informed consent and, 94

liability and compensation issues, 193

National Committee for Quality Assurance (NCQA), 171, 172-173, 175, 176, 231, 232

non-biomedical research, 245-246

Research Ethics Review Boards (Research ERBs), 104-105, 107

ACHRE, see Advisory Committee on Human Radiation Experiments

Adverse event reporting, 15, 16, 37, 47, 59, 68, 103, 148, 149-150, 153, 154, 157-158, 161, 165, 170, 192, 254, 261

Advisory Committee on Human Radiation Experiments (ACHRE), 4(n.8), 119, 213-214

AIDS, see HIV

American Association of University Professors, 43

American Medical Association, 118, 206-207

American Society of Gene Therapy (ASGT), 183

Animal studies, 37, 144, 147, 157, 200, 213, 274, 275

Anthrax, 212

Applied Research Ethics National Association (ARENA), 62, 64, 234

Association for the Accreditation of Human Research Protection Programs (AAHRPP), 4(n.4), 171, 173-175, 176, 232, 245-246

Association of American Medical Colleges (AAMC), 4(n.3), 62, 118, 183

Association of American Universities (AAU), 183

Association of Clinical Research Professionals, 183

Association of the British Pharmaceutical Industry, 194

Assurance of Compliance documents, 140

Attitudes and beliefs

see also Psychological effects;

Public opinion

dignity of research participants, 29, 31, 46, 165, 193-194, 238

informed consent, 125-126, 130-131, 132

participants in research, 125-126, 129-133

religious, 97

Audits, 80, 81, 88

committee recommendations, 16, 73, 78, 148-149

defined, 139

Food and Drug Administration (FDA), 69, 73

Research Ethics Review Boards (Research ERBs), 138

Award for Excellence in Human Research Protection, 142

B

Bayh-Dole Act, 185

Beaumont, William, 33

Behavioral and social research, see Non-biomedical research

Belmont Report, 70, 74-75, 92, 119, 181, 238

Best practices, 61, 106, 107, 163-164, 166, 171, 198

see also Good Clinical Practice (GCP)

Biologic license applications, 139

Biomedical Research Alliance of New York (BRANY), 84, 104

Bioterrorism, see Terrorism

Britain, see United Kingdom

C

Center for Drug Evaluation and Research (CDER), 146

Centers for Disease Control and Prevention, 212

Centers for Strategic International Studies, 215

Chief Executive Officers (CEOs), 54, 55, 62, 78, 87, 146, 253

Children, 43

Citizen Advocacy Center, 101, 133, 232

Classified reserach, 213-215

Committee on Human Research Participant Protections (proposed), 199

Common Rule (Federal Policy for the Protection of Human Subjects), 5, 47(n.2), 91, 120, 138, 139, 149, 178, 179, 198, 208, 210, 214, 237, 241-242

see also Institutional Review Boards (IRBs)

Compensation for injury, see Liability and compensation

Computer applications

see also Databases;

Internet



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