ALMANAC BETWEEN ISSUES August 26, 1999
April 1999 Comment to OMB from the University of Pennsylvania
April 5, 1999
(Via facsimile 202-395-4915)
Re: Comments on proposed revision to Circular A-110
Dear Mr. Charney,
The University of Pennsylvania appreciates the opportunity to comment on proposed revisions to OMB Circular A-110, The University is one of the nation's leading research universities with a current volume of over $400 million in federally-funded research, We have considered and wholly support the comments with regard to proposed revisions to Circular A-110 of our Washington- based associations: the Association of American Universities (AAU), the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), and the Association of University Technology Managers (AUTM).
Part of the University's core mission is to share knowledge with as wide an audience as possible, Indeed, it is the University's policy not to accept funding that requires research findings to be classified or unacceptably restricted, While we recognize the legitimate public policy concerns in regards to the accessibility and sharing of research data, we believe that the implementation of the proposed changes would be bad for science and burdensome for the science agencies, the institutions hosting federally-sponsored research, and in particular on the faculty conducting such research.
The Freedom of Information Act (FOIA), even applied in a limited way to federally-funded research, is too blunt an instrument to deal with such a complex subject, We understand that the proposed changes would limit the application of FOIA to data used in federal rulemaking and only after publication, but we believe that even these limits would not render the statute workable, We are particularly concerned with the following issues:
1) There is no clear definition of "data" or "publication." "Data" could range from notebooks to biological material to videotaped interviews, Similarly, there is no clear definition of "publication," which could range from publication in a scholarly journal to a "power point" presentation to colleagues and students. In addition, the proposal does not specify who would have the final authority to make these determinations. It is also unclear whether all data collected in a lengthy study must be made available, or is the requirement limited to data that in retrospect, proved critical to the conclusions of the study.
The use of such data could also be problematic, Data alone, absent interpretation and analysis, could potentially be meaningless or misleading, Thus, it is our belief that the wholesale availability of data used in reaching scientific conclusions would not only be impossible to implement, but would not fulfill a useful public purpose.
2) The new requirements do not adequately protect patient privacy and the confidentiality of medical records, Although FOIA provides an exemption for medical confidentiality, it is the agency, not the research institution that would make the determination as to what data should be masked or redacted, Thus, despite assurances to participants that information would remain confidential, including such information as the names, behavior and health status of patients, this information would become part of agency records,
3) Because the provision applies to all research with a public funding component, release of research data under FOIA also raises significant patent, privacy, and intellectual property concerns, While we understand that FOIA includes exemptions for trade secrets and commercial or financial information, it is not clear whether this exemption is adequate to protect research data that are proprietary or have potential commercial value, but that are not derived from a commercial entity, It is therefore our concern this provision will discourage industry/university collaborations, The new requirements may also interfere with the objectives of the Bayh-Dole Act (Public Law 96-517) which was intended to help speed the commercialization of research results by enabling universities to retain patent rights to inventions developed through federal funding.
4) There is no adequate description of who would be required to pay for the production of data, The proposed revision would compound the costs of research to institutions hosting federally-funded research, It would require the time and effort of laboratory personnel to comply with requests for data, and additional staff effort would be required to process data requests and maintain compliance records, Numerous and unreasonable requests for data could also invite costly and protracted litigation.
As previously mentioned, we believe that there are legitimate concerns within the scientific community, among policymakers, and in the many sectors affected by federal policy and rulemaking about the accessibility and sharing of research data, In fact, these issues are the subject of much debate and discussion among the scientific community and the prime sponsors of research, the government and the private sector, This is not to suggest, however, that there has been or will be a uniform federal policy to deal with these complex issues, Rather, it appears that the time may be ripe for carefully planned and coordinated consideration of the subject.
The statute that is fueling this change in the Circular was passed by Congress without the benefit of hearings, We are working with our Congressional delegation and other communities, scientific societies, and industry to persuade Congress to repeal, or at a minimum delay, implementation of this law, We believe a more thoughtful approach can be developed to pursue the important public policy goals of the appropriate sharing of data.
We believe a more reasoned approach would involve pursuing data-sharing policies that are field-specific and aimed at serving the public policy goal of assuring the validity of data and their interpretation for the purposes of federal rulemaking in a considered way. This effort would engage the university/scientific community, industry, and the federal science agencies. It is our belief that the National Academy of Sciences' (NAS) Government/University/Industry Research Roundtable is uniquely suited to this purpose and we urge the OMB to refer these issues to the NAS.
Again, we appreciate the opportunity to comment on these important issues.