An accreditation process should directly involve the kinds of institutions and research expertise being accredited, but an accreditation organization should not be beholden to any particular stakeholder or interest group. Accreditation bodies for HRPPPs will require input from 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 from a range of research fields appropriate to the intended range of applicant institutions.

SOME ISSUES THAT ACCREDITATION ALONE CANNOT ADDRESS

Some elements important to the protection of the rights and interests of those participating in research are not directly addressed in proposed programs for HRPPP accreditation. In most cases, an accreditation process could be used as an indirect means to improvement; however, further actions would be needed in parallel with the establishment of an accreditation process. The committee expects to come back to many of these topics in its second report and has discussed how to integrate some elements not currently emphasized into the accreditation process. The discussion below includes some suggestions to that effect.

Accreditation is not a short-term fix. It must be viewed as one element of a long-term strategy. The VA-NCQA accreditation program will operate in a relatively circumscribed system, but it will take several years to implement the system and several more to evaluate it. The national voluntary system being developed under AAHRPP may take even longer to establish. Before a program could be granted deemed status it would need to be given time to develop and mature. Turning over regulatory authority to an untested program would be very risky, reinforcing the need for pilot testing as a first step.

Identifying, Investigating, and Sanctioning Violations

Accreditation cannot totally replace federal regulation. Accreditation is rarely effective in dealing with bad actors—those who intentionally flout or ignore requirements. Monitoring, investigation, and enforcement are necessary to augment an accreditation system, and under the current regulatory framework these will remain functions of OHRP and the FDA.11 The main cause of error in many prominent controversies in research ethics lies with investigators who diverge from an agreed-upon protocol. Review of protocols cannot fix the prob-

11  

One recommendation of NBAC is to consolidate these functions into a single agency, as noted above.



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