The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Responsible Research: A Systems Approach to Protecting Research Participants
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