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Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Index

A

Abortion, 12, 119, 144

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

and compensation, 152, 246

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

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Alcohol use, 90, 91

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

Battery, 153, 155-156, 157

in DES liability cases, 240, 241

Behavioral differences, 6, 90-91

Belmont Report, 4, 42, 75-76, 77

Benchmark dose, 182

Beneficence, 4, 42, 75

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

Cancer, 44, 91-92, 93

of breast, 44, 91, 121, 238

and DES, 41, 270, 238, 239

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

Compensatory justice, 76, 80

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

drug interaction, 15, 185, 194

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

 

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

male-mediated, 162, 179, 181

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

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

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

Fetal tissue research, 44, 45

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

and DES, 237, 238

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

Foundations, 11, 108, 131

Fourteenth Amendment issues, 12, 143-150

Framingham study, 64, 65

Funding, see Costs and funding of research

G

Gender analyses, 3, 7, 20, 21, 30, 46, 101, 104, 114, 136, 207

reporting of, 3, 46, 49, 140

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

as basis for exclusion, 6, 99-100, 134

and clinical trial design, 6, 7, 20, 105, 139-141

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

 

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

from animal studies, 14, 177

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

Heterogeneity, 6, 97

HEW, see Department of Health, Education, and Welfare

HHS, see Department of Health and Human Services

Hispanics, 116, 117, 118-119

Homogeneity, 6, 97-98, 104, 120

Hormonal contraceptives, 5-6, 93-94, 118-119, 182, 185, 186

Hormonal differences, 5, 80, 88, 91-92

Hormonal status, 24, 120, 211

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

objectives, 19, 205-206

recommendations, 20-25, 206-207

Indian Health Service, 118

Infertility, 14, 141, 175

in DES children, 238

Informed consent, 37-40, 82

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

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

 

member recruitment and training, 22, 209

monitoring of policy implementation, 22, 205, 208-209

and study design, 21, 207

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

and drug response, 5, 92, 93

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

consent, 13, 153, 155-157

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

Lipid-solubility, 86, 89

Literature reviews, 20, 23-24, 50-63, 207, 210, 215-232

Lithium, 89

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

M

Magnesium sulfate, 188

Male bias, 8, 110, 111-112

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

registry inclusion of, 3, 69

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

heart disease, 64, 65-66, 78

Menstrual cycle, 5, 91, 111, 113, 120, 140-141

DES-related irregularity, 238

Mental health problems, 90

Meta-analysis, 101-102, 135

Metabolism, 86

Methodological issues, 8, 9, 10, 24-25, 95-103, 114-117, 125

in policy compliance, 24, 211

Methyl mercury, 179

Minimal risk, 142, 163

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

Multicenter studies, 4, 69

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

Nazis, 37, 68, 76

Negligence, 153-154, 156, 168-169

Neurodegenerative diseases, 90

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Neuroscience, 111

New drug applications (NDAs), 34, 158

DES approval, 237, 238

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

Objectivity, 109-110, 112

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

composition, 21, 208

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

Orphan drugs, 55, 221

Osteoporosis, 44, 89-90

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

Pharmacokinetics, 185, 187

gender differences, 5, 46, 139, 140-141

PHS 398 form, 24, 210

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

and AIDS, 66, 80

and drug response, 5, 92-93

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

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

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

surveillance, 14, 16, 175

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

Psychology, 50, 215-216

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

Public policy, 11, 108

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

justice issues, 81-82, 121

registry role in, 4, 69

sufficiency for subgroup analysis, 3, 7, 21, 49, 114, 122, 207

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Registries of clinical studies, 3-4, 47, 67-68, 69-70, 176

private industry involvement, 4, 70, 211

Regulations, 11, 130-131

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

and study design, 21, 207

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

Sterilization, 119, 121

Steroids, 88

Stress, 90, 111

Strict liability, 13, 154-155, 165, 168

DES cases, 239, 240, 241

Structure-activity relationships, 184

Study sections, 8, 205

see also Initial review groups;

Technical evaluation groups

Subgroup analysis, 3, 6, 7, 19, 100-101, 104-105, 114, 117, 136, 204

methodological guidance, 24-25, 210, 211

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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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

and study design, 21, 207

training in recruitment and retention issues, 10, 125

Teratogenicity, 13, 177

Terbutaline, 188

Termination of life support, 12, 143-144

Thalidomide, 40-41, 68, 159, 179

Torts, see Liability issues

Toxicokinetics, 14, 177

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

assessment of, 3, 47-49

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

Suggested Citation:"Index." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 Get This Book
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In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues.

Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies.

Leading experts present general principles for the ethical conduct of research on women--principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research.

Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research.

The book addresses present-day challenges to equity in four areas:

  • Scientific--Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics.
  • Social and Ethical--The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants.
  • Legal--Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases.
  • Risk--The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed.

This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

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