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Responsible Research: A Systems Approach to Protecting Research Participants
Strong organizational leadership and the promotion of an ethically based research culture (possibly complemented through appropriate accreditation standards) may help avoid the need for management policies regarding potential self-interests; however, a dedicated conflict of interest review process will remain essential. Guidelines for acceptable levels of conflict and policies for managing conflict should continue to be developed so that common professional standards can be implemented and refined.
In the committee’s view, because the Research ERB lacks the necessary resources or authority to ensure the appropriate management of potential conflicts of interest, the responsibility for assessing and managing financial conflicts of individuals (investigators, research staff, and Research ERB members) should lie with the research organization (see Recommendation 6.5). Likewise, organizations should ensure that an independent, external mechanism is in place for the evaluation of potential institutional conflicts (see Recommendation 6.6). In both instances, conflict of interest information should be communicated in a timely and effective manner to the Research ERB, which should make the final assessment with regard to ensuring participant protections.
The impact of institutional conflicts of interest as well as nonfinancial conflicts of interest at all levels of the research enterprise have not been explored sufficiently and are issues that, like the development of professional norms for individual conflicts of interest, should be rigorously pursued by federal agencies and appropriate interest groups.
Periodically Assess the National System
Complexity, opacity, and contradiction abound in interpretations of the rules and regulations that apply to human research, often confounding clear communication between agencies and institutions. Although the language of the Common Rule deserves a careful and comprehensive reassessment for clarity and relevancy after more than 20 years of use, its revision would be time-consuming and difficult, as each signatory agency must agree to the changes. Eventually, Congress will need to take the necessary steps to broaden and strengthen the federal oversight system and to make appropriate Common Rule modifications as needed.
One mechanism through which continuing and periodic review of the national participant protection system could be provided is NHRPAC.21 This committee was created by the Secretary of DHHS in concert with the creation of OHRP in June 2000 to provide expert advice and recommenda-
The recent dissolution of NHRPAC underscores the need for Congressional direction in the establishment of a nonpartisan, independent advisory committee focused on the policy issues relevant to ensuring the protection of research participants, as discussed in Chapter 7.