca/cgi/content/full/166/10/1279

Abstract:

When the research ethics board (REB) of hospital Z reviewed a phase II clinical trial protocol for an investigational drug, several ethical concerns were raised. The REB did not approve the protocol as submitted because of concerns regarding patient confidentiality. The REB wrote a letter to the clinical investigator at the hospital with its decision. The clinical investigator spoke to colleagues at other hospitals and discovered that 2 other REBs had approved the study. Did these other REBs document the same issue and ask for changes? Did they make an error of fact with respect to this issue by misinterpreting the information given to them? Or, did hospital Z’s REB commit such an error? Unfortunately, hospital Z’s REB will probably never know the answers to these questions. Of equal concern, the other hospitals’ REBs will probably never know of the concerns of hospital Z’s REB and its eventual decision.

Keywords:
* Canada * Clinical Trials as Topic/economics* * Clinical Trials as Topic/standards* * Drug Industry/economics* * Drug Industry/standards* * Ethics Committees, Research/economics* * Ethics Committees, Research/standards* * Humans * Research Support as Topic/economics* * Research Support as Topic/standards*