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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