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A deviation from standard design? Clinical trials, research ethics committees and the regulatory co-construction of organizational deviance

Hedgecoe, Adam 2013. A deviation from standard design? Clinical trials, research ethics committees and the regulatory co-construction of organizational deviance. Social Studies of Science n/a 10.1177/0306312713506141

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Abstract

Focusing on the high-profile drug disaster at London’s Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Social Sciences (Includes Criminology and Education)
Subjects: B Philosophy. Psychology. Religion > BJ Ethics
R Medicine > R Medicine (General)
Additional Information: Online publication date: 21 October 2013.
Publisher: SAGE Publications
ISSN: 0306-3127
Last Modified: 04 Jun 2017 05:09
URI: http://orca.cf.ac.uk/id/eprint/49017

Citation Data

Cited 4 times in Google Scholar. View in Google Scholar

Cited 12 times in Scopus. View in Scopus. Powered By Scopus® Data

Cited 4 times in Web of Science. View in Web of Science.

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