(4) how oversight mechanisms can ensure participants' safety in ongoing research;11 (5) the steps that research institutions and their leadership can take to cultivate a culture that puts the safety and interests of research participants foremost;12 and (6) 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. 13

The NCQA standards, if improved as recommended, could also be used —by NCQA, the Association for the Accreditation for Human Research Protection Programs (AAHRPP), or other accreditation organizations —as the basis for the development of accreditation standards for non-VA research organizations.

Accreditation will not be successful until it is widely accepted as a mark of excellence. To accomplish this, it should serve as an educational tool to raise the median overall performance of an accredited organization. To do this, accreditation standards and the processes in which they will be used must incorporate consistent feedback from the parties involved in the various aspects of an HRPPP. As discussed above, the local aspects of this issue (i.e., aspects that apply to individual applicant institutions) should be enhanced in the NCQA standards. The committee is encouraged that both NCQA and AAHRPP include stakeholder representatives in their programmatic leaderships (see Recommendation 2). Those who encounter problems in the research protection system, irrespective of the perspective that they represent in that system, need simple, con-


Chapter 3 describes some options for research monitoring and feedback. When organizations applying for accreditation conduct research that is monitored by DSMBs, for example, details of how those boards interact with investigators, IRBs, and research administrators would need to be evaluated for all or a representative sample of DSMBs. Reporting mechanisms for severe or unanticipated adverse events would similarly be necessary to evaluate all protocols or a representative sample of protocols. Ombudsman programs and reporting mechanisms for concerns, complaints, and other feedback mechanisms would be included. Pilot testing will likely reveal a wide variety of monitoring and feedback methods that will have to be accommodated in the accreditation process.


PRIM&R's Standard 1.16 calls for assessment of quality improvement programs, and NCQA's standards presented in Table C-3(B) do so with even more specificity. The committee believes that procedures for evaluating the informed-consent process in particular deserve special attention and will be both the foundation of effective protections and the best hope of shifting from documentation to performance measures.


Budget and staffing for IRB operations, monitoring and ombudsman programs, and other HRPPP components are not sufficient to evaluate quality and effectiveness. Insufficient budgets and staffing, however, would be clear indications of deficiencies. The committee sought information about budgets and staffing, but found few data. (The 1998 report by Bell and colleagues contains some data on IRBs and investigators at 491 institutions; it does not, however, include data on IRBs regulated only by the FDA, monitoring bodies, or administrative costs.) Extant data were insufficient for the committee to develop benchmarks for different kinds of organizations seeking accreditation. Such benchmarks will thus have to be established in light of experience from pilot testing.

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