Adam Hedgecoe - Trust in the system

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Trust in the system

INSCRIPTIONS

Series editors

Des Fitzgerald and Amy Hinterberger

Editorial advisory board

Vivette Garca Deister, National Autonomous University of Mexico

John Gardner, Monash University, Australia

Maja Horst, Technical University of Denmark

Robert Kirk, Manchester, UK

Stphanie Loyd, Laval University, Canada

Alice Mah, Warwick University, UK

Deboleena Roy, Emory University, USA

Hallam Stevens, Nanyang Technological University, Singapore

Niki Vermeulen, Edinburgh, UK

Megan Warin, Adelaide University, Australia

Malte Ziewitz, Cornell University, USA

Since the very earliest studies of scientific communities, we have known that texts and worlds are bound together. One of the most important ways to stabilise, organise, and grow a laboratory, a group of scholars, even an entire intellectual community, is to write things down. As for science, so for the social studies of science: Inscriptions is a space for writing, recording, and inscribing the most exciting current work in sociological and anthropological and any related studies of science.

The series foregrounds theoretically innovative and empirically rich interdisciplinary work that is emerging in the UK and internationally. It is self-consciously hospitable in terms of its approach to discipline (all areas of social sciences are considered), topic (we are interested in all scientific objects, including biomedical objects), and scale (books will include both fine-grained case studies and broad accounts of scientific cultures).

For readers, the series signals a new generation of scholarship captured in monograph form tracking and analysing how science moves through our societies, cultures, and lives. Employing innovative methodologies for investigating changing worlds, Inscriptions is home to compelling new accounts of how science, technology, biomedicine, and the environment translate and transform our social lives.

Trust in the system

Research Ethics Committees and the regulation of biomedical research

Adam Hedgecoe

M ANCHESTER U NIVERSITY P RESS

Copyright Adam Hedgecoe 2020

The right of Adam Hedgecoe to be identified as the author of this work has been asserted by him in accordance with the Copyright, Designs and Patents Act 1988.

Published by Manchester University Press

Altrincham Street, Manchester M1 7JA

www.manchesteruniversitypress.co.uk

British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from the British Library

ISBN 978 1 5261 5291 6 hardback

First published 2020

The publisher has no responsibility for the persistence or accuracy of URLs for any external or third-party internet websites referred to in this book, and does not guarantee that any content on such websites is, or will remain, accurate or appropriate.

Typeset by Newgen Publishing UK

To Sheridan, with love.

Contents

I am grateful to the European Commission (grant number MEXT-CT-2003-509551-ED-REG-HAR) for funding the research this book draws on and to John Abraham for helping me think about the original grant application.

I am extremely grateful to the Research Ethics Committee members who agreed to be observed and everyone who allowed me to interview them. The nature of presenting ethnographic data in an ethical, anonymised fashion necessarily means these people, without whom this book would not exist, never get the public recognition they deserve.

Richard Ashcroft and Naomi Pfeffer were both vital in guiding my initial thoughts about this topic, Professor Pfeffer most obviously through giving me access to her personal archive of policy documents.

Over the years at Cardiff University, a number of colleagues have provided me with thoughtful feedback on my ideas. I would like to thank Harry Collins, Rob Evans, Nicky Priaux, Martin Wienel, Gareth Thomas, and Joanna Latimer for their time and help. I would also like to thank Laura Stark and Chris Goldsworthy for their readings of the whole manuscript and suggested improvements.

Some of the data and ideas in this book have previously been published in:

Scandals, ethics and regulatory change in biomedical research, Science, Technology, & Human Values, 42:4 (2017), 577599.

Trust and regulatory organizations: The role of local knowledge and facework in research ethics review, Social Studies of Science, 42:5 (2012), 662683.

A deviation from standard design? Clinical trials, research ethics committees and the regulatory co-construction of organizational deviance, Social Studies of Science, 44:1 (2014) 5981.

I am making final revisions to this book in April 2020, at the height of the coronavirus lockdown. I would like to thank Sheridan, Davis, and Jed for supporting me in this whole project but especially in the final stages, at such a strange time.

ABPI	Association of the British Pharmaceutical Industry
AMS	Academy for Medical Sciences
BMA	British Medical Association
BMAA	BMA Archive
CCHMS	Central Committee for Hospital Medical Services
CEC	Central Ethical Committee
CHCs	Community Health Councils
CNEP	Continuous Negative Extrathoracic Pressure
COREC	Central Office for Research Ethics Committees
CRO	contract research organisation
CRS	cytokine release syndrome
CTIMPs	Clinical Trials of Investigational Medicinal Products
DER	Designated Engineering Representative
DH	Department of Health
DHSS	Department of Health and Social Security
DSMB	Data Safety Monitoring Board
FAA	Federal Aviation Administration
FTIM	first time in man
GAfREC	Governance Arrangements for NHS Research Ethics Committees
GMC	General Medical Council
HRA	Health Research Authority
IB	Investigators Brochure
ICH	International Conference on Harmonisation
IRB	Institutional Review Board
LREC	Local Research Ethics Committee
MAP	morning-after contraceptive pill
MASC	Medical Academic Staff Committee
MHRA	Medicines and Healthcare products Regulatory Agency
MMR	measles, mumps, and rubella
MRC	Medical Research Council
MRECs	Multi-centre Research Ethics Committees
MRI	magnetic resonance imaging
NA	National Archives
NBS	National Blood Service
NHS	National Health Service
NPSA	National Patient Safety Agency
NREAP	National Research and Ethics Advisors Panel
NRES	National Research Ethics Service
PHS	Public Health Service
PI	principal investigator
PIS	participant information sheet

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