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



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement