The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
national, voluntary, 55
recommendations for implementation phases of, 22 , 27
registration process for, 52 n
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), 13 n, 26 , 28 , 56 , 59 , 65 n
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, 54 n
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 , 13 n, 26 , 41 , 65 , 66 n, 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, 56 n
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 , 55 n
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, 92 n
Council for International Organizations of Medical Sciences (CIOMS) , 27 , 65
Council on Medical Education, 48