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



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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

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--> 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

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-->   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

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--> 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

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-->   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

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-->   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

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--> 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

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--> 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

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--> 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

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--> 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

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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