In the course of the second, more comprehensive, phase of the committee 's work, the committee may or may not revisit HRPPP accreditation. The future report will certainly address other strategies for improvement to supplement this report, such as educating investigators, augmenting resources for research oversight (at both the federal and the local levels), enhancing oversight of ongoing research (including monitoring bodies and reporting mechanisms), and other strategies.


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.

The process of establishing an accreditation system typically takes many years, and it must be continually adjusted, particularly in its initial phases. Current efforts to establish accreditation systems are just under way, and the proposed standards are new and untested. The process for the accreditation of HRPPPs is still being configured, and the organizaitons thus far identified to carry it out are taking on an unprecedented task. Two specific approaches have been presented to the committee. The process that is furthest along is a nascent accrediation process for the VA medical facilities being conducted by NCQA under a contract with the VA. That contract commenced in May 2000. Another organization, the Association for the Accreditation of Human Research Protection Programs (AAHRPP), was originally incorporated in March 2000, but its formal establishment is still under way (see Chapter 2).

These emerging accreditation programs are best viewed as pilot projects that will have to be evaluated in light of experience. Any accreditation system must be constructed as an evolving tool and part of a long-term strategy and cannot be expected to immediately correct deficiencies in the HRPPP system. As a component of a long-term strategy to improve the quality of research oversight, however, a nongovernmental accreditation process has promise and should be tested as soon as possible. The logical first step is to continue the VA accreditation program. The second step is to pilot test accreditation in academic health centers and private research organizations whose HRPPPs conform to the organizational structures for which both sets of draft standards were formulated: those that conduct research, directly employ investigators, and have IRBs. The

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