Closing the regulatory regress: GMP accreditation in stem cell laboratories

Stephens, Neil James, Lewis, Jamie Thornton ORCID: https://orcid.org/0000-0002-1065-6017 and Atkinson, Paul Anthony ORCID: https://orcid.org/0000-0001-7367-8160 2013. Closing the regulatory regress: GMP accreditation in stem cell laboratories. Sociology of Health & Illness 35 (3) , pp. 345-360. 10.1111/j.1467-9566.2012.01482.x

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Abstract

Contemporary biomedical research is conducted amidst regimes of national and transnational regulation. Regulation, like rules generally, cannot specify all the practicalities of their application. Regulations for biomedical research impose considerable constraints on laboratories and others. In principle, there is a never-ending regress whereby scientists have to provide increasingly more guarantees that protocols have been followed, standards reached and maintained, and rules adhered to. In practice, regulatory regress is not the actual outcome, as actors find ways of establishing closure for all practical purposes. Based on ethnographic case studies of two sites of biomedical work – the UK Stem Cell Bank and an anonymous laboratory working with primary human foetal material – this article documents the possibility of regulatory regress and strategies aimed at its closure.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Centre for Economic and Social Aspects of Genomics (CESAGen) Medicine Social Sciences (Includes Criminology and Education)
Subjects:	H Social Sciences > H Social Sciences (General) Q Science > QH Natural history > QH426 Genetics R Medicine > RM Therapeutics. Pharmacology
Uncontrolled Keywords:	regulation; stem cells; UK Stem Cell Bank; good manufacturing practice (GMP); regress
Publisher:	Wiley-Blackwell
ISSN:	0141-9889
Date of First Compliant Deposit:	30 March 2016
Last Modified:	06 May 2023 11:59
URI:	https://orca.cardiff.ac.uk/id/eprint/40567

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