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Regulatory Stewardship of Health Research

Navigating Participant Protection and Research Promotion

Edward S. Dove

This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides a new perspective on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of ‘regulatory stewardship’.
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Abbreviations

Edward S. Dove

AMS

=

Academy of Medical Sciences

AWI

=

Adults with Incapacity (Scotland) Act 2000

BMJ

=

British Medical Journal

CIOMS

=

Council for International Organizations of Medical Sciences

COREC

=

Central Office for Research Ethics Committees

CSO

=

Chief Scientist Office (Scotland)

CTIMP

=

Clinical Trial of an Investigational Medicinal Product

GAfREC

=

Governance Arrangements for Research Ethics Committees

GMC

=

General Medical Council

HARP

=

HRA Assessment Review Portal

HCRW

=

Health and Care Research Wales

HFEA

=

Human Fertilisation and Embryology Authority

HRA

=

Health Research Authority

HSC

=

Health and Social Care in Northern Ireland

HTA

=

Human Tissue Authority

IRAS

=

Integrated Research Application System

IRB

=

Institutional Review Board

LREC

=

Local Research Ethics Committee

MHRA

=

Medicines and Healthcare products Regulatory Agency

MRC

=

Medical Research Council

MREC

=

Multi-site Research Ethics Committee

NHS

=

National Health Service

NIH

=

National Institutes of Health

NIHR

=

National Institute for Health Research

NPSA

=

National Patient Safety Agency

NREAP

=

National Research and Ethics Advisors’ Panel

NRES

=

National Research Ethics Service

NRS

=

NHS Research Scotland

OECD

=

Organisation for Economic Co-operation and Development

OREC

=

Office for Research Ethics Committees

ORECNI

=

Office for Research Ethics Committees Northern Ireland

PIS

=

Participant Information Sheet

PRS

=

Proportionate Review Service

QA/QI

=

Quality Assurance/Quality Improvement

RCP

=

Royal College of Physicians of London

REB

=

Research Ethics Board

REC

=

Research Ethics Committee

REC SOPs

=

Standard Operating Procedures for Research Ethics Committees

  

RED

=

Research Ethics Database

RES

=

Research Ethics Service

RGF

=

Research Governance Framework for Health and Social Care

R&D

=

Research and Development

ShED

=

Shared Ethical Debate

SOP

=

Standard Operating Procedures

SSA

=

Site-Specific Assessment

UKECA

=

United Kingdom Ethics Committee Authority

WHO

=

World Health Organization