First, significant doubt exists regarding the capacity of the current system to meet its core objectives. Although all stakeholders agree that participant protection must be of paramount concern in every aspect of the research process, a variety of faults and problems in the present system have been noted. The common finding is that dissatisfaction with the current system is widespread.

Second, it has been shown that IRBs are “under strain” and “in need of reform” (AAU, 2001; GAO, 1996; Levine, 2001a; NBAC, 2001b; OIG 1998a, 2000a). The complexity of the issues, the variability in the research settings, the limitations of funding options, the demands of investigators and participants for access to research, and the accountability for institutional compliance have magnified and complicated IRBs’ responsibilities. This heavy burden has made it difficult both to recruit knowledgeable IRB members and to allow them sufficient time for the necessary ethical reflection.

Third, the existing regulatory framework (i.e., the Common Rule9 and the IRB system it created) cannot adequately respond to the complex and ever-changing research environment, with weaknesses related to gaps in authority, structure, and resources. Some of the problems can be addressed through interpretive guidance and clarification issued by the pertinent federal agencies and offices and through collaborations between federal authorities and private entities. However, in instances relating to deficiencies in authority, Congressional action is needed.

MAJOR RECOMMENDATIONS

The major recommendations of this report aim to ensure the protection of every research participant. The committee envisions a three-part strategy to achieve this goal, including refocusing the mission of the IRB on the thorough ethical review and oversight of research protocols; recognizing research participants’ contributions and integrating them into the system; and maintaining high standards for and continuing review of HRPPP performance. Specific recommendations are organized around these themes in the following summary. By contrast, the report itself has been sequenced according to the natural progression of the research process. Additionally, two tables at the conclusion of this summary categorize the committee recommendations into those that will require direct government action and those that will not (Tables ES.1 and ES.2). The tables also indicate which agencies, organizations, offices, or individuals have the primary responsibility for the implementation of each recommendation.

9  

45 CFR 46, Subpart A.



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