tional experiences and creating precedent cases. Although it is anticipated that the continued development and implementation of accreditation programs will contribute to the dissemination of best practices, this mechanism cannot substitute for the recommended deliberations at the national level. OHRP and NHRPAC, with input from the FDA to ensure that issues particular to drug, biologic and device research are incorporated, should initiate such efforts forthwith.

SUMMARY

The adequate review of research to ensure that human research participants are protected involves the evaluation of several factors that require specific expertise. The IRB structure should be redefined and renamed the “Research ERB” to assert its mandate to conduct ethics reviews on protocols on behalf of those who will eventually be enrolled in studies. However, the newly configured Research ERB cannot be expected to carry out all of the specialized tasks required of a comprehensive protection program. Therefore, when appropriate to the research risks and context, scientific and financial conflicts of interest review should occur through distinct mechanisms that feed into and inform the Research ERB’s comprehensive ethical review of research.

In order to carry out the responsibilities that should be under the purview of the Research ERB, all members should have core knowledge regarding human research ethics. In addition, at least 25 percent of the body’s membership should have no affiliation with the institution, not be trained as scientists, and be able to represent the local community and/or participant perspectives. To ensure that no study goes forward if a substantial portion of the Research ERB objects, no protocol should be approved absent three-quarters of the voting members’ agreement.

One of the primary responsibilities of the Research ERB is the review of consent forms and the informed consent process. The board should ensure that the consent forms convey information relevant to the participant’s decision about whether to enroll and limit, or preferably delete, any language that would serve only to protect the institution.

Robust, ethical review by the Research ERB could be enhanced by better employing risk-stratification, allowing boards to deal with minimal risk studies efficiently and devote more attention to high-risk studies. The review of multisite protocols could be streamlined by designating lead scientific review and ethics review committees, whose judgments would be subject to acceptance by the local review boards (this would include the sharing of conflict of interest determinations with the lead Research ERB). A common body of knowledge and guidance should be developed at the national level to assist review boards in their deliberations and promote consistency among the research oversight community.



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