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Ethical Conduct of Clinical Research Involving Children
American Cancer Society, 80
American Law Institute, 325 n.8
American Medical Association (AMA), 45 n.7, 46 n.9, 223
American Pediatric Society, 254
Anesthesia research, 168 , 183
Antibiotics, 50 , 76
Anticancer agents, 66 , 71-72 , 73 , 80 , 106
Anticonvulsants, 69
Antidepressants, 27 , 60
Antihistamines, 71
Arizona, 340 , 342 , 344 , 347 , 354
Arkansas, 340 , 342 , 344 , 347 , 354
Arthritis, 77
Assent. See also Consent process;
Informed consent;
Parental permission
age appropriateness of process, 7 , 8 , 156 , 171-172 , 173 , 179-180 , 183-185 , 192-193 , 205-207
cognitive development and, 179-180 , 205-206
comprehension of research participation and, 7 , 28 , 42 , 131-132 , 181-193 , 205-206
defined, 51 n.13, 101 , 146-147 , 156 , 327 , 394
discretion in documenting, 207
ethical principles, 40-41 , 50 , 84 , 148 , 192
experience of illness and, 131-132 , 189-190
forms, 193 , 206 , 207
historical evolution of policies, 50 , 51 n.13
information to be provided, 206
legal requirements for, 3 , 104 , 151-153 , 156-157 , 182 , 191 , 204
motivations for, 164 , 165 , 167 , 168 , 170 , 191
“mutual pretense” process and, 191
parental influence, 187 , 190-191 , 204-205
payment for participation and, 189 , 211
for placebo-controlled trials, 140
procedures for seeking, 148 , 149-151 , 156 , 172-173 , 205-207
purpose of research and, 171
recommended improvements in, 20 , 203-205
waiver of, 156
withdrawal from trials, 183 , 187-188 , 190 , 197
Association for the Accreditation of Human Research Protection Programs, 244
Association of American Medical Colleges, 244 n.2
Association of American Universities, 244 n.2
Association of Medical School Pediatric Department Chairs, 221
Assurance of compliance, 95 , 110 , 235 , 242 , 394
Asthma research, 77 , 80 , 167 , 168-169 , 191
Astrocytoma, 80
Atopic dermatitis, 77
Australian studies, 170 , 172 , 174 , 186
AZT, 108
B
Bartholome, William, 43
Bayley Scales of Infant Development, 125
Beaumont, William, 45 n.7
Beecher, Henry, 35 , 39 , 50 , 248
Behavioral studies, 384-385
Belmont Report , 40-41 , 43 , 52-53 , 93 , 110 , 255
Benefits of research, 1 , 25-26 , 58 .
See also Risk-benefit assessment
collateral or indirect, 132
defined, 115-116 , 395 , 396
direct, 42 , 132-133 , 136 , 154 , 158 , 204 , 218 , 396
ethical principles relating to, 40-44 , 45 n.7, 47
expectations of, 150 , 151 , 164 , 165 , 167 , 169 , 170 , 398
to other children, 115-116 , 126-127 , 149 n.2
peripheral, 149 n.2
potential, 115 , 116 , 133-134
prospective long-term studies, 39
Benzyl alcohol, 67
Bernard, Claude, 45 n.7
Best Pharmaceuticals for Children Act of 2002 , 2 , 30 , 68 , 89 , 106 n.3, 233 , 400
Bilirubin, 69
Boston University, 48
Brazelton Neonatal Behavioral Assessment Scale, 125
Breast cancer, 171
Brokowski, Carolyn, 182