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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Index A AAALAC. See Association for Assessment and Accreditation of Laboratory Animal Care AAHRPP. See Association for the Accreditation of Human Research Protection Programs AAMC. See Association of American Medical Colleges Academic health centers, 14 shutdowns at, 29–31 Acceptance of accreditation, need for widespread, 16 Accountability, calls for, 31–32 Accreditation, 117 vs. certification, 43 collecting data on and assessing impacts of, beginning now, 19–20, 90–91 effect on performance, 61–62 establishing nongovernmental organizations for, 11, 56–57 of human research participant protection programs, 5 initiating federal studies evaluating, 20, 91–93 to insure compliance with AAALAC standards, 47 issues not addressed by, 57–61 as a mark of excellence, 86 need for wide acceptance of, 16 pursuing through pilot testing, 10–11, 53–56 substituting private for public regulation, 46 as a supplement to governmental regulations, 45–46 Accreditation bodies, 49–50 Association for the Accreditation of Human Research Protection Programs , 10, 47, 49–50 Accreditation Outcome Table, 137–140 Accreditation process, elements of, 48–53 Accreditation programs accommodating distinct research methods and models within, 13–15, 69–70 appeals process, 53 coverage of, 7 data produced by, 89 development of, 22 directly involving research participants in, 18, 73–75 eligibility criteria for, 51 evaluating pilot, 89 and external evaluation, 52 failures of, 54n
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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs national, voluntary, 55 recommendations for implementation phases of, 22, 27 registration process for, 52n repeat accreditation, 53 and self-evaluation, 51–52 Accreditation standards articulating sound goals within, 12, 65–66 establishing flexible, ethics-based, and meaningful, 12–13, 66–67 ACHRE. See Advisory Committee on Human Radiation Experiments Adverse events (AEs), 141. See also Serious adverse events unexpected, 144 Advisory Committee on Human Radiation Experiments (ACHRE), 13n, 26, 28, 56, 59, 65n AEs. See Adverse events Affiliate's human research protection program, 141 Albuquerque Tribune, 26 AMA. See American Medical Association American Association of University Professors, 39 American Medical Association (AMA), 48 physician certification program announced by, 54n Animal Welfare Act of 1966, 47–48 Appeals process, 53 Applied Research Ethics National Association (ARENA), 43 Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), 47 Association for the Accreditation of Human Research Protection Programs (AAHRPP), 10, 47, 49–50, 52, 86, 90 Association of American Medical Colleges (AAMC), 5, 50, 52 Association of American Universities (AAU), 50 Association of American Universities (AAU) Task Force on Research Accountability, 5 B Belmont Report, The, 13n, 26, 41, 65, 66n, 116–117 Benefits, considerations of, in the draft standards for accreditation of VAMCs, 136, 171–175 Board on Behavioral, Cognitive, and Sensory Sciences, 40 Budget, for institutional review boards, 86 C Calls for accountability, 31–32 Certificates of Confidentiality, 141 Certification, vs. accreditation, 43 CIOMS. See Council for International Organizations of Medical Sciences Circular No. A-119, 17, 56 original intention of, 56n Cline, Martin, 58 Clinical research, shutdowns at academic and VA medical centers, 29–31 Clinical trials, rise of, 38–39 Collecting data, on accreditation, beginning now, 19–20, 90–91 Committee on Assessing the System for Protecting Human Research Subjects , 1–2 findings of, 6–10 task of, 5–6 Committee on National Statistics, 40 “Common Rule” governing human research, 80 origin of, 26, 62 signatories to, 16, 55n Community Clinical Oncology Program, 38 Comparisons, between draft NCQA and PRIM&R accreditation standards, 8 Compliance with standards, assessing, 76–77 Concerns, 115 Confidentiality issues, in the draft standards for accreditation of VA Medical Centers, 136, 180–182 Consent informed, 25, 36, 38, 183–194 monitoring, 74 Consortium of Social Science Associations (COSSA), 50 Consumer organizations, 74 Costs, of institutional review boards, 92n Council for International Organizations of Medical Sciences (CIOMS) , 27, 65 Council on Medical Education, 48
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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs D Data collection on accreditation, beginning now, 19–20, 90–91 guidelines for (under development), 141 for national statistical databases, 39 Data safety and monitoring boards (DSMBs), 61, 73, 117 expertise stipulated, 73 Data sources and methods, 105–114 draft standards for accreditation, 114 literature review, 113–114 presentations and public comment, 105–113 Deaths, Jesse Gelsinger, 4, 31, 58 Declaration of Helsinki, 27, 65, 85 “Deemed-status” programs, under Medicare certification, 46 Definitions, 32–43, 117–118, 141–144 Deloitte & Touche, 50 DHHS. See U.S. Department of Health and Human Services Distinct research methods and models, accommodating within accreditation programs, 13–15, 69–70 Documentation, 36, 60 IRBs maintaining, of their activities, 168–170 Draft accreditation outcomes, and remedial action, 138–140 Draft standards, 114 omissions in, 82–83 relation to existing regulatory requirements, 81 review of available, 76–83 Draft standards for accreditation of VAMCs, 135–195 components under development, 141 considerations of risks and benefits, 136, 171–175 domains of, 136 individual IRB structure and operations, 136, 156–170 informed consent, 136, 183–194 institutional responsibilities, 136, 145–155 operation of, 141 privacy and confidentiality, 136, 180–182 recruitment and subject selection, 136, 176–179 sources of, 136 submitting comments on, 195 DSMBs. See Data safety and monitoring boards Duke University, shutdowns at, 29 E Educating investigators, 59, 154–155 Eligibility criteria, for accreditation programs, 51 Ethics-based standards, establishing for accreditation, 12–13, 66–67 Evaluation of research protocols, systematic, by IRBs, 160–167 Evaluation process for accreditation development of, 22 external, 52 initiating federal studies for, 20, 91–93 pilot programs, 89 self, 51–52 Excellence, accreditation as a mark of, 86 Existing regulatory requirements base standards for, 15–17, 71–72 relation of standards to, 71–72 External evaluation, accreditation programs and, 52 F FDA. See Food and Drug Administration FDA Form 3454, 141 Federal Policy for the Protection of Human Subjects in Research, 26 Federal regulations. See Regulatory requirements Federal studies evaluating accreditation, initiate, 20, 91–93 Federalwide assurance (FWA), 142 Federation of American Societies for Experimental Biology (FASEB) , 50 Flexible standards, establishing for accreditation, 12–13, 66–67 Flexner, Abraham, 48 Food, Drug, and Cosmetic Act, Kefauver-Harris Amendments to, 24 Food and Drug Administration (FDA), 4, 24, 27, 142
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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Investigational New Drug Application, 142 investigations by, 19, 31, 64 FWA. See Federalwide assurance G GAO. See General Accounting Office Gelsinger, death of Jesse, 4, 31, 58 General Accounting Office (GAO), 13n, 50, 66n Goals, articulating within accreditation standards, 12, 65–66 Governmental regulations, accreditation as a supplement to, 45–46, 71 Guidelines for accreditation, three sets of, 78–79 Gunsalus, C. K., 62 H HCFA. See Health Care Financing Administration Health Care Financing Administration (HCFA), 46 Helsinki. See Declaration of Helsinki Hopkins standard, 48 HRPPPs. See Human research participant protection programs HRPPs. See Human research protection programs Human research enterprises, strains upon, 4 Human research participant protection programs (HRPPPs), 2–3, 37 accreditation of, 5, 10–14 controlling relevant elements of, 14 directly involving research participants in, 18, 73–75 evaluating pilot accreditation programs, 89 history of, 23 –26 information flow pathways within, 3, 37 naming of, 32n, 35–43 Human research protection programs (HRPPs), 117, 142 affiliate, 141 responsible for educating institutional staff, 154–155 systematic and comprehensive, 146-153 Human subjects. See Research participants/subjects/individuals studied in research Human subjects protections in the United States recent occurrences, 26–31 short history of, 24–26 I ICH-GCP. See International Conference on Harmonisation Guideline for Good Clinical Practice IDE. See Investigational Device Exemption Identifying violations, 57–59 Impacts of accreditation, beginning now, 19–20, 90–91 Implementing Human Research Regulations, 26 IND. See Investigational New Drug Application Independent IRBs, 14, 40–41 Indian Council of Medical Research, 27 Individual IRBs, structure and operations of, in the draft standards for accreditation of VA Medical Centers, 136, 156–170 Informed consent, 25 as an “exception” to protection, 190–194 centrality of, 36, 38 in the draft standards for accreditation of VA Medical Centers, 136, 183–194 measuring, 38 Institute for Human Gene Therapy, 58n Institute of Medicine (IOM), 1, 5–6, 40, 49 Institutes of Health Research, 27 Institutional associates, 25 Institutional/organizational officials, 118 Institutional responsibilities, in the draft standards for accreditation of VA Medical Centers, 136, 145–155 Institutional Review Boards: A Time for Reform, 29 Institutional review boards (IRBs), 2, 7, 118, 142. See also Independent IRBs; Individual IRBs appropriate to amount and nature of research reviewed, 157–159 budget and staffing for, 86 costs of, 92n defined, 4
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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs evaluating each research protocol systematically, 160–167 maintaining documentation of its activities, 168–170 need for taxonomy of, 19 origin of, 26 policies required of, 128–129 in proposed standards, 124–131 Institutions, 142 motivation to seek accreditation, 67 International codes, relevant for accreditation process, 27 International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP), 27, 40–41, 61, 63–64, 83 accreditation standards from, 78–79, 83 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 85 Investigating violations, 57–60 Investigational Device Exemption (IDE), 142 Investigational New Drug Application (IND), 142 Investigator/sponsors, 142 Investigators, 74, 118 contacting, 84n educating, 59, 154–155 principal, 142 in proposed standards, 131–133 IOM. See Institute of Medicine IRBs. See Institutional review boards J Joint Commission on Accreditation of Healthcare Organizations (JCAHO) , 46, 92 managed care accreditation program announced by, 54n K Kant, Immanuel, 41 Kefauver-Harris Amendments, 24, 36 Korn, David, 52 L Legally authorized representatives, 142–143 M MACRO. See Multi-Center Academic Clinical Research Organizations McCarthy, Charles, 59 MCMC. See Medical Care Management Corporation Measures, to accompany standards, developing, 67–68 Media reports, of the death of Jesse Gelsinger, 31, 60n Medical Care Management Corporation (MCMC), 50 Medicare certification, “deemed-status” programs under, 46 Medwatch, 143 Memorandum of understanding (MOU), 143 Methods, research, accommodating within accreditation programs, 13–15, 69–70 Minimal risk, 143 Models of accreditation, 45–62. See also Research methods and models applying to human research oversight , 53–57 elements of an accreditation process, 48–53 issues that accreditation alone cannot address, 57–61 Monitoring consent, 74 research, 42–43 MOU. See Memorandum of understanding MPAs. See Multiple project assurances Multi-Center Academic Clinical Research Organizations (MACRO), 51n Multi-center clinic trials, 61 Multiple project assurances (MPAs), 30n, 143 N National Association of IRB Managers, 43 National Association of State Universities and Land Grant Colleges , 50 National Bioethics Advisory Commission (NBAC), 13n, 16n, 28–29, 34, 49, 59, 93 National Breast Cancer Coalition, 42n National Cancer Institute (NCI), 38, 61
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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 26, 56 National Committee for Quality Assurance (NCQA), 1–2, 7–8, 10, 46 accreditation standards from, 78–80, 135–195 modifying standards from to initiate pilot programs, 18–19, 63, 84, 86–87 selecting Program Advisory Committee members, 83 National Endowment for the Humanities, 16n, 55n National Health Council, 50 National Human Research Protections Advisory Committee (NHRPAC), 93 National Institutes of Health (NIH), 25, 30n, 47, 84n National Research Act, 25 Natural Sciences and Engineering Council (Canada), 27 NBAC. See National Bioethics Advisory Commission NCI. See National Cancer Institute NCQA. See National Committee for Quality Assurance NHRPAC. See National Human Research Protections Advisory Committee NIH. See National Institutes of Health Nishimi, Robyn, 62 Nonbiomedical research, 39–40 Nongovernmental organizations, establishing for accreditation, 11, 14, 56–57 Nonmedical institutions, 15 Nuclear Regulatory Commission, 16n, 55n Nuremberg Code, 23–24, 36, 41 Nuremberg Military Tribunal, 24 O Office for Human Research Protections (OHRP), 27, 52 creation of, 30n list maintained by, 51n need for investigations by, 19, 64 Office for Protection from Research Risks (OPRR), 4, 25 shutdowns by, 29–30, 50 Office of Management and Budget, Circular No. A-119, 17, 56 Office of Technology Assessment, 62 Office of the Inspector General of DHHS OIG, 13n, 29, 56, 66n requesting federal studies for evaluating accreditation, 20, 91–93 Officials, institutional/organizational, 118 OHRP. See Office for Human Research Protections OIG. See Office of the Inspector General of DHHS Ombudsman programs, 74 OPRR. See Office for Protection from Research Risks Organizations, 118 appearing before the committee, 106 responsibilities, in proposed standards, 118–124 P Participants. See Research participants/subjects/individuals studied in research Performance effect of accreditation on, 61–62 minimum expectations for, 65 PHS. See U.S. Public Health Service Pilot accreditation programs, 10–11, 53–56 evaluating, 89 modifying NCQA standards to initiate, 18–19, 84, 86–87 Pilot testing, recommendations for initialstandards to begin, 84–87 Policy issues, 143 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 13n, 26, 55–56, 66n PricewaterhouseCoopers, 50 PRIM&R. See Public Responsibility in Medicine and Research Principles for ethics-based standards, establishing for accreditation, 12–13, 16, 66–67 underlying protection of humans studied in research, PRIM&R, 116–133 Privacy issues, in the draft standards for accreditation of VA Medical Centers, 136, 180–182 Private organizations, role of, 74 Privately funded research, rise of, 38–39
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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Procedures. See Standard operating procedures (SOPs) Proposed standards, 118–133 institutional review boards (IRBs), 124–131 investigators and other research personnel, 131–133 organizational responsibilities, 118–124 Protection. See Human research participant protection programs Protocol files. See Research protocol files Protocols. See Research protocols Public Responsibility in Medicine and Research (PRIM&R), 1, 6, 8–9, 49–50 accreditation standards from, 63, 77–80, 115–134 goals of, 116 principles underlying protection of humans studied in research, 116–133 Q Quality improvement (QI) mechanisms, 143 incorporating continuously into standards, 17, 72 R Recommendations, 10–20 for initial standards to begin pilot testing, 84–87 Recruiting research participants, in the draft standards for accreditation of VAMCs, 136, 176–179 Registration process, 52n Regulatory requirements base standards for, 15–17, 71–72 governmental, 45–46, 71 relation of standards to existing, 71–72 rigidity of existing, 55n Remedial action, draft accreditation outcomes and, 138–140 Repeat accreditation, 53 Research inherent risks of, 4 nonbiomedical, 39–40 rise of privately funded, 38–39 Research infrastructures, 118, 143 accommodating a variety of, 13–15, 69–70 Research methods and models, accommodating within accreditation programs , 13–15, 69–70 Research monitoring, 42–43 improving, 60–61 Research participants/subjects/individuals studied in research, 18n, 118, 142 directly involving in accreditation programs, 18, 73–75 in the draft standards for accreditation ofVA Medical Centers, 136, 176–179 naming of, 33–34 role of, 41–42 selecting and recruiting, 176–179 vulnerability of, 144 Research personnel, in proposed standards, 131–133 Research protocol files, 51n, 143 Research protocols, 51n, 143 conflicts over, 66n IRBs evaluating each systematically, 160–167 Risks, 171–175 considerations of, in the draft standards for accreditation of VA Medical Centers, 136, 171–175 minimal, 143 S SAEs. See Serious adverse events Safety reports (IND/IDE), 143 Sanctioning violations, 57–59 Secretary of Health and Human Services, 1, 5 requesting federal studies for evaluating accreditation, 20, 91–93 task statement from, 32 Selecting research participants, 176–179 Self-evaluation, accreditation programs and, 51–52 Serious adverse events (SAEs), 143–144 Shutdowns of clinical research, at academic and VA medical centers , 29–31 Social Sciences and Humanities Research Council (Canada), 27 SOP. See Standard operating procedure Special interests, policies required of IRBs with, 129 Sponsors, 41, 118, 144. See also Investigator/sponsors
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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs need for standards regarding roles and responsibilities of, 75–76 Staffing, for institutional review boards (IRBs), 86 Standard operating procedure (SOP), 144 Standards for accreditation, 63–87. See also Draft standards; Proposed standards; Appendix B and Appendix C articulating sound goals within, 12, 65–66 assessing compliance with, 76–77, 81–82 to begin pilot testing, recommendation for initial, 84–87 comparison of, 78–79 development of, 22 to encompass multiple research settings and methods, need for, 69–70 to enhance the role of research participants, need for, 73–75 establishing standards for the standards, 64–67 flexible, ethics-based, and meaningful, 12–13, 66–67 hortatory, 81 incorporating quality improvement mechanisms continuously into, 17, 72 international conference on harmonization guideline for good clinical practice, 83 measures to accompany, 67–68 NCQA, modifying to initiate pilot programs, 18–19, 84, 86–87 for quality improvement and self-study, 72 regarding roles and responsibilities of research sponsors, need for , 75–76 in relation to existing regulatory requirements, 15–17, 71–72 review of available drafts, 76–83 Statement of task, 32 Subjects. See Research participants/subjects/individuals studied in research Submitting comments, on the draft standards for accreditation of VA Medical 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 Unexpected adverse event, 144 United States v. Karl Brandt et al., 24 U.S. Congress, 4 requesting federal studies for evaluating accreditation, 20, 91–93 U.S. Department of Health and Human Services (DHHS), 4–5, 25, 46 Office for Human Research Protections (OHRP), 19, 27 Office of the Inspector General (OIG) of, 13n, 29 requesting federal studies for evaluating accreditation, 20, 63, 91–93 Secretary of, 1, 5 U.S. Department of Labor, 16n, 55n U.S. Department of Veterans Affairs (VA), 1–2, 4–5, 7–8, 10. See also Veterans Affairs Medical Center contract with NCQA, 92, 114 . facilities of, 14 human research protection accreditation program draft accreditation standards, 135–195 and the NCQA accreditation process, 50 shutdowns, 29–31 U.S. Public Health Service (PHS), 25 V VA. See U.S. Department of Veterans Affairs VAMC. See Veterans Affairs Medical Center Veterans Affairs Medical Center, draft standards for accreditation of, 135–195 Violations, identifying, investigating, and sanctioning, 57–59 Vulnerable subjects, 144 W Waiver authority, 36 Willowbrook State School for the Retarded, 25
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