August 30, 1999 - Revised Proposed Rulemaking on Access to Research Data

OMB Circular A-110 "Uniform Administration Requirements for Grants and Documents with Institutions of Higher Education, Hospitals and Other Nonprofit Organizations."

The Office of Management and Budget (OMB) has demonstrated great concern for the interests and sensitivity of the research and regulatory communities by providing clarifying definitions and additional background regarding its proposed revisions of Circular A-110. However, the American Society for Microbiology (ASM) remains convinced that the Shelby Amendment, irrespective of revision as proposed by the OMB, will continue as a threat to the conduct of research and invite litigation that will be disruptive to the OMB and other federal agencies as well as to research scientists and institutions. The ASM is the largest single life science Society in the world with over 42,000 members, including scientists and science administrators in academic, industrial and government institutions, working in a broad spectrum of subdisciplines, including medical and clinical microbiology, applied and environmental microbiology, virology, and molecular biology.

The ASM recognizes as admirable the OMB's attempt to balance the concerns of critics with those of proponents of the revision of Circular A-110. The ASM endorses the OMB definition of "research data," and the list of items identified by the OMB as exclusions from that definition. Particularly noteworthy is the OMB's position that recipients of federal funding are not required to submit information which in their judgement includes "trade secrets, commercial information" or "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy." This is a much appreciated, laudable expression of confidence in the discretion of researchers and research institutions.

The ASM concurs in the OMB tightened definition of "published" as "either when (A) Research findings are published in a peer-reviewed scientific or technical journal; or (B) A federal agency publicly and officially cites the research findings in support of a regulation."

The ASM supports also the OMB proposal to replace "used by the Federal Government in developing policy or rules" with "used by the Federal Government in a regulation," where regulation, for which notice and comment is required, is defined under the Administrative Procedures Act (5 U.S.C. 553).

In response to OMB's question pertaining to placing a dollar limitation on the scope of the proposed revision, the ASM is not aware of any regulatory actions that do not meet the $100 million threshold, and would, therefore, necessitate the release of research data to the public under FOIA. However, the ASM strongly favors the OMB suggestion that the proposed revision be limited to regulations that have a $100 million minimum impact. Such a limitation would favor the taxpayer by lightening the administrative burden of not only researchers and research institutions, but of grant funding federal agencies as well.

The total costs of providing data as required by the Shelby Amendment and the OMB revisions remain inestimable. It is not possible to predict how frequently federal agencies will cite federally funded research as a basis for rule making, or to forecast the demand for information that may be filed in response to these citations. However, there will be need for research institutions and for federal agencies as well to design and implement costly procedures for the storage, exchange and tracking of information that will be required to meet FOIA obligations. The means by which institutions will be reimbursed for these costs is not satisfactorily described in the OMB notice of August 11, 1999.

The ASM is convinced that the public interest will be ill-served by the Shelby Amendment, and that it is not likely to be rectified by continued refinement. The ASM remains supportive of repeal of the Shelby Amendment. As an alternative, the ASM continues to believe it best to start anew with Congressional briefings and/or hearings to identify areas of conflict and determine how they may best be resolved. The ASM again expresses willingness to participate in a thoughtful study of how, with a minimum of further disruption of the research and regulatory communities, measures may be taken that will satisfy the public's right to know. A thoughtful consideration of the question of disclosure of research results, with the full involvement of all interested parties, offers far more promise than further disagreement and continued revision of current proposals.

The ASM appreciates the opportunity to comment on an issue of great concern to its membership.