Index
A
AAHRPP, see Association for the Accreditation of Human Research Protection Programs, Inc.
AAMC, see Association of American Medical Colleges
AAU, see Association of American Universities
Academic research, 37, 58, 183
see also Accreditation
accountability, 50, 54-55, 56-57, 58, 250-252
Association of American Medical Colleges (AAMC), 4(n.3), 62, 118, 183
Association of American Universities (AAU) , 183
Federal Demonstration Partnership, 198
liability and compensation, 192
participant-investigator interactions, 113
Research Ethics Review Boards (Research ERBs), 81, 84, 86, 251-252
Accountability, general, 2, 5, 27, 38, 48, 50, 51, 175, 249-262
see also Accreditation;
Institutional Review Boards (IRBs);
Liability and compensation;
Research Ethics Review Boards (Research ERBs)
academic research, 50, 54-55, 56-57, 58, 250-252
ethical research culture, 7-8, 18, 23, 38, 54, 60, 61, 69, 117-118, 134, 167-168
human research participant protection programs (HRPPPs), general, 6, 7-8, 30, 44, 48, 50, 54-57, 249-262
pharmaceuticals industry, 55, 252-255
template form to document, 258-262
Accreditation, 2-4 (passim), 8, 15, 17, 21, 23-28, 31, 48, 57, 116, 163, 171-177, 187, 195-196
see also Institutional Review Boards (IRBs);
Research Ethics Review Boards (Research ERBs)
Association for the Accreditation of Human Research Protection Programs (AAHRPP), 4(n.4), 171, 173-175, 176, 232, 245-246
committee study methodology, 42, 231, 232-233, 235
Department of Veterans Affairs (VA), 172-173, 175, 176, 245
education about, 62
human research participant protection programs (HRPPPs), general, 3, 30, 116, 174, 175, 176-177, 193
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
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
personal data protection, 160, 239-240, 261
Research Ethics Review Boards (Research ERBs), education of, 99
Confidentiality and privacy, 4, 6, 40, 138, 156, 159-160, 205, 206, 207-211, 215-216, 256
electronic data protection, 160, 239-240, 261
Health Insurance Portability and Accountability Act (HIPAA) , 159-160, 179, 181-182, 205, 207-211
informed consent and, 119
non-biomedical research, 238, 239-240, 243-244
regulatory issues, general, 159-160, 205-211, 215-216
Research Ethics Review Boards (Research ERBs), 87, 100, 153, 160, 209-211
template form to document, 261
Conflicts of interest, 11, 17-18, 38, 41, 46, 53, 117-118, 132, 162-163, 182-187, 197
accreditation issues, 174
committee study methodology, 41, 42, 232, 235
financial, 2, 6, 10-11, 17, 24, 42, 46, 50, 55, 65, 72, 73-74, 82-83, 117-118, 183-186, 255-256
human research participant protection programs (HRPPPs), general, 46, 50, 53, 55, 65, 76
informed consent and, 119
institutional, 18, 27, 38, 39, 42, 95, 183, 185-186
National Science Foundation (NSF), 118, 184
non-biomedical research, 238
protocols, 10-11, 66-67, 78, 117, 255-256
recruitment and enrollment of research participants, 117
Research Ethics Review Boards (Research ERBs), 10-11, 18, 24, 72, 74-75, 82-87, 100, 101-102, 105, 118, 162-163, 182, 185-186, 187, 205
scientific, 2, 6, 11, 24, 42, 117
transparency, 65
Consortium to Examine Clinical Research Ethics, 58
Continuing medical education programs, 7, 60-61, 62, 113-116, 150
Continuous quality improvement, 7, 163-170
Contract research organizations (CROs), 48, 60, 85, 105, 147, 148, 178-179, 235, 252-255, 256
Cost factors, 16, 57-59, 235, 243
see also Funding;
Liability and compensation
multisite research, 104, 256-257
participants’ medical and rehabilitation services, 47
quality improvement research, 164
Research Ethics Review Boards (Research ERBs), 104-105
Council for International Organizations of Medical Sciences (CIOMS), 34, 188, 189-190
D
Data and Safety Monitoring Boards/Data Monitoring Committees (DSMB/ DMCs), 49, 68, 77, 82, 87, 91, 139, 147, 151, 152, 154-157, 158-159, 161, 170, 195, 235, 254, 256, 260-261
funding, 151
Data and safety monitoring, general, 49, 136-161 (passim), 260-261
see also Confidentiality and privacy
Food and Drug Administration (FDA), 137, 138, 139-141, 144-150, 151, 152, 156-157, 160, 161
funding, 138
Good Clinical Practice (GCP), 139, 140, 144, 147, 148, 150, 152
human research participant protection programs (HRPPPs), general, 49, 136, 141, 151, 160
informed consent, 141-142, 152, 154, 157
Institutional Review Boards (IRBs), 8, 9, 11, 44, 48, 55, 63(n.9), 71, 103, 136-137, 139, 141-145 (passim), 148, 149, 158-159
National Institutes of Health (NIH), 137, 150-151, 152, 156-157, 161
Office of Human Research Protections (OHRP), 141-143, 148, 150, 151, 159, 160-161
Research Ethics Review Boards (Research ERBs), 11, 16, 74, 88, 99, 100, 101, 138, 144, 145-146, 150, 152-154, 157-158, 161
Databases
see also Internet
quality assurance, 169-170
registries, clinical trials, 14, 22, 197, 201-204
Decisionally impaired persons, 31, 43, 125
Declaration of Helsinki, 32, 33-34
Denmark, 104
Department of Health and Human Services (DHHS)/Health Education and Welfare (DHEW), 38-39, 141, 177, 195, 199-200, 208, 232, 236
see also Food and Drug Administration (FDA);
National Institutes of Health (NIH);
Office for Human Research Protections (OHRP)
compensation for injury, 15, 188, 192
conflicts of interest, 184, 185-186
National Human Research Protections Advisory Committee (NHRPAC), 12, 18-19, 20-22, 39, 199
National Library of Medicine, 14, 201-202
Office of Research Integrity (ORI), 114
Office of the Inspector General (OIG), 4(n.8), 36-37, 68, 141, 143, 180, 203-204
Office of the Secretary, 20-22, 37-39
ongoing review of research, 136-137, 150
Public Health Service, 4(n.7), 79-80, 118, 184, 185(n.20)
quality improvement, 17, 69, 164
study at hand, committee charge, 1, 2, 30
Department of Veterans Affairs (VA)
accreditation efforts, 172-173, 175, 176, 245
liability and compensation issues, 188
non-biomedical research, 245
Office of Research Compliance and Assurance (ORCA), 166-168
professional education, 114
quality control, 166-168, 171, 172-173
Dignity of participants, 29, 31, 46, 165, 193-194, 238
see also Confidentiality and privacy;
Informed consent
Drugs, see Pharmaceuticals industry
DSMB/DMC, see Data and Safety Monitoring Boards/Data Monitoring Committees
E
Economic factors
see also Cost factors;
Financial conflicts of interest;
Funding;
Liability and compensation;
Non-biomedical research;
Socioeconomic status
genetics research, harm, 35-36
Education and training, see Academic research;
Internet;
Participant/patient education;
Professional education;
Public education
Emotional factors, see Psychological effects
Ethical and Policy Issues in Research Involving Human Participants, 47
Ethical issues, general, 2, 6, 60, 155, 162, 206-208
see also Accountability, general;
Confidentiality and privacy;
Conflicts of interest;
Informed consent;
Professional education;
Research Ethics Review Boards (Research ERBs)
committee study methodology, 2, 30, 31, 42-43, 235
cultural context of research, 7-8, 18, 23, 38, 54, 60, 61, 69, 117-118, 134, 167-168
historical perspectives, 29-30, 31, 33-34, 45, 99, 100
participant-investigator interactions, 2, 6, 13, 32, 42, 46, 48, 49, 67-68, 103, 108-135
European Convention on Human Rights and Biomedicine, 188
Experimental studies, 32, 34, 36
see also Radiation experiments
oversight and data and safety monitoring, 139
participant-investigator interactions, 111-112
F
FDA, see Food and Drug Administration
Federal Demonstration Partnership, 198
Federal government, general, 3, 4, 38-39, 44, 47, 150, 198-200
see also Funding;
Legislation;
Regulatory issues;
specific departments and agencies
academic research, 56-57
accreditation role, 171-172
committee recommendations, 2, 20-22, 44, 148, 198-200
conflicts of interest, 184
financial conflicts of interest, 10-11
liability and compensation, 194
national review system, 2, 3, 18-19, 21, 39, 88-89, 164, 165
certification of professionals, 116-117
professional education efforts, 61, 62
Federal Policy for the Protection of Human Subjects, see Common Rule
Federalwide Assurances, 140, 142
Financial conflicts of interest, 2, 6, 10-11, 17, 24, 42, 46, 50, 55, 65, 72, 73-74, 82-83, 117-118, 183-186, 255-256
Food and Drug Administration (FDA), 20-22, 49, 73, 74(n.5), 78, 79, 127, 165, 179, 198, 232
accountability, 55, 57, 251, 252-253
biologic license applications, 139
bioterrorism response drugs, 212, 213
Center for Drug Evaluation and Research (CDER), 146
clinical research, 14, 37, 39, 73, 112, 144, 150, 151, 160, 161, 181, 201-202
computerized data protection, 160
conflicts of interest, 118, 184
financial conflicts of interest, 86
genetics research, 157
inspections by, 69, 144, 145, 150
Investigational Device Exemption (IDE), 158, 258
Investigational New Drug Applications (IND), 112, 140, 146, 152, 157, 158, 201, 212, 251, 253, 255
liability and compensation, 192
New Drug Applications (NDA), 140
notification, 139
Office for Good Clinical Practice, 39
oversight and data and safety monitoring, 137, 138, 139-141, 144-150, 151, 152, 156-157, 160, 161
Premarket Approval (PMA), 139, 140, 157, 213
professional education, 114, 181
registries, clinical trials, 14, 201-202
Research Ethics Review Boards (Research ERBs), 73, 78, 79, 86, 87, 100, 103, 145-146, 152
Food and Drug Administration Modernization Act of 1997, 14(n.17), 201, 204(n.17)
Foreign countries, see International perspectives
see also Conflicts of interest
Freedom of Information Act, 167(n.3)
Funding, 2, 6, 8, 20, 21, 23-28, 32, 57-60, 69, 79, 150, 198, 250-252
Award for Excellence in Human Research Protection, 142(n.5)
Committee on Human Research Participant Protections, 199, 236
financial conflicts of interest, 2, 6, 10-11, 17, 24, 42, 46, 50, 55, 65, 72, 73-74, 82-83, 117-118, 183-186, 255-256
Food and Drug Administration (FDA), 73, 151, 156
human research participant programs, general, 23, 44, 52, 53, 54, 57-60
Institutional Review Boards (IRBs), 5, 58, 59, 73
liability and compensation issues, 188, 190
National Institutes of Health (NIH), 58, 59, 60, 79, 128, 151, 156, 161, 169, 251, 252, 255-256
non-biomedical research, 36, 240
oversight and data safety monitoring, 138
peer review and, 78-79
quality improvement, 17, 27, 164, 168-169
Research Ethics Review Boards (Research ERBs), 78-79, 105-106
terrorism response, 211
G
GCP, see Good Clinical Practice
Gelsinger, Jesse, 37-38, 236(n.1)
General Accounting Office (GAO), 4(n.8), 182
General Clinical Research Center (GCRC), 251
Genetics research, 35-36, 37-38, 148, 236(n.1)
Food and Drug Administration (FDA) oversight, 157
National Institutes of Health (NIH) oversight, 151
Research Ethics Review Boards (Research ERBs), 88
Germany, 189
Good Clinical Practice (GCP), 50, 55, 88, 154
oversight and data and safety monitoring, 139, 140, 144, 147, 148, 150, 152
professional education, 61, 114
Government role, see Federal government, general;
Legislation;
Regulatory issues;
State government
Greenwall Foundation, 236
Guidelines for Good Clinical Practice, see Good Clinical Practice (GCP)
H
Health Insurance Portability and Accountability Act (HIPAA), 4(n.5), 95, 159-160, 179, 181-182, 205, 207-211
Historical perspectives, 29-30, 31, 33-34, 37, 73
conflicts of interest, 183
continuing review of research, 143
ethical issues, general, 29-30, 31, 33-34, 45, 99, 100
ethics education, 63, 97, 99, 100
informed consent, 120-121, 134
journal articles, 203, 206-207
liability and compensation, 189-191, 192
monitoring and oversight, 141
Human research participant protection programs (HRPPPs), general, 1-2, 45-69, 141, 162-196
see also Institutional Review Boards (IRBs);
Research Ethics Review Boards (Research ERBs)
accountability, 6, 7-8, 30, 44, 48, 50, 54-57, 249-262
accreditation issues, 3, 30, 116, 174, 175, 176-177, 193
committee recommendations, 6, 9, 11, 12, 19-28, 44, 47, 54, 197-216
committee study at hand, methodology, 1, 3, 4, 30, 42, 231-236
conflicts of interest, 46, 50, 53, 55, 65, 76
data safety and monitoring plans, 49, 136, 141, 151, 160
definitional issues, 48-52
ethical research culture, 7-8, 18, 23, 38, 54, 60, 61, 69, 117-118, 134, 167-168
funding, 23, 44, 52, 53, 54, 57-60
participant-investigator interactions, 2, 6, 13, 32, 42, 46, 48, 49, 67-68, 103, 108-135, 157
protocols, 1-2, 6, 46, 49-51, 53, 56, 59, 65, 66-67, 68, 69, 76, 108-109, 136, 151, 162, 249-262
quality improvement, 17, 163, 168-171
Research Ethics Review Boards (Research ERBs), 9, 72, 102
risk classification, 90
Human Research Protections Acts, 47(n.2)
I
Incidence of research injuries, 21, 191
Incompetent participants, see Decisionally impaired persons
Informed consent, 2, 29, 38, 40, 42, 53, 67-68, 119-128, 130, 135, 141, 162, 181-182
accreditation and, 94
attitudes and beliefs about, 125-126, 130-131, 132
basic principles of research, 31, 32, 46, 206-207
bioterrorism response drugs, 212
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
community consent, 127-128
confidentiality and, 119
conflicts of interest, 83, 184, 187
consent forms, 64, 92-94, 103, 119, 121-122, 123-126, 130-131, 154, 181, 187
decisionally impaired persons, 31, 43, 125
disclosure documents, 93
financial conflicts of interest, 83
genetics research, 37
historical perspectives, 120-121, 134
Institutional Review Boards (IRBs), 38, 39-40, 92, 119-120, 123, 240-242
non-biomedical research, 36, 238, 240-242
oversight and data and safety monitoring, 141-142, 152, 154, 157
participant-investigator interactions, 2, 6, 13, 32, 42, 46, 48, 49, 67-68, 103, 108-135, 157
physician’s role, 120, 121, 125
professional education, 108-109, 119-120
protocols, 40, 93, 94, 108-111, 119-120, 125, 128
race/ethnicity of participant, 125
regulatory issues, general, 94-95, 121, 141-142
risk-appropriate safety monitoring, 93, 94, 122, 123
standardization, other, 110
video presentations, 94, 124, 126, 154
Inspections, 69, 144, 145, 148, 150
Institutional Review Boards (IRBs), 2, 3, 5, 6, 8-9, 36-37, 39-40, 48, 53, 70-74, 103, 141, 142, 184, 209, 215, 236
see also Accreditation;
Research Ethics Review Boards (Research ERBs)
academic research, 81, 84, 232
committee recommendations, 8-12, 60, 71, 110(n.3), 200
committee study methodology, 2, 3, 31, 232, 234, 235
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
continuing review, 143
education of members, 38, 60, 62, 63-64, 70, 114, 116
financial conflicts of interest, 55, 72, 73-74, 82, 86
informed consent, 38, 39-40, 92, 119-120, 123, 240-242
multicenter studies, 12, 39, 55, 215
non-biomedical research, 36, 43, 237-238, 239, 240-247
oversight and data and safety monitoring, 8, 9, 11, 44, 48, 55, 63(n.9), 71, 103, 136-137, 139, 141-145 (passim), 148, 149, 158-159
protocols, 5, 9, 38, 39, 56, 58, 63, 66-67, 73-74, 80-81, 88-89, 119-120, 239, 240
quality improvement/compliance, 68-69, 173
Research Ethics Review Boards (Research ERBs) renamed as, 9, 24, 71-72, 110-111(n.3), 136(n.1), 162(n.1), 201(n.5), 249(n.1)
risk classification, 68, 89-90
taxonomy of, 165
Institutional Review Boards: A Time for Reform, 37
Interdisciplinary approaches, see Multidisciplinary approaches
International Conference on Harmonisation, 50, 93(n.20), 189
oversight and data and safety monitoring, 151
professional education, 114
International Organization for Standardization, 210
International perspectives, 42-43, 50, 100, 129
see also Terrorism
compensation for injury, 15, 188
confidentiality and privacy, 210
Council for International Organizations of Medical Sciences (CIOMS), 34, 188, 189-190
Declaration of Helsinki, 32, 33-34, 62, 188
European Convention on Human Rights and Biomedicine , 188
multisite research, 104
Internet
accreditation, 172
confidentiality and privacy, 208(n.13)
continuing review of research, 143(n.6)
Federalwide Assurance agreement (FWA), 142(n.3)
gene therapy, 236(n.1)
investigational drug studies (FDA), 146
professional education, 60, 113-114, 115(n.6), 134, 198
protocol accountability, 249-250
public education, 65
registries, clinical trials, 14(n.16), 202(n.7, n.9), 201-204
Investigational Device Exemption (IDE), 158, 258
Investigational New Drug Applications (IND), 112, 140, 146, 152, 157, 158, 201, 212, 251, 253, 255
IRBs, see Institutional Review Boards
J
Journal articles, 158, 163, 168, 197, 203, 206-207, 235
L
Legal issues, see also Confidentiality and privacy;
Conflicts of interest;
Informed consent;
Legislation;
Liability and compensation;
Regulatory issues
see also Regulatory issues
Bayh-Dole Act, 185
Food and Drug Administration Modernization Act, 14(n.17), 201, 204(n.11)
Freedom of Information Act, 167(n.3)
Health Insurance Portability and Accountability Act (HIPAA), 4(n.5), 95, 159-160, 179, 181-182, 205, 207-211
Human Research Protections Acts, 47(n.2)
National Childhood Vaccine Compensation Injury Act, 194
Patent and Trademark Law Amendment Act , 185(n.19)
proposed/recommended, 4(n.6), 6, 47
Public Health Service Act, 4(n.7), 185(n.20)
Research Revitalization Act, 47(n.2)
Liability and compensation, 2, 14-15, 27, 42, 163, 178, 179-181, 188-195, 254-255
academic research, 192
accreditation and, 193
historical perspectives, 189-191, 192
informed consent forms, 93(n.20), 120-122
National Institutes of Health (NIH), 188, 194
Research Ethics Review Boards (Research ERBs), 88, 104, 194-195
transparency, 65
Litigation, see Liability and compensation Longitudinal studies, 241(n.8)
protocol review, 46
taxonomy of, 165
M
Marrett, Cora, 236-248
Medicaid, 180
Medicare, 35, 179, 180, 203, 208(n.16)
MedWatch, 149
Mentoring, 60, 81, 113, 114-115
Methodology, see Research methodology
Minority groups, see Race/ethnicity
Monitoring, 40, 81, 104, 136-161 (passim), 235
see also Oversight, general;
Quality control;
Risk-appropriate safety monitoring
adverse event reporting, 15, 16, 37, 47, 59, 68, 103, 148, 149-150, 153, 154, 157-158, 161, 165, 170, 192, 254, 261
continuing review, general, 3, 31, 32, 46, 49, 59, 63, 90, 91, 139, 143, 251-252, 254
Data and Safety Monitoring Boards/ Data Monitoring Committees (DSMB/DMC), 49, 68, 77, 82, 87, 91, 139, 147, 151, 152, 154-157, 158-159, 161, 170, 195, 235, 254, 256, 260-261
funding, 151
data and safety monitoring, general, 49, 136-161 (passim), 260-261
defined, 140
historical perspectives, 141
informed consent, 137, 152, 154
inspections, 69, 144, 145, 148, 150
internal, 16, 48, 78, 138, 149, 163
protocols, 5, 40, 137, 152, 154
Research Ethics Review Boards (Research ERBs), 74, 88, 99, 100, 101, 144, 152-154, 251-252, 254, 256
template forms to document, 260-261
Multicenter Academic Clinical Research Organization (MACRO), 84, 104
Multicenter research, 3, 7, 12, 25, 31, 37, 102, 215, 235
accountability, 50, 55, 56, 255-257
Institutional Review Boards (IRBs), 12, 39, 55, 215
oversight, 142
Research Ethics Review Boards (Research ERBs), 12, 102-104
Multidisciplinary approaches
national system review, 19, 21
oversight and data and safety monitoring, 139
risk classification, 89
Multiple Project Assurances (MPAs), 142
N
National Bioethics Advisory Commission (NBAC), 4, 38, 47, 74, 89-90, 96, 103, 116, 119, 128, 184, 232
continuing review of research, 137-138, 143, 149
National Center for Health Statistics (NCHS), 241(n.8)
National Childhood Vaccine Compensation Injury Act, 194
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 4(n.8), 31, 119, 143
National Committee for Quality Assurance (NCQA), 4(n.4), 171, 172-173, 175, 176, 231, 232
National Health Interview Survey, 241(n.8)
National Human Research Protections Advisory Committee (NHRPAC), 12, 18-19, 20-22, 39, 106, 119, 199-200, 232
National Institutes of Health (NIH), 20-22, 38-39, 50, 73, 82, 201-202, 256-257
see also Office for Human Research Protections (OHRP)
accreditation role, 166
committee study methodology, 232, 234
community involvement, 128
funding, 58, 59, 60, 79, 128, 151, 156, 161, 169, 251, 252, 255-256
genetics research, 151
liability and compensation issues, 188, 194
Office for Protection from Research Risks (OPRR), 37, 38, 75-76, 142, 199, 200, 232
oversight and data and safety monitoring, 137, 150-151, 152, 156-157, 161
peer review, 79-80
professional education efforts, 99, 114
public education, 127
National Library of Medicine (NLM), 14, 201-202
National Science Foundation (NSF), 58, 80
conflicts of interest, 118, 184
non-biomedical research, 238
New Drug Application (NDA), 140
Investigational New Drug Applications (IND), 112, 140, 146, 152, 157, 158, 201, 212, 251, 253, 255
New Zealand, 189
Non-biomedical research, 36, 43, 63, 90, 106, 236-248
accreditation, 245-246
conflicts of interest, 238
informed consent, 36, 238, 240-242
Institutional Review Boards (IRBs), 36, 43, 237-238, 239, 240-247
National Science Foundation (NSF), 238
observational studies, 32, 35, 36, 237
regulatory issues, general, 43, 242-244
O
Observational studies, 32, 35, 36, 237
see also Non-biomedical research
Office for Good Clinical Practice, 39
Office for Human Research Protections (OHRP), 7, 12, 18-19, 20-22, 37, 38, 39, 50, 57, 198
committee study methodology, 215, 232, 234
financial conflicts of interest, 86
informed consent, 141-142
non-biomedical research, 238-246 (passim)
oversight and data and safety monitoring, 141-143, 148, 150, 151, 159, 160-161
professional education efforts, 61, 160-161
quality improvement (QI), 165, 166-168
Research Ethics Review Boards (Research ERBs), 86, 87, 89, 92, 106
risk classification, 92
Office for Protection from Research Risks (OPRR), 37, 38, 75-76, 142, 199, 200, 232
Office of General Counsel, 50
Office of Research Compliance and Assurance (ORCA), 166-168
Office of Research Integrity (ORI), 114
Office of the Inspector General (DHHS), 4(n.8), 36-37, 68, 141, 143, 180, 203-204
OHRP Compliance Data by Institution, by Determination Letters Issues, and by Site-Visited Institution October 1998 to December 2001, 232
Ombudsman programs, 49, 68, 154
Oversight, general, 1, 2, 13, 38, 136-161 (passim), 197
see also Accreditation;
Data and safety monitoring;
Monitoring;
Quality control;
Regulatory issues
continuing review, general, 3, 31, 32, 46, 49, 59, 63, 90, 91, 143
definitional issues, 29(n.1), 139-140
federal human research participant protection programs (HRPPPs), 6, 18, 19, 42, 44, 47, 48, 52, 56, 90, 136-137
Food and Drug Administration (FDA), 137, 138, 139-141, 144-150, 151, 152, 156-157, 160, 161
funding, 138
Good Clinical Practice (GCP), 139, 140, 144, 147, 148, 150, 152
historical perspectives, 141
informed consent, 141-142, 152, 154, 157
inspections, 69, 144, 145, 148, 150
internal, 16, 48, 78, 138, 149, 163
Institutional Review Boards (IRBs), 8, 9, 11, 44, 48, 55, 63(n.9), 71, 103, 136-137, 139, 141-145 (passim), 148, 149, 158-159
National Institutes of Health (NIH), 137, 150-151, 152, 156-157, 161
non-biomedical research, 36, 43
Office for Human Research Protections (OHRP), 141-143, 148, 150, 151, 159, 160-161
participant-investigator interaction, 108, 131, 134
professional education, 7, 61, 63(n.9), 66, 107
Research Ethics Review Boards (Research ERBs), 11, 16, 74, 88, 99, 100, 101, 138, 144, 145-146, 150, 152-154, 157-158, 161
Ovieto Convention, 188
P
Participant/patient education, 2, 31, 64, 126, 130, 131, 150, 200-204
see also Informed consent;
Public education
general principles of research, 46
participant-investigator interactions, 2, 6, 13, 32, 42, 46, 48, 49, 67-68, 103, 108-135, 138
transparency, 7, 13-14, 52, 64-66
Patent and Trademark Law Amendment Act, 185(n.19)
Peer review, 73, 78-80, 110, 158
Percival, Thomas, 33
Pharmaceutical Research and Manufacturers of America (PhRMA), 62
Pharmaceuticals industry, 14, 34-35, 50, 78, 112, 194
see also Food and Drug Administration (FDA)
bioterrorism, response, 22, 28, 88, 197, 211-215
Physicians, 35, 78, 94, 98, 113, 130, 149, 180, 249, 252
informed consent, 120, 121, 125
oversight and data and safety monitoring, 139
Premarket approval (FDA), 139, 140, 157, 213
Preserving Public Trust: Accreditation and Human Research Participation, 3, 30, 48, 116, 164, 171, 173(n.10), 175, 231
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 4(n.8), 38, 119
Privacy, see Confidentiality and privacy Professional associations and societies, general, 3, 183, 240
see also specific associations and societies
Professional education, 31, 81, 108, 133-135, 174, 181, 198
accreditation, education about, 62
certification, 63, 96, 101, 113-114, 115-117, 133
computer data, personal data protection, 160
continuing medical education programs, 7, 60-61, 62, 113-116, 150
Department of Veterans Affairs (VA), 114
ethics, 2, 7-8, 52, 53, 60-64, 70, 113-117, 142, 147, 180
Food and Drug Administration (FDA), 114, 181
Good Clinical Practice (GCP), 61, 114
informed consent, 108-109, 119-120
Institutional Review Boards (IRBs), 38, 60, 62, 63-64, 70, 114, 116
Internet-based, 60, 113-114, 115(n.6), 134, 198
journal articles, 158, 163, 168, 197, 203, 206-207, 235
mentoring, 60, 81, 113, 114-115
National Institutes of Health (NIH), 99, 114
non-biomedical research, 246
participant-investigator interactions, 108, 110, 112-117, 133
informed consent, 108-109, 119-120
pathophysiology and pharmacology, 150
recruitment and enrollment of participants, 108-109
regulatory issues, general, 61, 62, 114, 115
Research Ethics Review Boards (Research ERBs), 88, 99-101, 106, 115-116, 133, 134, 150, 181
computer applications, 99
template form to document, 261
Protocols, 1-2, 6, 25, 32, 40, 41, 42, 46, 68, 70, 72-107, 154, 170, 251, 255-256
see also Scientific review
access to, stakeholders, 13-14
conflicts of interest, 10-11, 66-67, 78, 117, 255-256
definitional issues, 49-51
financial conflicts of interest, 10-11
human research participant protection programs (HRPPPs), general, 1-2, 6, 46, 49-51, 53, 56, 59, 65, 66-67, 68, 69, 76, 108-109, 136, 151, 162, 249-262
informed consent, 40, 93, 94, 108-111, 119-120, 125, 128
Institutional Review Boards (IRBs), 5, 9, 38, 39, 56, 58, 63, 66-67, 73-74, 80-81, 88-89, 119-120, 239, 240
non-biomedical research, 238
participant-investigator interactions, 2, 6, 13, 32, 42, 46, 48, 49, 67-68, 103, 108-113
professional education, 61, 108-109, 134-135
Research Ethics Review Boards (Research ERBs), 72-77, 78, 79, 82-84, 87, 93, 95, 98, 100, 101-104, 110, 112, 118, 128, 135, 152-153, 253-254
standard operating procedures, 139, 140, 152, 154
template forms to document, 258-261
Psychological effects, 165, 193-194
see also Attitudes and beliefs
dignity of participants, 29, 31, 46, 165, 193-194
genetics research, 35-36
non-biomedical research, 237
Public education, 13-14, 23, 64, 131, 200-204
see also Participant/patient education committee study methodology, access to, 234-235
registries, clinical trials, 14, 22, 197, 201-204
transparency, 7, 13-14, 52, 64-66, 69, 127-128, 234-235
Public Health Service, 79-80
conflicts of interest, 118, 184
Public Health Service Act, 4(n.7)
Public opinion, 14-15, 39, 215
participant-investigator interactions, 110, 130, 133
Research Ethics Review Boards (Research ERBs), 88
Public Responsibility in Medicine and Research (PRIM&R), 62, 63-64, 99, 231
PXE International, 232
Q
Quality control
see also Accreditation;
Good Clinical Practice (GCP);
Regulatory issues;
Standards
assurance, 2, 6, 42, 49, 53, 68-69, 88, 166-173 (passim), 181, 195
best practices, 61, 106, 107, 163-164, 166, 171, 198
cultural context of research, 7-8, 18, 23, 38, 54, 60, 61, 69, 117-118, 134, 167-168
Department of Veterans Affairs (VA), 166-168, 171, 172-173
human research participant protection programs (HRPPPs), general, 17, 163, 168-171
improvement (QI), 2, 6, 7, 8, 16, 17, 31, 42, 49, 68-69, 88, 94, 116, 142-143, 194, 195
continuous, 7, 163-170, 173-174
informed consent, 94, 126-127, 164
Institutional Review Boards (IRBs), 68-69, 173
Office for Human Research Protection (OHRP), 165, 166-168
peer review, 73, 78-80, 110, 158
professional education, 170, 172
Research Ethics Review Boards (Research ERBs), 88, 167, 168, 170, 194
R
Radiation experiments
Advisory Committee on Human Radiation Experiments (ACHRE), 4(n.8), 119, 213-214
Research Ethics Review Boards (Research ERBs), 88
RAND Corporation, 215
Recruitment and enrollment of participants, 41, 51, 77, 95
see also Informed consent
conflicts of interest, 117
professional education, 108-109
Research Ethics Review Boards (Research ERBs), 75, 81, 87, 154
template forms to document, 260
Registries, clinical trials, 14, 22, 197, 201-202
Regulatory issues, 4, 5, 20-28, 34, 39, 45, 47-48, 53, 56-57, 68, 89, 92, 103, 118, 129, 138-142, 235
see also Accreditation;
Food and Drug Administration (FDA);
Institutional Review Boards (IRBs);
Health Information Portability and Accountability Act (HIPAA) Legislation;
Office for Human Research Protections (OHRP);
Research Ethics Review Boards (Research ERBs);
Standards academic research, 50
Assurance of Compliance documents, 140
Belmont Report, 70, 74-75, 92, 119, 181, 238
Common Rule (Federal Policy for the Protection of Human Subjects), 5
confidentiality and privacy, 159-160, 205-211, 215-216
continuing review of research, 139, 143
exempt research and expedited review, 43, 90, 91, 112, 160, 176, 209, 238, 242-244
Federal Demonstration Partnership, 198
informed consent, 94-95, 121, 141-142
non-biomedical research, 43, 242-244
professional education about, 61, 62, 114, 115
risk-appropriate safety monitoring, 11, 68, 89
Religious factors, 97
Research Ethics Review Boards (Research ERBs), 9-12, 23-28, 70-88, 91-107, 176, 177-178, 179, 196, 201
academic research, 81, 84, 86, 251-252
audits, 138
certification of members, 101, 115
committee recommendations, 9, 11, 23-28, 71, 72, 96, 98, 102, 106, 138, 144, 162, 182
confidentiality and privacy, 87, 100, 153, 160, 209-211
conflicts of interest, 10-11, 18, 24, 72, 74-75, 82-87, 100, 101-102, 105, 118, 162-163, 182, 185-186, 187, 205
cost factors, 104-105
financial conflicts of interest, 10-11, 74-75, 82-83, 85-86
Food and Drug Administration (FDA), 73, 78, 79, 86, 87, 100, 103, 145-146, 152
genetics research, 88
historical perspectives, 88, 104, 194-195
human research participant protection programs (HRPPPs), 84
informed consent, 92-95, 100, 103, 123-124, 127, 128, 133, 134-135, 157-158, 181, 204
Institutional Review Boards (IRBs) renamed as, 9, 24, 71-72, 110-111(n.3), 136(n.1), 162(n.1), 201(n.5), 249(n.1)
membership, qualifications, and voting, 95-101
multicenter research, 12, 102-104
Office for Human Research Protection (OHRP), 86, 87, 89, 92, 106
oversight and data and safety monitoring, 11, 16, 74, 88, 99, 100, 101, 138, 144, 145-146, 150, 152-154, 157-158, 161
participant-investigator interactions, 110-111, 112
professional education, 88, 99-101, 106, 115-116, 133, 134, 150, 181
computer applications, 99
protocols, 72-77, 78, 79, 82-84, 87, 93, 95, 98, 100, 101-104, 110, 112, 118, 128, 135, 152-153, 253-254
quality control, general, 88, 167, 168, 170, 194
radiation experiments, 88
recruitment and enrollment of research participants, 75, 81, 87, 154
registries, clinical trials, 14, 204
risk-appropriate safety monitoring, 87, 90-92, 100, 107, 178, 196
Research methodology, 16, 100, 132
see also Longitudinal studies;
Protocols;
Scientific review
committee study at hand, 2-4, 5, 30-31, 40-44, 231-235, 236
experimental studies, 32, 34, 36, 111-112, 139
risk stratification, 91
sampling, 16, 45, 66, 73, 76, 90, 112, 164, 170
Research Revitalization Act, 47(n.2)
Resource needs, see Funding
Risk-appropriate safety monitoring, 2, 8, 9, 11, 20, 26, 31, 32, 40, 42, 49, 55, 56, 66, 68, 136, 154-155, 178, 235, 261
classification of risk, 16, 20, 89-92, 107
Data and Safety Monitoring Boards/ Data Monitoring Committees (DSMB/DMC), 49, 68, 77, 82, 87, 91, 139, 147, 151, 152, 154-157, 158-159, 161, 170, 195, 235, 254, 256, 260-261
informed consent and, 93, 94, 122, 123
participant-investigator interactions, 110
regulatory issues, general, 11, 68, 89
Research Ethics Review Boards (Research ERBs), 87, 90-92, 100, 107, 178, 196
transparency, 66
Risk stratification, 75-76, 90-92, 107
S
Sampling, 16, 45, 66, 73, 76, 90, 112, 164, 170
SBES research, see Non-biomedical research
conflicts of interest, 2, 6, 11, 24, 42, 117
Research Ethics Review Boards (Research ERBs)/Institutional Review Boards (IRBs), 72, 73, 75-76, 77, 87, 95, 97, 98, 100, 101-102
Single Project Assurances (SPAs), 142
Smallpox, 211-212
Social and behavioral research, see Non-biomedical research
Socioeconomic status, 43
Spanish, 189
Standard operating procedures, 139, 140, 152, 154
Standards, 2, 17, 46-47, 79-80, 88, 161, 163, 168-169
see also Accreditation;
Good Clinical Practice (GCP);
Protocols;
Quality control;
Regulatory issues
academic research, 50
best practices, 61, 106, 107, 163-164, 166, 171, 198
certification of professionals, 63, 96, 101, 113-114, 115-117, 133
conflicts of interest, 18
cost factors, 236
T
Terrorism, 22, 28, 197, 211-215
informed consent, 212
Research Ethics Review Boards (Research ERBs), 88
Transparency, 7, 13-14, 52, 64-66
U
United Kingdom, 71, 104, 189-190, 206
V
Veterans, see Department of Veterans Affairs (VA)
Video presentations, informed consent, 94, 124, 126, 154
W
World Wide Web, see Internet