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From page 261... ... 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, 4243, 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 1nJury Advocacy and activism, 1, 2, 37, 42-43, 69, 121, 192 261 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 Read the entire page →
From page 262... ... 262 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, 278, 238, 239 inequity in studies of, 52, 63, 218, 232 research abuse, 38-39 INDEX 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, 200-201 n Clear-cell adenocarcinoma (CCA) , 41, 178, 238, 239 Cleft lip, 190 Clinical studies, defined, 29, 95 Clinical trials, 29, 31, 34-35, 51-62 passzm, 67, 95-96, 216-231 passzm 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 Read the entire page →
From page 263... ... , 64-66 Costs and funding of research, 37 exclusion and recruitment issues, 2, 81-82, 100, 109, 119, 135 and injury compensation, 239, 246247 institutional structure, 11, 129- 131 and policy application, 11, 122, 129131 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) Read the entire page →
From page 264... ... , 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, 200-201 n Fixed sample size designs, 96 Florida, no-fault compensation scheme, 249 Fluoxetine, 184 INDEX Food, Drug, and Cosmetic Act (FDCA) Read the entire page →
From page 265... ... , 31, 66, 78, 80-81, 112, 143 Hydantoin, 177 I Immigrants, 123 Implementation issues, 19-25, 29, 203205 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, 118119, 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, 162164, 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, 200-201 n Initial review groups (IRGs) and assessment of gender differences, 8, 24, 105, 129- 130, 211 Read the entire page →
From page 266... ... 266 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, 198199, 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 INDEX guiding principles, 4-5, 28, 82-83 limitations to, 81-82 and national research agenda, 5, 2223, 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 Read the entire page →
From page 267... ... , 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) Read the entire page →
From page 268... ... , 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 INDEX 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 Pre-existing 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 Read the entire page →
From page 269... ... 96, 102 Recombinant DNA Advisory Committee (RAC) , 246 Recruitment and retention compensation, lo, 82, 122, 125 cultural and exploitation issues, 910, 20-21, 109, 119- 122, 124125, 207 justice issues, 81 -82, 121 registry role in, 4, 69 sufficiency for subgroup analysis, 3, 7, 21, 49, 114, 122, 207 Read the entire page →
From page 270... ... , 23, 133134, 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 INDEX 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 Read the entire page →
From page 271... ... 146 assessment of, 3, 47-49 271 Unethical treatment, 2, 8, 36, 82, 109, 121, 125 history of, 9-10, 37-40, 68, 76, 118119, 124-125 University of Chicago, DES liability cases, 239-241 University of Washington, liability insurance program, 244, 250251n 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 (WHI) Read the entire page →

From page 261...

... 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, 4243, 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 1nJury Advocacy and activism, 1, 2, 37, 42-43, 69, 121, 192 261 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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From page 262...

... 262 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, 278, 238, 239 inequity in studies of, 52, 63, 218, 232 research abuse, 38-39 INDEX 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, 200-201 n Clear-cell adenocarcinoma (CCA) , 41, 178, 238, 239 Cleft lip, 190 Clinical studies, defined, 29, 95 Clinical trials, 29, 31, 34-35, 51-62 passzm, 67, 95-96, 216-231 passzm 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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From page 263...

... , 64-66 Costs and funding of research, 37 exclusion and recruitment issues, 2, 81-82, 100, 109, 119, 135 and injury compensation, 239, 246247 institutional structure, 11, 129- 131 and policy application, 11, 122, 129131 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)

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From page 264...

... , 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, 200-201 n Fixed sample size designs, 96 Florida, no-fault compensation scheme, 249 Fluoxetine, 184 INDEX Food, Drug, and Cosmetic Act (FDCA)

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From page 265...

... , 31, 66, 78, 80-81, 112, 143 Hydantoin, 177 I Immigrants, 123 Implementation issues, 19-25, 29, 203205 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, 118119, 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, 162164, 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, 200-201 n Initial review groups (IRGs) and assessment of gender differences, 8, 24, 105, 129- 130, 211

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From page 266...

... 266 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, 198199, 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 INDEX guiding principles, 4-5, 28, 82-83 limitations to, 81-82 and national research agenda, 5, 2223, 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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From page 267...

... , 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)

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From page 268...

... , 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 INDEX 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 Pre-existing 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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From page 269...

... 96, 102 Recombinant DNA Advisory Committee (RAC) , 246 Recruitment and retention compensation, lo, 82, 122, 125 cultural and exploitation issues, 910, 20-21, 109, 119- 122, 124125, 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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From page 270...

... , 23, 133134, 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 INDEX 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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From page 271...

... 146 assessment of, 3, 47-49 271 Unethical treatment, 2, 8, 36, 82, 109, 121, 125 history of, 9-10, 37-40, 68, 76, 118119, 124-125 University of Chicago, DES liability cases, 239-241 University of Washington, liability insurance program, 244, 250251n 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 (WHI)

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Index Pages 261-271

Index
Pages 261-271