Closing the regulatory regress: GMP accreditation in stem cell laboratories
Article first published online: 6 AUG 2012
© 2012 The Authors. Sociology of Health & Illness © 2012 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.
Sociology of Health & Illness
Volume 35, Issue 3, pages 345–360, March 2013
How to Cite
Stephens, N., Lewis, J. and Atkinson, P. (2013), Closing the regulatory regress: GMP accreditation in stem cell laboratories. Sociology of Health & Illness, 35: 345–360. doi: 10.1111/j.1467-9566.2012.01482.x
- Issue published online: 28 MAR 2013
- Article first published online: 6 AUG 2012
- stem cells;
- UK Stem Cell Bank;
- good manufacturing practice (GMP);
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.