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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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Index

Edward S. Dove

Academy of Medical Sciences (AMS)

National Research Governance Service, proposal for 68

Report (2011) 60–62, 68, 88

ad hoc peer review 28

adults lacking mental capacity, research involving 12, 14, 52, 135–7

Mental Capacity Act 2005 52, 135–6, 138

Adults with Incapacity (Scotland) Act 2000 136–7

Al-Shami Salman, Rustam 88–9

AMS Report (2011) 60–62, 68, 88

Anderson, James 175–6

anthropological theory

liminality, and 100–106

rites of passage 101–3

rituals 103–6

socio-legal studies, and 84, 92–3, 97, 106

anthropology of regulation 4, 73, 183

benefits of 84, 95–6, 187–8

empirical research, role of 96–7

ethics review processes, and 108–30

influences on 93–6

institutionalism, and 95–6

interpretation 92

liminality, and 4, 73, 99–100

limitations of 93

observational studies 93–4

principles of 98

purpose of 92–3

reglementation studies 94–5

regulators as stewards 109, 138–57

regulatory connectivity, and 109

regulatory theory, and 96–7

scope of 4, 93–6

applications for review 1

electronic applications 46, 58

research categories requiring 11–12

Arm’s Length Body Review 52

Athanassoulis, Nafsika 120

balance

equity, and 167

need for 22–4, 77–8, 111–12, 147–9, 158, 163, 166–70

proportionate regulation 86–92

protection and promotion 143–9, 164, 166–70

risk-based regulation 84–92, 168

Baldwin, Robert 84, 104

Beecher, Henry 34–5

Beyleveld, Deryck 22, 162

black boxes of ethics review see ethics review processes

Black, Julia 79–80

Building on Improvement (2006) 55–6, 87–8

Burns, Tom 104–5

Burris, Scott 80, 83

Canada 20, 59

Care Act 2014 1, 185–6

definitions 10, 179

proportionate regulatory approach 89–90, 185–6

protection and promotion objectives 18, 64–5, 143–4, 169

regulatory requirements of 64–5

standardisation 89–90

Cave, Emma 22

Central Allocation System 48

Central Booking Service 58

Central Office for Research Ethics Committees (COREC) 46, 48, 52

Building on Improvement (2006) 55–6, 87–8

participant protection 55–6

Scientific Officers 55–6

chairperson of REC, role of 121–2, 153–4

children, research involving 12, 119

circular HSC(IS) 153 (1975) 37, 42

circular HSC(97) 23 (1997) 43–5, 50

circular HSG(91) 5 (1991) 42–3

circular MH(68) 33 (1968) 35, 37

Clinical Trials Directive 22, 45, 51–2

committee flags 14

consent, of participants 7, 49, 90–91, 151, 161

Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997) 17, 50

COREC see Central Office for Research Ethics Committees

Council for International Organizations of Medical Sciences (CIOMS) 38

CTIMP [Trials of an Investigational Medicinal Product] 12, 14

SOPs for 51–2

Curran, William 21

Declaration of Helsinki (2013) 8–9, 17, 37, 50, 148, 164, 169

digital Regulation Navigator 3

dignity, of participants 15, 17, 49–50, 53–4, 115, 164–5

Dunn, Michael 166–7

electronic applications mechanism 46, 58

empirical research

analysis methods of 72–3

anthropology of regulation, role in 96–7

challenges of 58–9

data analysis 198–200

data collection procedures 196–8

data sources 189–96

evidence-based framework, for 173–4

law, and 134–8, 173

method limitations, challenges and successes 200–202

ethics, generally

act of faith, as an 128–30

bureaucratic ethics vs. deliberative ethics 176–7

discourse ethics 176–7

law and ethics, regulatory connectivity 109, 134–8

purpose of 164

science and ethics, regulatory connectivity 109, 131–4

space, of 113–15, 164

ethics review processes 111–30

actor involvement 114–15

anthropology of regulation, and 108–30

balance, need for 111–12, 147–9, 158, 163, 167–8

committee chairperson, role of 121–2, 153–4

connectivity 109, 113–15, 130–38

consistency 110–111, 113–14

cross-committee communication 113–14

delayed research 148

ethics and law, connectivity of 134–8

ethics and science, connectivity of 131–4

ethics as act of faith 128–30

Ethics Officers, role of 115, 155–6

ethics of space 113–15

facilitation, and 160–62

guidelines for 111

homogeneity 114–15

liminality, and 102–3, 108–9, 128, 160–66, 168–9

observation, learning by 109–30

personal values, role of 110–111, 113, 121–2, 124–6

politics, influences of 20–24

poor research design 148

pragmatic ethics 121–3

proportionate approach 147–9, 158

researcher attitudes towards 139–43

researchers, attendance of 129–30

review categories 11–12

risk and benefits, liberal approach to 115–21, 168–9

rituals and routine, role of 123–8, 161–2

robustness, monitoring for 111

Scientific Officers, role of 55–6, 153–7

technical questions 112

training 110, 122–3, 135

ethics reviews, generally

categories of 11–12

development, reasons for 76

regulatory theory, and 76–7

ethics thickets 24–5

European Union

Clinical Trials Directive 22, 45, 51–2

Clinical Trials Regulation 133

Good Practice Directive 17

event licensing 8, 21–2, 112, 164

facilitation 7–8, 160–66

Farsides, Bobbie 160

feedback loops 168–9, 173–4

Friedman, Lawrence 92

GAfREC see Governance Arrangements for Research Ethics Committees

gene therapy studies 14, 120–21

Gilbert, Claire 39–40

Good Practice Directive 17

Governance Arrangements for Research Ethics Committees (GAfREC) 16–17, 48–50, 54

authorized RECs, establishment of 14

participant protection, and 15, 19, 164, 173

proportionate regulatory approach 90–91

regulatory connectivity 130–31

research promotion, and 16–17, 19, 54, 164, 173

revision 63

risk-based regulatory approach 85, 115

Standard Operating Procedures, applicability 11–12

Guidelines on the Practice of Ethics Committees in Medical Research (RCP Guidelines, 1984) 17–19, 38–9

Guidelines on the Practice of Ethics Committees in Medical Research (RCP Guidelines, 1990) 40, 169

Hancher, Leigh 78

health law

Care Act 2014 1, 10, 18, 64–5, 89–90, 143–4, 169, 185–6

Clinical Trials Directive 22, 45, 51–2

definitions 10, 179

Good Practice Directive 17

Medicines for Human Use (Clinical Trials) Regulation 2004 40, 51–2, 136

Mental Capacity Act 2005 52, 135–6, 138

proportionate regulatory approach 89–90, 185–6

protection and promotion objectives 18, 64–5, 143–4, 169

regulatory requirements of 64–5

standardisation 89–90

Health Research Authority

approval procedures 103, 156–7, 163

Assessment Review Portal (HARP) 67

background 61–3

controls, limitations of 67–9

cooperation obligations 65

decisional toolkits 156

ethics review guidelines 111

HRA Assessors 135, 156–7

objectives, balancing 143–9

participant protection 65, 143–9

powers of 65, 67–8, 74–5, 82–3, 163

proportionate regulatory approach 65–6, 88–91

quality control checks 57

regulatory stewardship of 150, 156–7

researcher attitudes regarding 139–43

research promotion 65–6, 143–9

risk-based regulatory approach 88–91

role of 24–5, 57, 62–5, 68, 82–3, 163

sample Ethical Review Form 201–8

standardisation and streamlining 64–6

training 135

health research, generally

definition 7

facilitation 7–8, 160–61

lifecycle of 174–6

purpose 169

regulatory space of 81–4

risk vs. benefit debate 115–19

health research lifecycle 174–6

Hedgecoe, Adam 32, 35, 40, 67, 70, 128–9, 166

history of RECs

circular HSC(IS) 153 (1975) 37, 42

circular HSC(97) 23 (1997) 43–5, 50

circular HSG(91) 5 (1991) 42–3

circular MH(68) 33 (1968) 35, 37

developmental inconsistency 39–41

developmental stages 32–45

influences on 8–9, 76–8

information asymmetries, and 77

local vs. central control 42–3, 45

MRC Report 1963 32–3

MREC system for multi-centre studies 43–5

multiplicity, challenges of 45–7

objectives conflicts 18–24, 36–7, 47–8

over-regulation, and 46–7

participant protection 35–6, 77

RCP Guidelines (1984/ 1990) 38–41

RCP Reports (1967/ 1973) 33–8

Red Book [circular HSG(91) 5 (1991)] 42–3

scope, expansion of 37–8

SOPs 11–12, 43, 46, 69

standardisation 45–7

supervisory responsibility conflicts 38, 40–41

US funding, role of 32–3

whistle-blowers, role of 33–5

Holm, Søren 22

HRA Assessment Review Portal (HARP) 67

Human Tissue Act 2004 52, 135, 137

informed consent 7, 49, 90–91, 161

instantiated regulation 5, 18, 26, 75, 108, 112, 150, 165, 182

Institute of Medical Ethics Report (1986) 40–41

institutionalism 95–6

Institutional Review Boards 113 see also research ethics committees

Integrated Research Application System (IRAS) 46, 58

International Ethical Guidelines for Biomedical Research Involving Human Subjects 1982 (CIOMS) 38

International Ethical Guidelines for Health-related Research Involving Humans 2016 (CIOMS) 9, 85, 90, 133

IRAS 46, 48

Jaeger, Jan Federici 115

Johnsson, Linus 176–7

Kerrison, Susan 68

law, generally see also health law

definition 3

empirical research methods 73

legal anthropology 93

limitations of 83

purpose of 70

RECs, controls over 5

regulatory connectivity with ethics 109, 134–8

regulatory space, role in 82–3, 93

socio-legal studies 84, 92–3, 97, 106

statutory requirements for clinical trials 134–5

training 135

Lee, Ronald 167

Lewis, Peter 39

liminality 4, 73

analytical benefits of 100, 103, 105–6, 168–9

anthropology of regulation, and 99–100

applicability 99–100

conceptual development 100–106

definition 99

disciplinary perspective 102

ethics review processes, and 108–9, 128, 168–9

phases of 166

regulatory processes, and 102–3, 128, 160–66

regulatory stewardship, and 160–66

risk-based regulation, and 100

rites of passage 101–3

rituals, role of 103–6

Lord Warner Report 2005 53–5, 87–8, 153

Machado, Nora 104–5

Manual for Research Ethics Committees (2003) 18

May, William 31

medical devices, research involving use of 12

medicinal products, research involving use of see CTIMP

Medicines and Healthcare Products Regulatory Agency 40

Medicines Control Agency 40

Medicines for Human Use (Clinical Trials) Regulation 2004 8, 11, 15, 30, 40, 51–2, 68, 134, 136

Mental Capacity Act 2005 52, 135–6, 138

meta-ethical reflection 112

Meyer, Michelle 87, 118, 168

Montgomery, Jonathan 112

Moore, Sally Falk 94–6

moral reasoning, influences of 121–2

Moran, Michael 78

multi-centre trials

MREC system 43–5

regulatory controls 51–2

National Institute of Health Research 56

National Patient Safety Agency 52

National Research Ethics and Advisors' Panel (NREAP) 56–7

National Research Ethics Service (NRES) 56–7

National Research Governance Service 68

National Social Care REC 10

Neuberger, Julia 41–3

New Zealand 20, 179

NHS RECs see also research ethics committees

appointments 11

authority, recognition of 12–13

authorized RECs 14

balance vs. optimization 23–4

committee flags 14

definition 10

development 14–15

meetings 13–14

membership 10–11

objectives conflicts 18–24, 36–7

overview 9–14

participant protection 15–16, 18–24, 31, 111–12, 164

political influences 20–24

power dynamics 20–21, 163

Proportionate Review 13, 57, 88, 90–91, 141

recognized RECs 14

regional locations 12–13

reports, publication of 13–14

Research Ethics Service 9–10

research promotion 16–24, 54–6, 64–6

review categories 11–12

roles of 14–24

SOPs 11–12, 43

time limits 13–14, 51

Noah, Lars 117

nodal governance 80–83

Northern Ireland, RECs in 11, 13

North Staffordshire research scandal 45–6

observation, learning by 109–30

online applications mechanism 46, 58

organisational deviance 128–9, 166

Oviedo Convention (1997) 17, 50

Pappworth, Maurice 33–5

participant consent 7, 49, 90–91, 151, 161

Participant Information Sheets 111–12

participant protection

consent 7, 49, 90–91, 151, 161

dignity, rights and safety 15, 17, 49–50, 53–4, 115, 164–5

ethics review guidelines 111–12

fair choice 161

REC policy development 15–16, 18–24, 31, 35–6, 54–6, 77

research promotion, balancing with 143–9, 164, 166–70

risk vs. benefits debate 115–21, 168–9

participant protection, and 111–12, 143–9, 164

Patterson, Robert 167

personal values, role of 110–111, 113, 121–2, 124–6

politics, influences on research ethics policies 20–24

Pollock, Allyson 68

polycentric governance 80–83, 163

poor research design 148

pragmatic ethics 121–3

predictability 127–8

prisoners, research involving 12, 14

proportionate regulation 86–92

limitations of 88–9

SOPs 90–91

trends 87–8

proportionate reviews 13, 57–8, 63, 141, 147–9, 158

Proportionate Review Service (PRS) 57–8, 90

RED (Research Ethics Database) 46, 58

Red Book (circular HSG(91) 5 (1991)) 42–3

reglementation studies 94–5

Regulation for the Fourth Industrial Revolution (2019) 2–3

regulation, generally

anthropology of (see anthropology of regulation)

balance, need for 22–4, 77–8, 163, 167–8

definition 3

development trends 27–9

ethics of space 173–4

event licensing 8, 21–2, 112, 164

instantiated regulation 5, 18, 26, 75, 108, 112, 150, 165, 182

normative model for 166–7, 171–80, 183–4

purpose 19, 84, 96

reforms, impact of 1, 29–30

regulatory connectivity 174

regulatory conversations 174–6, 185

regulatory flexibility 171–2, 184–5

regulatory lifecycle 174–6

regulatory processes 21–2

restrictions on 163–4

self-regulation vs. state regulatory control 38

trickle-down effect 27, 29

regulatory connectivity 109, 130–38, 159–60, 164–5, 174

spaces within 159–60

regulatory conversations 159–60, 166, 174–6, 185

feedback loops 168–9, 173–4

regulatory flexibility 75–6, 159–60, 165–6, 171–2, 184–5

regulatory processes 21–2

institutionalist approach 95–6

liminality, and 102–3, 128, 160–66, 168–9

regulatory space 76, 78–84, 99

HRA, of 81–4

institutionalist approach 95–6

interpretation 78–80

law, role in 82–3, 93

nodal governance, and 80–83

polycentric governance, and 80–83, 163

regulatory connectivity, and 159–60

relevance of 78–9

resources, interaction with 78–80

topology of 83–4

use of 80–84

regulatory stewardship

anthropology of regulation, and 109, 138–57

balance, need for 143–9, 163

chairperson, by 121–2, 153–4

definitions 149, 179

embeddedness of 165–6

Ethics Officers 115, 155–6

frameworks for 174–6

gatekeeping 150–51

HRA role 150

interests and responsibilities 139–43, 149, 160–61, 177–8, 185

legal basis for 179

liminality, and 160–66

managers, by 153–4, 156–7

methods and approaches 150–57

oversight, responsibility for 138–9, 160–61

participant protection and research promotion, balancing 143–9, 164, 166–70

principles of 179–80

purpose of 149–50, 160–61

RECs and researchers, relationships between 139–43

research proposal modification, and 151–2

research vs. audit role 152

Scientific Officers, by 55–6, 153–7, 178

stages and levels of 152–3, 179–80

work groups 128–9, 166, 179–80

regulatory theory

anthropology of regulation, and 96–7

authority, levels of 75

definition 74

ethics reviews, and 76–7

instantiated regulation 75

law, role in 82–3

limitations 91–2

polycentric regulation 80–82

proportionate regulation 86–92

RECs, of 74–5

risk-based regulation 84–92

rituals, role in 104–6

role of 74, 80

state vs. non-state controls 80–82

researchers, attendance of 129–30

research ethics boards see research ethics committees

research ethics committees

additional research suggestions 186–7

applications reviewed, trends 1

appointments to 11

attendance 177

authority, recognition of 12–13

authorized RECs 14

balance vs. optimization 23–4, 77–8, 163, 166–70

committee flags 14

criticisms of 58–61, 68–70

government responses to 59–69

over-regulation 59–60

self-regulation 59

definitions 10

development of 14–15

circular HSC(IS) 153 (1975) 37, 42

circular HSC(97) 23 (1997) 43–5, 50

circular HSG(91) 5 (1991) 42–3

circular MH(68) 33 (1968) 35, 37

inconsistency of 39–41

influences on 8–9, 76–8

information asymmetries, and 77

local vs. central control 42–3, 45

MRC Report 1963 32–3

MREC system for multi-centre studies 43–5

multiplicity, challenges of 45–7

objectives conflicts 18–24, 36–7, 47–8

over-regulation, and 46–7

participant protection 35–6, 77

RCP Guidelines (1984/ 1990) 38–41

RCP Reports (1967/ 1973) 33–8

scope, expansion of 37–8

SOPs 11–12, 43, 46, 69

stages of 32–45

standardisation 45–7

supervisory responsibility conflicts 38, 40–41

US funding, role of 32–3

whistle-blowers, role of 33–5

engagement with other RECs 113–14

ethics review processes (see ethics review processes)

EU Clinical Trials Directive, compliance with 51–2

importance of 1, 31–2

meetings 13–14, 177

membership 10–11

objectives conflicts 18–24, 36–7

overview 8–14

participant protection 15–16, 18–24, 31, 35–6, 54–6, 77, 111–12, 164

political influences on 20–24

power dynamics 2, 20–21, 163

proportionate regulation 87–8

Proportionate Reviews 13

public vs. private interests 77–8

recognized RECs 14

reforms 25–6

AMS Report (2010) 60–62, 68, 88

Central Allocation System 48

consolidation 67

COREC, role of 46, 48

efficiency 66–7, 69

HRA, establishment of (see Health Research Authority)

Lord Warner Report 53–5

National Institute of Health Research 56

need for 186

participant protection 54–6

reasons for 45–7

Research Governance Framework 46, 48–50, 52–3

Shared Ethical Debate scheme (ShED) 56–7

regional locations 12–13

regulatory development, and 14–15, 27–9, 31–2

reports, publication of 13–14

researcher attitudes towards 139–43

research promotion 16–24, 54–6, 64–6, 108, 143–9, 164

review categories 11–12

risk-based regulation, and 85–92, 161–2

role of 1, 8–9, 14–24, 31–2, 162

educational promotion 173

independence, and 74

objective conflicts 18–24, 36–7, 47–8

participant protection 15–16, 18–24, 31, 35–6, 54–6, 77, 111–12, 164

political influences on 20–24

primary vs. secondary responsibilities 15–17, 49–50, 54, 59, 63

regulatory theory, and 74–5

research promotion 16–24, 54–6, 64–6, 108, 143–9, 164

Standard Operating Procedures 11–12, 43, 46, 51–2, 57

time limits 13–14, 51

Research Ethics Database 46, 58

research ethics, generally

purpose of 31–2

review processes (see ethics review processes)

Research Ethics Service (NHS) 9–10

research governance see also Health Research Authority

efficiency improvement proposals 66–7, 69

proposals for 61–2

Research Governance Framework for Health and Social Care (RGF) 46, 48–50, 52–3, 66

research promotion

GAfREC 16–17, 54

participant protection, balancing with 143–9, 164, 166–70

REC role in 16–18, 54–6, 64–6, 108

Rid, Annette 91, 115

rights and safety of participants 15, 17, 49–50, 53–4, 115, 164–5

risk-based regulation 84–92, 115

definition 85–6, 116

liminality, and 100

limitations of 87, 116–17

RECs, role in 85–7, 161–2

scope of 116–17

SOPs 90–91

trends 87–8

risk-related decision-making

ethics review, role in 115–21, 168–9

gene therapy studies 120–21

high-risk/ unknown risk treatments for critical illness 120–21

research involving children 119

tolerance, role of 168–9, 173

rites of passage

anthropological theory of 101–3

rituals 103–6

anthropological theory of 103–6

ethics review, role in 108–9, 123–8, 161–2

expertise, of 126–7

Robertson, John 31

Ross, Allison 120

Royal College of Physicians

RCP Guidelines (1984) 17–19, 38–9, 164–5

RCP Guidelines (1990) 40, 169

RCP Guidelines (2017) 18–19

Report (1967) 33–4

Report (1973) 35–6

Sarat, Austin 93

satellite regulator model 76

Schneider, Carl 112

science, generally

regulatory connectivity with ethics 109, 131–4

Scientific Officers 55–6, 121, 153–7, 178

Scotland, RECs in 11, 13, 67, 153–5

Scott, Colin 79, 83

self-regulation 9, 21, 28, 59, 76

Shared Ethical Debate scheme (ShED) 56–7, 141–2

Single Issue Debate 56

social care services, research involving use of 12

socio-legal studies 84, 92–3, 97, 106

space, ethics of 113–15, 164, 173–4

Standard Operating Procedures

CTIMPS, for 51–2

NHS RECs, for 11–12, 43, 46, 57, 69, 172

risk-based and proportionate regulatory approaches, and 90–91

Stark, Laura 32, 76, 113

stem cell clinical trials 14

Stephens, Neil 75–6, 118

stewards, regulators as see regulatory stewardship

Szakolczai, Árpád 102–3, 138–9

technical questions 112

Thalidomide 33

Thomassen, Bjørn 99, 102

Thompson, Ian 39

time limits 13–14, 51

tolerance, role of 168–9, 173

training, for ethics reviews 110, 122–3, 135

UK Ethics Committee Authority (UKECA) 57, 68–9

UK Policy Framework for Health and Social Care Research (2017) 30, 66, 89

UK Stem Cell Bank 75, 91–2

United States

ethics reviews, development of 76–7

regulatory processes 23, 59

risk and benefits, review approaches to 115–16

van Gennep, Arnold 100–101

Veatch, Robert 23

Wales, RECs in 13

Warnock, Mary 122

whistle-blowers 33–5

Whitney, Simon 167

Wilson, Duncan 34

work groups 128–9, 166, 179–80