Ethical Conduct of Clinical Research Involving Children (2004) / Chapter Skim
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From page 409... ...
See also Harm Altruism, 164, 165, 167, 168, 170, 191 defined, 106, 394 American Academy of Pediatrics, 60, 65-66, in ethical principles, 46 120, 140, 161, 221, 251 409
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See also Consent process; Informed AZT, 108 consent; Parental permission age appropriateness of process, 7, 8, 156, 171-172, 173, 179-180, 183- B 185, 192-193, 205-207 cognitive development and, 179-180, Bartholome, William, 43 205-206 Bayley Scales of Infant Development, 125 Beaumont, William, 45 n.7 comprehension of research participation and, 7, 28, 42, 131-132, 181-193, Beecher, Henry, 35, 39, 50, 248 205-206 Behavioral studies, 384-385 Belmont Report, 40-41, 43, 52-53, 93, 110, defined, 51 n.13, 101, 146-147, 156, 327, 394 255 discretion in documenting, 207 Benefits of research, 1, 25-26, 58. See also Risk-benefit assessment ethical principles, 40-41, 50, 84, 148, 192 experience of illness and, 131-132, 189- collateral or indirect, 132 190 defined, 115-116, 395, 396 direct, 42, 132-133, 136, 154, 158, 204, forms, 193, 206, 207 historical evolution of policies, 50, 51 218, 396 n.13 ethical principles relating to, 40-44, 45 n.7, 47 information to be provided, 206 legal requirements for, 3, 104, 151-153, expectations of, 150, 151, 164, 165, 156-157, 182, 191, 204 167, 169, 170, 398 to other children, 115-116, 126-127, motivations for, 164, 165, 167, 168, 170, 191 149 n.2 "mutual pretense" process and, 191 peripheral, 149 n.2 potential, 115, 116, 133-134 parental influence, 187, 190-191, 204 205 prospective long-term studies, 39 payment for participation and, 189, 211 Benzyl alcohol, 67 Bernard, Claude, 45 n.7 for placebo-controlled trials, 140 procedures for seeking, 148, 149-151, Best Pharmaceuticals for Children Act of 156, 172-173, 205-207 2002, 2, 30, 68, 89, 106 n.3, 233, 400 purpose of research and, 171 recommended improvements in, 20, 203- Bilirubin, 69 205 Boston University, 48 Brazelton Neonatal Behavioral Assessment waiver of, 156 withdrawal from trials, 183, 187-188, Scale, 125 190, 197 Breast cancer, 171 Brokowski, Carolyn, 182
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, 71-72, disease-specific, 81 81, 88, 108, 261 effect of participation on outcomes, 150 Chloramphenicol, 27, 70 of emergency care, 87, 92, 155, 203 Chronic granulomatous disease, 80 enrollment and retention of participants, Clinical investigation, definition, 33, 165 80, 87-88, 217-218, 220, 223-224 n.5 expertise of investigators in pediatrics, 3, Clinical Investigation of Medicinal Products 63, 78-79, 91-92, 93-94, 99, 136, in the Pediatric Population, 111, 217 142-144, 244, 250 Clinical practice innovations, 32 facility appropriateness, 78, 92, 136, "radically new" procedures, 32 143 Clinical research. See also Clinical trials; family-centered care, 84-85 Pediatric drug research with healthy children, 27, 50, 117 benefits of, 25-26 with ill children, 27, 160, 170, 197-198 challenges, 59, 74-87 long-term monitoring and evaluation, clinical care distinguished from, 34, 150 82-83, 92, 275 as complex, high-stakes enterprise, 35- minority participants, 87-88 36 outcome measures, 75-78
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From page 412... ...
Part 46, Subpart Informed consent; Parental A) , 320-321 permission agencies adopting, 54, 95 adolescents, 183-186 criteria for research approval, 3, 97, 99 and assent, 7, 28, 42, 131-132, 181-193, defined, 395 205-206 exempted research, 53, 97, 99-100 children, 7, 183-185 expedited review, 53, 100, 117 cognitive development and, 179-180, historical evolution of, 52-53 205-206 informed consent, 53, 97 competency standards, 185 institutional assurances and in crisis situations, 7, 169-170 responsibilities, 95, 96-97 and decision making by parents, 166-178 institutional review boards, 97-99 experience with illness and, 131-132, minimal risk standard, 117, 121 171, 189-190 vulnerable populations, 52 format of presentation and, 181, 184 Compliance oversight harms and benefits, 42, 163-164, 183-186 accreditation perspective, 11, 21-22, interpretation of terms, 165 n.5 243-245 parents, 159-178 adverse event reporting, 105, 106-107, 231 purpose of research, 150, 164-165, 183 assurance of compliance, 95, 110, 235, 186, 398 242, 394 readability of forms, 160-163, 195, 206 of child participants in research, 29, 55, research needs, 208 234-239 rights of participants, 174, 183, 184, citations of noncompliance, 236 187-189, 197 concerns about, 230-234 therapeutic misconception, 7, 150, 151, of conflicts of interest, 232 164, 398
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situations, 7, 169- state laws and litigation, 201, 330-339 170, 171, 175, 186, 192, 196, 197- structure of, 8, 172-173, 196, 203-205, 198, 218 209 for emancipated and mature minors, 9, treatment vs. research participation, 161, 157-158 164-165, 174
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From page 414... ...
See also Pediatric drug waiver of parental permission, 9, 19-20, research 154-155, 200-203 costs, 35 for wards of the state, 158-159, 200- Drugs. See also specific drugs and 201, 209 classifications of drugs Consortium of Social Science Associations, developmental issues, 60, 61, 65-72, 81 244 n.2 dosing schedules and errors, 68, 69-70 Control groups, 81, 108, 117, 139-142, excipient safety, 67-68 151, 396, 397 extrapolation from adult studies, 2, 26Cooperative research groups, 71-72, 81, 87, 27, 43, 58, 60, 68-69, 71, 91 88, 91, 108 half-life, 69-70 Corticosteroids, 69, 71 labeling information for pediatric use, Cosmetic surgery, 185 60, 90-91 Council for International Organizations of misbranding, 67 n.6 Medical Sciences, 56-57, 127, 139, off-label use, 60-61, 67, 74, 397 217, 222, 256 Phase 1 trials, 397 Crossover studies, 81, 142 Cyclosporine, 27 Cystic Fibrosis Foundation, 88, 178, 218, E 221, 262 Economically disadvantaged persons, 10, Cystic fibrosis research, 75, 76, 77, 87, 108 109, 193, 271 42-43, 46, 122, 213, 214, 224, 331 Cytochrome P-450 1A2, 70 332, 333 Emancipated minors conditions for establishing, 323, 344-346 D consent, 104, 157-158, 324 defined, 157, 323, 324, 325 n.10, 396 Data and safety monitoring boards mature minors distinguished from, 325, composition of, 109 327-328 defined, 396 state laws, 323-324, 344-346 expertise in pediatrics, 37, 108, 252-253 Engelhardt, Tristram, 43 federal regulations, 97, 107-110 Ethical principles independence of, 109, 110 adverse events, 46 responsibilities of, 108-109, 140 AMA code, 45 n.7 Data monitoring committees.
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, 60 UNESCO guidelines, 56 n.17 Food and Drug Administration European Agency for the Evaluation of Modernization and Accountability Medicinal Products, 111 Act of 1997, 89, 400 European research, 175 Food and Drug Administration rules and Exempt research, 53, 99-100 policies Expedited review, 53, 99-100 adverse event reporting requirements, 106, 107 age categories, 63, 64, 65 F compliance oversight, 60 n.1, 67 n.6, 88, 91, 105 n.3, 106-107, 108, 233, 234Federal agencies. See also individual 235, 236-238 agencies conformity with Subpart D, 5, 53, 95, education and guidance for IRBs and 100, 400 investigators, 268-270 data monitoring committees, 108 policy development, guidance, data on foreign research, 110, 111, 233 collection, and research, 273-274 Good Clinical Practices Program, 55, 68, roles and responsibilities, 15-16, 18, 23, 234-235 267-274 guidance on research involving children, under Common Rule, 54 n.1 255 Federal Food, Drug, and Cosmetic Act, 48, incentives for pediatric drug research, 2, 67, 152, 230 27, 90-91 Federal rules and regulations.
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From page 416... ...
See also Adverse events, risk instances of harm to, 67, 70 defined, 114-115, 396 low-birth-weight, 82, 88 discomfort as, 115, 140 outcome measures in, 76 duration and magnitude considerations, pharmacokinetics of drugs, 69-70 123, 126, 128, 134 premature, 1, 26, 27, 58, 63, 67, 69, 75, identification of, 26 78, 80, 82, 87, 88 instances of, 67 well-child examination components, 124 prospective long-term studies, 39 Informed consent. See also Assent; unanticipated problems, 107 Comprehension of research Hauerwas, Stanley, 43 participation; Consent process; Hawaii, 340, 342, 344, 348, 355 Parental permission Health Insurance Portability and age of majority, 4, 94, 104, 154, 156, Accountability Act of 1996, 94, 388- 325-326, 354-362 390 defined, 146, 395
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From page 417... ...
INDEX 417 by emancipated and mature minors, recommendations, 14, 15, 18, 22-23, 157-158 138, 253, 258, 266 ethical principles, 2, 40, 45-47, 48-49, referral of protocols to the DHHS 147-149 Secretary or FDA Commissioner, exempted research, 53, 97, 99-100 102, 103, 116, 134, 137 n.6, 270 federal regulations, 53, 97, 151-153, 273 231 regulatory framework, 96-97, 97-99, general conditions for, 51, 116, 148- 101, 321, 400 149, 190 roles and responsibilities, 13-15, 28, 49, informational requirements for, 159 51, 53, 96-97, 105 n.3, 106, 108 for long-term studies, 83 109, 138, 232, 247, 251-267 parental permission distinguished from, sharing information about decisions, 55, 148-149, 159, 198-200 105, 134, 267, 274-275 for placebo-controlled trials, 139, 140- supplemental policies and guidance, 258, 141 261 reading levels and readability of forms, variability in decisions, 262-265 160-163 waiver of parental permission, 19, 84 Institute of Medicine, 30, 233, 234, 243, written basis for judgments, 6, 134 246, 251 Intelligence tests, 125 Institutional review boards International Conference on Harmonisation, central review model, 265-266 33 n.4, 56, 63, 71, 111, 139, 156 community and family input to, 14-15, 157, 217, 396, 397 254 International Covenant on Civil and composition, 35, 96, 97, 253-254 Political Rights, 49 n.12 consent policies and practices, 7, 8, 143- International Ethical Guidelines for 144, 156, 157, 158, 193-195, 321, Biomedical Research Involving 327 Human Subjects, 111 continuing review by, 99, 107 International research, regulation of, 56-57, database and information system, 266, 110, 232-233 267 Interventions, defined, 34 defined, 396-397 Intraocular lens replacement, 61 documentation of decisions and Investigators and research teams checklists, 55, 105, 134, 267, 242, child life specialists and child 257-259, 260-261 psychologists, 79 expedited review, 53, 100, 117 consent policies and practices, 20, 84, foreign, 56 193-195 guidance on research with children, 15, cultural sensitivity, 84 255-258, 268-270, 273 expertise in pediatrics, 3, 20, 63, 78-79, historical evolution of, 48-49, 51, 52 91-92, 93-94, 99, 136, 142-144, inspections of, 108 244, 250 minimal risk interpretation, 118-121 inspections of, 108 monitoring adverse events, 107-108 minimal risk interpretations by, 118-121 multicenter protocol review, 255, 261- payments to, 222-223, 227-228 266 progress reports, 99 Native American, 116 recommendations, 19, 250 payment policies, 216, 217-218, 219, roles and responsibilities, 12-13, 35, 84, 220-221, 224-225, 261 99, 142-143, 248-251 pediatric expertise on, 251-261 training and retention of, 86-87, 250 qualifications of members, 14, 22-23, Iowa, 340, 342, 344, 348, 356 37, 76-77, 86, 97-99, 158, 244, 248, Ivy, Andrew, 46, 47 n.10 251-255, 321
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, 89 Lasagna, Louis, 47 Minimal risk Lead abatement studies, 330-331 "daily life" reference, 5, 118, 121, 126 Legally authorized representative, defined, defining, 5, 115, 117-126, 397 101 developmental status or age Legislation. See also Regulatory framework considerations, 122, 124, 126 for protection; specific statutes discomfort as, 115 incentives for pediatric research, 89-90 ethical principles, 47 Leukemia, 26, 66, 75, 80, 82, 87, 88, 106, exemption or expedited review, 53 169, 184 for healthy children, 5, 117, 120, 121Lilly, Joseph, 169 125, 126 Lilly, Maureen, 58 for ill children, 120, 122-123 Lippincott, Sarah, 191-192 investigator and IRM interpretation, Long-term studies 118, 120-121 implementation, 83 moral and social implications, 5, 120-121 importance, 82 and no benefit to participant, 84, 103, 127 Louisiana, 340, 342, 344, 349, 357, 364- procedures categorized as, 123, 134-136 367 psychological tests, 125 recommended interpretation, 5-6, 126 relativistic interpretation, 5, 121-122, M 126, 127 routine examination standard, 4, 124-125 Maine, 325, 340, 342, 344, 349, 357, 366- socially allowable risks, 123 367 Minnesota, 340, 342, 345, 350, 357 Maryland, 328, 331-334, 339, 340, 342, Minor increase over minimal risk standard 345, 349, 357 benefit standard, 6, 115-116, 130, 328Massachusetts, 336, 340, 342, 345, 349, 329 357 commensurate procedure criterion, 128, Maternal and Child Health Bureau, 89 131-132, 395
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, 88, consent process, 162-163, 194-195 89 defined, 397 National Institutes of Health policies, 178, enrollment and retention of participants, 234 84 age categories, 64 in foreign countries, 110 Certificate of Confidentiality, 395 implementation of protective policies, Clinical Center, 47-48, 52, 222 28, 37, 39 clinical research curriculum grants, 86 need for, 92 historical evolution of, 47-48, 52 protocol review, 261-266 incentives for research, 2, 27, 52, 91-92 reporting adverse events, 107 IRB database and information system, risk categorization in, 120 266, 267, 275 size of study populations, 81 for monitoring data and safety, 105, 108 state regulation of, 4-5 notification of institution's variable review of, 261-266 noncompliance, 236 Mumps, 1 parental permission, 155 on payment for participation, 219-220, 222, 227 N prospective studies of immunosuppressive agents, 27 National Academy of Sciences, 25 recommended roles and responsibilities, National Association of State Universities 23, 269 and Land Grant Colleges, 244 n.2 regulations applicable to, 95, 97 National Bioethics Advisory Commission National Research Act of 1974, 52, 400 (NBAC) , 32-33, 34, 35, 56, 83 n.8, National Research Council, 30 113, 117, 136-137, 223, 232-233, Native Americans, IRBs, 116 248 Navaho Nation, 116 National Cancer Institute, 87, 108, 162, 265 Nebraska, 104, 340, 342, 345, 350, 358 National Center for Health Statistics Nebulized albuterol, 60 (NCHS)
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See also Assent; O Consent process; Informed consent compensation and, 331 Obesity, 77, 80 comprehension level and, 7, 42, 131Office for Human Research Protections, 53 132, 159-178, 198-200 n.15, 136 conditions/disorders not requiring central IRB review model, 265-266 permission for treatment, 354-362 compliance oversight by, 55, 99, 216, crisis-driven decision making, 169-170, 229, 232, 233, 234, 235-236, 239, 171 396 decision-making process, 166-178 determination letter, 216, 396 defined, 101, 146, 397 guidance on research involving children, ethical principles, 148 255 exceptions to requirements for, 324 payment guidelines, 215-216 expectations of benefit and, 151, 164 quality improvement initiative, 235, 165, 167, 169-171, 199-200 241-242 experience of illness and, 171 recommended roles and responsibilities, family physician's influence, 7, 168 6, 18, 23, 136, 155, 202, 203, 239, federal regulations, 103-104, 152-155 269, 270, 272 forms, 193 Office for Protection from Research Risks, by guardians, 49-50, 146, 154, 396 55 informational requirements for, 159-160 Office of Management and Budget, 239, informed, 198-200 241 informed consent distinguished from, Office of Public Health and Transfer, 55 148-149, 159 Ohio, 341, 342, 345, 351, 360 investigator's undue influence on, 173, Oklahoma, 341, 342, 345, 351, 360, 368- 174 369 legal requirements for, 3, 151-155, 331Oregon, 325, 341, 342, 346, 351, 360 337 Organ transplants, 27 limits of authority, 335 Otitis media, 80 motivation for decisions, 167-169 Outcome measures process, 149-151, 175-176 age-appropriate, 75-77 reading levels and readability of forms, consent and quantitative information 160-163 about, 163-164 research on decision making, 166-178 death, 75 risk-benefit standards, 331-337 defining, 75-78 views and results of consent process, developmental appropriateness, 76-77 168, 174, 175-176 normative data, 78 waiver of, 4, 9, 19-20, 51, 84, 94, 97, pain scales, 77 104, 154-155, 193, 194, 200-203, physical or cognitive functioning, 76-77 321, 335
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INDEX 421 Parents reimbursement for expenses, 10, 212, compensation for time and 213, 214, 217, 218, 219, 220, 225 inconvenience, 10, 212, 214, 217, 226, 398 219, 220, 221, 227, 228, 395 research on use of, 217-220, 227 defined, 101, 154, 397 and risk-benefit assessment, 132, 216, incompetent, 154 331 influence of children, 187, 190-191, risk-related, 10, 216, 218, 219-220, 221, 204-205 226-227 participation in clinical studies, 34 token payments or gifts, 212-213, 215 questions to ask during consent process, types of, 212-213, 221 12, 177-178 undue influence of, 9, 213, 214, 221 reimbursement for expenses, 10, 212, waiver of treatment costs as, 221 213, 214, 217, 218, 219, 220, 225- written policies on, 9, 222, 224-225 226, 398 Pediatric AIDS Clinical Trials Group, 88 responsibilities of, 160 Pediatric drug research. See also Clinical termination of rights, 329 research; Clinical trials Participants, defined, 397 with adolescents, 7, 64-66 Partnership for Human Research Protection, adverse effects by developmental stage, Inc., 244 67, 71-72, 82 Pattee, Suzanne, 178 age-appropriate formulations, 26-27, 61, Payment for participation 66, 67-68, 73 acceptable types of, 10, 225-227 with children, 63-64, 69, 76, 78, 79 to adolescents, 10, 213, 218-219, 227 commercial value of, 61-62, 89 amounts paid, 217, 218, 219 costs of, 61 bonuses for completion of study, 217, data monitoring committees, 108 224 direct benefits of, 133 and child's assent, 189, 211 disclosure of findings, 27 n.1, 106, 250 compensation for time and efficacy trials, 73, 133 inconvenience, 10, 212, 214, 217, ethical and regulatory standards, 60 n.1, 219, 220, 221, 227, 228, 395 62, 63, 85 ethical concerns, 9, 41, 211, 213-215, 220 incentives for, 30, 59, 89-92 federal regulations and policies, 215- with infants, 63, 67, 69, 70, 76, 78, 79 217, 220, 227 information gaps, 26-27 to guardians, 217 labeling for pediatric doses, 89 incentive payments, 189, 212, 213, 214- long-term follow-up and surveillance, 215, 216, 221, 227-228, 396 71-72, 75, 76, 82-83, 106, 275 for injuries related to research, 221-222, normative data, 75, 76, 78 227 patent protection, 89 IRB policies and practices, 9, 216, 217- payment for participation, 217 218, 219, 220-221, 223, 224-225 rationale for, 66-72 nonfinancial alternatives, 10, 214, 228 reporting adverse events, 106-107 OHRP guidelines, 215-216 pharmacodynamics, 66, 71, 72-73 and parental permission, 331 pharmacokinetic studies, 26-27, 63, 66, to physicians' for finders' fees, 222-223, 68-70, 72, 73, 133 227-228 process for, 72-74 professional organizations' positions on, for unique diseases, 67, 72, 73, 78 221 waiver of labeling requirements, 90 recommendations for improving, 9-10, Pediatric Emergency Care Applied Research 21, 223-228 Network, 155 recruitment advertising, 217-218, 220, Pediatric Pharmacology Research Network, 223-224 88
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See also individual conflict of interest, 390-392 organizations historical evolution of policies, 45-54, recommended role of, 250-251 151-153, 231 Protection of Pupil Rights Amendment, 321 importance of, 3, 29 Prussia, 45 international efforts to harmonise, 56-57 Pseudomonas aeruginosa infection, 109 privacy of subjects, 388-390 Psoriasis research, 217 Research. See also Clinical research; Public Citizen, Health Research Group, 221 Pediatric drug research Public Responsibility in Medicine and definitions, 31-33, 114 Research, 244 n.2 quality improvement projects Public review and comment process, 55 distinguished, 32 Pulmonary hypertension, 89 Research Involving Children, 52-53, 255 Retinoblastoma, 80 Retinopathy of prematurity, 1, 26 Q Rhode Island, 341, 342, 346, 351, 360-361, 368-369 Quality improvement Rhode Island Hospital, 271 government initiative, 39, 55, 241-243 Risk.
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whole protocol, 136- 18, 122 n.1, 134, 135, 136, 272, 273 138 Shirkey, Harry, 59 and consent issues, 131, 140-141, 154, Simone, Joseph V., 66 163-164, 331-337 Sleep research, 55, 271 correlates of health and disease and, Smallpox research, 45, 46, 55, 116, 133, 129-130 271 developmental status or age Social Security Administration, 95, 100, 321 considerations, 6, 122, 124, 126, 128 Society for Adolescent Medicine, 201, 202, direct benefit standard, 42, 132-133, 203, 251 138 Society for Pediatric Research, 221, 251, disorder or condition criterion, 6, 126, 254, 270 128-131, 133, 136, 395 South Carolina, 325, 341, 342, 346, 352, environmental considerations, 133 361, 368-369 ethnic, cultural, and religious South Dakota, 341, 342, 346, 352, 361, considerations, 116 368-369 foreseeable benefit to others, 126-127 Sponsors of research government guidance, 134-136 financial rewards, 35 justice considerations, 122, 129-130, roles and responsibilities, 274-275 131 Stanford-Binet Intelligence Scale, 125 minimal risk standard, 5, 6, 102-103, State regulatory framework 117-126, 136 age of consent for medical care, 4, 94, minimization of risk from procedures, 104, 156, 201, 322-323, 325-326, 134-136, 142-144 354-362 minor increase over minimal risk age of majority, 4, 94, 322-323, 342 standard, 102-103, 126-128, 136, 343 137, 138, 140 case law examples, 328, 330-337 no benefit to participant, 84, 103, 127, education-related research in school 130-131, 132-134, 137, 138, 331- settings, 340-341, 344-346 337 emancipated minors, 323-324 payment for participation and, 132, 216, illustrations of state laws, 331-337 331 mature minor provisions, 324-325, 347 placebo-control trials, 139-142 352 presentation of information in consent recommendations, 4-5 forms, 163-164 research-specific legislation, 326-328 privacy considerations, 28 research-specific regulations, 328-330 prospective long-term studies, 39 uniform guidelines and national recommendations, 5-6, 17-18, 126, 127- discussion, 337-339 129, 130-131, 134-136, 138 wards of the state, 328-330, 364-375, regulatory framework, 5, 101-103 384-387 required determinations, 117, 118 Subpart A See Common Rule subjectivity of, 118, 120, 265 Subpart D vital importance standard, 6, 130, 133- age of majority, 322 134 agencies adopting, 95, 96, 100, 232, 321 Roche, Ellen, 234 ambiguities in, 232 categories of approvable research, 3, 4, 102-103, 117 S consent to participate in research, 3, 103-104, 322 Sagan, Leonard, 44 defined, 398 Schizophrenia, 27
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Department of Health and Human Wards of the state Services policies. See also Food and consent laws, 104, 158-159, 200, 321, Drug Administration 328-330, 338, 364-375 adverse event reporting requirements, defined, 101, 398 106, 107 experimental research on, 50, 338 age categories, 64 protocol scenario, 384-387 compliance oversight, 231-232, 233 Washington State, 167, 341, 343, 346, 352, criticisms of, 55, 94 362, 374-375
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INDEX 425 Wechsler Intelligence Scale for Children, World Health Organization, 56 n.17 125 World Medical Association, 49, 110, 139 Wechsler Preschool and Primary Scale of Worsfold, Victor, 43 Intelligence, 125 Wyoming, 341, 343, 346, 352, 362 West Virginia, 341, 343, 346, 352, 362 Willowbrook State School, 50, 332 n.15 Wisconsin, 341, 343, 346, 352, 362, 374- Y 375 Women's Health Initiative, 43 Yasui, Lise, 196
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