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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"Index." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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INDEX 209 Index A issues not addressed by, 57-61 AAALAC. as a mark of excellence, 86 See Association for Assessment and need for wide acceptance of, 16 Accreditation of Laboratory Animal pursuing through pilot testing, 10-11, Care 53-56 AAHRPP. substituting private for public regula- See Association for the Accreditation of tion, 46 Human Research Protection Programs as a supplement to governmental regula- AAMC. tions, 45-46 See Association of American Medical Accreditation bodies, 49-50 Colleges Association for the Accreditation of Academic health centers, 14 Human Research Protection Pro- shutdowns at, 29-31 grams, 10, 47, 49-50 Acceptance of accreditation, need for Accreditation Outcome Table, 137-140 widespread, 16 Accreditation process, elements of, 48-53 Accountability, calls for, 31-32 Accreditation programs Accreditation, 117 accommodating distinct research meth- vs. certification, 43 ods and models within, 13-15, 69-70 collecting data on and assessing impacts appeals process, 53 of, beginning now, 19-20, 90-91 coverage of, 7 effect on performance, 61-62 data produced by, 89 establishing nongovernmental organiza- development of, 22 tions for, 11, 56-57 directly involving research participants of human research participant protection in, 18, 73-75 programs, 5 eligibility criteria for, 51 initiating federal studies evaluating, 20, evaluating pilot, 89 91-93 and external evaluation, 52 to insure compliance with AAALAC failures of, 54n standards, 47

INDEX 210 national, voluntary, 55 Benefits, considerations of, in the draft recommendations for implementation standards for accreditation of phases of, 22, 27 VAMCs, 136, 171-175 registration process for, 52n Board on Behavioral, Cognitive, and Sen- repeat accreditation, 53 sory Sciences, 40 and self-evaluation, 51-52 Budget, for institutional review boards, 86 Accreditation standards C articulating sound goals within, 12, 65-66 Calls for accountability, 31-32 establishing flexible, ethics-based, and Certificates of Confidentiality, 141 meaningful, 12-13, 66-67 Certification, vs. accreditation, 43 ACHRE. CIOMS. See Advisory Committee on Human See Council for International Organiza- Radiation Experiments tions of Medical Sciences Adverse events (AEs), 141. Circular No. A-119, 17, 56 See also Serious adverse events original intention of, 56n unexpected, 144 Cline, Martin, 58 Advisory Committee on Human Radiation Clinical research, shutdowns at academic Experiments (ACHRE), 13n, 26, 28, and VA medical centers, 29-31 56, 59, 65n Clinical trials, rise of, 38-39 AEs. Collecting data, on accreditation, begin- See Adverse events ning now, 19-20, 90-91 Affiliate's human research protection pro- Committee on Assessing the System for gram, 141 Protecting Human Research Sub- Albuquerque Tribune, 26 jects, 1-2 AMA. findings of, 6-10 See American Medical Association task of, 5-6 American Association of University Pro- Committee on National Statistics, 40 fessors, 39 “Common Rule” governing human American Medical Association (AMA), 48 research, 80 physician certification program origin of, 26, 62 announced by, 54n signatories to, 16, 55n Animal Welfare Act of 1966, 47-48 Community Clinical Oncology Program, Appeals process, 53 38 Applied Research Ethics National Associa- Comparisons, between draft NCQA and tion (ARENA), 43 PRIM&R accreditation standards, 8 Association for Assessment and Accredita- Compliance with standards, assessing, tion of Laboratory Animal Care 76-77 (AAALAC), 47 Concerns, 115 Association for the Accreditation of Confidentiality issues, in the draft stan- Human Research Protection Pro- dards for accreditation of VA Medi- grams (AAHRPP), 10, 47, 49-50, 52, cal Centers, 136, 180-182 86, 90 Consent Association of American Medical Col- informed, 25, 36, 38, 183-194 leges (AAMC), 5, 50, 52 monitoring, 74 Association of American Universities Consortium of Social Science Associa- (AAU), 50 tions (COSSA), 50 Association of American Universities Consumer organizations, 74 (AAU) Task Force on Research Costs, of institutional review boards, 92n Accountability, 5 Council for International Organizations of B Medical Sciences (CIOMS), 27, 65 Belmont Report, The, 13n, 26, 41, 65, 66n, Council on Medical Education, 48 116-117

INDEX 211 D privacy and confidentiality, 136, 180-182 Data collection recruitment and subject selection, 136, on accreditation, beginning now, 19-20, 176-179 90-91 sources of, 136 guidelines for (under development), 141 submitting comments on, 195 for national statistical databases, 39 DSMBs. Data safety and monitoring boards See Data safety and monitoring boards (DSMBs), 61, 73, 117 Duke University, shutdowns at, 29 expertise stipulated, 73 E Data sources and methods, 105-114 Educating investigators, 59, 154-155 draft standards for accreditation, 114 Eligibility criteria, for accreditation pro- literature review, 113-114 grams, 51 presentations and public comment, Ethics-based standards, establishing for 105-113 accreditation, 12-13, 66-67 Deaths, Jesse Gelsinger, 4, 31, 58 Evaluation of research protocols, system- Declaration of Helsinki, 27, 65, 85 atic, by IRBs, 160-167 “Deemed-status” programs, under Medi- Evaluation process for accreditation care certification, 46 development of, 22 Definitions, 32-43, 117-118, 141-144 external, 52 Deloitte & Touche, 50 initiating federal studies for, 20, 91-93 DHHS. pilot programs, 89 See U.S. Department of Health and self, 51-52 Human Services Excellence, accreditation as a mark of, 86 Distinct research methods and models, Existing regulatory requirements accommodating within accreditation base standards for, 15-17, 71-72 programs, 13-15, 69-70 relation of standards to, 71-72 Documentation, 36, 60 External evaluation, accreditation pro- IRBs maintaining, of their activities, grams and, 52 168-170 F Draft accreditation outcomes, and reme- FDA. dial action, 138-140 See Food and Drug Administration Draft standards, 114 FDA Form 3454, 141 omissions in, 82-83 Federal Policy for the Protection of relation to existing regulatory require- Human Subjects in Research, 26 ments, 81 Federal regulations. review of available, 76-83 See Regulatory requirements Draft standards for accreditation of Federal studies evaluating accreditation, VAMCs, 135-195 initiate, 20, 91-93 components under development, 141 Federalwide assurance (FWA), 142 considerations of risks and benefits, Federation of American Societies for 136, 171-175 Experimental Biology (FASEB), 50 domains of, 136 Flexible standards, establishing for accred- individual IRB structure and operations, itation, 12-13, 66-67 136, 156-170 Flexner, Abraham, 48 informed consent, 136, 183-194 Food, Drug, and Cosmetic Act, Kefauver- institutional responsibilities, 136, Harris Amendments to, 24 145-155 Food and Drug Administration (FDA), 4, operation of, 141 24, 27, 142

INDEX 212 Investigational New Drug Application, Human subjects protections in the United 142 States investigations by, 19, 31, 64 recent occurrences, 26-31 FWA. short history of, 24-26 See Federalwide assurance I G ICH-GCP. GAO. See International Conference on Har- See General Accounting Office monisation Guideline for Good Gelsinger, death of Jesse, 4, 31, 58 Clinical Practice General Accounting Office (GAO), 13n, IDE. 50, 66n See Investigational Device Exemption Goals, articulating within accreditation Identifying violations, 57-59 standards, 12, 65-66 Impacts of accreditation, beginning now, Governmental regulations, accreditation 19-20, 90-91 as a supplement to, 45-46, 71 Implementing Human Research Regula- Guidelines for accreditation, three sets of, tions, 26 78-79 IND. Gunsalus, C. K., 62 See Investigational New Drug Applica- H tion HCFA. Independent IRBs, 14, 40-41 See Health Care Financing Administra- Indian Council of Medical Research, 27 tion Individual IRBs, structure and operations Health Care Financing Administration of, in the draft standards for accredita- (HCFA), 46 tion of VA Medical Centers, 136, Helsinki. 156-170 See Declaration of Helsinki Informed consent, 25 Hopkins standard, 48 as an “exception” to protection, 190-194 HRPPPs. centrality of, 36, 38 See Human research participant protec- in the draft standards for accreditation tion programs of VA Medical Centers, 136, 183-194 HRPPs. measuring, 38 See Human research protection programs Institute for Human Gene Therapy, 58n Human research enterprises, strains upon, 4 Institute of Medicine (IOM), 1, 5-6, 40, 49 Human research participant protection Institutes of Health Research, 27 programs (HRPPPs), 2-3, 37 Institutional associates, 25 accreditation of, 5, 10-14 Institutional/organizational officials, 118 controlling relevant elements of, 14 Institutional responsibilities, in the draft directly involving research participants standards for accreditation of VA in, 18, 73-75 Medical Centers, 136, 145-155 evaluating pilot accreditation programs, Institutional Review Boards: A Time for 89 Reform, 29 history of, 23 -26 Institutional review boards (IRBs), 2, 7, information flow pathways within, 3, 37 118, 142. naming of, 32n, 35-43 See also Independent IRBs; Human research protection programs Individual IRBs (HRPPs), 117, 142 appropriate to amount and nature of affiliate, 141 research reviewed, 157-159 responsible for educating institutional budget and staffing for, 86 staff, 154-155 costs of, 92n systematic and comprehensive, 146-153 defined, 4 Human subjects. See Research participants/subjects/ individuals studied in research

INDEX 213 evaluating each research protocol sys- MACRO. tematically, 160-167 See Multi-Center Academic Clinical maintaining documentation of its activi- Research Organizations ties, 168-170 McCarthy, Charles, 59 need for taxonomy of, 19 MCMC. origin of, 26 See Medical Care Management Corpora- policies required of, 128-129 tion in proposed standards, 124-131 Measures, to accompany standards, devel- Institutions, 142 oping, 67-68 motivation to seek accreditation, 67 Media reports, of the death of Jesse International codes, relevant for accredita- Gelsinger, 31, 60n tion process, 27 Medical Care Management Corporation International Conference on Harmonisa- (MCMC), 50 tion Guideline for Good Clinical Medicare certification, “deemed-status” Practice (ICH-GCP), 27, 40-41, 61, programs under, 46 63-64, 83 Medwatch, 143 accreditation standards from, 78-79, 83 Memorandum of understanding (MOU), International Conference on Harmonisa- 143 tion of Technical Requirements for Methods, research, accommodating within Registration of Pharmaceuticals for accreditation programs, 13-15, 69-70 Human Use, 85 Minimal risk, 143 Investigating violations, 57-60 Models of accreditation, 45-62. Investigational Device Exemption (IDE), See also Research methods and models 142 applying to human research over- Investigational New Drug Application sight, 53-57 (IND), 142 elements of an accreditation process, Investigator/sponsors, 142 48-53 Investigators, 74, 118 issues that accreditation alone cannot contacting, 84n address, 57-61 educating, 59, 154-155 Monitoring principal, 142 consent, 74 in proposed standards, 131-133 research, 42-43 IOM. MOU. See Institute of Medicine See Memorandum of understanding IRBs. MPAs. See Institutional review boards See Multiple project assurances J Multi-Center Academic Clinical Research Joint Commission on Accreditation of Organizations (MACRO), 51n Healthcare Organizations (JCAHO), Multi-center clinic trials, 61 46, 92 Multiple project assurances (MPAs), 30n, managed care accreditation program 143 announced by, 54n N K National Association of IRB Managers, 43 Kant, Immanuel, 41 National Association of State Universities Kefauver-Harris Amendments, 24, 36 and Land Grant Colleges, 50 Korn, David, 52 National Bioethics Advisory Commission L (NBAC), 13n, 16n, 28-29, 34, 49, 59, Legally authorized representatives, 93 142-143 National Breast Cancer Coalition, 42n M National Cancer Institute (NCI), 38, 61

INDEX 214 National Commission for the Protection Office of the Inspector General of DHHS of Human Subjects of Biomedical OIG, 13n, 29, 56, 66n and Behavioral Research, 26, 56 requesting federal studies for evaluating National Committee for Quality Assur- accreditation, 20, 91-93 ance (NCQA), 1-2, 7-8, 10, 46 Officials, institutional/organizational, 118 accreditation standards from, 78-80, OHRP. 135-195 See Office for Human Research Protec- modifying standards from to initiate tions pilot programs, 18-19, 63, 84, 86-87 OIG. selecting Program Advisory Committee See Office of the Inspector General of members, 83 DHHS National Endowment for the Humanities, Ombudsman programs, 74 16n, 55n OPRR. National Health Council, 50 See Office for Protection from Research National Human Research Protections Risks Advisory Committee (NHRPAC), 93 Organizations, 118 National Institutes of Health (NIH), 25, appearing before the committee, 106 30n, 47, 84n responsibilities, in proposed standards, National Research Act, 25 118-124 Natural Sciences and Engineering Council P (Canada), 27 Participants. NBAC. See Research participants/subjects/ See National Bioethics Advisory Com- individuals studied in research mission Performance NCI. effect of accreditation on, 61-62 See National Cancer Institute minimum expectations for, 65 NCQA. PHS. See National Committee for Quality See U.S. Public Health Service Assurance Pilot accreditation programs, 10-11, 53-56 NHRPAC. evaluating, 89 See National Human Research Protec- modifying NCQA standards to initiate, tions Advisory Committee 18-19, 84, 86-87 NIH. Pilot testing, recommendations for initial- See National Institutes of Health standards to begin, 84-87 Nishimi, Robyn, 62 Policy issues, 143 Nonbiomedical research, 39-40 President's Commission for the Study of Nongovernmental organizations, establish- Ethical Problems in Medicine and ing for accreditation, 11, 14, 56-57 Biomedical and Behavioral Nonmedical institutions, 15 Research, 13n, 26, 55-56, 66n Nuclear Regulatory Commission, 16n, 55n PricewaterhouseCoopers, 50 Nuremberg Code, 23-24, 36, 41 PRIM&R. Nuremberg Military Tribunal, 24 See Public Responsibility in Medicine O and Research Office for Human Research Protections Principles (OHRP), 27, 52 for ethics-based standards, establishing creation of, 30n for accreditation, 12-13, 16, 66-67 list maintained by, 51n underlying protection of humans studied need for investigations by, 19, 64 in research, PRIM&R, 116-133 Office for Protection from Research Risks Privacy issues, in the draft standards for (OPRR), 4, 25 accreditation of VA Medical Centers, shutdowns by, 29-30, 50 136, 180-182 Office of Management and Budget, Circu- Private organizations, role of, 74 lar No. A-119, 17, 56 Privately funded research, rise of, 38-39 Office of Technology Assessment, 62

INDEX 215 Procedures. dating within accreditation programs, See Standard operating procedures 13-15, 69-70 (SOPs) Research monitoring, 42-43 Proposed standards, 118-133 improving, 60-61 institutional review boards (IRBs), Research participants/subjects/individuals 124-131 studied in research, 18n, 118, 142 investigators and other research person- directly involving in accreditation pro- nel, 131-133 grams, 18, 73-75 organizational responsibilities, 118-124 in the draft standards for accreditation Protection. ofVA Medical Centers, 136, 176-179 See Human research participant protec- naming of, 33-34 tion programs role of, 41-42 Protocol files. selecting and recruiting, 176-179 See Research protocol files vulnerability of, 144 Protocols. Research personnel, in proposed stan- See Research protocols dards, 131-133 Public Responsibility in Medicine and Research protocol files, 51n, 143 Research (PRIM&R), 1, 6, 8-9, 49-50 Research protocols, 51n, 143 accreditation standards from, 63, 77-80, conflicts over, 66n 115-134 IRBs evaluating each systematically, goals of, 116 160-167 principles underlying protection of Risks, 171-175 humans studied in research, 116-133 considerations of, in the draft standards Q for accreditation of VA Medical Cen- Quality improvement (QI) mechanisms, ters, 136, 171-175 143 minimal, 143 incorporating continuously into standards, S 17, 72 SAEs. R See Serious adverse events Recommendations, 10-20 Safety reports (IND/IDE), 143 for initial standards to begin pilot test- Sanctioning violations, 57-59 ing, 84-87 Secretary of Health and Human Services, Recruiting research participants, in the 1, 5 draft standards for accreditation of requesting federal studies for evaluating VAMCs, 136, 176-179 accreditation, 20, 91-93 Registration process, 52n task statement from, 32 Regulatory requirements Selecting research participants, 176-179 base standards for, 15-17, 71-72 Self-evaluation, accreditation programs governmental, 45-46, 71 and, 51-52 relation of standards to existing, 71-72 Serious adverse events (SAEs), 143-144 rigidity of existing, 55n Shutdowns of clinical research, at aca- Remedial action, draft accreditation out- demic and VA medical centers, 29-31 comes and, 138-140 Social Sciences and Humanities Research Repeat accreditation, 53 Council (Canada), 27 Research SOP. inherent risks of, 4 See Standard operating procedure nonbiomedical, 39-40 Special interests, policies required of rise of privately funded, 38-39 IRBs with, 129 Research infrastructures, 118, 143 Sponsors, 41, 118, 144. accommodating a variety of, 13-15, 69-70 See also Investigator/sponsors Research methods and models, accommo-

INDEX 216 need for standards regarding roles and Unexpected adverse event, 144 responsibilities of, 75-76 United States v. Karl Brandt et al., 24 Staffing, for institutional review boards U.S. Congress, 4 (IRBs), 86 requesting federal studies for evaluating Standard operating procedure (SOP), 144 accreditation, 20, 91-93 Standards for accreditation, 63-87. U.S. Department of Health and Human See also Draft standards; Services (DHHS), 4-5, 25, 46 Proposed standards; Office for Human Research Protections Appendix B and Appendix C (OHRP), 19, 27 articulating sound goals within, 12, 65-66 Office of the Inspector General (OIG) assessing compliance with, 76-77, 81-82 of, 13n, 29 to begin pilot testing, recommendation requesting federal studies for evaluating for initial, 84-87 accreditation, 20, 63, 91-93 comparison of, 78-79 Secretary of, 1, 5 development of, 22 U.S. Department of Labor, 16n, 55n to encompass multiple research settings U.S. Department of Veterans Affairs and methods, need for, 69-70 (VA), 1 -2, 4-5, 7-8, 10. to enhance the role of research partici- See also Veterans Affairs Medical Center pants, need for, 73-75 contract with NCQA, 92, 114 establishing standards for the standards, facilities of, 14 64-67 human research protection accreditation flexible, ethics-based, and meaningful, program draft accreditation stan- 12-13, 66-67 dards, 135-195 hortatory, 81 and the NCQA accreditation process, 50 incorporating quality improvement shutdowns, 29-31 mechanisms continuously into, 17, 72 U.S. Public Health Service (PHS), 25 international conference on harmoniza- V tion guideline for good clinical VA. practice, 83 See U.S. Department of Veterans Affairs measures to accompany, 67-68 VAMC. NCQA, modifying to initiate pilot pro- See Veterans Affairs Medical Center grams, 18-19, 84, 86-87 Veterans Affairs Medical Center, draft for quality improvement and self-study, standards for accreditation of, 135-195 72 Violations, identifying, investigating, and regarding roles and responsibilities of sanctioning, 57-59 research sponsors, need for, 75-76 Vulnerable subjects, 144 in relation to existing regulatory W requirements, 15-17, 71-72 Waiver authority, 36 review of available drafts, 76-83 Willowbrook State School for the Statement of task, 32 Retarded, 25 Subjects. See Research participants/subjects/ individuals studied in research Submitting comments, on the draft stan- dards for accreditation of VA Medi- cal Centers, 195 T Task statement, 32 Taxonomy of IRBs, need for, 19 Time for Reform, A, 29 Tri-Council Statement (Canada), 27 Tuskegee Syphilis Study, 25, 34 U Understanding Accreditation, 68

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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