Index
Abelson, J.,
Academia Platonica (Neoplatonic Florentine Academy), 218
Academy of Medical Sciences (AMS, UK),
goals and mission of,
accountability
governance and,
institutional decision-making and, 211
medical device failure and,
non-traditional medicine and, 299
actor-networks
Big Data research and,
global health emergency guidelines and,
adaptive governance principles
Big Data research and,
evolution of,
structures and processes in,
visibility,
adaptivity, in health research governance,
Addgene company,
Additional Protocol (2005),
add-on services in reproductive medicine
ethical issues with,
patient choice dynamic in, 380
regulation of,
risks of,
advertising of innovative intervention, oversight of,
Advisory Commission on Regenerative Medicine and Cellular Therapies (Argentina),
advisory committees
adaptive governance and,
Advisory Commission on Regenerative Medicine and Cellular Therapies (Argentina),
in bioethics,
Bioethics Advisory Body,
future of health research regulation and,
health policy advice and,
advocates, public engagement with, 117
agency, automated healthcare regulation and, , 273
aggregated data, individual discrimination and stigmatisation and, 242
aggregative theories, public interest and, 240
Aitken, Mhairi, 14, ,
Alder Hey organ retention scandal,
Aldrick, Philip, 270
Allen, A. L., 75
All of Us initiative,
All Party Parliamentary Group on Surgical Mesh Implants,
alternative medicine
history and evolution of,
research regulation of,
uncertainty of knowledges and practices and,
as in vitro add-on,
Althusser, L.,
animal research
embryo research and,
human material in animals and,
interspecies research and,
in neuroscience,
regulation and oversight of,
shifting regulatory boundaries in,
vulnerability issues in regulation of,
Animals Containing Human Material (Academy of Medical Sciences),
Annas, George, 352
Ansell, C., ,
anticipatory knowledge
emerging science and technology oversight and,
in global health emergency research,
participatory health governance and,
anti-science politics
health policy formation and,
health research regulation and, 222
traditional and non-conventional medicine and,
Argentina
agricultural strength and health fragmentation in,
cell therapy research governance in,
construction of research governance in,
current health legal/regulatory framework in,
health research regulation in,
ArthritisPower network,
artificial intelligence (AI)
best practices guidelines and, 175
co-dependent human-technology embodiment and,
continuous learning, research-therapy divide and,
existence conditions and, 272
as medical device,
regulatory responsibility and,
voluntariness in,
assisted reproduction, human germline research and,
Association of University Technology Managers,
Australia
cloning research in,
evidence-informed health policy in,
Australian Academy of Learned Societies, 220
autologous mesenchymal stem cell case study, clinical innovation oversight and,
automated healthcare regulation
balance of interests in,
moral development and agency and,
regulatory responsibility and,
self-development and agency issues and, 273
stewardship responsibilities in,
autonomy
artificial intelligence and, 271
disclosure of research findings and,
health research ethics guidelines,
health research regulation and,
individualistic conceptions of,
informed consent and, ,
non-invasive prenatal testing and,
privacy and, 246
relational conceptions of,
availability heuristic, risk-benefit analysis and,
Aviesan initiative,
Baier, A.,
Ballantyne, A.,
Barbazza, E.,
Barber Surgeons of Edinburgh, 218
Barsdorf, Nicola,
Bea, Sara,
Beauchamp, T. L., 39,
beliefs, facts and, health policy and, 217
benefit analysis
risk-benefit analysis and,
social value and,
benefit evaluation, social value and, 54
benefits, defined,
benefit sharing
challenges to,
common heritage argument for,
data access agreements and, 191
descriptive argument for,
governance frameworks for,
health research regulation and,
history and rationale for,
procedures for,
benefit treatment, social value and, 54
Bennet, C. J.,
Bennett, Alan,
Beresford, P.,
Berger, M.,
best practices
displacement of traditional medicine in,
examples,
health research regulation,
in vitro fertilisation and, 374
Big Data research. See also data-driven research
adaptive governance in regulation of,
analytical techniques in,
deliberative participatory practices and,
effective governance of,
participatory governance of research and, 121
patient and public involvement in,
regulatory scholarship on,
structures and processes in,
systemic oversight framework for,
uncertainty in,
voluntariness in,
Biobricks Foundation,
Bioethics (journal), social value debate in,
biosecurity regulations, in Argentina,
blaming, medical device failure and,
Blasimme, Alessandro, 217
blinded trials, evidence-based medicine and,
Blueprint for Dynamic Oversight of Emerging Science and Technologies,
Boyd, Ian, 217
Bracken-Roche, D.,
Bradwell, P., 118
Brandeis, S. D., 75
Brassington, Iain,
Braun, K., , 117
Breakthrough Device designation (FDA),
Briggs (Lord Justice),
bright line ideology, human germline research and,
broad consent principle,
Broad Institute,
Brownsword, Roger,
Bryant, R.,
burdened populations, solidarity in health research for,
Burgess, Michael M., 14, ,
Bush, George W., ,
Caldicott Principles,
Caldicott Report,
Canada
autonomy guidelines in,
ethics review in,
genetics research regulation in,
Canadian Academy of Engineering,
Canadian Academy of Health Sciences,
Canadian Tri-Council,
capacity perspective
cooperative tool for capacity building, 153
participatory governance and, 127
vulnerability and,
in vulnerability research,
Care Act 2014 (UK),
care.data scheme (UK), , ,
Carroll, T.,
Carter, P.,
Categorical Imperative (Kant),
cell therapy research, Argentinian governance of,
centralised supervision and coordination, participatory governance and,
Chambers, Simone,
Chan, Sarah,
Charities Commission (UK),
children, relational autonomy of,
Childress, J. F., 39,
chimeric organisms
interspecies research and,
research guidelines involving, 360
shifting regulatory boundaries in research on,
vulnerability issues in research on,
Chuong, Kim H.,
circumstances, vulnerability and,
citizens’ forums, participatory health systems governance and,
clinical decision support (CDS) software
AI/ML software,
research-therapy divide and,
clinical equipoise, component analysis and,
clinical research
innovation in marketplace and,
social value in,
ClinicalStudyDataRequest,
clinical trials regulatory paradigm
economics of clinical guidelines and,
evidence-based medicine and,
medical device trials,
pay-to-participate clinical trials and,
regulatory research and,
social value and, 52
traditional and alternative medicines and,
clinical utility of information, disclosure of research findings based on, 231
Clinton, Bill,
Cloatre, Emilie,
cloning
ethical review of, ,
international health policy frameworks on,
legislation involving,
terminology and definitions of,
clustered regularly interspersed palindromic repeats (CRISPR) patents,
ethical issues in,
human gene editing regulation,
human germline research and,
co-dependent human-technology embodiment
enhancement innovations and,
identity and integrity issues in,
coercive isomorphism, 213
cognitive bias, risk-benefit analysis and,
cognitive disability, relational autonomy and,
Colbert, Jean-Baptiste, 218
Coleman, Carl H., 14,
Coleman, S.,
collaborative licensing,
patent regulation and,
collaborative research
Argentinian-University of Edinburgh research governance collaboration,
Big Data research and,
categories of,
clinical innovation oversight and,
data sharing collaborations, trust in,
human germline research,
in interspecies research,
in neuroscience, 308
participatory health governance and, ,
patent rights and, 141
trust and,
commercialisation of research
benefit sharing and,
data access and,
group vulnerability and, 97
health research regulation and, 7
common heritage argument for benefit sharing,
common interest theory
group privacy and,
public interest and,
common value theory,
communitarian approach
automated health regulation and,
benefit sharing,
global health emergencies and,
informed consent and,
institutional decision-making and, 210
risk-benefit analysis and, 138
community advisory boards, participatory health systems governance and,
Compangie du Gai Sçavoir, 218
comparative effectiveness research, minimal risk principle and,
competition, patent regulation and,
complementarity, governance structures and, 264
component analysis, risk-benefit analysis using,
confidentiality
in Big Data research, 123
duty of confidence and,
in neuroscience research, 308
privacy and, 79
public interest guidelines and,
Confidentiality Advisory Group (CAG) (HRA, UK), ,
Confronting the Liminal Spaces of Health Research Regulation project, 3
consent or anonymise regulation model, 4
consent to contact policies,
consultation, public engagement through,
consumerist approach
autologous mesenchymal stem cell case,
clinical innovation and intervention and, 289
innovation oversight and limits of,
medical device regulation and,
misinformation about reproductive medicine and, 379
non-traditional medicine and, 299
patient and public involvement and,
in vitro fertilisation and,
consumers, public engagement with, 117
context
in adaptive governance, 262
in global health emergency guidelines,
health research regulation and role of,
in human germline research,
of institutions,
proportionality and,
rule-based and practice-based health regulation and,
Contreras, Jorge,
controlled access, data-driven research,
Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Council of Europe),
Convention on Biological Diversity (CBD) (1992), 149
cooperative practice, human germline research,
cooperative tool for capacity building, benefit sharing and, 153
co-optation, participatory governance and, 127
costs of health research, solidarity on,
Council for International Organizations of Medical Sciences (CIOMS),
benefit sharing guidelines and,
global health emergency guidelines and, ,
guidelines,
health practices guidelines,
informed consent and, ,
reasonable availability model of,
risk-benefit analysis guidelines, 137
social value in health research regulation and, , ,
on third-party risks,
Council of Canadian Academies (CCA),
Council of Europe
data protection law and,
genetics research regulation and,
informed consent and,
Council on Health Research for Development (COHJRED),
COVID-19 pandemic
health practices guidelines and,
research exceptionalism and,
credibility tactics, participatory governance and, 127
Crick, Bernard, 96
criminal law
genetics research regulation and,
human embryo research and,
physical integrity and identity in,
crisis research
global health emergency guidelines and,
human gene editing regulation and,
risk assessment in,
social value of,
criticism, of research ethics,
cross-border data sharing, in Big Data research, 123
cultural issues
disclosure of research findings and,
interspecies biomedical research regulations and,
medical device failure and,
privacy and,
culturally significant information, protection of, 242n.23
Cunningham-Burley, Sarah, 14,
Curran, William,
cyborg perspective, enhancement innovations and, 383
D’Amour, D., 83
data access
agreements, 191
centralised access, genotype/phenotype database, 193
challenges and future directions,
governance of,
harmonisation of policies and processes in, 196
independent, interdisciplinary access,
multi-study access, EGA, 192
oversight coordination,
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,
Data Access Committees (DACs),
adaptive governance and,
controlled vs. open access data and,
monitoring of data use and,
multi-study access, EGA, 192
oversight coordination,
resources, effectiveness and efficiency in, 195
data-driven research. See also Big Data research
automated healthcare regulation and, 270
controlled vs. open access data,
current and future trends in,
disclosure of research findings and,
duty of confidence and privacy of,
EGA and, 192
group privacy protections in,
health research regulation and,
informed consent and,
integrity and ethics protections,
monitoring of data use and,
in neuroscience, 308
privacy rights and,
producer rights and interests in,
public engagement in, 116,
public perceptions of, 217
relationality in,
rules-based vs. practice-based approaches in regulation of,
subject rights and,
trustworthiness of research governance and,
value and social values in,
Data Protection Act 2018 (DPA, UK)
enactment of, 69
HRR community lobbying and,
neuroscience research and,
research governance and,
Data Protection Regulation 2016/679 (GDPR) (EU),
data sharing
governance frameworks for,
informed consent and,
in neuroscience research, 308
participatory learning in regulatory governance and,
privacy protection and,
public engagement and, 116
trustworthiness in,
Datta, A. K., 376
Davidson, S.,
decision-making
accountability and risk aversion issues in, 211
central objectives in,
disclosure of research findings for purposes of, 231
in global crisis emergencies,
health research regulation and,
inclusion and equality in, 127
institutional influences on,
institutional structure and composition and,
path dependencies and historical influences in,
privacy in,
public interest and,
public vs. private duties in, 211
social value and, 54
Declaration of Alma Ata (1978),
Declaration of Chiang Mai, 300
Declaration of Helsinki
autonomy guidelines in,
benefit sharing in,
group access to research participation in,
informed consent in,
post-trial obligations in,
social value in, ,
vulnerability guidelines in, 18,
Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks,
De Cleen, B.,
deep learning, medical devices and, 281
deferred consent,
deficit model of public understanding,
Degeling, C, 117
deliberative practices
diversity theory and,
participatory health governance and,
public expertise mobilisation and,
Delphi policy study,
democratic approach, patient and public involvement and,
De Novo premarket review process (FDA),
deontological theory, privacy and,
descriptive argument for benefit sharing,
diabetic retinopathy, software as medical device for diagnosis of,
dialogue, public engagement and role of,
digital consent technology, 110
DiMaggio, P., 210
disaster research
global health emergency guidelines and,
public engagement in,
risk assessment in,
social value of,
disclosure of research findings
criteria for disclosure, 231
ethical issues linked to,
guidelines and recommendations about,
informed consent and, 107
narrative function of results,
participant’s interests and,
physical integrity and identity and,
discourse ethics, privacy and,
discrimination, in vulnerability research,
distributed responsibility, governance and,
diversity, public expertise mobilisation and,
Dixon-Woods, Mary,
Dove, Edward S., , ,
downstream research, national policy frameworks for genetics and,
duress, informed consent and,
duty of care, disclosure of research findings and, 233
duty to participate principal, disclosure of research findings and,
Dworkin, Gerald,
Dworkin, Ronald, 272
dynamic consent, 110,
Ebola outbreak
experimental interventions and vulnerability in,
randomized controlled clinical trials in,
unregistered interventions in, 319
Eckstein, Lisa, 231
EC Regulation 141/2000,
Editas company,
Edwards, Robert,
effectiveness of medical devices, marginalised focus on,
efficacy
social value and estimation of,
in traditional medicine, research on,
egalitarian diversity and inclusiveness,
Egelie, Knut,
Eisenberg, Rebecca, 141
electronic signatures, informed consent and, 110
Emanuel, E., ,
enforceable norms, solidarity and,
engagement, proportionality and,
enhancement innovations, development of,
epistemic injustice, relational autonomy and,
epistemic integration, medical device failure and,
Epstein, S., 127
equality
diversity theory and,
non-invasive prenatal testing and,
Ethical and Policy Issues in International Research (National Bioethics Advisory Commission),
ethical issues in health research
autonomy guidelines,
benefit sharing and,
in Big Data research, 123
bioethics advisory committees,
chimeric research oversight and guidelines and,
data protections and,
disclosure of research findings and,
enhancement innovations and, 383
ethical approvals process and,
ethical licensing,
evaluation of regulatory changes and,
exemption for types of research,
future directions in,
genome-editing and,
global health emergencies and,
health policy formation and,
human-technology embodiment and,
incidental findings and, ,
interspecies research,
learned and academic societies’ influence on, 220
learning healthcare systems and,
Learning Health Research Regulation System and,
net risk test and,
neuroscience and, 304,
participants’ interests and needs and,
placebo controls in evidence-based medicine and, 299
politics and,
prenatal testing and,
process simplification and harmonisation and,
protection of culture and, 242n.23
randomized controlled clinical trial and,
regulatory design and,
regulatory process and,
relational autonomy and,
reproductive medicine and,
research integrity and,
review as regulatory process in,
review of,
risk identification and,
standardisation of review processes,
vulnerability guidelines,
in vulnerability research,
ethical licensing,
Ethics Advisory Board (US Dept. of Health, Education and Welfare),
Ethics Guidelines for Trustworthy AI (EC), 271
Ethics Review Committee (WHO),
The Ethics of Research Related to Healthcare in Developing Countries (Nuffield Council on Bioethics),
EU Directive 95/46/EC, , 171
EU Directive 2001/20/EC,
EU Directive 2004/24/EC,
EU Regulation 2017/745,
EU Regulation 2017/746,
Europe, health research regulation in, 1
European Commission
benefit sharing guidelines,
Guidelines for Trustworthy AI, 175
risk-benefit analysis guidelines, 137
European Convention on Human Rights (ECHR), ,
European Court of Human Rights, 75,
European Directive on Traditional Herbal Medicine Products (THMPD),
European General Data Protection Regulation,
European Genome-phenome Archive (EGA), 192
European Group on Ethics in Science and New Technologies to the European Commission,
European Medicines Agency (EMA)
advanced therapies regulation and, 324
Argentinian regulatory harmonisation with,
regulatory science and, 394
reproductive medicine add-on services regulation and,
European Open Science Cloud (EOSC),
European Union (EU)
Data Protection Regulation 2016/679 (GDPR),
data protection regulation in, , , 171,
medical device approvals by,
medical device regulation in,
traditional and herbal medicine regulation in,
European Union Clinical Trials Directive, , , , ,
evidence-based healthcare. See also non-evidence-based medicine
Big Data research and,
economics of clinical guidelines and,
health policy formation and,
learned and academic societies’ evaluation of, 220
norms of evidence and,
placebo controls and,
risk-benefit analysis and ethics review and,
traditional and alternative medicines and,
excessive risk, risk-benefit analysis and,
existence conditions, automated healthcare regulation and, 272
expectations in health research
Argentinian regulation of,
failure and,
neuroscience and,
reproductive immunology mythology and,
reproductive medicine and role of, 374
experimental interventions
global health emergencies and,
vulnerability and,
experts and expertise
evidence-based medicine and,
future of health research regulation and,
health policy advice and,
learned and academic societies,
mobilisation in health research regulation of,
representation and inclusiveness issues in,
explicability, artificial intelligence and, 271
exploitation
group vulnerability to,
vulnerability in health research and,
externalist perspective, relational autonomy and, 31
external validity, in RCTs, 133
facilitative leadership
participatory governance and,
proportionality and,
failure in health research
expectations and,
history of, 158
legal interpretations and constructions of,
risk assessment and prevention,
systemic causes of harm and,
values failure, 395
failure of care data, public interest in HRR and,
fair benefits model, benefit sharing and, 153
Fairmichael, F., 395
fair participation, global health emergency research and,
Federal Advisory Committee Act (US),
Federal Policy for the Protection of Human Subjects (Common Rule, US), , , , 223
Federal Regulations on Research With Human Participants (US),
federal science advisor,
feedback policies
disclosure of research findings and,
ethical responsibilities in,
participants’ interest and,
Feeney, Oliver,
fictional man paradigm, public interest litigation and, 69
final cause/objective, of institutional decision-making body,
Financial Services Authority (FSA, UK),
Fineman, M. A., 19
first-order proportionality, defined,
Fish, Stanley, 210
510(k) pathway, medical device trials,
Flear, Mark,
flexibility, in health research governance,
Foley, T., 395
follow-on research, non-exclusive research tool licensing and,
Food, Drug and Cosmetic Act (US), medical device definition in,
Food and Drug Administration (FDA, US)
advanced therapies regulation and, 324
Argentian regulatory harmonisation with,
clinical decision support software and,
IDx-DR AI diagnostic system approval by,
medical device approvals and,
minimal risk principle in regulations and,
politics and,
premarket review proposal,
risk-based medical device classification, 279
risk-benefit analysis in, 134
waivers of consent and,
foresighting, anticipatory knowledge and,
forms of engagement, health regulation research and, 14
for-profit health research, benefit sharing and,
foundational research tools, non-exclusive research tool licensing,
Four Principles,
14-day rule
embryo research and,
evolution of,
grounds for revisiting,
in HFE ACT, 367
special status principle and,
theoretical basis for,
Franklin, Benjamin,
free riders argument, enforceability of solidarity and,
Frewer, L. J., 114
Fricker, Miranda, 90nn.1–2
Friedman, Marilyn, 31
Fukushima disaster, emergency healthcare and,
functional complementarity, 264
Fung, A., ,
Gallagher, N., 118
Ganguli-Mitra, Agomoni, , ,
Gash, A., ,
gastrulation, human embryo research and,
Gelsinger, Jesse, 222
gender equity
autonomy and, 31
benefit sharing and marginalisation of,
medical device failure and marginalisation of,
physical integrity and identity and,
reproductive medicine and,
Gene Editing Summits,
gene-editing techniques, balancing of interests and,
General Guidelines for the Research of Non-Conventional Medicines (WHO),
General Medical Council (GMC),
general public, classification of, 117
gene therapy research, 222
genetics research
Argentinian genetically modified crops,
co-dependent human-technology embodiment and,
cultural protections and, 242n.23
group vulnerability and,
harmonization of regulations on,
human gene editing,
interspecies research,
risk identification in,
genomic initiatives,
co-dependent human-technology embodiment and,
disclosure of research findings and,
ethical licensing for,
human genome definitions in,
normative systems regulation,
participants’ interest in,
probabilistic vs. predictive results in,
regulation of,
Genomics England initiative, 6,
Genotype/Phenotype database (dbGaP), 193
Ghinea, Narcyz,
Giddens, Anthony, 257
Global Alliance for Genomics and Health, , 195
Global Code of Conduct for Research in Resource-Poor Settings, 152
global health emergency research (GHER)
data sharing in,
emergency context in,
future issues and challenges in,
governance and oversight guidelines and practices,
justification for,
social value and ethics in,
trustworthy institutions in,
global non-autonomy, situational vulnerability and, 33
Glover, Anne (Dr.),
Good Clinical Practice (WHO), 152
Good Clinical Practice Guidelines (ICH), ,
good will, trust and, 84
Google Deep Minds’ health data processing project,
Gotze, J.,
Governance Arrangements for Research Ethics Committees (GafREC), 179
governance of research. See also participatory governance
adaptive governance, Big Data research regulation,
Argentinian cell therapy research,
benefit sharing and,
data governance frameworks, ,
data subject rights,
defined, 257
ethical approvals process and,
genomics research, normative framework in,
global health emergency research,
health research regulation and, , 14
implementation of effective models,
inefficiencies in, 202
innovation oversight and,
institutional dimensions of health research and,
international health policy frameworks and,
learned and academic societies as experts for,
national policy frameworks for genetics and,
in neuroscience, 304,
patent regulation and,
principles-based regulation and,
privacy and,
public engagement and,
rule, principles and guidance-based initiatives,
structures and processes,
trustworthiness of,
group-level solidarity,
health research and,
groups
common interest and privacy of,
legal privacy protection for,
risk identification in research on,
vulnerability in health research for,
Guerrini, Christi,
Guideline 20 (CIOMS),
Guidelines for Human Experimentation (Germany),
Guidelines for Methodologies on Research and Evaluation of Traditional Medicine (WHO),
Guidelines for Trustworthy AI (European Commission), 175
Gusterson, Hugh,
H3Africa benefit sharing initiative, 153
Haas, Nayeli Urquiza,
Habets, M.,
Hacking, Ian,
Hancock, Matt, 271
harm
artificial intelligence and prevention of, 271
automated healthcare and,
in Big Data research, 123
expectations and failure involving,
future harm, prevention of,
in global crisis emergencies,
group vulnerability and, 97
proportionality of,
risk identification and,
social value and, 54
systemic causes of,
Harmon, Shawn H. E.,
harmonization of regulation, genetics research and,
Harper, Steven,
Hastings Center Report, social value in,
Hawley, K. J., 88n.45
Health and Care Act 2012 (UK),
healthcare
access to, ,
automated healthcare,
disclosure of research findings and,
failure of care data,
regulatory regimes vs., 6
research and, 6
research-therapy divide in technology governance and,
resistance to participatory governance in, 125
health research, value-driving paradigm for,
Health Research Authority (HRA) (UK), 205
Confidentiality Advisory Group (CAG),
institutional overview of,
Proportionate Review Service,
public interest guidelines,
health research regulation
Argentinian advanced therapies research,
automated healthcare,
benefit sharing and,
best practices and,
clinical innovation and barrier of,
countervailing trends inf,
current and future trends in,
design innovations in,
disclosure of findings, protocols for,
evaluation of changes to,
expert and advisory advice in, ,
failure in,
future issues for,
human embryo research,
human gene editing,
human germline research,
institutional influence in,
interspecies research and,
key concepts in,
learned and academic societies’ influence on,
of medical devices, ,
in neuroscience research, 304
non-evidence based reproductive medicine and,
patent regulation,
policy advice sources in,
privacy and public interest in,
problems and issues with,
process simplification and harmonisation and,
public interest appeals in,
recent changes in,
responsive regulation development,
review as regulatory process and,
risk-benefit analysis in,
rule, principles and guidance-based initiatives,
shared practices in,
software as medical device and,
solidarity in,
supplementary guidance and,
traditional and non-conventional medicines,
visibility of,
health research systems
informed consent and evolution of,
participatory governance in,
health systems research, social value in,
He Jiankui, , 351,
Held, V. P., 240
Heller, Michael, 141
hematopoietic progenitor cells (HPC), Argentinian regulation of research on,
Hendl, Tereza,
Heneghan, Carl J.,
High Level Expert Group (HLEG),
Hilgartner, Stephen, 139
Hinterberger, Amy,
Hirsch Index,
historical influences, institutional decision-making and,
Ho, Calvin W. L.,
Hodgson, G. M.,
Hoffmann (Lord),
homeopathic practices, guidelines for,
Horizon Programme, 152
human assemblage ideology, human-technology embodiment and,
human-centric governance, automated healthcare regulation and, 272
human challenge trials, debate over,
human embryo research
admixed embryos,
evolution of regulatory framework for,
14-day rule and,
interspecies research and,
regulation of research on,
revisiting 14-day rule in,
special status principle in,
terminology and definitions of,
threshold of humanity principle and,
Human Fertilisation and Embryology Act and Authority, HFEA (1990, UK)
Code of Practice,
data protection regulation in, 171
human embryo research and, ,
human germline research and,
reproductive immunology warning and,
reproductive medicine add-on services and,
revisions to,
in vitro fertilisation licensing and, 374
human gene editing
harmonization of regulations on,
international health policy frameworks and,
moral concerns over,
national policy frameworks for,
normative regulatory systems for,
slippery slope ideology and,
Human Genome Organization (HUGO),
Human Genome Project,
open access and,
human germline research
context in,
ethical debates over,
future research challenges in,
global regulation and scientific justice,
harmonization of regulations on,
international health policy frameworks and,
national policy frameworks for,
normative regulatory framework for,
overview,
regulation, responsibility and cooperative research in,
terminology and definitions,
Human Medicines Regulations 2012 (UK),
Human Reproductive Cloning Act (2001, US),
human rights
automated healthcare regulation and, 270
disclosure of research findings and,
duty of confidence and, 246
genetics research regulation and,
human embryo research and,
identity as human right, 390n.49
privacy as,
Human Rights Act 1998 (UK),
Human Tissue Act 2004,
Human Tissue Authority, 205
human values, health research regulation and, 7
Hunt, Matthew,
Hurricane Katrina, distrust of government response in,
Hurst, S. A., , 25
Hutter, B.,
hypothesis-driven trials, social value of, 54
Hyun, Insoo, 361
idem principle of identity,
identity
disclosure of research findings and,
human-technology embodiment and,
narrative as, health research participation and,
right to, 390n.49
IDx-DR AI diagnostic system, risk assessment and market approval,
IMDRF (International Medical Device Regulators Forum), software as medical device regulations and,
Immergut, E., 208
incidental research findings,
in neuroscience research, , 313
inclusiveness
in health research governance,
non-invasive prenatal testing and,
inclusive public engagement
data intensive health research and,
public expertise and,
incommensurability, proportionality and,
independent, interdisciplinary data access,
independent review boards, privacy and,
Indian Ocean tsunami, emergency healthcare and,
indirect benefit, in RCTs, 133
individuals and individualism
autonomy guidelines in research ethics and,
data governance and,
group vulnerability and,
individual vulnerability in research,
institutional decision-making and role of, 211
information technology, collaborative licensing,
informed consent
alternate models of,
basis for,
in Big Data research, 123
consent to contact policies and,
cultural factors in, 242n.23
data protection and, 67n.15
digital consent mechanisms and, 110
evolution of health research and,
fetishisation of,
group vulnerability and,
legal requirements for,
limitations of,
overview of, 103
privacy and,
proportionality and, 40
relational autonomy and, ,
right of refusal and, 108
solidarity in health research and,
trust and,
vulnerability and, ,
waivers of,
written forms of,
infrastructural vulnerability, health research regulation and, 396,
inherent vulnerability, 33
innovative health research
autologous mesenchymal stem cell intervention,
clinical innovation in medical marketplace,
collaborative licensing and,
conflicts of interest in,
disturbance of regulation from,
emerging science and technology oversight and,
enhancement innovations,
ethical licensing and,
government intervention and,
market forces and, ,
medical device regulation and,
national policy frameworks for genetics and,
oversight and, ,
overuse of non-evidenced based therapies,
patent regulation and,
patent rights and, 141
self-regulatory patent rights models and,
Institute of Medicine (IOM, US), 124,
Institutional Animal Care and Use Committee (IACUC), 360
institutional capture, public engagement and,
institutional review boards (IRBs)
design and performance criticism of,
purpose of,
risk-benefit analysis and,
single board (sIRB),
institutions
accountability and risk aversion issues in, 211
context of,
decision-making body objectives in,
decision-making body structure and composition,
defined,
design of, participatory governance and,
health research regulation and, ,
influences on decision-making in,
inter-institutional influences in, 213
path dependencies and historical influences in,
public vs. private duties in, 211
solidarity of, health research and,
trust in,
instrumentality, public engagement and,
integrity, human-technology embodiment and,
intellectual property rights
collaborative licensing and,
patent regulation and,
intended research findings,
Interministerial Commission for Research and Medicaments of Advanced Therapies (Argentina),
internal validity, in RCTs, 133
International Bioethics Committee (UNESCO),
International Cancer Genome Consortium/25K Initiative, 193
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH),
International Covenant on Civil and Political Rights (UN),
International Ethical Guidelines for Health-related Research,
International Ethical Guidelines for Health-Related Research Involving Humans (CIOMS), , , 169,
international health policies
genetics research regulation and,
human germline research,
International Organization for Standards (ISO), ,
interpersonal solidarity,
interspecies biomedical research
chimeric organisms,
regulation of,
shifting regulatory boundaries in,
vulnerability issues,
interventions
autologous mesenchymal stem cell case study,
clinical innovation oversight and,
component risk-benefit analysis,
risk identification in,
social value of, ,
in vitro fertilisation add-on procedures,
intrauterine culture, absence of effectiveness research on, 379
investigational therapeutics, global health emergencies and use of, 319
In Vitro Diagnostic Medical Devices Regulation (IVDR), ,
in vitro fertilisation (IVF)
add-on procedures in,
costs of, 375
culturing technological advances in, ,
failure rate in,
14-day rule and,
non-evidence-based medicine in,
patient choice dynamics in, 380
special status principle in,
threshold of humanity principle in,
time pressures in,
Warnock Report findings and,
ipse principle of identity,
Isasi, Rosario,
issue characteristics, rare disease research,
Jackson, Emily,
Jacobs, Marie Andree, 304
Jasanoff, Sheila,
Johnson, Summer, 218
justice
autonomy guidelines and,
as benefit sharing argument, ,
human germline research,
informed consent and,
medical device failure and,
Kant, Immanuel,
Kaye, Jane,
Kerasidou, Angeliki, ,
Kerridge, Ian,
Kieslich, Katharina, 14,
Kipnis, K., 396,
Klitzman, R., 203
Knight, D.,
knowledge production
failure as tool for,
medical device failure and organisation of,
participatory government and forms of,
participatory health governance and,
risk-benefit analysis and,
Koops, Bert-Jaap, 273
Kurunmäki and Miller, 159
labelling approach, vulnerability research and,
Lane, Neal,
Lange, M. Meeke,
Langwick, Stacey, 304
Laurie, Graeme, , 165, , , ,
laws and legislation
Argentinian health research regulation and,
data protection law,
fetishisation of consent and,
genomics research and,
group privacy protections and,
human embryo special status in,
informed consent and,
institutional decision-making and,
medical device regulation and,
physical integrity and identity in,
politics and barriers to, 223
privacy and,
public interest and,
shifting regulatory boundaries in animal research and,
traditional and non-conventional medicines and,
leadership support, participatory governance and,
learning healthcare systems
continuous learning and research-therapy divide in,
current and future trends in, 199
disclosure of research findings and,
minimal risk principle and,
patient engagement in, 124
regulatory science and,
risk identification in,
Learning Health Research Regulation System (LHRRS)
basic goals and features of,
ecosystem for,
learning healthcare systems and regulatory science and,
overview of,
proposals for, 5,
value and social values in,
legitimacy
medical device failure and,
of public engagement,
public interests and,
Lemley, Mark,
licensing
collaborative licensing,
ethical licensing,
mixed licensing models,
non-exclusive research tool licensing,
reproductive medicine add-on services,
temporary licensing, 165
in vitro fertilisation and, 374
lifecyle assessment, software as medical device regulations and,
liminality
advisory bodies and, 221
AI/ML device regulation and, 278
artificial intelligence and,
health policy advice and,
health research regulation and,
limited disclosure of information, informed consent and, 107
Lipworth, Wendy,
Lloyd-Bostock, S.,
Long Term Plan (NHS), 271
low-and-middle income countries (LIMC)
benefit sharing in,
biotechnology regulation in,
global health emergencies in,
regulatory thresholds in, 353
trust in health research in, ,
vulnerability of groups in,
Lowi, Theodore,
Luna, F.,
Lysagt, Tamra,
MacCormick, N.,
machine learning
IDx-DR AI diagnostic system,
as medical device,
Mackenzie, Catriona, 32
maker movement, evolution of,
Managing Ethico-social, Technical and Administrative Issues in Data ACess (METADAC, UK), 126
March, J.,
Margulis, S. T., 242
market forces
autologous mesenchymal stem cell case,
clinical innovation and,
medical device regulation and, ,
overuse of non-evidenced based therapies and,
patent regulation and,
in reproductive medicine,
Markingham, Dan, 21
May, William, 178
Mayo Clinic Biobank deliberation,
McLeod, Carolyn, 32,
McMillan, Catriona, ,
Medical Assistance in Dying and When Antibiotics Fail (CCA),
medical devices. See also software as medical device (SaMD)
artificial intelligence/machine learning as,
clinical trials for,
current and future regulation concepts and perspectives,
expectations for,
failure of,
future challenges in regulation of,
knowledge base for,
market forces in regulation of,
participatory learning in regulatory governance of,
post-market surveillance of,
re-embedded risk and sociality and,
risk-based FDA classification of, 279
temporary licensing for, 165
Medical Devices Regulation (MDR, EU), 161,
Medicines and Healthcare Products Regulatory Agency (UK), 205,
Médicins sans Frontières,
Medina, José,
Megan’s Law,
mental health research, risk identification in,
Meslin, Eric M.,
Mesmer, Anton,
METADAC (Managing Ethical, Sociotechinical and Administrative issues in Data Access),
metal-on-metal hips, expectations and failure involving,
MEURI (monitored emergency use of unregistered and experimental interventions) scheme, 319
Mexican General Health Law, 97
Mill, John Stuart, 78
Miller, Franklin, 235,
Millum, Joseph,
mimetic isomorphism, 213
minimal risk principle, health research regulation and,
mixed licensing models, patent regulation and,
Mode 2 research, social values and,
Moffett, A., 376
monitoring, in health research governance,
moral agency
automated healthcare regulation and,
global health emergencies and,
human-technology embodiment and,
trust and, 85
trustworthy institutions and,
moral hazard, mixed licensing model and,
multi-agency research networks
learning healthcare systems and,
participatory health systems governance and, 126
multi-disciplinary efforts
institutional decision-making and,
learning healthcare systems and,
multilevel engagement strategies, participatory governance and, 128
Munsie, Megan,
Murtagh, M. J., 126
my data phenomenon, health research regulation and,
Nabatchi, T.,
Nagoya Protocol on Access and Benefit-Sharing, 149
narrative tools, research findings as,
National Academies of Sciences, Engineering and Medicine (NASEM, US),
National Academy of Science (NAS), chimera research guidelines,
National Administration of Drugs, Food and Medical Technology (ANMAT),
National Agency of Promotion of Science and Technology (ANPCYT, Argentina),
National Bioethics Advisory Commission (NBAC, US),
National Bioethics Advisory Commission (US),
National Commission for Agricultural Biotechnology (CONABIA) (Argentina),
National Consultative Committee on Ethics (France), 221
National Electronic Health Record System (NEHRS) (Australia),
National Health Service (NHS)
fertility treatment funding in, 375
non-conventional treatment regulation and,
research ethics and, 179
National Institute for Health and Care Excellence (NICE, UK), ,
in vitro fertilisation guidelines in, 375
National Institute for Transplantation (INCUCAI, Argentina),
National Institutes of Health (NIH, US),
chimeric research moratorium,
national policy frameworks, genetics research and,
National Statement on Ethical Conduct in Human Research (Australia NHMRC),
natural ecosystem, health regulation and role of,
natural killer cells, reproduction medicine and mythology about,
negative function, innovation oversight and,
net risk test, risk-benefit analysis and,
networks of actors, adaptive governance and,
neuroimaging techniques, ethical issues and,
‘A New Pathway for the Regulation and Governance of Health Research’ (AMS report),
New Zealand, evidence-informed health policy in,
NHS Act 2006,
Section 251, 68
NHS Trusts, 205
NHSX (UK), 271
Nicholls, Stuart G.,
Nickel, P. J.,
Nicol, Dianne,
Nielsen, Jane,
non-assertion covenants, patent regulation,
non-conventional medicine
history and evolution of,
research regulation of,
uncertainty of knowledges and practices and,
non-evidence based medicine, in vitro fertilisation and,
non-exclusive research tool licensing, patent rights and,
non-identifiable data, duty of confidence and, 246
non-invasive prenatal testing (NIPT), regulation of,
normative rationales
autonomy and, 32
disclosure of research findings and,
genomics research,
human embryo research and challenges of,
human gene editing regulations,
incidental research findings and,
learning healthcare systems and,
in neuroscience research,
normative isomorphism, 213
normic diversity,
principles-based regulation and, 259
privacy protection and,
public engagement and,
rules- and principles-based regulation and, 169,
North, D.,
Notice of Proposed Rule Making,
Nowotny, H.,
Nuffield Council on Bioethics, , 221, ,
Nuremberg Code, , , 169
Nuu-chahnulth people, genetics research and, 242n.23
Obama, Barack,
O’Doherty, Kieran C.,
OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data,
off-label use of medicines, reproductive medicine add-ons,
off-target humanised tissue, interspecies research and problem of, ,
Olsen, J.,
O’Mathuna, D.,
100,000 Genomes project,
O’Neill, Onora, 9,
Ontario Cancer Research Ethics Board (OCREB),
open data and open science
data-driven research,
disclosure of research findings and,
health research regulation and,
patent regulation and,
trust and,
Opinion on Ethical Aspects of Clinical Research in Developing Countries (European Group on Ethics),
optimism bias, overuse of non-evidenced based therapies and,
organ donation/retention, regulations concerning,
Organisation for Economic Co-operation and Development (OECD), data governance and,
Oshana, Marina, 31
Ostrom, Elinor,
Osuji, P.,
outputs of health research, 100
over-inclusive labelling, vulnerability in research and,
Oviedo Convention, ,
pain relief protocols, vulnerability and, 19
Pang, T., 124
participants in health research
benefit sharing with,
disclosure of research findings and,
feedback to, 230
interests of, disclosure guidelines and,
in neuroscience research, 308
participatory governance. See also governance of research
clinical innovation oversight and,
enabling conditions for,
health research regulation and, ,
health research systems,
institutional designs for,
international initiatives in,
participatory learning systems, regulatory governance and,
patent aggregation, 145
patent pledges,
patent pools,
patent rights and regulation
benefit sharing principle and,
ethical licensing,
government intervention and,
health research innovation and,
mixed licensing models,
non-exclusive research tool licensing,
as private regulation,
self-regulatory models for,
paternalism, vulnerability in research and, 22
path dependency, institutional decision-making and,
pathogenic vulnerability, 91
patient and public involvement (PPI). See also public engagement
benefit treatment and, 54
consumerist and democratic approaches to,
disclosure of research findings and,
health research regulation and, 46, ,
identity interests in,
increased demand for,
participatory governance in health research and,
patient-centered care, learning healthcare systems and,
Patient-Centered Outcomes Research Institute (POCRI, US),
patient choice dynamics, reproductive medicine regulation and, 380
patient health data
consent to contact policies and,
disclosure of research findings and role of, 233
research regulations for use of,
Patient Network for Advanced Therapies (APTA Network, Argentina), 329
patterns of action, institutional decision-making and,
PAWORNET system (Riles),
perceptions of risk, risk-benefit analysis and,
performance of medical devices, research focus on,
permission to contact policies,
permissive function, innovation oversight and,
permitted embryo concept,
personal data protection, privacy and,
Personal Genome Project,
pharmaceutical industry, solidarity-based research and,
placebo controls, evidence-based medicine and,
placental sampling, autonomy and consent to,
planned adaptations, research governance and, 264
policy formation in health research
Delphi policy study,
disclosure of research findings and,
evidence and evidence gathering and,
expert and advisory advice in,
future issues in,
genetics research regulation and,
international policy frameworks and,
learned and academic societies as experts for,
national genetics research frameworks for,
panaceas ideology in,
politics in health research
anti-science politics and,
group membership and,
group vulnerability and,
health research regulation and,
human germline research and,
individual vulnerability,
interspecies biomedical research regulations and,
non-traditional medicine and, 299
patent regulation and,
policy advice experts and advisory committees and,
protection and, 97
public expertise and,
trustworthiness and,
vulnerabilities and power in,
polycentricity, Big Data research and,
population groups
data on,
in health research regulation,
positive function, innovation oversight and,
Postan, Emily,
post-market surveillance, medical device regulation and,
post-trial obligations, benefit sharing and,
Potter, N. Nyquist,
poverty, vulnerability and,
Powell, W., 210
power
benefit sharing and role of,
definitions and analysis of,
group vulnerability and,
participatory governance and devolution of,
patent regulation and,
resource imbalance with,
trust and parity in,
vulnerabilities in health research politics and,
vulnerability and,
Prainsack, Barbara, 14,
precarity
in global crisis emergencies,
vulnerability and,
Precision Medicine Initiative (PMI, US), ,
predictive influences, institutional decision-making in health regulation and, 208
preparedness principles, in global health emergency research,
preponderance theory, public interest and, 240
prescriptive influences, institutional decision-making in health regulation and, 208
Prictor, Megan,
primary research, findings from,
primitive streak development, human embryo research and,
principles-based regulation
AFIRRM model and,
Big Data research,
development of,
health research regulation and,
limitations,
privacy
atomistic conception of,
in Big Data research, 123
data access governance and,
data protection law and,
defined,
duty of confidence and,
group privacy,
health research regulation and, , 14
as human right,
informed consent and,
legal protection of group privacy,
in modern context, 73
normativity of,
in personal data protection,
public interest and,
research governance and,
risk to violation of, 130
private sector healthcare
genomics research and,
learning healthcare systems and,
medical device regulation and,
misinformation about reproductive medicine and, 379
patents as,
procedural ambiguity, neuroscience research and,
procedural complementarity, 264
professionalised lay experts, participatory governance and, 127
Professional Standards Authority (PSA, UK),
progressive value, benefit analysis and,
proportionality
analytical complexities,
defined,
emerging science and technology oversight and,
in global health emergency research,
of harms,
health research regulation and,
procedural approaches to,
of review,
social value and,
protected experimental use, patent regulation and,
protection, politics in health research and, 97,
protocol risks, vulnerability of participants and, 21
Public Accountability for Health-Related Research, CIOMS guidelines and,
public engagement. See also patient and public involvement; patient and public involvement (PPI)
anti-science politics and,
consultation and,
critique in,
empowerment and, 116
evaluation of,
forms of,
global health emergencies and,
health research regulation and, 7,
human germline research and,
inclusive approach to,
layers of,
narrative of findings as tool for,
overview, 112
participatory learning in regulatory governance and,
public expertise mobilisation and,
representation and inclusiveness issues in,
trust and legitimacy challenges in,
trustworthiness of research governance and,
types of publics in, 117
public funding, patent regulation and,
Public Health England, Value of Vaccines campaign, 115
public interest
automated healthcare and balancing of,
CIOMS Public Engagement guidelines and,
common interests and,
contested concepts of,
data acceptability and,
data protection law and,
decision-making in, 211
deliberative public engagement and,
health research regulation and,
holistic concepts of,
as legal device,
privacy and, 78,
trust and legitimacy challenges in,
public-private models
genomics research regulation,
learning healthcare systems and,
public reason, public interest and,
pure public, classification of, 117
Quality-Adjusted Life Years, proportionality and social value,
Quality-Adjusted Time Without Symptoms and Toxicity (Q-TWIST) test, 138
Quality Management System (QMS), AI/ML medical device regulation and,
quandary ethics, medical device failure and, 163
Raab, C. D.,
Rahmizadeh, V., 203
Rai, R.,
randomised clinical trials (RCTs)
design in reproductive medicine for,
evidence-based medicine and,
global health emergency research and challenges of,
reproductive medicine and lack of,
risk-benefit analysis and,
range of sensitivities, privacy and, 79
rare disease research, solidarity in,
Raz, Joseph, 31
REACH platform,
real-time responsiveness, global health emergencies and,
reasonable availability model, benefit sharing and,
reasonableness and reason-giving, diversity theory and,
reasonable risk, risk-benefit analysis and,
redundancy, Big Data research and,
Reed, Chris,
reflexivity, in health research governance,
refusal, informed consent and right of, 108
regenerative medicine
advanced therapies in, 324
Argentinian governance of research in,
regulation and oversight of,
vulnerability issues in,
registrant risk assessment scale (RRAS),
regulatory committees, institutional context for, 205
regulatory/governance approach (RGA)
AI/ML medical devices and,
to health research,
participatory learning systems and,
regulatory lapse, emerging technologies and,
regulatory regimes
clinical care vs., 6
clinical innovation oversight and, 289
inefficiencies in committees,
innovation oversight and,
medical devices and changes in,
recent challenges for,
regulatory responsibility
automated healthcare regulation and,
human germline research,
regulatory science, learning healthcare systems and,
relational autonomy
informed consent and,
participatory governance and,
principles of,
vulnerability and,
reliability, trustworthiness and, 88n.45
Reliable Replacement Warhead (RRW) program,
reliance, trust in global health research and,
representation and representativeness
group vulnerability and,
participatory governance and,
in public engagement,
representative diversity,
reproductive autonomy, non-invasive prenatal testing and,
reproductive immunology
lack of research and regulation of,
off-label use of,
reproductive medicine. See also cloning
add-on services regulation in,
alternative treatments in,
context in research on,
disclosure guidance in, 231,
evolution of regulatory framework for,
14-day rule and,
global regulations and policies and, 352,
human gene editing and, ,
innovation oversight in,
non-evidence-based medicine in,
patient choice dynamics in, 380
pre-implantation genetic diagnosis and,
risks of add-ons in,
threshold of humanity principle in,
researchers ethical capacities, global health emergencies and,
research ethics boards (REBs)
purpose of,
risk-benefit analysis and,
research ethics committees (RECs), 46
design and performance criticism of,
fetishisation of consent and,
future directions for,
innovation oversight and,
neuroscience research and, 304
purpose of,
regulatory role of,
risk-benefit analysis and,
social value and,
standardisation of procedures for,
Research Involving People Living in Developing Countries: Position Statement and Guidance Notes for Applicants (Wellcome Trust), 151
research-therapy divide, continuous learning systems and,
Resnik, D. B., 52
resource/power imbalance, participatory governance and,
respect for persons, autonomy guidelines and,
responsiveness, in health research governance,
review, proportionality of,
revisionism, scientific claims and, 49
Richardson, Megan, 246
Richert, Lucas,
Rid, A., ,
The Right to Privacy (Richardson), 246
rigorous justification, proportionality and, 43
Rijke, J., 263
Riles, Annelise,
Rip, A.,
risk
defined, 130
failure in health research and,
in health research governance,
identification of,
institutional aversion to, 211
medical device classification based on, 279
re-embedded risk in medical devices,
of reproductive add-on treatments,
SaMD risk characterization framework,
social value of research and,
risk-benefit analysis
benefits identification,
disclosure of research findings and,
first-order proportionality and,
in health research regulation,
health research regulation and, 14
medical devices and,
methodologies for,
procedural issues,
public interest and role of,
quantification of,
risk identification in,
risk object designation
AI/ML algorithm and,
medical device regulation and,
re-embedded risk and sociality and,
regulatory governance and,
software as medical device,
Robertson, John, 178
Roche, Ellen, 21
Rogers, Wendy A., 13,
Rose v. Secretary of State for Health,
Rowe, G., 114
Royal Academy of Sciences, 218
Royal Society of Canada,
Rudge, Chris,
rules-based approaches (RBAs)
automated healthcare regulation and,
development of,
health research regulation and,
limitations,
R (Source Informatics) v. Department of Health, 246
R (W,X,Y and Z) v. Secretary of State for Health (2015),
safety
expectations and failure involving,
of traditional medicine, research on,
Salter, B.,
Schaefer, Gerald Owen,
Schulz, S., , 117
science and technology studies (STS)
health research regulation in,
public engagement in,
traditional and non-conventional medicines and,
scientific uncertainty, risk-benefit analysis and,
secondary research
findings from,
institutional decision-making on,
regulation of,
second-order proportionality, defined,
security, data access governance and,
self-development, automated healthcare regulation and, 273
self-narrative, health research participation and,
self-regarding attitudes, relational autonomy and, 32
self-trust, relational autonomy, 32
semi-autonomous consent, 110
sequencing, in health research regulation,
Serwadda, D.,
Seth, Nayha, ,
Sherkow, Jacob,
Shreve, N., 376
Simm, Kadri,
single institutional review board (sIRB), proposals for,
situational vulnerability, 33
slippery slope ideology, human germline research and,
social learning, adaptive governance and,
social practices of healing,
social value
application of,
automated health regulation and,
benefit analysis and,
benefit evaluation and, 54
benefit treatment and, 54
decision-making and, 54
of global health emergency research,
global health emergency research and,
meaning of,
proportionality and,
re-embedded risk in medical devices and,
scholarly debate on,
in sociology of science,
solidarity as,
values and, ,
sociology of science
neuroscience research and,
social value in,
therapeutic interactions research, 299
software as medical device (SaMD)
IDx-DR AI diagnostic system,
regulation of,
risk characterization framework,
solidarity
applicability and adjustments in HHR and,
automated health regulation and,
as benefit sharing argument,
as community and system value,
in health research regulation, 14,
meaning of,
rare diseases and orphan drugs research and,
Somatic Gene and Engineered Cell Therapies (CCA),
somatic gene therapy, regulation of,
somatic/germline distinction, human germline research and, 350
Sorauf, F. J., 240
Sorbie, Annie, 14,
Spanish Agency for Medicaments, Argentinian collaboration with, 329
special vulnerability paradigm,
health research ethics and,
stakeholder engagement
automated health regulation and,
Big Data research and,
data protections and, 189
failure in health research and,
independent, interdisciplinary data access and,
marginalisation in vaginal mesh failure and,
principles-based approaches and,
value-driving paradigm for,
stare decisis, institutional decision-making and,
Stark, Laura,
stem cell research
Argentinian regulation of,
autologous mesenchymal stem cell case,
regulation and oversight of,
shifting regulatory boundaries in,
vulnerability issues in regulation of,
Stem Cell Research Oversight (SCRO) committees, interspecies research oversight, 360
stereotyping, in vulnerability research,
stewardship
ethics in health research and,
health research regulation and, 268,
participatory health research governance and, 124
Stewart, Cameron,
Stilgoe, J., 112
Stoljar, Natalie, 13,
study design and size, RCTs and, 133
subjectivity, public engagement and,
substantial equivalence principle, medical device risk and,
supplementary guidance, health research regulation,
surrogate licensing, patent regulation and,
systemic oversight
AFIRRM model and, 262
Big Data research and,
context in, 262
structures of governance and, 263
systems approach
participatory governance in health research and,
to research regulation,
system value, solidarity as,
Taylor, Mark, , ,
technology
Argentinian regulation of,
automated healthcare,
automated healthcare regulation and,
collaborative licensing and,
disturbance of regulation from,
failure of,
health research regulation and, ,
informed consent and evolution of,
non-exclusive research tool licensing and,
patent rights and innovation in, 141
regulatory lapse and,
regulatory responsibility and,
Tello, J. E.,
temporary licensing, for medical devices, 165
ten Have, H., 91
Ter Muelen, Ruud,
Testlin, Henri, 218
theory-practice gaps, rule-based and practice-based health regulation and,
therapeutic misconception, benefit sharing and,
third-party risks, identification of,
Thompson, J., 127
Tietjens, Diana, 31
Tongan people, cultural protections for, 242n.23
tools for health research regulation, overview,
top-down public engagement, 112
Townsend, David, 14,
Traditional Chinese Medicine (TCM), ,
Traditional Herbal Medicine Products (THMPD), European Directive on,
traditional medicine
economics of clinical guidelines for,
history and evolution of,
integration and regulation as subordination,
research regulation of,
uncertainty of knowledges and practices and,
tragedy of the anticommons, 141
transnational dynamics, human germline research and, 353
transparency
in benefit sharing,
in collaborative research,
data across governance and, , 192
informed consent and,
proportionality and, 43
public engagement and,
Trudeau, Justin, ,
Trump, Donald,
trust
automated health regulation and,
in data sharing collaborations,
global health emergencies and building of,
in global health research,
in institutions,
Learning Health Research Regulation System and,
participatory governance and,
risk-benefit analysis and,
trustworthiness and, , ,
trustworthiness, public expertise and, ,
Trustworthy Institutions in Global Health Research Collaborations,
Turner, Victor, 278
Tuskegee syphilis study, 28,
UK Biobank,
uncertainty
governance and,
in neuroscience research,
traditional and non-conventional medicines and,
UN Declaration on Human Cloning,
Understanding Patient Data and National Health Service England report, ,
undue inducement, benefit sharing and,
unitary theory, public interest and, 240
United Kingdom
data protection law in,
duty of confidence and privacy protection in,
evidence-informed health policy in,
interspecies biomedical research regulations in,
medical device regulation in,
research process simplification and harmonisation and,
United States
patient and public involvement in health research in, , 126
third-party risk protocols in,
Universal Declaration of Human Rights,
Universal Declaration on Bioethics and Human Rights (UNESCO), 152
Universal Declaration on the Human Genome and Human Rights (UNESCO),
universality, of vulnerability, 19
upper limit on permissible risk, risk-benefit analysis guidelines, 137
vaginal mesh
expectations and failure involving,
gender marginalisation of harm from,
validity in health research
disclosure of findings criteria and, 231,
external vs. internal validity, 133
values
automated health regulation and,
commonly-held value, public interest and,
disclosure of research findings based on, 231,
learning healthcare systems and,
patent regulation and,
social value and, ,
Valverde, Mariana,
van Delden, Johannes JM, 14,
van der Graaf, Rieke, 14,
van Lente, H.,
virtuous action, global health emergencies and,
voluntariness
disclosure of research findings criteria based on, 231,
informed consent and,
of trust,
vulnerability
ambiguity in HRR and,
benefit sharing and,
definition and analysis of, ,
global health emergency guidelines and,
of groups,
health research regulation and, 13
individuals’ vulnerability,
interspecies biomedical research and realignment of,
labelling approaches to research on,
layers of, 396,
politics of health research and,
power and,
in rare disease research, 62
relational autonomy and,
in research ethics guidelines,
risk assessment and,
taxonomy, 24
trust and,
universal capacity and,
Wainwright, Steven, 313
Waldby, Catherine,
Warnock Committee of Inquiry into Human Fertilisation and Embryology, report by,
Warren, Mark,
Weijer, Charles, , 96
welfare state, enforceability of solidarity and,
Wellcome Trust
on benefit sharing, 151
Blueprint for Dynamic Oversight of Emerging Science and Technologies,
public interest and,
Understanding Patient Data initiative,
Wendler, D.,
Wenner, Danielle,
Wertheimer, A., 52
Western Herbalism,
Whitton, Tess,
WHO Guidance for Managing Ethical Issues in Infectious Disease Outbreaks,
Wiersma, Miriam,
Wilcox, D.,
Willis, R.,
Wilsdon, J.,
Working Group on Disaster Research Ethics (WGDRE),
World Health Organization (WHO)
bioethics advisory committees and, 221
CIOMS collaboration with, ,
global health emergency guidelines and,
Good Clinical Practice, 152
health practices guidelines,
health systems framework,
traditional medicine and,
World Medical Association (WMA),
Wright, E. O., ,
written assessments, risk-benefit analysis and,
Wynne, B.,
Yishai, Y., 125
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