Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 10-19
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From page 10... ...
RECOMMENDATIONS Recommendation 1: Pursue Accreditation Through Pilot Testing as One Approach Accreditation of HRPPPs should be pursued as one promising approach to improving the human participant protection system. The first step is implementation of pilot programs to test standards, establish accreditation processes, and build confidence in accreditation organizations.
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From page 11... ...
An accreditation process should directly involve the kinds of institutions being accredited, but an accreditation organization should not be beholden to any particular stakeholder or interest group. Accreditation bodies for HRPPPs will require input Tom academic health centers, organizations representing research sponsors, nongovernmental research organizations, private firms developing products and services tested in studies with humans, participants, IRB members and staff from both academic and nonacademic institutions, research administrators in both academic and nonacademic institutions, and individuals Mom a range of research fields appropriate to the intended range of applicant institutions.
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From page 12... ...
Recommendation 4: Establish Flexible, Ethics-Based, and Meaningful Standards Accreditation standards should meet the following minimal criteria: 1. They should be based on sound and widely accepted ethical principles.6 s The committee does not mean that any member who could have a conflict with any conceivable protocol coming to an IRB for review should be excluded from service on an IRB but, rather, means that the individual should recuse himself or herself from reviewing such protocols.
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From page 13... ...
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 Models Within Accreditation Programs The accreditation process should accommodate other research organizations in addition to the traditional models provided by academic health centers and VA facilities.
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From page 14... ...
One of the virtues of a nongovernmental voluntary accreditation process is its flexibility, and nongovernmental accreditation bodies should not find it difficult to accommodate disparate organizational structures, but it is not yet clear how the current proposed standards or accreditation processes would do so.
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From page 15... ...
Recommendation 6: Base Standards on Existing Regulations Accreditation standards should start from federal regulations for the protection of human research participants but should augment those regulations. The process should be iterative and continual, with evolution of both accreditation standards and the operations of accredited organizations, creating incentives for accredited organizations to improve.
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From page 16... ...
By using standards that emphasize processes of continual quality improvement instead of an exclusive focus on regulatory compliance, the way may be open to the development of future standards that center on HRPPP performance, in addition to the current focus on documentation. For example, an HRPPP that demonstrates that it can ensure informed consent because it has data showing that participants understand the protocols in which they are enrolled could begin to supplant or augment paper audits of signed informed-consent forms.
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From page 17... ...
The formulation of standards, the conduct of accreditation site visits, and external evaluation must therefore be intimately linked. Recommendation 7: Incorporate Continuous Quality Improvement Mechanisms into Standards Accreditation organizations should emphasize the process of selfstudy, evaluation, and continual quality improvement among applicants.
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From page 18... ...
Standards should also reflect stronger participant involvement beyond securing signatures on informed-consent documents. Recommendation 9: Use Modified NCQA Standards to Initiate Pilot Programs Pilot accreditation programs should start from the accreditation standards and processes proposed by NCQA for VA facilities, as adapted for use in other organizational contexts.
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From page 19... ...
mechanisms by which research institutions and, where applicable, research sponsors can be held accountable for ensuring sufficient funding, structural support, and professional rewards for HRPPPs. The NCQA standards, if improved as recommended, could also be used by NCQA, AAHRPP, or other accreditation organizations as the basis for the development of accreditation standards for non-VA research organizations.
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