Skip to main content Accessibility help
×
Home
Hostname: page-component-99c86f546-45s75 Total loading time: 2.168 Render date: 2021-12-07T13:36:47.029Z Has data issue: true Feature Flags: { "shouldUseShareProductTool": true, "shouldUseHypothesis": true, "isUnsiloEnabled": true, "metricsAbstractViews": false, "figures": true, "newCiteModal": false, "newCitedByModal": true, "newEcommerce": true, "newUsageEvents": true }

Index

Published online by Cambridge University Press:  09 June 2021

Graeme Laurie
Affiliation:
University of Edinburgh
Edward Dove
Affiliation:
University of Edinburgh
Agomoni Ganguli-Mitra
Affiliation:
University of Edinburgh
Catriona McMillan
Affiliation:
University of Edinburgh
Emily Postan
Affiliation:
University of Edinburgh
Nayha Sethi
Affiliation:
University of Edinburgh
Annie Sorbie
Affiliation:
University of Edinburgh

Summary

Type
Chapter
Information
Publisher: Cambridge University Press
Print publication year: 2021

Index

Abelson, J., 254255
Academia Platonica (Neoplatonic Florentine Academy), 218
Academy of Medical Sciences (AMS, UK), 358359
goals and mission of, 35
access to healthcare
benefit sharing and, 154156
orphan drug research and, 62
solidarity and, 5961
accountability
governance and, 123124
institutional decision-making and, 211
medical device failure and, 163164
non-traditional medicine and, 299
actor-networks
Big Data research and, 257259
global health emergency guidelines and, 316317
adaptive governance principles
Big Data research and, 257265
evolution of, 257259
structures and processes in, 263265
visibility, 264265
adaptivity, in health research governance, 259260
Addgene company, 142144
Additional Protocol (2005), 105106
add-on services in reproductive medicine
ethical issues with, 375377
patient choice dynamic in, 380
regulation of, 377379
risks of, 380381
advanced therapies
Argentinian regulation of, 324331
regenerative medicine and, 324
advertising of innovative intervention, oversight of, 292295
Advisory Commission on Regenerative Medicine and Cellular Therapies (Argentina), 325326
advisory committees
adaptive governance and, 263265
Advisory Commission on Regenerative Medicine and Cellular Therapies (Argentina), 325326
in bioethics, 220222
Bioethics Advisory Body, 284285
future of health research regulation and, 222224
health policy advice and, 215216
advocates, public engagement with, 117
affected public
classification of, 117
data-intensive health research and, 118119
AFIRRM oversight model
Big Data research and, 259260
future challenges for, 265
implementation of, 260263
agency, automated healthcare regulation and, 268269, 273
aggregated data, individual discrimination and stigmatisation and, 242
aggregative theories, public interest and, 240
Aitken, Mhairi, 14, 7071, 112129
Alder Hey organ retention scandal, 212213
Aldrick, Philip, 270
Allen, A. L., 75
All of Us initiative, 103104
All Party Parliamentary Group on Surgical Mesh Implants, 162165
alternative medicine
history and evolution of, 296298
research regulation of, 296305
uncertainty of knowledges and practices and, 303304
as in vitro add-on, 375377
Althusser, L., 251252
animal research
embryo research and, 356364
human material in animals and, 358359
interspecies research and, 356364
in neuroscience, 310312
regulation and oversight of, 359362
shifting regulatory boundaries in, 362363
vulnerability issues in regulation of, 363364
Animals Containing Human Material (Academy of Medical Sciences), 358359
Annas, George, 352
Ansell, C., 124125, 128129
anticipatory knowledge
emerging science and technology oversight and, 397399
in global health emergency research, 322323
participatory health governance and, 285286
anti-science politics
health policy formation and, 216218
health research regulation and, 222
traditional and non-conventional medicine and, 301302
Argentina
agricultural strength and health fragmentation in, 324325
cell therapy research governance in, 325326
construction of research governance in, 328329
current health legal/regulatory framework in, 330331
health research regulation in, 324331
Arnstein, S. R., 114, 116
ArthritisPower network, 126127
artificial intelligence (AI)
best practices guidelines and, 175
co-dependent human-technology embodiment and, 383384
continuous learning, research-therapy divide and, 277286
existence conditions and, 272
as medical device, 277286
regulatory responsibility and, 271274
voluntariness in, 107108
assisted reproduction, human germline research and, 348350
Association of University Technology Managers, 142143
Australia
cloning research in, 347348
evidence-informed health policy in, 216218
Australian Academy of Learned Societies, 220
authority. See governance
autologous mesenchymal stem cell case study, clinical innovation oversight and, 290292
automated healthcare regulation
balance of interests in, 267268
moral development and agency and, 273274
regulatory responsibility and, 271274
self-development and agency issues and, 273
stewardship responsibilities in, 268269
autonomy
artificial intelligence and, 271
disclosure of research findings and, 233234
health research ethics guidelines, 2729
health research regulation and, 1315
individualistic conceptions of, 2930
informed consent and, 104105, 108109
non-invasive prenatal testing and, 267268
privacy and, 246
relational conceptions of, 2736
availability heuristic, risk-benefit analysis and, 134135
Aviesan initiative, 103104
Baier, A., 8485
balance of interests
automated healthcare regulation and, 272
health research regulation and, 268
Ballantyne, A., 2324
Barbazza, E., 123124
Barber Surgeons of Edinburgh, 218
Barsdorf, Nicola, 5152
Bea, Sara, 356364
Beauchamp, T. L., 39, 169170
beliefs, facts and, health policy and, 217
Belmont Report (1979), 78
autonomy guidelines in, 2729
social values, 4647
vulnerability guidelines in, 1718, 33
beneficence
autonomy guidelines and, 2729
informed consent and, 104105
proportionality and, 39
benefit analysis
risk-benefit analysis and, 132134
social value and, 5354
benefit evaluation, social value and, 54
benefits, defined, 149151
benefit sharing
challenges to, 154156
common heritage argument for, 150151
data access agreements and, 191
descriptive argument for, 150151
governance frameworks for, 151153
health research regulation and, 148157
history and rationale for, 149151
procedures for, 153154
benefit treatment, social value and, 54
Bennet, C. J., 241243
Bennett, Alan, 145146
Beresford, P., 121123
Berger, M., 251252
best practices
displacement of traditional medicine in, 299301
examples, 192195
health research regulation, 173175
in vitro fertilisation and, 374
Big Data research. See also data-driven research
adaptive governance in regulation of, 257265
analytical techniques in, 257259
deliberative participatory practices and, 125126
effective governance of, 260263
participatory governance of research and, 121
patient and public involvement in, 121123
regulatory scholarship on, 257259
structures and processes in, 263265
systemic oversight framework for, 259260
uncertainty in, 262263
voluntariness in, 107108
biobanks
disclosure of research findings and role of, 233
regulation of, 67
Biobricks Foundation, 142143
bioethics
advisory committees, 220222, 284285
French law on, 264
medical device failure and, 162165
Bioethics (journal), social value debate in, 5152
biosecurity regulations, in Argentina, 324325
blaming, medical device failure and, 163164
Blasimme, Alessandro, 217
blinded trials, evidence-based medicine and, 298299
Blueprint for Dynamic Oversight of Emerging Science and Technologies, 397399
bottom-up participation
participatory health governance and, 124125
principles-based regulation and, 259
Boyd, Ian, 217
Bracken-Roche, D., 2022
Bradwell, P., 118
Brandeis, S. D., 75
Brassington, Iain, 1415
Braun, K., 112113, 117
Breakthrough Device designation (FDA), 278281
Briggs (Lord Justice), 245246
bright line ideology, human germline research and, 349350
broad consent principle, 103104
Broad Institute, 143146
Brownsword, Roger, 266274
Bryant, R., 159160
burdened populations, solidarity in health research for, 5961
Burgess, Michael M., 14, 6970, 248256
Bush, George W., 216218, 222223
Caldicott Principles, 167168
Caldicott Report, 248249
Canada
autonomy guidelines in, 2729
ethics review in, 200201
genetics research regulation in, 337340
Canadian Academy of Engineering, 219220
Canadian Academy of Health Sciences, 219220
Canadian Tri-Council, 1920
capacity perspective
cooperative tool for capacity building, 153
participatory governance and, 127
vulnerability and, 2425
in vulnerability research, 2022
Care Act 2014 (UK), 182184
care.data scheme (UK), 118119, 122123, 248249
Carroll, T., 159160
Carter, P., 6970
Categorical Imperative (Kant), 7879
cell therapy research, Argentinian governance of, 325326
centralised supervision and coordination, participatory governance and, 128129
Chambers, Simone, 252253
Chan, Sarah, 344355
Charities Commission (UK), 301302
children, relational autonomy of, 3436
Childress, J. F., 39, 169170
chimeric organisms
interspecies research and, 357358
research guidelines involving, 360
shifting regulatory boundaries in research on, 362363
vulnerability issues in research on, 363364
China, human gene editing in, 337341, 351, 353
Chuong, Kim H., 121129
circumstances, vulnerability and, 2324
citizens
identity interests in health research regulation and, 397399
public engagement with, 117
citizens’ forums, participatory health systems governance and, 125126
clarity of purpose
participatory governance and, 128
public engagement and, 118119
clinical decision support (CDS) software
AI/ML software, 278281
research-therapy divide and, 277278
clinical equipoise, component analysis and, 135136
clinical research
innovation in marketplace and, 287295
social value in, 5152
ClinicalStudyDataRequest, 192195
clinical trials regulatory paradigm
economics of clinical guidelines and, 301302
evidence-based medicine and, 298299
medical device trials, 279281
pay-to-participate clinical trials and, 290292
regulatory research and, 59
social value and, 52
traditional and alternative medicines and, 299301
clinical utility of information, disclosure of research findings based on, 231
Clinton, Bill, 221222
Cloatre, Emilie, 296305
cloning
ethical review of, 221222, 335336
international health policy frameworks on, 340341
legislation involving, 347348
terminology and definitions of, 347348
clustered regularly interspersed palindromic repeats (CRISPR) patents, 143146
ethical issues in, 267268
human gene editing regulation, 335336
human germline research and, 345346
co-dependent human-technology embodiment
enhancement innovations and, 383384
identity and integrity issues in, 384386
coercive isomorphism, 213
cognitive bias, risk-benefit analysis and, 134135
cognitive disability, relational autonomy and, 3436
Colbert, Jean-Baptiste, 218
Coleman, Carl H., 14, 130138
Coleman, S., 119120
collaborative licensing, 144145
patent regulation and, 144145
collaborative research
Argentinian-University of Edinburgh research governance collaboration, 325326
Big Data research and, 257259
categories of, 8283
clinical innovation oversight and, 289290
data sharing collaborations, trust in, 8789
human germline research, 350352
in interspecies research, 363364
in neuroscience, 308
participatory health governance and, 124125, 285286
patent rights and, 141
trust and, 8182
collective interests
health research regulation and, 7, 14
public expertise mobilisation and, 253255
commercialisation of research
benefit sharing and, 154156
data access and, 192195
group vulnerability and, 97
health research regulation and, 7
common good
automated health regulation and, 268269
privacy and, 78
common heritage argument for benefit sharing, 150151
common interest theory
group privacy and, 241243
public interest and, 240241
Common Rule. See Federal Policy for the Protection of Human Subjects (Common Rule, US)
common value theory, 240241
communitarian approach
automated health regulation and, 268269
benefit sharing, 153154
global health emergencies and, 319320
informed consent and, 108109
institutional decision-making and, 210
risk-benefit analysis and, 138
community advisory boards, participatory health systems governance and, 125126
community values. See social value
Compangie du Gai Sçavoir, 218
comparative effectiveness research, minimal risk principle and, 199200
competency
autonomy and, 31
informed consent and, 106
competition, patent regulation and, 140141
complementarity, governance structures and, 264
complementary and alternative medicine (CAM). See alternative medicine
component analysis, risk-benefit analysis using, 135136
confidentiality
in Big Data research, 123
duty of confidence and, 245246
in neuroscience research, 308
privacy and, 79
public interest guidelines and, 6770
Confidentiality Advisory Group (CAG) (HRA, UK), 6770, 212213
Confronting the Liminal Spaces of Health Research Regulation project, 3
consent. See informed consent
consent or anonymise regulation model, 4
consent to contact policies, 201202
consultation, public engagement through, 115116
consumerist approach
autologous mesenchymal stem cell case, 290292
clinical innovation and intervention and, 289
innovation oversight and limits of, 292295
medical device regulation and, 386389
misinformation about reproductive medicine and, 379
non-traditional medicine and, 299
patient and public involvement and, 121123
in vitro fertilisation and, 375377
consumers, public engagement with, 117
context
in adaptive governance, 262
in global health emergency guidelines, 316317
health research regulation and role of, 275276
in human germline research, 348350
of institutions, 207208
proportionality and, 3738
rule-based and practice-based health regulation and, 172173
Contreras, Jorge, 141142
controlled access, data-driven research, 190191
Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Council of Europe), 243245
Convention on Biological Diversity (CBD) (1992), 149
cooperative practice, human germline research, 350352
cooperative tool for capacity building, benefit sharing and, 153
co-optation, participatory governance and, 127
costs of health research, solidarity on, 5961
Council for International Organizations of Medical Sciences (CIOMS), 1820
benefit sharing guidelines and, 151153
global health emergency guidelines and, 316317, 320322
guidelines, 4749
health practices guidelines, 173175
informed consent and, 105106, 200201
reasonable availability model of, 152153
risk-benefit analysis guidelines, 137
social value in health research regulation and, 4647, 4951, 199200
on third-party risks, 130132
Council of Canadian Academies (CCA), 219220
Council of Europe
data protection law and, 243245
genetics research regulation and, 340341
informed consent and, 105106
Council on Health Research for Development (COHJRED), 8586
COVID-19 pandemic
health practices guidelines and, 173175
research exceptionalism and, 318320
credibility tactics, participatory governance and, 127
Crick, Bernard, 96
criminal law
genetics research regulation and, 337340
human embryo research and, 358359
physical integrity and identity in, 385386
crisis research
global health emergency guidelines and, 316317
human gene editing regulation and, 335336
risk assessment in, 199200
social value of, 317318
criticism, of research ethics, 200201
cross-border data sharing, in Big Data research, 123
cultural issues
disclosure of research findings and, 233234
interspecies biomedical research regulations and, 362363
medical device failure and, 163164
privacy and, 241243
culturally significant information, protection of, 242n.23
Cunningham-Burley, Sarah, 14, 112129
Curran, William, 181182
cyborg perspective, enhancement innovations and, 383
D’Amour, D., 83
data access
agreements, 191
centralised access, genotype/phenotype database, 193
challenges and future directions, 195196
governance of, 187196
harmonisation of policies and processes in, 196
independent, interdisciplinary access, 193194
multi-study access, EGA, 192
oversight coordination, 195196
producers’ rights and interests and, 194
resources, effectiveness and efficiency in, 195
tiered access, International Cancer Genome Consortium/25K Initiative, 193
transparency and reflexive governance, 194195
Data Access Committees (DACs), 188189
adaptive governance and, 263265
controlled vs. open access data and, 190191
monitoring of data use and, 191192
multi-study access, EGA, 192
oversight coordination, 195196
resources, effectiveness and efficiency in, 195
data-driven research. See also Big Data research
automated healthcare regulation and, 270
controlled vs. open access data, 190191
current and future trends in, 198199
disclosure of research findings and, 231234
duty of confidence and privacy of, 245246
EGA and, 192
group privacy protections in, 243245
health research regulation and, 78
informed consent and, 103104
integrity and ethics protections, 188189
monitoring of data use and, 191192
in neuroscience, 308
privacy rights and, 7577
producer rights and interests in, 189190
public engagement in, 116, 118119
public perceptions of, 217
relationality in, 5961
rules-based vs. practice-based approaches in regulation of, 170171
subject rights and, 188189
trustworthiness of research governance and, 248249
value and social values in, 394396
Data Protection Act 2018 (DPA, UK)
enactment of, 69
HRR community lobbying and, 7172
neuroscience research and, 310312
research governance and, 167169
Data Protection Regulation 2016/679 (GDPR) (EU), 7577
data sharing
governance frameworks for, 187188
informed consent and, 105108
in neuroscience research, 308
participatory learning in regulatory governance and, 284285
privacy protection and, 7374
public engagement and, 116
trustworthiness in, 8789
Datta, A. K., 376
Davidson, S., 115116
Dawson, A., 91, 97
decision-making
accountability and risk aversion issues in, 211
central objectives in, 208209
disclosure of research findings for purposes of, 231
in global crisis emergencies, 317318
health research regulation and, 99101
inclusion and equality in, 127
institutional influences on, 205214
institutional structure and composition and, 209211
path dependencies and historical influences in, 212213
privacy in, 7577
public interest and, 240241
public vs. private duties in, 211
social value and, 54
Declaration of Alma Ata (1978), 299301
Declaration of Chiang Mai, 300
Declaration of Helsinki
autonomy guidelines in, 2729
benefit sharing in, 151152
group access to research participation in, 172173
informed consent in, 105107
post-trial obligations in, 152153
social value in, 4647, 5253
vulnerability guidelines in, 18, 9091
Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, 103104
De Cleen, B., 251252
deep learning, medical devices and, 281
deferred consent, 107108
deficit model of public understanding, 112113
Degeling, C, 117
deliberative practices
diversity theory and, 252253
participatory health governance and, 124126
public expertise mobilisation and, 248256
Delphi policy study, 397399
democratic approach, patient and public involvement and, 121123
De Novo premarket review process (FDA), 278281
deontological theory, privacy and, 7879
descriptive argument for benefit sharing, 150151
diabetic retinopathy, software as medical device for diagnosis of, 278281
dialogue, public engagement and role of, 119120
digital consent technology, 110
DiMaggio, P., 210
direct benefit
in RCTs, 133
social value as, 4951, 5354
disaster research
global health emergency guidelines and, 316317
public engagement in, 319320
risk assessment in, 199200
social value of, 317318
disclosure of research findings
criteria for disclosure, 231
ethical issues linked to, 229238
guidelines and recommendations about, 230231
informed consent and, 107
narrative function of results, 235236
participant’s interests and, 234235
physical integrity and identity and, 385386
discourse ethics, privacy and, 7980
discrimination, in vulnerability research, 2022
distributed responsibility, governance and, 123124
diversity, public expertise mobilisation and, 253255
Dixon-Woods, Mary, 179180
Dove, Edward S., 3031, 3435, 99101
downstream research, national policy frameworks for genetics and, 337340
duress, informed consent and, 107108
duty of care, disclosure of research findings and, 233
duty to participate principal, disclosure of research findings and, 234235
Dworkin, Gerald, 2930
Dworkin, Ronald, 272
dynamic consent, 110, 248249
Ebola outbreak
experimental interventions and vulnerability in, 9293
randomized controlled clinical trials in, 132134
unregistered interventions in, 319
Eckstein, Lisa, 231
EC Regulation 141/2000, 6263
Editas company, 143146
Edwards, Robert, 373374
effectiveness of medical devices, marginalised focus on, 162165
efficacy
social value and estimation of, 5354
in traditional medicine, research on, 299301
egalitarian diversity and inclusiveness, 252253
Egelie, Knut, 143144
Eisenberg, Rebecca, 141
electronic signatures, informed consent and, 110
Emanuel, E., 4647, 180181
empowerment
participatory health governance and, 124125
public engagement and, 116
enforceable norms, solidarity and, 5859
engagement, proportionality and, 4445
enhancement innovations, development of, 383384
epistemic injustice, relational autonomy and, 3536
epistemic integration, medical device failure and, 165166
Epstein, S., 127
equality
diversity theory and, 252253
non-invasive prenatal testing and, 267268
Ethical and Policy Issues in International Research (National Bioethics Advisory Commission), 151152
ethical issues in health research
autonomy guidelines, 2729
benefit sharing and, 151153
in Big Data research, 123
bioethics advisory committees, 220222
chimeric research oversight and guidelines and, 359362
data protections and, 188189
disclosure of research findings and, 229238
enhancement innovations and, 383
ethical approvals process and, 307309
ethical licensing, 145146
evaluation of regulatory changes and, 202203
exemption for types of research, 200201
future directions in, 182185
genome-editing and, 267268
global health emergencies and, 315323
health policy formation and, 217218
human-technology embodiment and, 384386
incidental findings and, 229230, 309310
interspecies research, 357358
learned and academic societies’ influence on, 220
learning healthcare systems and, 391394
Learning Health Research Regulation System and, 394396
net risk test and, 136137
neuroscience and, 304, 310312
participants’ interests and needs and, 234235
placebo controls in evidence-based medicine and, 299
politics and, 9293
prenatal testing and, 267268
process simplification and harmonisation and, 200201
protection of culture and, 242n.23
randomized controlled clinical trial and, 132134
regulatory design and, 182184
regulatory process and, 178180
relational autonomy and, 3033
reproductive medicine and, 375377
research integrity and, 188189
review as regulatory process in, 178180
review of, 177186
risk identification and, 130132
standardisation of review processes, 182184
vulnerability guidelines, 1718
in vulnerability research, 2022
ethical licensing, 145146
Ethics Advisory Board (US Dept. of Health, Education and Welfare), 366368
Ethics Guidelines for Trustworthy AI (EC), 271
Ethics Review Committee (WHO), 320322
The Ethics of Research Related to Healthcare in Developing Countries (Nuffield Council on Bioethics), 151152
EU Directive 95/46/EC, 167168, 171
EU Directive 2001/20/EC, 200201
EU Directive 2004/24/EC, 300301
EU Regulation 2017/745, 382383
EU Regulation 2017/746, 382383
Europe, health research regulation in, 1
European Commission
benefit sharing guidelines, 154156
Guidelines for Trustworthy AI, 175
risk-benefit analysis guidelines, 137
European Convention on Human Rights (ECHR), 7475, 245246
European Court of Human Rights, 75, 245246
European Directive on Traditional Herbal Medicine Products (THMPD), 297298
European General Data Protection Regulation, 105106
European Genome-phenome Archive (EGA), 192
European Group on Ethics in Science and New Technologies to the European Commission, 151152
European Medicines Agency (EMA)
advanced therapies regulation and, 324
Argentinian regulatory harmonisation with, 328329
regulatory science and, 394
reproductive medicine add-on services regulation and, 377379
European Open Science Cloud (EOSC), 78
European Union (EU)
Data Protection Regulation 2016/679 (GDPR), 7577
data protection regulation in, 6770, 167169, 171, 243245
medical device approvals by, 160161
medical device regulation in, 386389
regulatory regime in, 14, 56
traditional and herbal medicine regulation in, 300301
European Union Clinical Trials Directive, 67, 130132, 199200, 340341, 347348
evidence-based healthcare. See also non-evidence-based medicine
Big Data research and, 257259
economics of clinical guidelines and, 301302
health policy formation and, 216218
learned and academic societies’ evaluation of, 220
norms of evidence and, 303304
placebo controls and, 298299
risk-benefit analysis and ethics review and, 137138
traditional and alternative medicines and, 296305
excessive risk, risk-benefit analysis and, 136137
exclusion criteria
proportionality and, 40
in vulnerability research, 2022
existence conditions, automated healthcare regulation and, 272
expectations in health research
Argentinian regulation of, 327328
failure and, 159162
neuroscience and, 308309
reproductive immunology mythology and, 376377
reproductive medicine and role of, 374
experimental interventions
global health emergencies and, 318320
vulnerability and, 9293
experts and expertise
evidence-based medicine and, 298299
future of health research regulation and, 222224
health policy advice and, 215224
learned and academic societies, 218220
mobilisation in health research regulation of, 248256
representation and inclusiveness issues in, 251253
explicability, artificial intelligence and, 271
exploitation
group vulnerability to, 9395
vulnerability in health research and, 9192
externalist perspective, relational autonomy and, 31
external validity, in RCTs, 133
facilitative leadership
participatory governance and, 128129
proportionality and, 4243
failure in health research
expectations and, 159162
history of, 158
legal interpretations and constructions of, 161162
risk assessment and prevention, 158166
systemic causes of harm and, 162165
values failure, 395
failure of care data, public interest in HRR and, 6970
fair benefits model, benefit sharing and, 153
Fairmichael, F., 395
fairness
artificial intelligence and, 271
non-invasive prenatal testing and, 267268
fair participation, global health emergency research and, 318320
Federal Advisory Committee Act (US), 220221
Federal Policy for the Protection of Human Subjects (Common Rule, US), 4647, 182184, 199201, 223
Federal Regulations on Research With Human Participants (US), 130132
federal science advisor, 222223
feedback policies
disclosure of research findings and, 231234
ethical responsibilities in, 236238
participants’ interest and, 234235
Feeney, Oliver, 143144
fertility medicine. See in vitro fertilisation; reproductive medicine
fictional man paradigm, public interest litigation and, 69
final cause/objective, of institutional decision-making body, 208209
Financial Services Authority (FSA, UK), 257259
Fineman, M. A., 19
first-order proportionality, defined, 3738
Fish, Stanley, 210
510(k) pathway, medical device trials, 279281
Flear, Mark, 158166
flexibility, in health research governance, 259260
Foley, T., 395
follow-on research, non-exclusive research tool licensing and, 142143
Food, Drug and Cosmetic Act (US), medical device definition in, 278281
Food and Drug Administration (FDA, US)
advanced therapies regulation and, 324
Argentian regulatory harmonisation with, 328329
clinical decision support software and, 277278
IDx-DR AI diagnostic system approval by, 278281
medical device approvals and, 160161
minimal risk principle in regulations and, 199200
politics and, 216218
premarket review proposal, 282283
risk-based medical device classification, 279
risk-benefit analysis in, 134
waivers of consent and, 200201
foresighting, anticipatory knowledge and, 285286
forms of engagement, health regulation research and, 14
for-profit health research, benefit sharing and, 154156
Foucault, Michel, 163, 383
foundational research tools, non-exclusive research tool licensing, 142143
Four Principles, 169170
14-day rule
embryo research and, 365372
evolution of, 366368
grounds for revisiting, 370372
in HFE ACT, 367
special status principle and, 367370
theoretical basis for, 368370
Franklin, Benjamin, 220221
free riders argument, enforceability of solidarity and, 5859
Frewer, L. J., 114
Fricker, Miranda, 90nn.1–2
Friedman, Marilyn, 31
Friesen, Phoebe, 202, 299
Fukushima disaster, emergency healthcare and, 319320
functional complementarity, 264
Fung, A., 124125, 127129
Gallagher, N., 118
Ganguli-Mitra, Agomoni, 9293, 275276, 315323
Gash, A., 124125, 128129
gastrulation, human embryo research and, 368370
Gelsinger, Jesse, 222
gender equity
autonomy and, 31
benefit sharing and marginalisation of, 152156
medical device failure and marginalisation of, 162165
physical integrity and identity and, 385386
reproductive medicine and, 354355
Gene Editing Summits, 335336
gene-editing techniques, balancing of interests and, 267268
General Data Protection Regulation (GDPR, EU), 6770, 167169, 171, 243245
procedural complementarity in, 264
General Guidelines for the Research of Non-Conventional Medicines (WHO), 299301
General Medical Council (GMC), 377381
general public, classification of, 117
gene therapy research, 222
genetics research
Argentinian genetically modified crops, 324325
co-dependent human-technology embodiment and, 383384
cultural protections and, 242n.23
group vulnerability and, 9597
harmonization of regulations on, 341343
human gene editing, 335343
interspecies research, 356364
risk identification in, 130132
genomic initiatives, 103104
co-dependent human-technology embodiment and, 383384
disclosure of research findings and, 231234
ethical licensing for, 145146
human genome definitions in, 346348
normative systems regulation, 336341
participants’ interest in, 234235
probabilistic vs. predictive results in, 232233
regulation of, 267268
Genomics England initiative, 6, 103104
Genotype/Phenotype database (dbGaP), 193
Ghinea, Narcyz, 287295
Giddens, Anthony, 257
Global Alliance for Genomics and Health, 103104, 195
Global Code of Conduct for Research in Resource-Poor Settings, 152
global health emergency research (GHER)
data sharing in, 8789
emergency context in, 316317
future issues and challenges in, 322323
governance and oversight guidelines and practices, 320322
justification for, 318320
social value and ethics in, 5152
trustworthy institutions in, 8189
global non-autonomy, situational vulnerability and, 33
Glover, Anne (Dr.), 222223
Good Clinical Practice (WHO), 152
Good Clinical Practice Guidelines (ICH), 105106, 173175
good will, trust and, 84
Google Deep Minds’ health data processing project, 118119
Gotze, J., 119120
Governance Arrangements for Research Ethics Committees (GafREC), 179
governance of research. See also participatory governance
adaptive governance, Big Data research regulation, 257265
Argentinian cell therapy research, 325326
benefit sharing and, 151153
data governance frameworks, 5961, 187196
data subject rights, 188189
defined, 257
ethical approvals process and, 307309
genomics research, normative framework in, 336341
global health emergency research, 320322
health research regulation and, 12, 14
implementation of effective models, 260263
inefficiencies in, 202
innovation oversight and, 292295
institutional dimensions of health research and, 205214
international health policy frameworks and, 340341
learned and academic societies as experts for, 218220
national policy frameworks for genetics and, 337340
in neuroscience, 304, 310312
patent regulation and, 141142
principles-based regulation and, 257259
privacy and, 7780
public engagement and, 119120
rule, principles and guidance-based initiatives, 167176
structures and processes, 263265
trustworthiness of, 248249
group-level solidarity, 5859
health research and, 5961
groups
common interest and privacy of, 241243
legal privacy protection for, 243246
risk identification in research on, 130132
vulnerability in health research for, 9395
Guerrini, Christi, 145146
Guideline 20 (CIOMS), 320322
Guidelines for Human Experimentation (Germany), 1718
Guidelines for Methodologies on Research and Evaluation of Traditional Medicine (WHO), 297298
Guidelines for Trustworthy AI (European Commission), 175
Gusterson, Hugh, 285286
H3Africa benefit sharing initiative, 153
Haas, Nayeli Urquiza, 296305
Habets, M., 5354
Hacking, Ian, 285286
Hancock, Matt, 271
harm
artificial intelligence and prevention of, 271
automated healthcare and, 266274
in Big Data research, 123
expectations and failure involving, 160162
future harm, prevention of, 158166
in global crisis emergencies, 317318
group vulnerability and, 97
proportionality of, 3940
risk identification and, 130132
social value and, 54
systemic causes of, 162165
Harmon, Shawn H. E., 382390
harmonization of regulation, genetics research and, 341343
Harper, Steven, 216218
Hastings Center Report, social value in, 5152
Havasupai tribe, 138
health research on, 130132
protection for, 242n.23
Hawley, K. J., 88n.45
Health and Care Act 2012 (UK), 301302
healthcare
access to, 5962, 154156
automated healthcare, 266274
disclosure of research findings and, 231234
failure of care data, 6970
regulatory regimes vs., 6
research and, 6
research-therapy divide in technology governance and, 277286
resistance to participatory governance in, 125
health research, value-driving paradigm for, 394396
Health Research Authority (HRA) (UK), 205
Confidentiality Advisory Group (CAG), 212213
institutional overview of, 208209
Proportionate Review Service, 182184
public interest guidelines, 6770
health research regulation
Argentinian advanced therapies research, 324331
automated healthcare, 266274
benefit sharing and, 148157
best practices and, 173175
clinical innovation and barrier of, 287290
countervailing trends inf, 201202
current and future trends in, 197203
design innovations in, 182184
disclosure of findings, protocols for, 229238
evaluation of changes to, 202203
expert and advisory advice in, 215224, 248256
failure in, 158166
future issues for, 222224
human embryo research, 365372
human gene editing, 335343
human germline research, 350352
institutional influence in, 205214
interspecies research and, 356364
key concepts in, 1315
learned and academic societies’ influence on, 218220
of medical devices, 277286, 382390
in neuroscience research, 304
non-evidence based reproductive medicine and, 373381
patent regulation, 139147
policy advice sources in, 215224
privacy and public interest in, 239247
problems and issues with, 13
process simplification and harmonisation and, 200201
public interest appeals in, 6667
recent changes in, 35
responsive regulation development, 333334
review as regulatory process and, 178180
risk-benefit analysis in, 130138
rule, principles and guidance-based initiatives, 167176
shared practices in, 5961
software as medical device and, 277286
solidarity in, 5664
supplementary guidance and, 173175
traditional and non-conventional medicines, 296305
visibility of, 264265
health research systems
informed consent and evolution of, 103104
participatory governance in, 123126
health systems research, social value in, 5152
He Jiankui, 345346, 351, 354355
Held, V. P., 240
Heller, Michael, 141
hematopoietic progenitor cells (HPC), Argentinian regulation of research on, 326328
Hendl, Tereza, 287295
Heneghan, Carl J., 160161
High Level Expert Group (HLEG), 78
Hilgartner, Stephen, 139
Hinterberger, Amy, 356364
Hirsch Index, 4749
historical influences, institutional decision-making and, 212213
Ho, Calvin W. L., 277286
Hodgson, G. M., 207208
Hoffmann (Lord), 245246
homeopathic practices, guidelines for, 301302
homogeneity
of institutions, 213
vulnerability and, 3334
Horizon Programme, 152
human assemblage ideology, human-technology embodiment and, 384386
human-centric governance, automated healthcare regulation and, 272
human challenge trials, debate over, 318320
human embryo research
admixed embryos, 358359
evolution of regulatory framework for, 366368
14-day rule and, 365366
interspecies research and, 356364
regulation of research on, 365372
revisiting 14-day rule in, 370372
special status principle in, 367368
terminology and definitions of, 347348
threshold of humanity principle and, 370372
Human Fertilisation and Embryology Act and Authority, HFEA (1990, UK)
Code of Practice, 378379
data protection regulation in, 171
human embryo research and, 358359, 365368
human germline research and, 346350
reproductive immunology warning and, 376377
reproductive medicine add-on services and, 378379
revisions to, 368370
in vitro fertilisation licensing and, 374
human gene editing
harmonization of regulations on, 341343
international health policy frameworks and, 340341
moral concerns over, 336341
national policy frameworks for, 337340
normative regulatory systems for, 335343
slippery slope ideology and, 349350
Human Genome Organization (HUGO), 149151
Human Genome Project, 103104
open access and, 190191
human germline research
context in, 348350
ethical debates over, 344355
future research challenges in, 354355
global regulation and scientific justice, 352353
harmonization of regulations on, 341343
international health policy frameworks and, 340341
national policy frameworks for, 337340
normative regulatory framework for, 336341
overview, 345346
regulation, responsibility and cooperative research in, 350352
terminology and definitions, 346348
humanitarian crises
health care regulation and, 199
research ethics in, 315323
social value of research in, 317318
humanity, threshold of
enhancement innovations and, 383
human embryo research and, 370372
Human Medicines Regulations 2012 (UK), 377379
Human Reproductive Cloning Act (2001, US), 347348
human rights
automated healthcare regulation and, 270
disclosure of research findings and, 233234
duty of confidence and, 246
genetics research regulation and, 340341
human embryo research and, 366368
identity as human right, 390n.49
privacy as, 7475
Human Rights Act 1998 (UK), 245246
Human Tissue Act 2004, 212213
Human Tissue Authority, 205
human values, health research regulation and, 7
Hunt, Matthew, 315323
Hurricane Katrina, distrust of government response in, 319320
Hurst, S. A., 2122, 25
Hutter, B., 161162
hypothesis-driven trials, social value of, 54
Hyun, Insoo, 361
idem principle of identity, 384386
identity
disclosure of research findings and, 229238
human-technology embodiment and, 384386
narrative as, health research participation and, 235236
right to, 390n.49
IDx-DR AI diagnostic system, risk assessment and market approval, 278284
IMDRF (International Medical Device Regulators Forum), software as medical device regulations and, 282283
Immergut, E., 208
incidental research findings, 229230
in neuroscience research, 309310, 313
inclusiveness
in health research governance, 259260
non-invasive prenatal testing and, 267268
inclusive public engagement
data intensive health research and, 118119
public expertise and, 251253
incommensurability, proportionality and, 4142
independent, interdisciplinary data access, 193194
independent review boards, privacy and, 7577
Indian Ocean tsunami, emergency healthcare and, 317320
indirect benefit, in RCTs, 133
individuals and individualism
autonomy guidelines in research ethics and, 2930
data governance and, 5961
group vulnerability and, 9596
health research regulation and, 7, 14
individual vulnerability in research, 9293
institutional decision-making and role of, 211
informational privacy, 75
data protection and, 7577
risks to, 130
information technology, collaborative licensing, 144145
informed consent
alternate models of, 200201
basis for, 104105
in Big Data research, 123
consent to contact policies and, 201202
cultural factors in, 242n.23
data protection and, 67n.15
digital consent mechanisms and, 110
evolution of health research and, 103104
fetishisation of, 181182
group vulnerability and, 9596
legal requirements for, 105108
limitations of, 108109
overview of, 103
privacy and, 7577
proportionality and, 40
relational autonomy and, 3031, 3436
right of refusal and, 108
solidarity in health research and, 5961
trust and, 248249
vulnerability and, 1718, 2022
waivers of, 199200
written forms of, 108109
infrastructural vulnerability, health research regulation and, 396, 2324
inherent vulnerability, 33
innovative health research
autologous mesenchymal stem cell intervention, 290292
clinical innovation in medical marketplace, 287295
collaborative licensing and, 144145
conflicts of interest in, 292295
disturbance of regulation from, 382383
emerging science and technology oversight and, 397399
enhancement innovations, 383384
ethical licensing and, 145146
government intervention and, 141142
market forces and, 140141, 292295
medical device regulation and, 386389
national policy frameworks for genetics and, 337340
oversight and, 287290, 292295
overuse of non-evidenced based therapies, 292295
patent regulation and, 139147
patent rights and, 141
self-regulatory patent rights models and, 142146
Institute of Medicine (IOM, US), 124, 391394
Institutional Animal Care and Use Committee (IACUC), 360
institutional capture, public engagement and, 118119
institutional review boards (IRBs)
design and performance criticism of, 180181
purpose of, 177178
risk-benefit analysis and, 137138
single board (sIRB), 200201
institutions
accountability and risk aversion issues in, 211
context of, 207208
decision-making body objectives in, 208209
decision-making body structure and composition, 209211
defined, 207208
design of, participatory governance and, 127129
health research regulation and, 1415, 205214
influences on decision-making in, 208213
inter-institutional influences in, 213
path dependencies and historical influences in, 212213
public vs. private duties in, 211
solidarity of, health research and, 5961
trust in, 8687
instrumentality, public engagement and, 113116
integrity, human-technology embodiment and, 384386
intellectual property rights
collaborative licensing and, 144145
patent regulation and, 140141
intended research findings, 229230
interconnectedness
in health research regulation, 2
learning healthcare systems and, 391394
inter-institutional design
health research regulation and, 213
learning healthcare systems and, 391394
Interministerial Commission for Research and Medicaments of Advanced Therapies (Argentina), 328329
internal validity, in RCTs, 133
International Bioethics Committee (UNESCO), 340341
International Cancer Genome Consortium/25K Initiative, 193
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), 105106
International Covenant on Civil and Political Rights (UN), 105106
International Ethical Guidelines for Health-related Research, 4647
International Ethical Guidelines for Health-Related Research Involving Humans (CIOMS), 3536, 4647, 169, 199200
international health policies
genetics research regulation and, 340341
human germline research, 352353
International Organization for Standards (ISO), 167168, 282283
interpersonal solidarity, 5859
interpretive community, 210
disclosure of research findings and, 236238
interspecies biomedical research
chimeric organisms, 357358
regulation of, 356364
shifting regulatory boundaries in, 362363
vulnerability issues, 363364
interventions
autologous mesenchymal stem cell case study, 290292
clinical innovation oversight and, 287290
component risk-benefit analysis, 135136
risk identification in, 130132
social value of, 4951, 5354
in vitro fertilisation add-on procedures, 375377
intrauterine culture, absence of effectiveness research on, 379
investigational therapeutics, global health emergencies and use of, 319
In Vitro Diagnostic Medical Devices Regulation (IVDR), 382383, 386389
in vitro fertilisation (IVF)
add-on procedures in, 375377
costs of, 375
culturing technological advances in, 368370, 373374
failure rate in, 375377
14-day rule and, 365366
non-evidence-based medicine in, 373381
patient choice dynamics in, 380
special status principle in, 367368
threshold of humanity principle in, 370372
time pressures in, 374377
Warnock Report findings and, 366368
ipse principle of identity, 384386
Isasi, Rosario, 335343
isomorphism
institutional decision-making and, 210
inter-institutional influences and, 213
issue characteristics, rare disease research, 6162
Jackson, Emily, 373381
Jacobs, Marie Andree, 304
Jasanoff, Sheila, 306307
Johnson, Summer, 218
justice
autonomy guidelines and, 2729
as benefit sharing argument, 150151, 154156
human germline research, 352353
informed consent and, 104105
medical device failure and, 162165
Kant, Immanuel, 7879
Kaye, Jane, 103111
Kerasidou, Angeliki, 1415, 8189
Kerridge, Ian, 287295
Kieslich, Katharina, 14, 5664
Kipnis, K., 396, 2324
Klitzman, R., 203
Knight, D., 159160
knowledge production
failure as tool for, 162165
medical device failure and organisation of, 162165
participatory government and forms of, 126127
participatory health governance and, 285286
risk-benefit analysis and, 132134
Koops, Bert-Jaap, 273
Kurunmäki and Miller, 159
labelling approach, vulnerability research and, 2022
ladder of public participation, 114, 116
Lane, Neal, 223224
Lange, M. Meeke, 2324
Langwick, Stacey, 304
Laurie, Graeme, 110, 165, 264265, 277278, 285286, 391400
laws and legislation
Argentinian health research regulation and, 330331
data protection law, 243245
fetishisation of consent and, 181182
genomics research and, 336341
group privacy protections and, 243246
human embryo special status in, 367368
informed consent and, 108109
institutional decision-making and, 212213
medical device regulation and, 388389
physical integrity and identity in, 385386
politics and barriers to, 223
privacy and, 241243
public interest and, 6770
shifting regulatory boundaries in animal research and, 362363
traditional and non-conventional medicines and, 303304
leadership support, participatory governance and, 127129
learning healthcare systems
continuous learning and research-therapy divide in, 277286
current and future trends in, 199
disclosure of research findings and, 231234
minimal risk principle and, 199200
patient engagement in, 124
regulatory science and, 391394
risk identification in, 130132
Learning Health Research Regulation System (LHRRS)
basic goals and features of, 399400
ecosystem for, 397399
learning healthcare systems and regulatory science and, 391394
overview of, 110
proposals for, 5, 391400
value and social values in, 394396
legitimacy
medical device failure and, 163164
of public engagement, 250251
public interests and, 240241
Lemley, Mark, 140141
Leopoldina Society, 218, 220
licensing
collaborative licensing, 144145
ethical licensing, 145146
mixed licensing models, 143144
non-exclusive research tool licensing, 142143
reproductive medicine add-on services, 377379
temporary licensing, 165
in vitro fertilisation and, 374
lifecyle assessment, software as medical device regulations and, 282283
liminality
advisory bodies and, 221
AI/ML device regulation and, 278
artificial intelligence and, 277278
health policy advice and, 215216
health research regulation and, 222224
Liminal Spaces Project, 3
emerging science and technology oversight and, 397399
limited disclosure of information, informed consent and, 107
Lipworth, Wendy, 287295
Lloyd-Bostock, S., 161162
local governance reviews
global health emergencies and, 319320
inefficiencies with, 202
Long Term Plan (NHS), 271
low-and-middle income countries (LIMC)
benefit sharing in, 152156
biotechnology regulation in, 324325
global health emergencies in, 317318
regulatory thresholds in, 353
trust in health research in, 8182, 8586
vulnerability of groups in, 9395
Lowi, Theodore, 6162
Luna, F., 2324
Lysagt, Tamra, 287295
MacCormick, N., 208209
machine learning
IDx-DR AI diagnostic system, 281284
as medical device, 277286
Mackenzie, Catriona, 32
maker movement, evolution of, 382383
Managing Ethico-social, Technical and Administrative Issues in Data ACess (METADAC, UK), 126
March, J., 209211
Margulis, S. T., 242
market forces
autologous mesenchymal stem cell case, 290292
clinical innovation and, 287295
medical device regulation and, 382383, 386389
overuse of non-evidenced based therapies and, 292295
patent regulation and, 140141
in reproductive medicine, 375377
Markingham, Dan, 21
May, William, 178
Mayo Clinic Biobank deliberation, 125126
McLeod, Carolyn, 32, 3435
McMillan, Catriona, 333334, 365372
Medical Assistance in Dying and When Antibiotics Fail (CCA), 219220
medical devices. See also software as medical device (SaMD)
artificial intelligence/machine learning as, 277286
clinical trials for, 279281
current and future regulation concepts and perspectives, 382390
expectations for, 160162
failure of, 158166
future challenges in regulation of, 389390
knowledge base for, 162165
market forces in regulation of, 386389
participatory learning in regulatory governance of, 284285
post-market surveillance of, 388389
re-embedded risk and sociality and, 281284
risk-based FDA classification of, 279
temporary licensing for, 165
Medical Devices Regulation (MDR, EU), 161, 386389
Medicines and Healthcare Products Regulatory Agency (UK), 205, 377