Literature DB >> 22882658

Closing the regulatory regress: GMP accreditation in stem cell laboratories.

Neil Stephens1, Jamie Lewis1, Paul Atkinson1.   

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.
© 2012 The Authors. Sociology of Health & Illness © 2012 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.

Entities:  

Keywords:  UK Stem Cell Bank; good manufacturing practice (GMP); regress; regulation; stem cells

Mesh:

Year:  2012        PMID: 22882658     DOI: 10.1111/j.1467-9566.2012.01482.x

Source DB:  PubMed          Journal:  Sociol Health Illn        ISSN: 0141-9889


  3 in total

1.  Accelerating Innovation in the Creation of Biovalue: The Cell and Gene Therapy Catapult.

Authors:  John Gardner; Andrew Webster
Journal:  Sci Technol Human Values       Date:  2017-04-06

2.  Doing laboratory ethnography: reflections on method in scientific workplaces.

Authors:  Neil Stephens; Jamie Lewis
Journal:  Qual Res       Date:  2017-04-13

Review 3.  Optimising Translational Research Opportunities: A Systematic Review and Narrative Synthesis of Basic and Clinician Scientists' Perspectives of Factors Which Enable or Hinder Translational Research.

Authors:  Nina Fudge; Euan Sadler; Helen R Fisher; John Maher; Charles D A Wolfe; Christopher McKevitt
Journal:  PLoS One       Date:  2016-08-04       Impact factor: 3.240

  3 in total

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