December 15, 2003

Dr. Margo Schwab
Office of Information and Regulatory Affairs
Office of Management and Budget
725 17th Street, NW
New Executive Office Building, Room 10201
Washington, DC 20503

Re: Comments on Proposed Bulletin on Peer Review and Information Quality

The American Institute of Biological Sciences (AIBS) submits the following comments in response to the Office of Management and Budget (OMB) request for public comments on the Proposed Bulletin on Peer Review and Information Quality. AIBS is an umbrella scientific organization comprised of roughly 6,000 individual members and more than 80 professional societies and scientific organizations representing the breadth of the basic and applied biological sciences.

The scientific peer review process plays an important role in ensuring the quality of the scientific method, including assessments of data quality and interpretation. Peer review can and should play a role in the government's regulation development and review process. Scientists and other scholars are in the knowledge business, however. Scientists are trained to pose next generation questions and experiments based on their understanding and interpretation of what is currently known about a given issue. Thus, guidance to peer review panels considering the research underlying potential regulatory actions should be appropriately directed to ensure the focus of the panel is not merely on what might someday be known, but rather on the quality of the information being considered. If scientists are charged with simply identifying what is not understood, the public and scientific communities will view the use of peer review in the regulatory process as little more than a tool to delay or weaken regulations that do not support a political agenda or constituency.

As an objective of the Bulletin is to increase the public trust in the peer review of research findings that underpin government actions, we commend the idea of utilizing review panels convened by scientific and scholarly societies on behalf of federal agencies. With appropriate compensation for the costs associated with identifying reviewers and convening panels, many scholarly societies and organizations could provide peer review services. Outsourcing this function to non-partisan scholarly societies would add credibility to a commonly criticized process. However, OMB should ensure agencies properly budget for these services so that limited intramural and extramural research funds are not diverted for use in the regulatory process.

The Bulletin's guidance concerning the transparency of review panel membership and findings should be balanced with privacy and due consideration of the reporting burden that would be placed on potential panel members. The Bulletin suggests the potential disclosure of positions, funding sources, and other relevant information for the preceding five to ten years. The Office of Management and Budget should carefully consider on a case by case basis the necessity for requiring individuals to disclose information for more than the preceding five years. The time and record-keeping burdens associated with disclosing activities conducted more than five years ago may strongly dissuade highly qualified individuals from serving on review panels. Also, the proposed Bulletin suggests that agencies should avoid using researchers employed by or that receive funds from the regulatory agency. Government scientists and government funded academic scientists must not be uniformly prevented from serving on review panels when they are appropriately qualified. It is conceivable that for many areas in which the government must review research findings, the most qualified individuals are government researchers or individuals receiving federal funds to conduct research. For some highly specialized programs, the pool of qualified reviewers is already so small that it would be virtually impossible to find individuals that have had no dealings with the program. Moreover, scientific reputation is important in the scientific community and few scientists are willing to sacrifice the respect of their peers to endorse questionable scientific data. Most professional scientific societies have established professional codes of ethical conduct and standards that help ensure scientists do not intentionally misinterpret or misrepresent research findings for personal gain.

Thank you for your careful consideration of these issues. If you have questions or require additional information, please contact Dr. Robert E. Gropp at 202-628-1500 x 250.

Robert E. Gropp, PhD
Senior Public Policy Representative

Adrienne J. Froelich, PhD
Director of Public Policy

Richard T. O'Grady, PhD
Executive Director

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