Index
A
discussed during consent procedure, 15, 193, 194
Abuses by researchers, see Unethical treatment
Access to research
policy development, 2, 36, 37, 42-43, 69
registry information, 3, 4, 69, 70
Accountability for policy implementation, 19, 203, 205
Acquired immune deficiency syndrome, see AIDS
Adenosis, 238
Adipose tissue, 86
Adverse reactions, 16, 89, 131, 140, 189
liability issues, 12, 150, 165-167
see also Prenatal and preconceptual injury
Advocacy and activism, 1, 2, 37, 42-43, 69, 121, 192
African Americans, 117
research abuses of, 38, 39, 76, 118, 121
see also Tuskegee Syphilis Study
Age and age groups, 5, 23, 77, 82, 83, 99, 119-120, 209
database information on, 4, 24, 70
see also Aging and the elderly;
Menopause and postmenopausal women;
Reproductive and childbearing potential
Aging and the elderly, 89-90, 120, 185
research abuses and inequity, 38, 44, 54, 66, 220
see also Menopause and postmenopausal women
AIDS, 37, 54, 56, 59, 143, 220-221, 223-224, 228-229
activism and advocacy, 2, 31, 37, 42-43
inequity in studies of, 3, 49, 55, 56, 66, 78, 80-81, 112, 222, 223
Alaskan natives, 116, 117, 118
Alcohol, Drug Abuse, and Mental Health Administration, 43, 70n
Alzheimer's disease, 90
American Indians, 116, 117, 118
American Lung Association, 131
Animal studies, 14, 31, 34, 175, 176, 177, 182, 184
Anorexia nervosa, 91
Antihypertensive drugs, 89, 188
Anxiety disorders, 90
Arthritis, 89
Asian populations, 116, 117, 119, 123
Aspirin, 86
B
Background incidence, 14, 175, 178-179
Baltimore Longitudinal Study of Aging, 44
in DES liability cases, 240, 241
Behavioral differences, 6, 90-91
Belmont Report, 4, 42, 75-76, 77
Benchmark dose, 182
Benign classifications, 149-150
Benzodiazepines, 86
Bias, see Gender bias; Male bias;Social influences and biases
Birth control, see Contraception and contraceptive measures
Birth defects, see Prenatal and preconceptual injury
Body size and composition, 85, 86, 87
and pregnancy, 92-93
Breast cancer, 44, 91, 121, 238
Breastfeeding, see Lactation and nursing
Bulimia, 91
C
inequity in studies of, 52, 63, 218, 232
research abuse, 38-39
Cardiovascular disease, see Heart disease
Causation, see Proof of causation
Cervical abnormalities, 238
Childbearing, see Pregnancy; Prenatal and preconceptual injury;Reproductive and childbearing potential
Children, see Prenatal and preconceptual injury
Chorion villi sampling, 200-201n
Clear-cell adenocarcinoma (CCA), 41, 178, 238, 239
Cleft lip, 190
Clinical studies, defined, 29, 95
Clinical trials, 29, 31, 34-35, 51-62 passim, 67, 95-96, 216-231 passim
alternatives to, 7-8, 101-103, 135, 211
DES, 237
design and methodology, 6, 96-101, 135-137
detection of adverse effects, 16, 189
and reproductive and developmental risks, 14-15, 175
see also Registries of clinical studies
Compensation for injury, 14, 76, 169, 243-251
international guidelines, 246
medical malpractice, 167, 248-250
national system proposals, 244-248
to offspring, 13-14, 160-161, 169, 247
under tort system, 154, 156, 243, 247-248
Conceptualization, 8, 9, 20, 114, 115-117, 123, 124, 207, 208, 211
Confounding effects, 20, 21, 80, 207
Conscience exemptions, 18, 199
Consent, see Informed consent
Constitutional issues, 12, 143-150
decisional privacy, 12, 143-146
equal protection clause, 12, 146-150
Contraception and contraceptive measures, 14, 15, 67, 175, 176, 181, 185-187, 193-194, 247
hormonal, 5-6, 93-94, 118-119, 182, 185, 186
Controlled trials, 96
Cooperative agreement applications, 130
DES studies, 239
Coronary Drug Project (CDP), 65
Coronary heart disease (CHD), 64-66
Costs and funding of research, 37
exclusion and recruitment issues, 2, 81-82, 100, 109, 119, 135
and injury compensation, 239, 246-247
institutional structure, 11, 129-131
and policy application, 11, 122, 129-131
registry role in controlling, 4, 69
representative sampling impacts, 23, 7, 23, 24, 104, 122, 125, 204, 210, 211
scientific advisory council role, 23, 209-210
Council for International Organizations of Medical Sciences (CIOMS)
injury compensation guidelines, 246
Craniometry, 112
Crossover trials, 96
D
Data collection and databases, 8, 9, 19, 23, 102, 116-117, 123, 211
birth defects, 189
policy implementation role, 19, 23, 68, 205, 206, 207
on study population composition, 3, 21, 24, 45, 46-47, 49, 209
see also Registries of clinical studies
Decisional privacy, 12, 143-146
Declaration of Helsinki
Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, 38
Department of Energy, 142
Department of Health and Human Services (DHHS)
and injury compensation, 243, 245
regulations on pregnant women as research subjects, 16, 18-19, 141-142, 194-195, 200
see also Department of Health, Education, and Welfare;
Food and Drug Administration;
National Institutes of Health;
Public Health Service
Department of Health, Education, and Welfare (HEW), 39-40, 244-245, 251n
Department of the Army, 142
Department of Veterans Affairs, 142
Depression, 90
DES, 40, 41, 68, 159, 178, 237-241
development of, 237-238
legal actions, 41, 160, 238-241
Design of studies, 6, 14-15, 96-101, 135-137
cultural and bias issues, 8, 9, 10, 109, 123-124, 125
liability issues, 166
use of social science research in, 9, 10, 20-21, 115, 207
Developing countries, recruitment in, 78
Developmental toxicants, 14, 15, 176
risk assessment, 14, 175, 176-185
Dibromochloropropane, 179
Diethylstilbestrol, see DES
Dieting, 91
Distributive justice, 76-79, 80, 81
Domestic violence, 90
Dose-response information, 182
Drug development, 11, 30-35, 42, 132
Duplication of research, 4, 69
E
Eating disorders, 91
Economic background, see Poor population; Socioeconomic status
Ectopic pregnancy, 238
Education, see Training and education
Elderly persons, see Aging and the elderly
Eli Lilly, 239-241
Endogenous hormones, 91-92
Eniwetok, 119
Epidemiological studies, 102
Epigenetic damage, 181
Estrogen replacement, see Hormone replacement therapy Ethical issues and boundaries, 4, 8, 9, 10, 42, 75, 130
Ethnic groups, see Race and ethnicity
Excessive inducement, 10, 82, 122, 125
Exclusion from studies, 30, 53, 77, 219
constitutional issues, 12, 143-150
justifications for, 2, 6, 17-18, 36, 45, 98-100, 103, 134, 197-200, 209
liability issues, 12, 13, 29, 150, 165-167
of pregnant women, 16-19, 197-200
Expenditures, see Costs and funding of research
Exploitation, see Unethical treatment
Exposure definition, 178
External validity, 96-97
F
False universalism, 114
Federal Employee's Compensation Act (FECA), 245, 251n
Federal Employees Liability Reform and Tort Compensation Act, 157
Federal Government, see Costs and funding of research;Department of Health and Human Services; Legislation and statutes;National Institutes of Health; Public policy; Regulations
Federal Tort Claims Act (FTCA), 157-158, 243
Fetal death, 238
Fetoscopy, 200-201n
Fixed sample size designs, 96
Florida, no-fault compensation scheme, 249
Fluoxetine, 184
Food, Drug, and Cosmetic Act (FDCA), 131
Food and Drug Administration (FDA), 27, 37, 41, 131, 203
drug approval process, 34-35, 40, 42, 45-46, 48, 137-141, 158
early trial phase participation guidelines, 60, 67, 139-140, 192-193, 229
and exclusion on reproductive basis, 41, 45, 60, 67, 137-139, 141, 147, 149
legal actions against, 151, 157-158
policy consistency and congruence, 11, 167-168
and registration of privately funded studies, 4, 70
Fourteenth Amendment issues, 12, 143-150
Funding, see Costs and funding of research
G
Gender analyses, 3, 7, 20, 21, 30, 46, 101, 104, 114, 136, 207
Gender bias, 8-9, 37, 65-66, 110-114, 123-124
in heart disease studies, 3, 43, 44, 46, 49, 54, 64-66, 220
studies of, 50-51, 54, 124, 215-217, 220
Gender differences, 28-29, 84-86, 111-112
absence in most situations, 5, 6-7, 85-86, 103-104
alternative assessment methods, 7-8, 24-25, 101-103, 211
inadequacy of analysis, 3, 5, 46, 49, 54-55, 221
physiological, 5-6, 86-90, 111, 113
psychosocial, 6, 90-91, 111-112
studies and database, 7, 19, 20, 23, 207, 210
Gender-specific conditions
adequacy of investigation, 27, 30, 36-37, 78
and AIDS, 66
as basis for study exclusion, 6, 103, 134
drug development for, 52, 218-219
General Accounting Office (GAO), 2, 43, 44, 45-46, 47-48
Generalization and extrapolation, 28, 29, 113-114, 217
assurance of appropriateness, 5, 9, 83, 96-97
and racial and ethnic groups, 117, 124
Genetic damage, paternal, 181
Genital abnormalities, in DES children, 238-239
Gout, 89
Grant applications, 4, 24, 45, 69, 130, 133-134, 210
Guidelines, 2, 11, 19, 38, 39, 41, 108, 204
of FDA, on clinical trial inclusion, 67, 139-141, 192-193
of FDA, on early trial phase exclusion, 41, 60, 67, 137-140, 141, 229
for grant applications, 24, 45, 133-134, 210
see also Regulations
H
Health care benefits, see Insurance reimbursement
Heart disease, 3, 43, 44, 46, 49, 54, 64-66, 113, 220
Heparin, 86
HEW, see Department of Health, Education, and Welfare
HHS, see Department of Health and Human Services
Homogeneity, 6, 97-98, 104, 120
Hormonal contraceptives, 5-6, 93-94, 118-119, 182, 185, 186
Hormonal differences, 5, 80, 88, 91-92
see also Menstrual cycle
Hormone replacement therapy, 5-6, 94-95
for heart disease prevention, 64
Human immunodeficiency virus (HIV), 31, 66, 78, 80-81, 112, 143
Hydantoin, 177
I
Immigrants, 123
Implementation issues, 19-25, 29, 203-205
recommendations, 20-25, 206-207
Indian Health Service, 118
in DES children, 238
cultural issues, 10, 20-21, 109, 118-119, 122-123, 125, 207
in DES liability cases, 240-241
and injury compensation, 243, 244, 245
liability issues, 13, 153, 155-157
paternal, 17, 142, 164-165, 193, 197
of pregnant women, 17, 142, 162-164, 193, 195, 196-197
and prenatal injury, 13, 15, 17, 161, 162-165, 247
of reproductive risks, 14, 15, 175, 176, 182, 184-185, 192, 193, 200-201n
Initial review groups (IRGs)
and assessment of gender differences, 8, 24, 105, 129-130, 211
member recruitment and training, 22, 209
monitoring of policy implementation, 22, 205, 208-209
training in recruitment and retention issues, 10, 125
Injury, see Adverse reactions; Prenatal and preconceptual injury
Institutional Review Boards (IRBs), 1, 39, 40, 70, 130-131, 205
and conscience exemption, 18, 199
consent procedures, 10, 15, 17, 40, 158-159, 192, 193, 194
and exclusion on reproductive basis, 15, 17-18, 193, 194
investigator education and training, 11-12, 21, 168, 208
liability issues, 158-159
and pregnant women's participation, 17-18, 41, 142, 194, 195, 198-199, 200
risk-benefit assessment, 191-192
and study design, 9, 10, 21, 176, 207, 208
and study population composition, 21, 207, 208
Insurance reimbursement
and clinical studies registry, 4, 70
for research-related injury, 14, 168, 244, 247
Internal validity, 97
International Clearinghouse for Birth
Defects Monitoring, 189
Investigators
concerns of conscience, 18, 199
training and education of, 10, 11-12, 125, 168
women as, 9, 111, 112, 124, 136
In vitro analysis, 14, 31, 175, 177, 184
Isotretinoin, 179
J
Jewish Chronic Disease Hospital, 38-39
Justice in clinical research, 2, 42, 75, 121
distributive paradigm, 76-79, 80, 81
guiding principles, 4-5, 28, 82-83
limitations to, 81-82
and national research agenda, 5, 22-23, 77, 78, 81, 82, 204, 209
oppression and power, 79-81
K
Kefauver-Harris amendments, 40
L
Lactation and nursing
participation and consent issues, 15, 79, 138, 187, 194
Language of participants, 10, 123, 125
Legal issues, 11-12, 29, 128-169
constitutional, 12, 128, 143-150
federal policies, 11-12, 132-142
institutional structure, 11, 129-131
see also Liability issues
Legislation and statutes, 2, 4, 7, 11, 27, 44, 132-133
drug approval process, 40
justice and inclusion issues, 24, 203, 211
recourse for injury under, 157-158, 243, 245, 250
see also National Institutes of Health Revitalization Act
Liability issues, 12-14, 128-129, 150-167, 168-169
compensation, 154, 156, 243, 247-248
DES legal actions, 41, 160, 238-241
pharmaceutical companies, 13, 150, 151-152, 154-155, 165-167, 168, 170n, 239-241, 244, 246
prenatal injury, 12-13, 29, 128-129, 159-165, 171n
of study exclusion, 12, 13, 29, 150, 165-167
Lipid Research Clinic, 65
Literature reviews, 20, 23-24, 50-63, 207, 210, 215-232
Lithium, 89
M
Magnesium sulfate, 188
Male norm, 8-9, 80, 110, 113-114
Mania, 90
Maternity, see Pregnancy; Prenatal and preconceptual injury
Men
DES injuries of, 238
and justice in research, 5, 23, 77, 78, 80, 82
reproductive risks to, 12, 14-15, 138, 162, 175, 178, 179, 181, 182, 193
see also Male bias;
Male norm;
terms beginning with Gender
Menopause and postmenopausal women, 5-6, 94-95
disease prevention study, 45
Menstrual cycle, 5, 91, 111, 113, 120, 140-141
DES-related irregularity, 238
Mental health problems, 90
Metabolism, 86
Methodological issues, 8, 9, 10, 24-25, 95-103, 114-117, 125
Methyl mercury, 179
Minority groups, see Race and ethnicity
Miscarriage, 179
and DES, 237
Model Federal Policy, 141-142
Monetary inducement, 10, 82, 122, 125
Monitoring, of policy compliance, 19, 21, 22, 206
see also Surveillance and monitoring
Multiple Risk-Factor Intervention Trials (MRFIT), 44, 51, 65, 99, 100, 217
N
National Childhood Vaccine Injury Act, 250
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 4, 41, 75, 245
National Institutes of Health (NIH), 10, 11, 27, 129-130
failure to implement inclusion policy, 2, 43, 47-48
investigator training and education, 9, 10, 11-12, 21, 45, 125, 207
lack of injury compensation policies, 243
legal actions against, 151, 157-158, 170n
policy consistency and congruence, 11, 167-168
policy implementation and guidance, 22, 23-25, 45, 105, 132-137, 193, 203-211 passim
recommended studies, 7, 8, 10, 23, 105, 210, 211
registry implementation and use, 2, 47, 67-68, 70
see also Office of Protection from Research Risks;
Office of Research on Women's Health
National Institutes of Health (NIH) Revitalization Act, 2, 27, 44-45, 135-137, 233-236
registry provision, 3, 47, 68, 69, 136
representative sample provision, 2-3, 7, 9-10, 24-25, 104, 114, 119, 125, 132-133, 135-137, 147, 204
National Library of Medicine (NLM), 68, 129
National Research Act, 41
National research agenda, 1, 2, 4, 37, 69
principles of justice in, 5, 22-23, 77, 78, 81, 82, 204, 209
Negligence, 153-154, 156, 168-169
Neurodegenerative diseases, 90
Neuroscience, 111
New drug applications (NDAs), 34, 158
Nicotine, 86
No-fault compensation, 245, 249, 250, 250-251n
Nonsteroidal anti-inflammatory agents, 89
Nuremberg Code, 37-38
Nursing, see Lactation and nursing
O
Observer bias, see Gender bias; Male bias
Obstetrics and gynecology, 112
Occupational medicine, 111-112
Office of Medical Applications of Research, 67
Office of Protection from Research Risks (OPRR), 130
monitoring of study population
recommended revision to Subpart B, 18-19, 200
Office of Research on Women's Health (ORWH), 43-44, 46
clinical studies registry, 3, 68
data collection on study gender composition, 3, 68
subgroup analysis funding, 23, 210
Offspring, see Prenatal and preconceptual injury
Oppression and power, 79-81
Oral contraceptives, see Hormonal contraceptives
Our Bodies, Ourselves, 42
Ovarian cancer, 44
P
Pacific Islanders, 116, 117, 119, 123
Paradigm shifts, 109-110
Parallel trials, 96
Peer review, of policy interpretations, 22, 209
Pew Foundation, 131
Pharmaceutical industry
alternative assessment techniques, 102-103
and DES liability, 239-241
liability issues, 13, 150, 151-152, 154-155, 165-167, 168, 170n, 244, 246
new drug studies, 45-46
research support, 11, 131, 205, 211
Pharmacodynamics, 46, 139, 185
gender differences, 5, 46, 139, 140-141
Physicians, liability of, 167, 248-250
Physician's Health Study, 43, 65, 99-100
Physiological gender differences, 5-6, 86-90
Policy, see Guidelines; Legislation and statutes; National research agenda; Public policy; Regulations
Poor population, 10, 76, 78, 80-81, 82, 119, 121, 122, 123
Postmarketing studies, 35, 102, 190
Potential defendants, 157-159, 161-162
Preexisting conditions, of pregnant women, 16, 188
Preferential treatment, 5, 80, 81, 82-83
Pregnancy
importance of clinical studies during, 15-16, 79, 188
male-mediated toxicity, 162, 179
medical management issues, 16, 23, 188-189, 194
participation policies and issues, 2, 11, 15-19, 36, 40-41, 67, 69, 79, 134, 144-146, 148-149, 170n, 184-185, 188-190, 193, 194-200, 210
see also Abortion;
Developmental toxicants;
Prenatal and preconceptual injury
Premature births, and DES, 237, 238-239
Prenatal and preconceptual injury
background incidence, 14, 178-179
compensation issues, 13-14, 160-161, 169, 247
consent issues, 13, 15, 17, 161, 162-165, 247
liability issues, 12-13, 29, 128-129, 159-165, 171n
see also Developmental toxicants;
Reproductive and childbearing potential
Prescription drug consumption, 89
President's Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research, 245
Preterm labor, 188
Private research support, 11, 108, 131, 205, 211
Procedural justice, 76
Professional associations, 22
Proof of causation, 13, 15, 152, 154, 160, 169, 247
vaccine injuries, 250
Protectionist policies, 2, 36-42, 44, 47, 68-69, 113, 122-123
Psychiatry, 111
Psychosocial gender differences, 6, 90-91, 112
Publication of research, 22, 211
Public Health Service (PHS)
and injury compensation, 244-245
policy consistency and congruence, 11, 167-168
Task Force on Women's Health Issues, 43
Public opinion and perceptions
equity of research participation, 1, 43-44, 45
consistency and congruence in, 11, 167-168
constitutional issues, 12
implementation issues, 19-25, 29, 203-211
protectionism versus access, 2, 36, 42, 44
see also Constitutional issues;
Guidelines;
Legislation and statutes;
Regulations
R
Race and ethnicity, 2, 7, 21, 37, 69, 114-119, 124-125, 209
data collection and studies on, 23, 24, 115-117, 124, 211
history of unethical treatment, 9-10, 38-40, 118-119, 121, 122, 124 -125
justice issues, 5, 23, 77, 78, 80-81, 82, 83, 209
methodological issues, 9, 20, 115-117, 124, 125, 136-137, 207
policy issues, 11, 12, 134, 135-137
recruitment and consent issues, 10, 114, 119-123, 125
registry information on, 3, 4, 69, 70, 211
and societal bias, 8, 37, 112, 114-119
study section membership, 22, 209
see also African Americans;
Alaskan natives;
American Indians;
Asian populations;
Hispanics;
Pacific Islanders
Randomized controlled clinical trials, 96, 102
Recombinant DNA Advisory Committee (RAC), 246
Recruitment and retention
compensation, 10, 82, 122, 125
cultural and exploitation issues, 9-10, 20-21, 109, 119-122, 124-125, 207
sufficiency for subgroup analysis, 3, 7, 21, 49, 114, 122, 207
Registries of clinical studies, 3-4, 47, 67-68, 69-70, 176
private industry involvement, 4, 70, 211
affecting pregnant women's participation, 16, 18-19, 141-142, 194-195
consistency and congruence in, 11, 167-168
expanded access to experimental drugs, 42
to protect research subjects, 2, 8, 39, 40, 41
Reproductive and childbearing potential, 12, 14-15, 29, 79-80, 109, 175-176
consent issues, 14, 15, 175, 176, 182, 184-185, 192, 193, 200-201n
participation and exclusion policies, 2, 11, 15, 36, 40-41, 46, 55, 67, 78, 120, 134, 141, 147, 149, 192-194, 222
risk assessment, 14, 175, 176-191
risks for men, 12, 14-15, 138, 162, 175, 178, 179, 181, 182, 193
see also Contraception and contraceptive measures;
Lactation and nursing;
Pregnancy;
Prenatal and preconceptual injury
Requests for applications (RFAs), 23, 209, 210
DES studies, 239
Requests for proposals (RFPs), 23, 133-134, 209, 210
Researchers, see Investigators
Respect for persons, 4, 42, 75
Retention, see Recruitment and retention
Risk assessment for reproductive risks, 14, 175, 176-191
Risk-benefit analysis, 9, 15, 40, 176, 191-200
and recruitment in developing countries, 78
Risk factors, as basis for study exclusion, 6, 103
Ritodrine, 188
Rural background, 114
S
Scientific advisory councils, 205
research priority determination, 22-23, 209-210
Scientific review boards, 205
Sedentary lifestyle, 90
Sensitivity to gender and cultural concerns
evaluation of, 22
of IRG and TEG members, 22
Sentinel malformations, 189-190
Sequential sample designs, 96
Sexual orientation, 114
Sleep disorders, 90
Smoking, 90-91
Social influences and biases, 8-9, 29, 37, 108-110, 115-116, 123-124
Social insurance systems, 248
Social sciences, research use in study design, 9, 10, 20-21, 115, 207
Socioeconomic status, 8, 9-10, 114, 117, 119-120, 121, 123, 125
database information on, 24, 211
see also Poor population
Sports medicine, 111-112
Standard of care, 153-154
Statutes, see Legislation and statutes
Stephenson-Wydler Technology Innovation Act, 67-68, 70n
Steroids, 88
Strict liability, 13, 154-155, 165, 168
Structure-activity relationships, 184
see also Initial review groups;
Technical evaluation groups
Subgroup analysis, 3, 6, 7, 19, 100-101, 104-105, 114, 117, 136, 204
supplemental NIH funding for, 23, 210
Subjectivity, 109-110
Surveillance and monitoring, 7, 102-103, 105
of developmental effects, 14, 16, 175
T
Technical evaluation groups (TEGs), 130
and assessment of gender differences, 24, 211
member recruitment and training, 22, 209
monitoring of policy implementation, 22, 205, 208-209
training in recruitment and retention issues, 10, 125
Terbutaline, 188
Termination of life support, 12, 143-144
Thalidomide, 40-41, 68, 159, 179
Torts, see Liability issues
Training and education
gender and cultural concerns, 9, 21, 22, 207
of IRG and TEG members, 22
in policy requirements, 11-12, 19, 168
recruitment and retention issues, 10
Transport of toxicant, paternal, 181
Tuskegee Syphilis Study, 39, 76, 118, 244
U
Underrepresentation, 2, 4-5, 30, 78-79, 146
Unethical treatment, 2, 8, 36, 82, 109, 121, 125
history of, 9-10, 37-40, 68, 76, 118-119, 124-125
University of Chicago, DES liability cases, 239-241
University of Washington, liability insurance program, 244, 250-251n
Urban background, 114
Uterine abnormalities, 238
V
Vaccine injury compensation, 250
Vaginal dysplasia, 238
Validity of research results and analyses, 9, 10, 96-97, 113, 114, 125, 210
Valproic acid, 184
Value neutrality, 108
Variance, 6
Virginia, no-fault compensation scheme, 249
Voluntariness of participation, 5, 81, 82, 83
Vulnerable population, pregnant women as, 16, 18-19, 41, 69, 194-195, 200
W
Waste of research funds, 4, 69
Women's Health Equity Act (WHEA), 44
Women's Health Initiative (HI), 45
World Health Organization (WHO) injury compensation guidelines, 246
Wrongful life, 161-162