The American Society for Microbiology (ASM) welcomes the opportunity to comment on the Office of Management and Budget (OMB) notice of proposed rule making published in the Federal Register of February 4, 1999, outlining how the OMB intends to implement P.L. 105-277, which includes a provision directing the OMB to amend Circular A-110 "to require all Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act..." (FOIA).
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 shares in a widespread belief that the OMB proposal leaves many issues unresolved and creates others that require clarification. To attempt to work under what has been proposed would be burdensome and disruptive to the work of many microbiologists and others engaged in federally funded research and clinical studies. The ASM understands that the 1980 decision of the U.S. Supreme Court in Forsham vs. Harris concluded that data generated by a federally funded research program are not "agency records" subject to public disclosure under the FOIA if the data have not yet been obtained by the agency. Consistent with this interpretation, the ASM supports H.R. 88, which has been filed by Congressman George Brown to amend P.L. 105-277 by striking the provisos that require data produced under federal grants be made available to the public under the FOIA. H.R. 88 would obviate a need for the rule making now proposed by the OMB.
The ASM supports amendment of P.L. 105-277 as called for by H.R. 88 knowing fully that the subject of public access to research data is a concern that deserves and demands further consideration. Indeed, the ASM believes it best to start anew with Congressional briefings and/or hearings to identify need and consider how that need may best be satisfied. The ASM is willing to participate in a thoughtful study of how, with a minimum of disruption of the research and regulatory communities, measures may be crafted that will satisfy the public's right to know. A careful consideration of the question of disclosure of research results with the full involvement of interested parties, offers far more promise than further disagreement over current proposals.
The OMB proposed rule change is a laudable effort to minimize the impact of implementation of a section of P.L. 105-277 that is unacceptable to the research community. In drafting the proposed rule change, the OMB demonstrated great sensitivity to many of the research community's concerns, and focused on issues that are subject to interpretation. These issues, as enumerated below, should be addressed and can serve as the basis for briefings and/or hearings that may result in reassuring guidelines for measures that respect the public's right to know without attacking, disrupting or delaying federally funded research that is designed to serve the public good.
- A guide for differentiating data included under the FOIA from data excluded as well as a definition of data that clarifies whether or not medical files, lab notebooks, draft manuscripts, charts, computer discs, video tapes, audio tapes, etc. are included.
- The degree to which making research results available to the public under the FOIA may constitute premature disclosure and prejudice professional journals against publishing those results, or infringe on the rights of researchers to protect their intellectual property by copyright and patent.
- The burden of costs of a program that would be enormous and particularly troublesome because the expenses of information storage, exchange and tracking would be distributed among federal agencies as well as all federally funded research sites at schools, universities, hospitals and other nonprofit institutions.
- Compliance by researchers and institutions must be considered from the enforcement perspective, and thought needs to be given to financial as well as other possible penalties for noncompliance. There also is the problem of locus of responsibility when a researcher simultaneously conducts investigations at more than one institution, when a researcher changes institutions, and when a researcher is conducting investigations supported in part by both public and private sources.
- The possible threat to intellectual property rights posed by application of the FOIA to the results of federally funded research, and its impact on continued implementation of the Bayh-Dole Act of 1980 which has been remarkably successful in promoting technology transfer from universities to the marketplace.
- Applicability to and effect on the Small Business Innovative Research Program (SBIR), the Small Business Technology Transfer Program (SBTT) and the Advanced Technology Program (ATP) which are notable in their outstanding contribution to the current balance of industry-government-university collaboration.
The ASM thanks you for this opportunity to comment on an issue of momentous concern to the research community, and strongly urges your consideration of the items presented above.