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Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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INDEX

A

Accreditation, 198-199, 243-245, 394

Acetaminophen, 67

Acne research, 80, 185

Adolescent Medicine HIV/AIDS Research Network, 262, 264

Adolescents. See also Assent;

Emancipated minors;

Mature minors;

Wards of the state

comprehension of research participation, 183-185

consent process for, 8, 9, 154, 156, 171-172, 192-194, 200-201, 204, 206, 207, 322

decisional maturity, 186, 325

defined, 62, 64-66

developmental physiology, 62, 65-66

enrolled in clinical trials, 87

medical examination components, 124

payment for participation, 10, 213, 218-219, 227

pharmacokinetics in, 70

privacy issues, 158, 187, 205, 323, 327

runaways and throw-aways, 200

waiver of parental permissions, 354-362

Adverse events. See also Harm

defined, 106, 394

in ethical principles, 46

examples of, 28-29, 82, 234

monitoring, 37, 105, 106-107

in placebo-controlled trials, 142

reporting requirements, 105, 106-107, 231

serious, 398

Advisory Committee on Human Radiation Experiments, 48, 164, 165

Advocates and advocacy for participants, 154-155, 159, 208, 328-329, 339

Age of consent

for medical care, 4, 94, 156, 325-326, 354-362

for research participation, 94, 326-328

Age of majority

defined, 394

state laws, 94, 104, 322-323, 342-343

Agency for Health Research and Quality, 90

AIDS, 78

Alabama, 104, 325, 340, 342, 344, 347, 354, 364-365

Alaska, 340, 342, 344, 347, 354

Albert Einstein College of Medicine, 271

Alexander, Leo, 46 n.9, 47 n.10

Allergy and Asthma Network, 194, 221

Allergy research, 80

Altruism, 164, 165, 167, 168, 170, 191

American Academy of Pediatrics, 60, 65-66, 120, 140, 161, 221, 251

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

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

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

C

Caffeine, 70

California, 325, 340, 342, 344, 347, 354

Canada, 168, 173

Cancer research, 66, 71-72, 73, 77, 80, 81, 87, 88, 162, 170, 174, 175, 182, 189-190, 218

Cardiac disease, 67, 77, 87-88, 89

Center for Drug Evaluation Research, 55

Centers for Disease Control and Prevention, 161

Centers for Education and Research on Therapeutics, 90

Central Intelligence Agency, 95, 100, 321

Cerebral palsy, 77

Cherokee Nation, 116

Children. See also Assent

cognitive development, 179-180

comprehension of research participation, 7, 183-185

defined, 63-64, 101, 154, 321

enrolled in clinical trials, 87

in foster care, 321, 322 n.2, 328

as interpreters for parents, 199

mortality rates, 80

neglected or abused, 154, 200, 328, 329, 335

outcome measures in, 76

pharmacokinetics in, 69, 70

Children’s Health Act of 2000 , 53, 54, 96, 100, 233, 400

Children’s Hospital Boston, 220-221

Children’s Hospital of Pittsburgh, 271

Children’s Oncology Group (COG), 71-72, 81, 88, 108, 261

Chloramphenicol, 27, 70

Chronic granulomatous disease, 80

Clinical investigation, definition, 33, 165 n.5

Clinical Investigation of Medicinal Products in the Pediatric Population, 111, 217

Clinical practice innovations, 32

“radically new” procedures, 32

Clinical research. See also Clinical trials;

Pediatric drug research

benefits of, 25-26

challenges, 59, 74-87

clinical care distinguished from, 34, 150

as complex, high-stakes enterprise, 35-36

context for, 59-62

definitions, 33-34, 395

experimental, 33, 396

importance of, 29

infrastructure, 83, 86-87, 92, 238

multidisciplinary, 86

organization and administration, 36

policies and procedures, 36

resources, 36

on stored biological specimens, 83

structures, 36

therapeutic vs. nontherapeutic, 33-34, 50, 331-337

unethical practices, 28, 331-332

Clinical trials. See also Multicenter trials;

Pediatric drug research

active treatment, 394

administering interventions and measurements, 78-79

behavioral considerations, 79

blinded, 151, 170, 395

children’s rules for, 188

control groups, 81, 108, 117, 139-142, 151, 396, 397

cooperative research groups, 71-72, 81, 87, 88, 91, 108

costs, 35, 83, 275

crossover studies, 81, 142

data on children’s participation, 87-88

designing and conducting, 2-3, 74-87, 91-92, 142-143

developmental considerations, 67, 71-72, 82

direct-benefit characterization, 34

disease-specific, 81

effect of participation on outcomes, 150

of emergency care, 87, 92, 155, 203

enrollment and retention of participants, 80, 87-88, 217-218, 220, 223-224

expertise of investigators in pediatrics, 3, 63, 78-79, 91-92, 93-94, 99, 136, 142-144, 244, 250

facility appropriateness, 78, 92, 136, 143

family-centered care, 84-85

with healthy children, 27, 50, 117

with ill children, 27, 160, 170, 197-198

long-term monitoring and evaluation, 82-83, 92, 275

minority participants, 87-88

outcome measures, 75-78

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

perceptions and expectations of participants, 150, 151, 164, 165 n.5, 168, 170, 398

Phase 1, 72, 73, 133, 170, 397

Phase 2, 73, 397

Phase 3, 73, 397

placebo-controlled, 81, 108, 139-142, 155, 159, 164-165, 329-330, 398

progress reports, 99

prospective studies, 27

protocols, 398

quality-of-life interventions, 172

randomized controlled, 81, 159, 164-165, 168

recruitment practices, 217-218, 220, 223-224

registry, 88, 242

small study populations, 80-82, 91, 142

standard treatment, 398

suspension or termination, 194, 229, 234, 236

with wards of the state, 385-386

withdrawal from, 174, 183, 187-188, 190, 197, 215

Collins, Frances, 193

Colorado, 325, 340, 342, 344, 347, 354

Common Rule (45 C.F.R. Part 46, Subpart A), 320-321

agencies adopting, 54, 95

criteria for research approval, 3, 97, 99

defined, 395

exempted research, 53, 97, 99-100

expedited review, 53, 100, 117

historical evolution of, 52-53

informed consent, 53, 97

institutional assurances and responsibilities, 95, 96-97

institutional review boards, 97-99

minimal risk standard, 117, 121

vulnerable populations, 52

Compliance oversight

accreditation perspective, 11, 21-22, 243-245

adverse event reporting, 105, 106-107, 231

assurance of compliance, 95, 110, 235, 242, 394

of child participants in research, 29, 55, 234-239

citations of noncompliance, 236

concerns about, 230-234

of conflicts of interest, 232

critical reports on, 231-234

data limitations and needs, 10-11, 230, 233, 234, 238-239, 240, 242, 243

determination letters, 29, 235-236, 396

by FDA, 56-57, 60 n.1, 105 n.3, 234, 236-238, 239

“for-cause” investigations, 232, 235

of foreign research, 56-57, 232-233

of human research, 230-234

monitoring, 37, 105, 106-107

“not-for-cause” evaluations, 232, 235

by OHRP, 232, 234, 235-236, 239, 241-242, 396

progress in, 29, 55

quality improvement perspective, 11, 235, 241-243

recommendations, 21-22, 238-239, 247-248

reporting requirements, 105, 106-107, 231

suspension or termination of research, 194, 229, 234, 236

voluntary actions by institutions and sponsors, 11, 238, 240-245

Comprehension of research participation.

See also Assent;

Consent process;

Informed consent;

Parental permission

adolescents, 183-186

and assent, 7, 28, 42, 131-132, 181-193, 205-206

children, 7, 183-185

cognitive development and, 179-180, 205-206

competency standards, 185

in crisis situations, 7, 169-170

and decision making by parents, 166-178

experience with illness and, 131-132, 171, 189-190

format of presentation and, 181, 184

harms and benefits, 42, 163-164, 183-186

interpretation of terms, 165 n.5

parents, 159-178

purpose of research, 150, 164-165, 183-186, 398

readability of forms, 160-163, 195, 206

research needs, 208

rights of participants, 174, 183, 184, 187-189, 197

therapeutic misconception, 7, 150, 151, 164, 398

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Condition, defined, 128-129, 130

Conference on Social Responsibility in Pediatric Research, 48

Confidentiality

assurances in consent process, 193

Certificate of, 395

ethical principles, 40

genetic studies and, 28

harm from violation of, 115, 116

for minors, 158, 187, 323, 327

regulations, 53, 388-390

translators and interpreters and, 199

Conflict of interest

compliance oversight, 238

defined, 395

financial, 35

finders’ fees as, 223

nonfinancial, 35

physician recruitment of own patients as, 35-36, 223

regulations, 390-392

Connecticut, 340, 342, 344, 347, 355

Consent process. See also Assent;

Informed consent;

Parental permission

accreditation standards, 244

for adolescents, 8, 9, 154, 156, 171-172, 192-194, 200-201, 204, 206, 207, 322

adverse events and, 107

advocates and independent research monitors, 154-155, 159, 202-203, 328-329

age appropriateness of, 7, 8, 156, 171-172, 173, 179-180, 183-185, 192-193, 205-207

assessment of participant’s understanding, 166

benefit and risk descriptions, 150-151, 154, 160, 163-164, 166, 184, 199-200

collaborative model of decision making, 173, 174-175, 209

community consultation and public disclosure, 155

continuous model, 171, 175, 177, 188-189, 192, 197-198

in crisis (acute-care) situations, 7, 169-170, 171, 175, 186, 192, 196, 197-198, 218

for emancipated and mature minors, 9, 157-158

for emergency care trials, 87, 155, 175, 203

family physician’s influence, 7, 152, 168, 173-175, 177, 213

family systems perspective, 172-173, 196, 203-205, 209

form design and content, 149-150, 153-154, 156, 160-163, 166, 181, 182, 184, 191, 193, 194, 198, 206, 207, 217, 222

for future use of stored tissue samples, 83

historical evolution of, 45-47, 48, 49-50

interpreters and translators, 177, 180, 198-199

investigator training for, 208

involvement of children in, 7-8, 40-41, 148, 149-151, 156-157, 171-173, 192, 205-207

IRB policies and practices, 7, 8, 140-141, 149-151, 156, 157, 158-159, 162-163, 193-195, 196, 201-203, 207

language and cultural considerations, 8, 175-176, 177, 180, 198-199, 206-207

litigation concerns and, 150, 152, 331-334

for multisite studies, 162-163, 194-195

outcome information presented in, 163-164

payment discussed in, 9, 215, 217, 222, 224-225

purpose of research presented in, 50, 84, 150-151, 159, 164-165, 182-186

quantitative information about outcomes, 163-164, 173

questions for parents to ask, 12, 177-178

recommended improvements in, 8, 18-21, 151, 166, 191, 195-209

regulatory requirements, 3, 4, 9, 48, 153-154, 400

research directions, 208-209

rights of participants explained, 174, 183, 184, 187-189, 197, 199

state laws and litigation, 201, 330-339

structure of, 8, 172-173, 196, 203-205, 209

treatment vs. research participation, 161, 164-165, 174

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

type and amount of information, 157, 172-173, 174

undue influences on, 9, 173, 174, 213-214, 215, 216, 221

verbal presentation of information, 7-8, 156, 161, 166, 175, 181, 188-189, 194-195, 196, 207

views and results of, 168, 174, 175-176

waiver of parental permission, 9, 19-20, 154-155, 200-203

for wards of the state, 158-159, 200-201, 209

Consortium of Social Science Associations, 244 n.2

Control groups, 81, 108, 117, 139-142, 151, 396, 397

Cooperative research groups, 71-72, 81, 87, 88, 91, 108

Corticosteroids, 69, 71

Cosmetic surgery, 185

Council for International Organizations of Medical Sciences, 56-57, 127, 139, 217, 222, 256

Crossover studies, 81, 142

Cyclosporine, 27

Cystic Fibrosis Foundation, 88, 178, 218, 221, 262

Cystic fibrosis research, 75, 76, 77, 87, 108-109, 193, 271

Cytochrome P-450 1A2 , 70

D

Data and safety monitoring boards

composition of, 109

defined, 396

expertise in pediatrics, 37, 108, 252-253

federal regulations, 97, 107-110

independence of, 109, 110

responsibilities of, 108-109, 140

Data monitoring committees. See Data and safety monitoring boards

Declaration of Helsinki, 33 n.4, 49-50, 57, 110, 111, 139

Delaware, 340, 342, 344, 347, 355, 364-365

Denver Developmental Screening Test II, 125

Developing countries, 57, 67

Diabetes research, 55, 65, 77, 87, 169, 184, 189, 190, 218, 271

Didanosine, 110

Diethylene glycol, 67

Disease, defined, 33

Disorder, defined, 128

District of Columbia, 340, 342, 344, 347

Dornase alpha (Pulmozyme), 76

Drug Amendments of 1962 , 400

Drug research. See also Pediatric drug research

costs, 35

Drugs. See also specific drugs and classifications of drugs

developmental issues, 60, 61, 65-72, 81

dosing schedules and errors, 68, 69-70

excipient safety, 67-68

extrapolation from adult studies, 2, 26-27, 43, 58, 60, 68-69, 71, 91

half-life, 69-70

labeling information for pediatric use, 60, 90-91

misbranding, 67 n.6

off-label use, 60-61, 67, 74, 397

Phase 1 trials , 397

E

Economically disadvantaged persons, 10, 42-43, 46, 122, 213, 214, 224, 331-332, 333

Emancipated minors

conditions for establishing, 323, 344-346

consent, 104, 157-158, 324

defined, 157, 323, 324, 325 n.10, 396

mature minors distinguished from, 325, 327-328

state laws, 323-324, 344-346

Engelhardt, Tristram, 43

Ethical principles

adverse events, 46

AMA code, 45 n.7

Belmont Report, 40-41, 43, 52-53, 93, 110, 213

beneficence and nonmaleficence, 40-44, 45 n.7, 47

Declaration of Helsinki, 33 n.4, 49-50, 57, 139

education and training in, 268-270

foreseeable benefit of research and, 44

for future use of stored tissue samples, 83

historical evolution of, 44-53

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

implementation, 85

informed consent and assent, 2, 40-41, 45-47, 48-49, 50, 84, 147-149, 192

justice, 41, 42-43, 57, 122, 129-130

nonbeneficial research and, 42, 43

Nuremberg Code, 46-47, 49

payment for participation, 41, 213-215

physician-patient relationship and, 44

placebo-controlled trials, 139-142

for research involving children, 7, 43, 51, 52-53, 93, 101, 183-185, 188

respect for persons (autonomy), 40-42

in review of protocols, 48-49

and trust, 25

UNESCO guidelines, 56 n.17

European Agency for the Evaluation of Medicinal Products, 111

European research, 175

Exempt research, 53, 99-100

Expedited review, 53, 99-100

F

Federal agencies. See also individual agencies

education and guidance for IRBs and investigators, 268-270

policy development, guidance, data collection, and research, 273-274

roles and responsibilities, 15-16, 18, 23, 267-274

under Common Rule, 54 n.1

Federal Food, Drug, and Cosmetic Act, 48, 67, 152, 230

Federal rules and regulations. See also Common Rule;

Compliance oversight;

Food and Drug

Administration rules and policies;

National Institutes of Health policies;

Subpart D

adverse event reporting, 105, 106-107

ambiguity in, 4, 94, 102-103, 106, 114, 230, 231, 232

applicable research, 230, 247

for assent, 3, 104, 151-153, 156-157, 182, 191, 204

assurance of compliance declaration, 97, 110, 394

for continuing review, 99

data and safety monitoring boards, 107-110

data monitoring committees, 105, 107-110

foreign research, 56-57, 110

historical evolution of, 52-57

minimal risk defined in, 115

for parental permission, 3, 152-155, 193

payment for participation, 215-217

Federation of American Societies of Experimental Biology, 244 n.2

Federation of Pediatric Organizations, 86

Fetal research, 52

Florida, 340, 342, 344, 348, 355, 364-365

Fluoxetine (Prozac), 60

Food and Drug Administration Modernization and Accountability Act of 1997 , 89, 400

Food and Drug Administration rules and policies

adverse event reporting requirements, 106, 107

age categories, 63, 64, 65

compliance oversight, 60 n.1, 67 n.6, 88, 91, 105 n.3, 106-107, 108, 233, 234-235, 236-238

conformity with Subpart D, 5, 53, 95, 100, 400

data monitoring committees, 108

on foreign research, 110, 111, 233

Good Clinical Practices Program, 55, 68, 234-235

guidance on research involving children, 255

incentives for pediatric drug research, 2, 27, 90-91

for informed consent, 48, 94, 154, 400

on institutional review boards, 400

Investigational New Drug Application, 56, 111, 152

Office of Pediatric Therapeutics, 238

Office of Science and Health Coordination, 234-235

for parental permission, 9, 154, 155, 201-202, 203

payment guidelines for participants, 216, 217, 227

on pediatric drug trials, 2, 71, 73, 75-76, 90-91

on placebo-controlled trials, 139 n.8

protocols referred to Commissioner, 102, 116, 134

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

recommended roles and responsibilities, 18, 23, 269

regulations, 3, 4, 9, 53, 54, 95-96, 100, 193, 230, 321, 400

review and monitoring program, 105, 106-107, 236-237

Forced expiratory volume at 1 sec (FEV1) , 76

G

“Gasping syndrome,” 67

Gelsinger, Jesse, 55, 234

General Clinical Research Centers, 261

Genetic Alliance, 221

Genetic research, 75, 80, 116, 171, 182, 186, 193, 253

gene therapy trials, 28, 39, 55, 105, 109, 150, 234, 271

Georgia, 340, 342, 344, 348, 355

Germany, 46

Glantz, Leonard, 44

Glucuronyl transferase, 70

Gonorrhea, 45

Good Clinical Practices Program, 55, 68, 234-235

Good manufacturing practices, 68

Gorman, Richard, 90

“Gray baby syndrome,” 70

Guardians, 101, 154, 217, 321, 396

Guideline for Good Clinical Practice, 110-111

H

Harbor-UCLA Medical Center, 271

Harm. See also Adverse events,

risk defined, 114-115, 396

discomfort as, 115, 140

duration and magnitude considerations, 123, 126, 128, 134

identification of, 26

instances of, 67

prospective long-term studies, 39

unanticipated problems, 107

Hauerwas, Stanley, 43

Hawaii, 340, 342, 344, 348, 355

Health Insurance Portability and Accountability Act of 1996 , 94, 388-390

Hemophilia, 123

Hepatitis, 50

Hess, Alfred F., 46

Hexachlorophene, 69

Hippocrates, 40

HIV research and testing, 88, 108, 171-172, 194, 262, 264, 271

Hohmann, Elizabeth, 239

Human Genome Project, 28, 39

Human research participants protection program

components or modules, 37

core functions, 37

defined, 396

ethical principles, 39-44

historical evolution of policies, 52

implementation challenges, 28, 29-30, 37-38

for multicenter trials, 37, 39

systems perspective, 36-39

Human subjects

defined, 34, 396

Hyaline membrane disease, 27

I

Ibuprofen, 167

Idaho, 340, 342, 344, 348, 356

Illinois, 340, 342, 344, 348, 356, 364-365

Immunosuppressive agents, 27

In vitro fertilization, 52

Indian Health Service, 116

Indiana, 325, 340, 342, 344, 348, 356

Infants

defined, 63

experiments on orphans, 46

functioning and behavior, 125

instances of harm to, 67, 70

low-birth-weight, 82, 88

outcome measures in, 76

pharmacokinetics of drugs, 69-70

premature, 1, 26, 27, 58, 63, 67, 69, 75, 78, 80, 82, 87, 88

well-child examination components, 124

Informed consent. See also Assent;

Comprehension of research participation;

Consent process;

Parental permission

age of majority, 4, 94, 104, 154, 156, 325-326, 354-362

defined, 146, 395

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

 

by emancipated and mature minors, 157-158

ethical principles, 2, 40, 45-47, 48-49, 147-149

exempted research, 53, 97, 99-100

federal regulations, 53, 97, 151-153, 231

general conditions for, 51, 116, 148-149, 190

informational requirements for, 159

for long-term studies, 83

parental permission distinguished from, 148-149, 159, 198-200

for placebo-controlled trials, 139, 140-141

reading levels and readability of forms, 160-163

Institute of Medicine, 30, 233, 234, 243, 246, 251

Institutional review boards

central review model, 265-266

community and family input to, 14-15, 254

composition, 35, 96, 97, 253-254

consent policies and practices, 7, 8, 143-144, 156, 157, 158, 193-195, 321, 327

continuing review by, 99, 107

database and information system, 266, 267

defined, 396-397

documentation of decisions and checklists, 55, 105, 134, 267, 242, 257-259, 260-261

expedited review, 53, 100, 117

foreign, 56

guidance on research with children, 15, 255-258, 268-270, 273

historical evolution of, 48-49, 51, 52

inspections of, 108

minimal risk interpretation, 118-121

monitoring adverse events, 107-108

multicenter protocol review, 255, 261-266

Native American, 116

payment policies, 216, 217-218, 219, 220-221, 224-225, 261

pediatric expertise on, 251-261

qualifications of members, 14, 22-23, 37, 76-77, 86, 97-99, 158, 244, 248, 251-255, 321

recommendations, 14, 15, 18, 22-23, 138, 253, 258, 266

referral of protocols to the DHHS Secretary or FDA Commissioner, 102, 103, 116, 134, 137 n.6, 270-273

regulatory framework, 96-97, 97-99, 101, 321, 400

roles and responsibilities, 13-15, 28, 49, 51, 53, 96-97, 105 n.3, 106, 108-109, 138, 232, 247, 251-267

sharing information about decisions, 55, 105, 134, 267, 274-275

supplemental policies and guidance, 258, 261

variability in decisions, 262-265

waiver of parental permission, 19, 84

written basis for judgments, 6, 134

Intelligence tests, 125

International Conference on Harmonisation, 33 n.4, 56, 63, 71, 111, 139, 156-157, 217, 396, 397

International Covenant on Civil and Political Rights, 49 n.12

International Ethical Guidelines for Biomedical Research Involving Human Subjects, 111

International research, regulation of, 56-57, 110, 232-233

Interventions, defined, 34

Intraocular lens replacement, 61

Investigators and research teams

child life specialists and child psychologists, 79

consent policies and practices, 20, 84, 193-195

cultural sensitivity, 84

expertise in pediatrics, 3, 20, 63, 78-79, 91-92, 93-94, 99, 136, 142-144, 244, 250

inspections of, 108

minimal risk interpretations by, 118-121

payments to, 222-223, 227-228

progress reports, 99

recommendations, 19, 250

roles and responsibilities, 12-13, 35, 84, 99, 142-143, 248-251

training and retention of, 86-87, 250

Iowa, 340, 342, 344, 348, 356

Ivy, Andrew, 46, 47 n.10

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

J

Jenner, Edward, 45

Jewish Chronic Disease Hospital Study, 331-332

Johns Hopkins University, 332

Joint Commission on the Accreditation of Healthcare Organizations, 244

Jonsen, Albert, 53 n.14

K

Kansas, 340, 342, 344, 348, 356

Kennedy Krieger Institute, 331-332

Kentucky, 340, 342, 344, 349, 356-357

Kernicterus, 69

Kidney disease, 92

Koski, Greg, 229

L

Lamivudine, 110

Lasagna, Louis, 47

Lead abatement studies, 330-331

Legally authorized representative, defined, 101

Legislation. See also Regulatory framework for protection;

specific statutes

incentives for pediatric research, 89-90

Leukemia, 26, 66, 75, 80, 82, 87, 88, 106, 169, 184

Lilly, Joseph, 169

Lilly, Maureen, 58

Lippincott, Sarah, 191-192

Long-term studies

implementation, 83

importance, 82

Louisiana, 340, 342, 344, 349, 357, 364-367

M

Maine, 325, 340, 342, 344, 349, 357, 366-367

Maryland, 328, 331-334, 339, 340, 342, 345, 349, 357

Massachusetts, 336, 340, 342, 345, 349, 357

Maternal and Child Health Bureau, 89

Mature minors

abortion law, 336

consent to research, 104, 158, 203, 204, 206, 323

consent to treatment, 336-337, 347-352

defined, 325, 397

emancipated minors distinguished from, 325, 327-328

state laws, 324-325, 336-337, 347-352

status events for consenting to health care, 347-352

McCormick, Richard, 43

Measles, 1, 26, 45

Medical Device User Fee and Modernization Act of 2002 , 60 n.1

Medical experiment, 165 n.5

Medical research, 165 n.5

Medical study, 165 n.5

Mentally ill, institutionalized persons, 42-43, 50, 51 n.13, 334-336

Methylphenidate (Ritalin), 60

Michigan, 340, 342, 345, 349, 357

Midazolam hydrochloride (Versed), 89

Minimal risk

“daily life” reference, 5, 118, 121, 126

defining, 5, 115, 117-126, 397

developmental status or age considerations, 122, 124, 126

discomfort as, 115

ethical principles, 47

exemption or expedited review, 53

for healthy children, 5, 117, 120, 121-125, 126

for ill children, 120, 122-123

investigator and IRM interpretation, 118, 120-121

moral and social implications, 5, 120-121

and no benefit to participant, 84, 103, 127

procedures categorized as, 123, 134-136

psychological tests, 125

recommended interpretation, 5-6, 126

relativistic interpretation, 5, 121-122, 126, 127

routine examination standard, 4, 124-125

socially allowable risks, 123

Minnesota, 340, 342, 345, 350, 357

Minor increase over minimal risk standard

benefit standard, 6, 115-116, 130, 328-329

commensurate procedure criterion, 128, 131-132, 395

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

defining, 118, 120, 126-128, 397

disorder or condition criterion, 6, 128-131, 395

recommendations, 130-131

research-only procedures, 137

Minorities, 175

Mississippi, 104, 340, 342, 345, 350, 358

Missouri, 340, 342, 345, 350, 358

Montana, 340, 342, 345, 350, 358

Mothers of Asthmatics, 221

Multicenter trials

consent process, 162-163, 194-195

defined, 397

enrollment and retention of participants, 84

in foreign countries, 110

implementation of protective policies, 28, 37, 39

need for, 92

protocol review, 261-266

reporting adverse events, 107

risk categorization in, 120

size of study populations, 81

state regulation of, 4-5

variable review of, 261-266

Mumps, 1

N

National Academy of Sciences, 25

National Association of State Universities and Land Grant Colleges, 244 n.2

National Bioethics Advisory Commission (NBAC), 32-33, 34, 35, 56, 83 n.8, 113, 117, 136-137, 223, 232-233, 248

National Cancer Institute, 87, 108, 162, 265

National Center for Health Statistics (NCHS), 63, 64

National Commission for Quality Assurance, 244

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 6, 33 n.4, 40, 43, 51 n.13, 52, 53, 93, 101, 125, 126, 127, 129, 131-132, 134, 136, 138, 139, 154, 156, 200, 201, 268-269, 400

Belmont Report, 40-41, 43, 52-53, 93, 110, 255

Research Involving Children, 52-53, 255

National Conference of State Legislators, 338

National Governors Association, 338

National Health Council, 244 n.2

National Human Research Protections Advisory Committee (NHRPAC), 122, 123, 127, 129, 131, 135, 269

National Institute of Allergy and Infectious Diseases, 88

National Institute of Child Health and Human Development (NICHD), 88, 89

National Institutes of Health policies, 178, 234

age categories, 64

Certificate of Confidentiality, 395

Clinical Center, 47-48, 52, 222

clinical research curriculum grants, 86

historical evolution of, 47-48, 52

incentives for research, 2, 27, 52, 91-92

IRB database and information system, 266, 267, 275

for monitoring data and safety, 105, 108

notification of institution’s noncompliance, 236

parental permission, 155

on payment for participation, 219-220, 222, 227

prospective studies of immunosuppressive agents, 27

recommended roles and responsibilities, 23, 269

regulations applicable to, 95, 97

National Research Act of 1974 , 52, 400

National Research Council, 30

Native Americans, IRBs, 116

Navaho Nation, 116

Nebraska, 104, 340, 342, 345, 350, 358

Nebulized albuterol, 60

Nelson, Robert M., 211

Nelson Textbook of Pediatrics, 63, 64, 65

Neonatal Research Network, 88

Neonates, 63, 69, 70, 124, 168, 175.

See also Infants

Netherlands, 167

Nevada, 340, 342, 345, 350, 358

New England Medical Center Hospital, 271

New Hampshire, 341, 342, 345, 350, 358, 366-367

New Jersey, 341, 342, 345, 350, 358-359, 366-367

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

New Mexico, 341, 342, 345, 351, 359, 368-369

New York, 334-336, 339, 341, 342, 345, 351, 359

New Zealand studies, 167-168

North Carolina, 341, 342, 345, 351, 359

North Dakota, 341, 342, 345, 351, 359, 368-369

Nuremberg Code, 46-47, 49, 152

Nutrition research, 184

O

Obesity, 77, 80

Office for Human Research Protections, 53 n.15, 136

central IRB review model, 265-266

compliance oversight by, 55, 99, 216, 229, 232, 233, 234, 235-236, 239, 396

determination letter, 216, 396

guidance on research involving children, 255

payment guidelines, 215-216

quality improvement initiative, 235, 241-242

recommended roles and responsibilities, 6, 18, 23, 136, 155, 202, 203, 239, 269, 270, 272

Office for Protection from Research Risks, 55

Office of Management and Budget, 239, 241

Office of Public Health and Transfer, 55

Ohio, 341, 342, 345, 351, 360

Oklahoma, 341, 342, 345, 351, 360, 368-369

Oregon, 325, 341, 342, 346, 351, 360

Organ transplants, 27

Otitis media, 80

Outcome measures

age-appropriate, 75-77

consent and quantitative information about, 163-164

death, 75

defining, 75-78

developmental appropriateness, 76-77

normative data, 78

pain scales, 77

physical or cognitive functioning, 76-77

quality-of-life, 77

surrogate measures, 75-76

survival after diagnosis and disease-free survival, 75

Oversight of regulations. See Compliance oversight

P

Pain assessment and management, 77, 79

Parental permission. See also Assent;

Consent process;

Informed consent

compensation and, 331

comprehension level and, 7, 42, 131-132, 159-178, 198-200

conditions/disorders not requiring permission for treatment, 354-362

crisis-driven decision making, 169-170, 171

decision-making process, 166-178

defined, 101, 146, 397

ethical principles, 148

exceptions to requirements for, 324

expectations of benefit and, 151, 164-165, 167, 169-171, 199-200

experience of illness and, 171

family physician’s influence, 7, 168

federal regulations, 103-104, 152-155

forms, 193

by guardians, 49-50, 146, 154, 396

informational requirements for, 159-160

informed, 198-200

informed consent distinguished from, 148-149, 159

investigator’s undue influence on, 173, 174

legal requirements for, 3, 151-155, 331-337

limits of authority, 335

motivation for decisions, 167-169

process, 149-151, 175-176

reading levels and readability of forms, 160-163

research on decision making, 166-178

risk-benefit standards, 331-337

views and results of consent process, 168, 174, 175-176

waiver of, 4, 9, 19-20, 51, 84, 94, 97, 104, 154-155, 193, 194, 200-203, 321, 335

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Parents

compensation for time and inconvenience, 10, 212, 214, 217, 219, 220, 221, 227, 228, 395

defined, 101, 154, 397

incompetent, 154

influence of children, 187, 190-191, 204-205

participation in clinical studies, 34

questions to ask during consent process, 12, 177-178

reimbursement for expenses, 10, 212, 213, 214, 217, 218, 219, 220, 225-226, 398

responsibilities of, 160

termination of rights, 329

Participants, defined, 397

Partnership for Human Research Protection, Inc., 244

Pattee, Suzanne, 178

Payment for participation

acceptable types of, 10, 225-227

to adolescents, 10, 213, 218-219, 227

amounts paid, 217, 218, 219

bonuses for completion of study, 217, 224

and child’s assent, 189, 211

compensation for time and inconvenience, 10, 212, 214, 217, 219, 220, 221, 227, 228, 395

ethical concerns, 9, 41, 211, 213-215, 220

federal regulations and policies, 215-217, 220, 227

to guardians, 217

incentive payments, 189, 212, 213, 214-215, 216, 221, 227-228, 396

for injuries related to research, 221-222, 227

IRB policies and practices, 9, 216, 217-218, 219, 220-221, 223, 224-225

nonfinancial alternatives, 10, 214, 228

OHRP guidelines, 215-216

and parental permission, 331

to physicians’ for finders’ fees, 222-223, 227-228

professional organizations’ positions on, 221

recommendations for improving, 9-10, 21, 223-228

recruitment advertising, 217-218, 220, 223-224

reimbursement for expenses, 10, 212, 213, 214, 217, 218, 219, 220, 225-226, 398

research on use of, 217-220, 227

and risk-benefit assessment, 132, 216, 331

risk-related, 10, 216, 218, 219-220, 221, 226-227

token payments or gifts, 212-213, 215

types of, 212-213, 221

undue influence of, 9, 213, 214, 221

waiver of treatment costs as, 221

written policies on, 9, 222, 224-225

Pediatric AIDS Clinical Trials Group, 88

Pediatric drug research. See also Clinical research;

Clinical trials

with adolescents, 7, 64-66

adverse effects by developmental stage, 67, 71-72, 82

age-appropriate formulations, 26-27, 61, 66, 67-68, 73

with children, 63-64, 69, 76, 78, 79

commercial value of, 61-62, 89

costs of, 61

data monitoring committees, 108

direct benefits of, 133

disclosure of findings, 27 n.1, 106, 250

efficacy trials, 73, 133

ethical and regulatory standards, 60 n.1, 62, 63, 85

incentives for, 30, 59, 89-92

with infants, 63, 67, 69, 70, 76, 78, 79

information gaps, 26-27

labeling for pediatric doses, 89

long-term follow-up and surveillance, 71-72, 75, 76, 82-83, 106, 275

normative data, 75, 76, 78

patent protection, 89

payment for participation, 217

rationale for, 66-72

reporting adverse events, 106-107

pharmacodynamics, 66, 71, 72-73

pharmacokinetic studies, 26-27, 63, 66, 68-70, 72, 73, 133

process for, 72-74

for unique diseases, 67, 72, 73, 78

waiver of labeling requirements, 90

Pediatric Emergency Care Applied Research Network, 155

Pediatric Pharmacology Research Network, 88

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Pediatric Research Equity Act of 2003, 90, 400

PedsQL 4.0 instrument, 77

Pellegrino, Henry, 248

Pennsylvania, 341, 342, 346, 351, 360

Percival, Thomas, 45 n.7

Pertussis, 45, 168

Pharmacodynamics, 71, 397

Pharmacokinetics, 68-70, 397

Phenolbarbitol, 71

Phenylketonuria, 58

Phenytoin, 69

Placebo-controlled trials, 81, 108, 139-142, 155, 159, 164-165, 329-330, 398

Polio, 1, 26

Polycystic ovary syndrome, 65

Pregnant women, 52

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 53-54

Prisoners, 42-43, 52, 159, 231, 321, 328

Privacy issues, 115, 158, 187, 205, 323, 327, 339

Professional societies. See also individual organizations

recommended role of, 250-251

Protection of Pupil Rights Amendment, 321

Prussia, 45

Pseudomonas aeruginosa infection, 109

Psoriasis research, 217

Public Citizen, Health Research Group, 221

Public Responsibility in Medicine and Research, 244 n.2

Public review and comment process, 55

Pulmonary hypertension, 89

Q

Quality improvement

government initiative, 39, 55, 241-243

projects as research, 32

R

Radiation experiments, 48, 50

Radiation therapy, 26, 59, 82

Ramsey, Paul, 43

REACH (Reaching for Excellence in Adolescent Care and Health), 262

Recombinant DNA Advisory Committee, 269

Recommendations

assent and permission process, 8, 18-21, 151, 166, 191, 195-209

compliance oversight, 10-11, 21-22, 238-239, 247-248

data collection, 10-11, 23, 238-239, 247-248, 273-274

federal agency responsibilities, 23, 273-274

institutional review boards, 14, 15, 18, 22-23, 138, 253, 258, 266

payment policies, 9-10, 21, 223-228

risk-benefit assessments, 5-6, 17-18, 126, 127-129, 130-131, 134-136, 138

Recruitment of participants, 217-218, 220, 223-224

Regulatory framework for protection. See also Compliance oversight;

Federal rules and regulations;

State regulatory framework;

specific statutes

conflict of interest, 390-392

historical evolution of policies, 45-54, 151-153, 231

importance of, 3, 29

international efforts to harmonise, 56-57

privacy of subjects, 388-390

Research. See also Clinical research;

Pediatric drug research

definitions, 31-33, 114

quality improvement projects distinguished, 32

Research Involving Children, 52-53, 255

Retinoblastoma, 80

Retinopathy of prematurity, 1, 26

Rhode Island, 341, 342, 346, 351, 360-361, 368-369

Rhode Island Hospital, 271

Risk. See also Minimal risk

defined, 114, 398

to others, 116

procedures categorized by, 5-6, 123, 134-136

reasonableness of, 138-142

Risk-benefit assessment

algorithm, 117, 119

basic concepts, 114-116

clinical equipoise criterion, 138-142

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

commensurate procedure criterion, 6-7, 128, 130, 131-132, 395

by components vs. whole protocol, 136-138

and consent issues, 131, 140-141, 154, 163-164, 331-337

correlates of health and disease and, 129-130

developmental status or age considerations, 6, 122, 124, 126, 128

direct benefit standard, 42, 132-133, 138

disorder or condition criterion, 6, 126, 128-131, 133, 136, 395

environmental considerations, 133

ethnic, cultural, and religious considerations, 116

foreseeable benefit to others, 126-127

government guidance, 134-136

justice considerations, 122, 129-130, 131

minimal risk standard, 5, 6, 102-103, 117-126, 136

minimization of risk from procedures, 134-136, 142-144

minor increase over minimal risk

standard, 102-103, 126-128, 136, 137, 138, 140

no benefit to participant, 84, 103, 127, 130-131, 132-134, 137, 138, 331-337

payment for participation and, 132, 216, 331

placebo-control trials, 139-142

presentation of information in consent forms, 163-164

privacy considerations, 28

prospective long-term studies, 39

recommendations, 5-6, 17-18, 126, 127-129, 130-131, 134-136, 138

regulatory framework, 5, 101-103

required determinations, 117, 118

subjectivity of, 118, 120, 265

vital importance standard, 6, 130, 133-134

Roche, Ellen, 234

S

Sagan, Leonard, 44

Schizophrenia, 27

Secretary’s Advisory Committee on Human Research Protections (SACHRP), 6, 18, 122 n.1, 134, 135, 136, 272, 273

Shirkey, Harry, 59

Simone, Joseph V., 66

Sleep research, 55, 271

Smallpox research, 45, 46, 55, 116, 133, 271

Social Security Administration, 95, 100, 321

Society for Adolescent Medicine, 201, 202, 203, 251

Society for Pediatric Research, 221, 251, 254, 270

South Carolina, 325, 341, 342, 346, 352, 361, 368-369

South Dakota, 341, 342, 346, 352, 361, 368-369

Sponsors of research

financial rewards, 35

roles and responsibilities, 274-275

Stanford-Binet Intelligence Scale, 125

State regulatory framework

age of consent for medical care, 4, 94, 104, 156, 201, 322-323, 325-326, 354-362

age of majority, 4, 94, 322-323, 342-343

case law examples, 328, 330-337

education-related research in school settings, 340-341, 344-346

emancipated minors, 323-324

illustrations of state laws, 331-337

mature minor provisions, 324-325, 347-352

recommendations, 4-5

research-specific legislation, 326-328

research-specific regulations, 328-330

uniform guidelines and national discussion, 337-339

wards of the state, 328-330, 364-375, 384-387

Subpart A. See Common Rule

Subpart D

age of majority, 322

agencies adopting, 95, 96, 100, 232, 321

ambiguities in, 232

categories of approvable research, 3, 4, 102-103, 117

consent to participate in research, 3, 103-104, 322

defined, 398

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

definitions, 101

historical evolution of, 53

minimal risk standard, 117, 121

risk-benefit assessment, 101-103, 133-134

Sudden infant death syndrome, 75, 167-168

Sulfanilamide, 67

Sulfonamides, 67, 69

Surfactant therapy, 26, 27

Syphilis, 45

T

Tennessee, 336-337, 341, 342, 346, 352, 361, 368-373

Tetracyclines, 71

Texas, 341, 342, 346, 352, 361

Theophylline, 70

Therapeutics Development Network (TDN), 88, 218, 262

Therapeutic misconception, 7, 150

Tobramycin solution for inhalation (TOBI), 76, 108-109

Toulmin, Stephen, 43

Tuberculosis studies, 46, 195

Tuskegee Syphilis Study, 52, 331

Typanocentesis, 120

U

United Nations, 49 n.12

Education, Social and Cultural Organization, 56 n.17

University of California at Los Angeles, 220, 271

University of Maryland, 332

University of North Carolina, 271

University of Pennsylvania, 28, 55

University of Rochester Medical Center, 321 n.1

University of Washington, 222, 271

U.S. Department of Education, 54, 95, 100, 321

U.S. Department of Health and Human Services policies. See also Food and Drug Administration

adverse event reporting requirements, 106, 107

age categories, 64

compliance oversight, 231-232, 233

criticisms of, 55, 94

on foreign research, 110-111

funding allocations, 90

historical evolution of, 51, 52-53, 54

on investigator qualifications, 99

on payment of participants, 214, 220, 223, 227

protocols referred to the Secretary, 103, 116, 134, 137, 270-273

public review and comment process, 55

regulations on protection of human subjects, 2, 3, 4, 9, 52-53, 94, 95, 96, 100, 102-103, 106, 153, 155, 193, 200, 230, 321, 400-401

U.S. Department of Health, Education and Welfare, 51, 52, 54

U.S. General Accounting Office, 88, 231-232

U.S. Public Health Service grants, 49, 153

U.S. Surgeon General, policy statements, 48-49, 51, 152-153

Utah, 341, 343, 346, 352, 361, 372-373

V

Vaccine research, 26, 27, 45, 50, 55, 116, 133, 161, 168, 183, 271

Vaughn, Andrell, 146

Vermont, 341, 343, 346, 352, 361

Veterans Administration, 222

Virginia, 341, 343, 346, 352, 361

Vulnerable groups

consent laws, 51 n.13, 320, 322, 329-330, 331-337

economically disadvantaged persons, 42-43, 46, 122, 331-332, 333, 337

mentally ill, institutionalized persons, 42-43, 50, 51 n.13, 334-336, 337

prisoners, 42-43, 52, 159, 231, 321, 328

underuse and overuse of, 42-43

W

Wards of the state

consent laws, 104, 158-159, 200, 321, 328-330, 338, 364-375

defined, 101, 398

experimental research on, 50, 338

protocol scenario, 384-387

Washington State, 167, 341, 343, 346, 352, 362, 374-375

Suggested Citation:"Index." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Wechsler Intelligence Scale for Children, 125

Wechsler Preschool and Primary Scale of Intelligence, 125

West Virginia, 341, 343, 346, 352, 362

Willowbrook State School, 50, 332 n.15

Wisconsin, 341, 343, 346, 352, 362, 374-375

Women’s Health Initiative, 43

World Health Organization, 56 n.17

World Medical Association, 49, 110, 139

Worsfold, Victor, 43

Wyoming, 341, 343, 346, 352, 362

Y

Yasui, Lise, 196

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In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies.

Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

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