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, 54
nnational, 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
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
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
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
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
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
Investigational New Drug Application, 142
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
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
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
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
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
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
contacting, 84n
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 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 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
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
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
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
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
See also Investigator/sponsors
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
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
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
