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Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

ethics education, 60, 62

Federal Demonstration Partnership, 198

funding, 58, 59

liability and compensation, 192

participant-investigator interactions, 113

Research Ethics Review Boards (Research ERBs), 81, 84, 86, 251-252

scientific review, 79, 81

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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

fraud, 179, 180

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

ethics reviews, 8, 104

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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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)

basic principles, 31-32, 56

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

False Claims Act, 179, 181

FDA, see Food and Drug Administration

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

audits, 69, 73

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

funding, 73, 151, 156

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

multicenter studies, 55, 103

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

Fraud, 179, 180

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

academic research, 58, 59

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

private, 8, 32, 188, 190

quality improvement, 17, 27, 164, 168-169

Research Ethics Review Boards (Research ERBs), 78-79, 105-106

terrorism response, 211

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

HIV, 43, 131, 202(n.8)

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

committee recommendations, 13, 24, 25, 92, 120, 130

committee study methodology, 3, 31, 235

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

language issues, 124, 125

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

funding, 5, 58, 59, 73

informed consent, 38, 39-40, 92, 119-120, 123, 240-242

membership, 38, 95-96

multicenter studies, 12, 39, 55, 215

national system, 19, 39

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

public transparency, 64, 65

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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

Nuremburg Code, 32, 33, 62

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

fraud, 179, 180

Legislation, 20-22, 47-48

see also Regulatory issues

Bayh-Dole Act, 185

False Claims Act, 179, 181

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)

state-level, 47-48, 65

Liability and compensation, 2, 14-15, 27, 42, 163, 178, 179-181, 188-195, 254-255

academic research, 192

accreditation and, 193

funding and, 188, 190

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

Maryland, 48, 65

Mass media, 3, 15, 37

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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

cost factors, 104, 256-257

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

informed consent, 128, 134

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

confidentiality issues, 238, 239-240, 243-244

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

conflicts of interest, 238

funding, 36, 240

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

Nuremburg Code, 32, 33, 62

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

multicenter studies, 35, 90

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

protocols, 5, 40, 137, 138

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

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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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)

accountability, 55, 252-255

bioterrorism, response, 22, 28, 88, 197, 211-215

vaccines, 194, 211-212

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

quality monitoring, 170, 172

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

Project LEAD, 101, 134, 232

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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

mass media, 3, 15, 37

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

mass media, 3, 15, 37

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

funding, 17, 27, 164, 168-169

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

Race/ethnicity, 100, 125

Radiation experiments

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

informed consent, 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

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

accreditation, 104-105, 107

audits, 138

certification of members, 101, 115

commercial, 79, 80, 85-86, 88

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

funding, 78-79, 105-106

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

bias, 46, 47, 76, 83, 111

committee study at hand, 2-4, 5, 30-31, 40-44, 231-235, 236

experimental studies, 32, 34, 36, 111-112, 139

non-biomedical research, 36, 236-247

observational studies, 32, 35-36, 237

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
×

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

Scientific review, 76-81, 155

academic research, 79, 81

conflicts of interest, 2, 6, 11, 24, 42, 117

peer review, 73, 78-80

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

Project LEAD, 101, 134, 232

reporting, 148, 149-150

State government, 47-48, 65

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

Vaccines, 194, 211-215

Veterans, see Department of Veterans Affairs (VA)

Video presentations, informed consent, 94, 124, 126, 154

W

World Wide Web, see Internet

Suggested Citation:"Index." Institute of Medicine. 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. doi: 10.17226/10508.
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Responsible Research: A Systems Approach to Protecting Research Participants Get This Book
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When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies.

Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes:

  • Improved research review processes,
  • Recognition and integration of research participants' contributions to the system, and
  • Vigilant maintenance of HRPPP performance.

Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsors–but also including volunteers who may agree to serve as research participants.

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