Academy of Nutrition and Dietetics
, 7
Accountability
, 25, 66, 71, 80, 88, 104, 108
Advanced consent
, 158, 161, 163
Advanced Therapy Medicinal Products
, 107, 112n12
Allocational vulnerability
, 156
Alzheimer’s Association
, 160
American Chemical Society
, 95
American Society for Parenteral and Enteral Nutrition
, 7
Animal research
, 2–3, 8n4, 24, 29n15
Animal welfare
, 2, 14, 116
Anonymized data/anonymization
, 45, 47, 48, 55–58, 68, 69, 74, 78, 79
Antiepileptic drug (AEDs)
, 75–76, 77
Arms Trade Treaty (2014)
, 139
Association for Responsible Research and Innovation in Genome Editing (ARRIGE)
, 6, 115–125
Association of Internet Researchers Ethics Working Committee
, 58
Australia
, 123, 186
diet therapy
, 174
drug therapy model
, 189
Autonomy
, 24, 29n14, 66, 68–70, 78, 79, 102, 103, 110, 162
and capacity to consent
, 153
ethical principle of
, 149–153
and informed consent
, 150–153
Beauchamp & Childress
, 24, 29n14, 149
Benefit, as criteria for research
, 72
Berkelely University
, 119
Bias
, 45, 47, 54, 67, 77, 120, 149, 195
Big Data
, 45–47, 49–54
bias and representativeness of research
, 54
claims against data sharing
, 75
core values, attachment of
, 67–75
data use, reuse, and misuse
, 50–53
defined
, 64–66
in genetic data
, 77–79
in healthcare and life sciences
, 63–80
for health professionals and researchers
, 64–66
in health research
, 77
online recruitment
, 53
in public health
, 76–77
research ethics in digital era
, 54–56, 58
use in life sciences
, 5
Bill & Melinda Gates Foundation (BMGF)
, 16
Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium (BBMRI-ERIC)
, 60n20, 65
Code of Conduct for Health Research
, 58
Bioethics
, 14, 58, 69, 80, 155
Bioinformatics
, 63, 65, 76
Biologic, Toxin and Weapons Convention (BTWC)
, 139
Biosafety
, 87, 88, 90, 93, 118
Biosafety Level 3 (BSL 3)
, 90
Biosafety Level 4 (BSL 4)
, 90
Biotechnology and Biological Sciences Research Council (BBSRC)
, 3
Body mass index (BMI)
, 169, 178–179
Broad consent
, 48, 49, 69–71, 79, 80
Business Insider
, 187–188
Canadian Animal Care Committee
, 3
Capacity to consent
autonomy and
, 153
informed consent in persons without
, 159–162
CBRN Security Culture
, 95
Center for Infectious Diseases Research and Policy (CIDRAP)
, 36
Centers for Disease Control & Prevention (CDC)
, 35, 36, 39
Cervical cancer screening, in India
, 15–16
Charpentier, Emmanuelle
, 119
Charter of Fundamental Rights of the European Union
, 47, 59n3
art. 1 (rights to human dignity)
, 47
art. 7 (respect of private and family life)
, 47
art. 8 (data protection)
, 47
art. 13 (right to freedom of arts and sciences)
, 47
art. 21 (non-discrimination)
, 47
Chemical Weapons Convention (CWC)
, 139
China
genome editing
, 117, 123
international collaborative genetic research project
, 16–17
Kadoorie Biobank
, 65
Chinese Academy of Sciences
, 111n5
Civil security
, 90, 91, 100
Clinical dementia research
, 7, 147–164
ethical challenges and issues in
, 158–159
informed consent in persons without capacity to consent
, 159–162
ethical framework and decision-making in
autonomy
, 149–153
decision-making capacity and competence
, 153–155
vulnerability
, 155–157
ethical questions
, 162–163
recommendations for
, 163–164
Clinical Trials Regulation
, 103
Cognitive vulnerability
, 156
College of Commissioners
, 101
Commission for the Study of Ethical Problems in Medicine & Biomedical and Behavioral Research
, 79
Competence
, 100, 103, 104, 150, 153–155, 162
“Complete Khoisan and Bantu Genomes from southern Africa”
, 17
Convention for the Protection of Human Rights
, 59n2
Article
, 13, 122
Coronary Health and Improvement Program
, 194
Council of Europe (CoE)
, 57, 60n17, 111n6
Convention for the Protection of Human Rights and Fundamental Freedoms
, 59n2
Council of State, France
, 106, 121
Court of Justice of the European Union
, 106, 121
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeat) array
, 106, 107, 115–122, 124
CRISPR-Cas9 system
, 90, 99, 100, 102–108, 117, 120, 122, 139
Cultural sensitivity
, 23
peer educators for sex workers
, 22
safety and ethics
, 86–87
Culture of safety and security, shaping
, 85–95
added value of
, 94
current and future direction of
, 93–84
ethics review to safety governance in emerging technologies, using
, 89–90
ethics review to security governance in emerging technologies, using
, 92–93
Framework Program
, 9, 94–95
safety governance
, 87–89
security and ethics
, 90–91
security governance
, 91
DASH (Dietary Approaches to Stop Hypertension) Diet
, 172, 173, 176–178
Data
anonymized/anonymization
, 45, 47, 48, 55–58, 68, 69, 74, 78, 79
bias in
, 45, 47, 54, 67, 77, 120, 149, 195
Big Data. See Big Data
donors, data sharing risks for
, 75
ethics approach toward
, 56–59
extraction
, 64
minimization
, 48, 49, 59, 75
misuse
, 45, 50–53, 57, 58, 67, 80
ownership
, 13, 66–67, 76, 77, 79
producers, costs and burdens for
, 75
quality
, 49, 67, 68, 76
reuse
, 50–53
science
, 46, 49, 54, 58, 59
security
, 48, 55
storage
, 66–67
use
, 50–53
Data protection
, 4, 5, 45–51, 54–57, 60n8, 67, 68, 80
regulation of
, 47–49
right to
, 54, 59n4
Data Protection Directive 95/46/EC
, 5, 56
Data Protection Working Party
Article
, 29, 48, 49, 59n6, 60n7, 60n8
Data sharing
, 46, 47, 58, 66–67, 71, 72, 74, 76, 77, 80
claims against
, 75
Decision-making capacity
, 7, 147, 149–155, 157, 158, 160
myths of
, 155
Declaration of Helsinki
, 132
Article
, 21, 25
Defense Advanced Research Projects Agency (DARPA)
, 135
Deferential vulnerability
, 156
De-identification. See Anonymized data/anonymization
Deliberate Release Directive
, 104
Department of Health and Human Services
, 16
Devinsky Antiepileptic Drug Study
, 77
Dietary Approaches to Stop Hypertension (DASH). See DASH (Dietary Approaches to Stop Hypertension) Diet
Diet therapy
, 7, 169–181
complexity of
, 178–181
defined
, 170–171
and science
, 175–177
simplicity of
, 178–181
Digital era, ethical challenges in
, 5, 45–60, 70
Big Data
, 49–54
privacy and data protection safeguards
, 47–49
research ethics
, 54–59
Directive 90/220/EEC
, 111n8
Directive 90/385/EEC
, 112n10
Directive 98/44/EC
, 112n12
Directive 2001/18/EC
, 106, 111n1, 111n8, 111n9, 121
Article 2(2)
, 105
Article
, 3, 105
Directive 2001/20/EC
, 59n5, 86, 111n7
Directive 2001/83/EC
, 111n10
Direct-to-consumer (DTC)
products
, 133
testing
, 78
Distributive justice
, 72–74
Do-It-Yourself (DIY) movement
, 121, 133–134, 139
Doudna, Jennifer
, 116, 119
DowDuPont Pioneer
, 117, 125n3
Drug therapy model, for nutrition mismatch
, 187–190
Dual use
, 6, 92, 103, 108, 109, 112n17
definitions of
, 130–132
in neuroscientific and neurotechnological research
, 129–142
do-it-yourself/neurobiohacking
, 133–134
ethical address and guidance
, 139–141
extant treaties and regulations
, 138–139
military/warfare
, 134–138
viability of
, 130
Dual Use Research of Concern (DURC)
, 130–132, 134, 138–140
in neuroscience and neurotechnology
, 132–133
Dynamic consent
, 70
advantages of
, 70–71
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG)
, 189
Ebola hemorrhagic fever. See Ebola virus disease (EVD)
Ebola virus disease (EVD)
, 46
background of
, 35–36
care in resource-limited settings
, 5, 18, 33–42, 36–38
epidemic, ethical considerations associated with
, 42
healthcare workers, fear and stigmatization of
, 38–39
repatriation of international workers, from EVD-affected countries
, 39–41
EFSA Panel on GMOs
, 101, 111n3
Electronic health records
, 64, 66
Equality
gene editing
, 102, 110
Equity
, 66, 72, 73, 103, 108, 110
promotion, in international research
, 11–29
Ethics
approach toward data
, 56–59
bioethics
, 14, 58, 69, 80, 155
codes, for life sciences
, 4
dumping. See Ethics dumping
governance
, 15
in situ
, 6–8
neuroethics
, 135, 141
research
, 54–59
review. See Ethics review
safety and
, 86–87
security and
, 90–91
Ethics dumping
, 11–18, 23, 26, 27, 28n1, 90
case studies
, 14–18
China, international collaborative genetic research project in
, 16–17
India, cervical cancer screening in
, 15–16
In life sciences
, 4–5
retrospective approval for study in Liberia, seeking
, 18
San people-involved international genomics research
, 17
tools
, 13
Ethics review
, 4, 6, 23, 55, 56, 58, 85
to safety governance in emerging technologies, using
, 89–90
to security governance in emerging technologies, using
, 92–93
EU Law, gene editing governance in
, 103–105
Eurobarometer survey
, 2, 47
European Academies Science Advisory Council (EASAC)
, 101
European Commission (EC)
, 4, 12, 60n8, 60n15, 90, 131
General Data Protection Regulation (GDPR) 2016/679
, 5
Horizon 2020 Ethics Appraisal Procedure
, 86, 89, 92–93, 102, 104
Joint Research Centre
, 101
Scientific Committees
, 101–102
Society Unit
, 28n1
European Commission Report
, 131
European Convention of Human Rights
, 47
European Group on Ethics (EGE)
, 103, 104
European Medicines Agency (EMA)
, 106, 132
European Research Area (ERA)
, 5
European Steering Committee
, 6, 123
European Union (EU)
, 2, 3, 6, 12, 47, 60n15, 88, 90
Charter of Fundamental Rights
, 47
gene editing governance
, 99–112
Exploitation prevention, in international research
, 11–29
Exploratory analysis of data
, 64
Gene drive
, 99, 101, 102, 107–109, 118, 119, 124
Gene editing
, 6, 90, 93, 139
advances of
, 116
developments, marketable products derived from
, 119–120
extended applications of
, 118–119
governance, in EU
, 99–112
ethical challenges to
, 102–104
EU-wide regulatory intervention, need for
, 109–111
gene drive
, 107–109
regulatory questions and legal status of
, 104–107
responsible use of
, 115–125
risks and regulation of
, 121–122
General Data Protection Regulation (GDPR) 2016/679
, 5, 46–49, 53, 56–57
art. 4.11
, 48
art. 7.3
, 50
art. 14.5 (b)
, 49
art. 31 (1)
, 57
art. 35 (1)
, 57
art.
, 89, 49, 55
art. 3.1ii
, 60n17
broad consent
, 48
Genetically modified organisms (GMOs)
, 87, 100, 101, 104–106, 109, 111n1
Genetic data, Bid Data in
, 77–79
Genetic discrimination
, 78, 79, 80n1
Genetic exceptionalism
, 79, 80
Genetic Information Non Discrimination Act (GINA)
, 78
Genome-wide association studies (GWAS)
, 67
German Ethics Council
, 103
Germany
dual use in neuroscientific and neurotechnological research
, 141
ethical review to safety governance
, 90
repatriation of international workers
, 40
Global Alliance for Genomics and Health (GA4GH) for
, 65
Global Code of Conduct for Research in Resource-Poor Settings
, 5
Article
, 1, 27
developing
, 26–28
ethics dumping
, 27
Exploitation Risk Table
, 27
Harvard Catalyst Regulatory Foundations
social media research, peculiarities of
, 57
Healthcare, Big Data in
, 63–80
Healthcare Risk Management
, 40
Healthcare workers (HCWs)
, 15, 37
Ebola transmission, fear and stigmatization of
, 33–34, 38–39, 41, 42
Health research
, 15, 46, 58, 63, 64, 66, 76
Big Data in
, 77
High-income countries (HICs)
, 12, 13, 17, 28
High Level Group of the Commission’s Scientific Advice Mechanism (SAM)
, 55, 57, 101
Honesty
, 24–26, 74–75
intellectual
, 74
radical
, 74
Horizon 2020 Ethics Appraisal Procedure
, 12, 28, 28n2, 59, 60n21, 86, 89, 92–93, 102, 104
House of Commons Science & Technology Committee
, 51
Human Fertilisation and Embryology Authority (HFEA)
, 117
Human Heredity and Health in Africa (H3Africa)
, 65
Human–machine interactive networks
, 136
Human rights
, 25, 46, 51, 56, 59, 86, 90, 92
IBM X-Force Research (2017)
, 53
India
, 123
cervical cancer screening in
, 15–16
ethics dumping
, 15
Information disclosure
, 151–152
Informed consent (IC)
, 7, 13, 14, 16, 17, 23, 26, 51, 52, 76, 78–80, 132
autonomy and
, 150–153
basic elements of
, 150–151
clinical dementia research
, 147, 149, 158, 159, 163
decision-making capacity
, 154
peer educators for sex workers
, 21–22
in persons without capacity to consent
, 159–162
advanced consent
, 161
proxy consent
, 160–161
supported decision-making
, 161–162
respect for
, 68–71
vulnerability
, 156, 157
INSERM (the French National Institute for Health and Medical Research) Ethics Committee (IEC)
, 123
Institute of Electrical and Electronics Engineers (IEEE)
Model Process for Addressing Ethical Concerns during System Design
, 58–59
Institute of Medicine
, 71
Institutional Review Boards (IRBs)
, 18, 132, 159
Intelligence Advanced Research Projects Activity (IARPA)
, 135
Intensified data sourcing
, 64
International Agency for Research on Cancer (IARC)
, 16
International Association of Gerontology and Geriatrics (IAGG)
, 148
International Atomic Energy Agency (IAEA)
, 94, 95
International Declaration on Human Genetic Data (IDHGD)
, 79
International Ebola Response Team
, 38
International justice
, 28
International research, equity promotion and exploitation prevention in
, 11–29
ethics dumping
, 13–18
Global Code of Conduct for Research in Resource-Poor Settings, developing
, 26–28
TRUST’s global engagement activities
, 18–24
Internet. See Digital era, ethical challenges in
Interventional research
, 71
In vitro fertilization (IVF)
, 117
Irish Council for Bioethics
, 55–56
National Academy of Medicine
, 111n5
National Academy of Sciences (NAS)
, 100, 111n5, 197
National Action Plan on Breast Cancer (NAPBC)
Working Group
, 79
National Institutes of Health (NIH, USA)
, 16, 55, 171, 179, 186
Office of Science Policy (OSP)
, 130–131
National Research Council of the United States Academy of Sciences (NRC)
, 134, 135
National security
, 90–92, 131, 135, 140
Netherlands, the
ethical review to security governance
, 93
ethical review to safety governance
, 90
gene editing
, 106, 121
repatriation of international workers
, 39, 40–41
Neural systems modeling
, 136
Neurobiohacking
, 133–134, 140
Neuroscientific research, dual use in
, 129–142
military/warfare. See Military/warfare dual-use applications, of neuroscientific and neurotechnological research
Neurotechnological research, dual use in
, 129–142
military/warfare. See Military/warfare dual-use applications, of neuroscientific and neurotechnological research
Neurotechnologies Industry Report
, 134
New Breeding Techniques (NBT)
, 101, 110, 121
New Zealand
“Predator-free 2050” plan
, 119
War on Rats
, 125n7
Next-generation sequencing technologies
, 67, 78
Non-discrimination
, 47, 56, 57, 59, 110
Non-Human Primates (NHP)
, 3
Non-invasive brain stimulation (NIBS)
, 131
Non-maleficence
, 24, 102, 130
Nuffield Council on Bioethics
, 103
Nuffield Council Report
, 134
Nutrition mismatch, medical practice for
, 185–198
drug therapy model
, 187–190
nutrition therapy model
, 190–195
public intervention model
, 195–198
Nutrition therapy model
, 190–195
Partners for Health and Development in Africa (PHDA)
, 18
Sex Workers Outreach Programme
, 21
Personalized medicine
, 190
Pew Charitable Trusts
, 188
Precautionary Principle
, 88–89, 90, 100, 122
Precision medicine
, 65, 68, 190
Precision Medicine Initiative
, 65
President’s Commission on Bioethics Report
, 79
Principles of Humane Experimental Technique, The (Russell and Burch)
, 3
Privacy
, 2, 5, 45, 47–57, 59, 64, 66–69, 71, 75, 76, 78–80, 110, 149, 158
genetic
, 78
losses
, 72
right to
, 56
Psychological operations (PSYOPS)
, 137
Public data
, 47, 51–52, 57–59
Public health, Big Data in
, 76–77
Public health-oriented ethics
, 69
Public intervention model, for nutrition mismatch
, 195–198
Regulation on Medical Devices
, 103
Repatriation of international workers, from EVD-affected countries
, 39–41
Research and development (R&D)
, 2, 187–188
Research and innovation (R&I)
, 2
Research ethics, in digital era
, 54–59
Research Ethics Committees (REC)
, 58, 89, 90, 93, 132, 159
Research integrity
, 2, 26, 75
Research production process, in life sciences
, 1–2
Resilience
, 74, 75, 136–137
Resource-limited countries, EVD care in
, 36–38
Respect for autonomy
, 149
Respect for informed consent
, 68–71
Respect for persons
, 68–71, 150, 162
Respect of private and family life
, 47
Responsible Research and Innovation (RRI)
, 86, 94
Restoring Active Memory (RAM)
, 135
Right to data protection
, 59n4
Right to freedom of arts and sciences
, 47
Right to human dignity
, 47
Risk assessment
, 87, 89, 101, 102, 107–109, 141
Risk of harm
, 68, 153, 157
Riyadh Intensive Care Program Mortality Prediction Algorithm
, 77
Royal Society Working Group on Neuroscience
, 111n5, 141
Safety, and ethics
, 86–87
Safety culture, defined
, 94
Safety governance
, 87–89, 93
in emerging technologies, ethics review to
, 89–90
San Code of Research Ethics
, 21, 24
San Diego-based biotech Human Longevity
, 65
San, the
, 18
people, international genomics research using
, 17
Research and Media Contract
, 21
sex workers, peer educators for
, 19, 21–22
Scientific Committee on Consumer Safety (SCCS)
, 102, 111n4
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)
, 102, 111n4
Scientific Committee on Health and Environmental Risks (SCHER)
, 102, 111n4
Second International Conference on Nutrition (ICN2)
, 7
Security
, 2, 6, 48, 53, 55, 57, 67, 68, 85–95, 132–134, 139
civil
, 90, 91, 100
communities
, 109
and ethics
, 90–91
human
, 91, 92
national
, 90–92, 131, 135, 140
Security governance
, 85, 86, 90, 91
in emerging technologies, ethics review to
, 92–93
Sex workers
, 18
in LMICs
, 28n9
in San, peer educators for
, 19, 21–22
Sex Workers Outreach Programme
, 21
Situational vulnerability
, 156
Social vulnerability
, 156
Solidarity
, 39, 66, 73–74, 110
South African San Institute (SASI)
, 18
Spain
repatriation of international workers
, 39, 40
Stakeholder engagement
, 19
Supported decision-making
, 158, 161–162
Sustainability
, 25, 72–73, 108
Sweden
gene editing
, 106, 121
Systems medicine
, 63, 65, 76
Therapeutic Lifestyle Changes (TLC) Diet
, 172, 173
Transcription Activator-Like Effector Nucleases (TALENs)
, 106, 116
Transparency
, 26, 49, 60n7, 66, 71–73, 76, 101, 110, 123
Treaty on the Functioning of the European Union
Article 16.1
, 59n4
Trust
, 22, 50, 57, 58, 68, 70–72, 77, 80, 99, 110, 111, 138, 180
TRUST project
, 4, 5, 11–29
care
, 25
fairness
, 24–25
global engagement activities
Kenyan Research Ethics Committee perspective
, 23
meeting of many minds
, 24
sex workers in San, peer educators for
, 19, 21–22
honesty
, 25–26
respect
, 25
timeline of
, 20
Tufts Center for the Study of Drug Development
, 187
Uncertainty, in safety governance
, 88
UNESCO
, 103, 104, 110
International Declaration on Human Genetic Data (IDHGD)
, 79
United Kingdom (UK)
Genomics England
, 65
Human Fertilisation and Embryology Authority (HFEA)
, 117
Royal Society
, 111n5
United Nations (UN)
Leadership Council of the Sustainable Development Solutions Network
, 28
Security Council Resolution 1540
, 139
United States (US, USA)
Department of Agriculture (USDA)
, 117, 121, 125n11, 196
Department of Health and Human Services
, 16
drug therapy model
, 188, 189
Federal Bureau of Investigation)
, 134
Food and Drugs Administration (FDA)
, 187
gene editing developments, marketable products derived from
, 119
Genetic Information Non Discrimination Act (GINA)
, 78
National Academy of Medicine
, 111n5
National Academy of Sciences (NAS)
, 100, 111n5, 197
National Institutes of Health (NIH)
, 16, 55, 171, 179, 186
Precision Medicine Initiative
, 65
repatriation of international workers
, 40
safety governance in
, 88
United States’ National Research Council
, 141
US Patent and Trademark Office (USPTO)
, 107