THE NEED FOR BETTER ADVICE AND GUIDANCE AT THE FEDERAL LEVEL

Complexity, opacity, and contradiction abound in interpretations of the rules and regulations that apply to human research; these confound clear communication between agencies and institutions. Federal regulations are complex and subject to broad interpretation. Although the language of the Common Rule1 deserves a careful and comprehensive reassessment for clarity and relevancy, revising it would be time consuming and difficult, because 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 modify the Common Rule where needed. In the interim, however, several steps can be taken to promote its uniform interpretation and clarify its intent.

The committee applauds the emphasis of the Office for Human Research Protections (OHRP) on “protection without over-reaction” and the increased emphasis on providing education and engaging in discussion. However, agencies such as OHRP and the Food and Drug Administration (FDA) should do more to clarify the existing regulations and to provide illustrative guidance to institutions. This could occur through a number of approaches: agencies (and perhaps the accreditation bodies) could place this information on the Web, conduct workshops, visit institutions to provide education, begin the process of developing best practices through case studies (see Recommendation 3.8), and compile and disseminate examples of acceptable and unacceptable scenarios.

Clear guidance from the funding agencies and recognition that the situations that face research organizations are more alike than different would help dissipate the self-protective, over-reactive climate found in many research organizations today. Because it is not uncommon for multiple points of contact to occur between agencies and research organizations, it is even more important that readily accessible information is available to research organizations and that their staff members make frequent use of it. A body such as the Federal Demonstration Partnership2 could assess the effectiveness of the communication and interaction between the relevant oversight and funding agencies and the academic research organizations.

1  

45 CFR 46, Subpart A.

2  

The Federal Demonstration Partnership was convened by the Government-University-Industry Research Roundtable to provide a forum where universities, research institutions, and federal representatives come together to assess university-government research collaborations. See www.fdp3.org.



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