Behavioral Research (the President's Commission) in reviewing regulations created in the wake of the National Commission and echoed in reports of the Advisory Committee on Human Radiation Experiments (ACHRE) in 1995 and the Office of the Inspector General (OIG) of DHHS in 1998 and 2000 (ACHRE, 1995; DHHS OIG, 1998a,b,c,d, 2000a,b,c; President's Commission, 1981, 1983).

Recommendation 2: Establish a Nongovernmental Accreditation Organization(s).

Organizations formulating accreditation standards and carrying out the accreditation process should be independent, nongovernmental organizations. These organizations should include within their programmatic leaderships the perspective of the relevant stakeholders in the applicant HRPPP community (i.e., institutions, investigators, sponsors, and participants).

As discussed above, one of the chief virtues of a nongovernmental accreditation system is that it can evolve over time without requiring new federal regulations at each step. The regulations are demonstrably unresponsive to dramatic changes in how research is conducted; a nongovernmental accreditation system may be more responsive by comparison and would comport with Circular A-119 of the Office of Management and Budget, which urges the use of nongovernmental “voluntary consensus standards” where possible (OMB, 1998).10

The committee envisions an accreditation process that will continually evolve to update standards over time and to incorporate the variety of organizational structures through which human research programs are reviewed and carried out. The operations of organizations seeking accreditation will also evolve. The parallel evolution of accreditation standards and HRPPP operations should be an iterative process, with the formulation of standards efficiently informed by knowledge acquired in the accreditation process. The formulation of standards, the conduct of accreditation site visits, and external evaluation must therefore be intimately linked and appropriately responsive to feedback.

Organizations formulating standards and conducting the accreditation process should

  1. be national in scope;

  2. be familiar with the operations of institutions that apply for accreditation; and

  3. incorporate the perspectives of research participants within their programmatic leaderships.

10  

Circular A-119 was intended mainly for technical standards pertaining to products, but it also contemplates “related management systems practices” (see http://www.whitehouse.gov/omb/circulars/a119/a119.html).



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