Appeals Process

Institutions that fail to get accredited or that are given probationary status will need a credible appeals process. This may be through the accreditation body itself or may require some involvement of FDA or OHRP.6 The NCQA standards include a standard for an appeals process by the applicant institution; the PRIM&R standards do not.

Repeat Accreditation

Accreditation is not permanent. The models of accreditation reviewed by the Lewin Group in 1998 involved accreditation terms of 3 to 5 years. The NCQA program plans a 3-year accreditation cycle. The AAHRPP accreditation term has not yet been firmly specified, but it is expected to be 3 to 5 years. The process for reapplication might or might not differ from that for initial accreditation. It is likely that accredited organizations with few untoward events would face a more abbreviated process, but this is likely to be decided in light of experience.

APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT

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. This effort should be evaluated for its impact on protecting the rights and interests of participants in 3 to 5 years.

Accreditation as a mark of excellence—of achievement well beyond regulatory compliance—might offer an HRPPP a competitive advantage over nonaccredited competitors in seeking support from sponsors or access to participants, researchers, or students. That is, NIH or other funding review committees might look more favorably on research proposals from accredited institutions than on those from nonaccredited ones, those recruiting participants might advertise accreditation as a hallmark of quality and safety, or private drug and device firms might preferentially site clinical trials that they sponsor at accredited research institutions (or have them reviewed by accredited IRBs).

6  

For example, mammography accreditation entails a two-layer appeals process, first to the private body, but if it is denied, then the private body's decision can be appealed directly to FDA (Lewin Group, 1998).



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