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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
They should be flexible and adapted to different kinds of researchand different research institutions.
They should encourage accredited organizations to shift from a culturethat relies on external compliance checks to a culture that putssafety and voluntary participation foremost.
They should facilitate compliance with federal regulations but shouldaim to move an organization toward having stronger protection ofhuman research participants.
To the extent possible, they should focus on the use of meaningfulmeasures of how well the rights and interests of research participantsare being protected rather than simple determination of whether informed-consentstatements have been signed or IRB meetings were duly constituted.
The committee believes that the draft NCQA standards are close to meeting the criteria in Recommendations 3 and 4 for pilot testing in VA facilities, and if they are modified as suggested under Recommendation 9, they could be used as the basis for pilot tests of HRPPP standards outside VA facilities.
Recommendation 5: Accommodate Distinct Research Methods and ModelsWithin Accreditation Programs
The accreditation process should accommodate other research organizationsin addition to the traditional models provided by academic healthcenters and VA facilities. The accreditation process should alsocover research other than clinical research.
Proposed NCQA standards were designed for VA facilities only. PRIM &R standards were prepared with a broader range of institutions in mind, but the committee heard strong, consistent comments that they do not fully recognize either the diversity of institutions or the full range of research (IOM, 2001). The standards proposed by NCQA and PRIM&R focus on HRPPPs that comprise a research institution, investigators, and IRBs. These elements are present in VA
The principles laid out in The Belmont Report are one foundation (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Accreditation standards, however, should also incorporate the recommendations of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission, 1981, 1983), the recommendations of the Advisory Committee for Human Radiation Experiments (ACHRE, 1995), recommendations presented in reports of the National Bioethics Advisory Commission (NBAC, 1998, 1999a,b, forthcoming-a, forthcoming-b), the recommendations of the Office of the Inspector General of DHHS (DHHS OIG, 1998b, 2000b), and the recommendations of the General Accounting Office (GAO, 1996). In addition, recommendations from reports and declarations of private bodies and independent scholars should be incorporated. This presupposes that an advisory apparatus is available to cull this literature.