Comments by William R. Brody, President

On behalf of The Johns Hopkins University, I am submitting comments on OMB s proposed revisions to circular A-110 announced in the Federal Register on February 4, 1999. In addition to its own comments in this letter, the University endorses the thoughtful comments of the Association of American Medical Colleges and the Council on Government Relations, as well as the suggestion of the Association of American Universities that the National Academy of Sciences study the issue of federal data sharing policy to determine how best the objective of reasonable access to data by interested parties can be achieved without unduly threatening patient confidentiality, premature release of sensitive data, licensing/patent agreements, as well an expected increase of litigation to resolve questions regarding ownership of data.

The Johns Hopkins University, founded in 1876 as the nation s first research university, is committed to the free and open exchange of scientific and scholarly information. The exchange among scientists of research data has led to unprecedented breakthroughs in this century in every field of scholarly endeavor and the transfer of that data to industry has contributed to a sturdy, expanding economy and a standard of living that by almost any measure is second to none. The proposed revisions would expose data generated from all federally funded research at colleges and universities, no matter how premature or indecisive, to demands for disclosure under the Freedom of Information Act (FOIA) without regard for the need to preserve proprietary rights. I simply do not believe that the proponents of these changes have fully contemplated their far- reaching implications and the devastation on the products of our laboratories that would result. Release of data from research as it has been accomplished until now has accommodated the many competing interests and rights in that data, including the rights of government sponsors of research, faculty researchers, and private industry seeking to develop the results of research to commercially viable products. The congressional mandate to require all data produced under federally sponsored research grants at colleges and universities disrupts this balance in ways that have not been fully considered. We are concerned for a variety of reasons that subjecting all data produced from federally funded research release under FOIA could have unintended negative consequences for academic research and technology transfer.

The interest most directly imperiled by the proposed revisions to A-110 is the right of a faculty researcher to control the release of his or her own intellectual property. Universities traditionally have protected the right of their faculties to publish as an inherent part of academic freedom. The right of researchers to determine the appropriateness and timeliness of making research findings public is a necessary adjunct to the freedom to publish. Through a variety of procedures, granting agencies also have respected these rights of faculty. For example, recognizing that promising research often extends beyond funding cycles and requires continuing support, the National Institutes of Health do not release raw data reported in progress reports or applications for renewal funding prior to a decision to renew funding.

A broad requirement to make raw data, the foundation for the faculty member s intellectual property, available to the public under FOIA effectively nullifies the faculty member s right to control release of research findings regardless of whether the findings are tentative or final, protected by patent filings or not. I fear that our brightest researchers, knowing their most promising research results, their methods and their ideas may be subject to appropriation by unscrupulous or less talented peers, will simply choose to leave academic research for the private sector which already holds out the enticement of higher salaries and benefits. I cannot overstate what that would mean for the advancement of science if our nation s universities were to lose these people.

A second concern is the potential effect of a broad mandate to release research data on the transfer of promising technology to the market for commercialization. The new legislation and proposed revisions to A-110 fly in the face of Congress mandate in the Bayh-Dole Act to develop new technologies from government sponsored research. Protection of intellectual property rights in data is a prerequisite for the securing of patents and license agreements transferring laboratory research to the marketplace in the form of commercialization of new technology. Often it is necessary to delay for a short time the release of research data until intellectual property rights are established through the patent process. It is not clear to what extent the statutory exemptions to FOIA would be deemed by the granting agencies to apply and whether the courts will agree with agency decisions to withhold information under those exemptions. It can be anticipated, though, that relationships with private industry will be affected by the perception that rights in data are subject to protracted litigation, and possible loss. Thus, a real cost to the country is the chilling effect these revisions will have on joint projects of universities and private national and international industrial partners.

Even more onerous to universities is the potentially confiscatory effect of the law and proposed revisions to A-110. Research data are recorded in many forms, including laboratory notebooks, computer files, specimens, formulae, laboratory media, photographs, entries in medical records, computer-generated drawings, and large computer data bases. In some cases, particularly in the case of computer databases, the raw data from research is itself a valuable commodity that the university where it was created may license. If that data is available to the public for free under FOIA, whether the request is made because of whim or caprice, political motivation, or to obtain proprietary information for private profit, the university will be deprived of potentially significant revenue. Release of data to the public except through appropriate procedures when that release is timely would be a costly, onerous process.

An additional concern to academic medical centers is the potential compromise of confidential medical information relating to patients from the release of certain data, even if the names of human subjects are masked. Medical researchers are deeply troubled that the very broad promises of confidentiality human research subjects expect and receive may be subject to modification based upon uncertain criteria that the researchers cannot easily explain. Further, researchers involved in longitudinal data-gathering studies are concerned that they may be required to release research findings prematurely. This could be misleading to the public, and pose problems related to the future use and ownership of valuable data.

Not to be ignored is that a significant burden of compliance will be placed upon universities. In cases in which the data are cell lines or other tangible laboratory products, providing the data through samples may result in a reduction in their quantity and compromise their usefulness for future study. In other cases, even if out of pocket costs are reimbursed to the institution, the volume of data and burden of reproducing them will be enormous and could virtually monopolize the time and energies of researchers and agency personnel, while diverting funds that rightfully should be devoted to their work.

Finally, it is reasonable to predict that these revisions will clog the courts with new litigation and with the concomitant burden on universities of mounting a defense to attempts to invade faculty laboratories. The vague terms and definitions in FOIA, which have never before been applied to research data in the hands of private universities, will lead to a flood of litigation over non-compliance. Other areas that may witness increased litigation involve the potential breakdown of patient confidentiality, and disputes over ownership and origin of research data.

The Johns Hopkins University strongly supports the timely release of public research data developed under federal awards and, along with its sister research universities, has been in the forefront of doing just that. However, for the reasons I have described, I believe that the proposed revisions to Circular A-110 do not advance this purpose and place at risk many significant rights and public objectives. For this reason, Johns Hopkins, along with many other research universities, is working with Congress to repeal or modify the legislation which was passed without full consideration of its impact. In the meantime, a reasonable step for the Office of Management and Budget would be to adopt the proposal of the Association of American Universities recommending that the National Academy of Sciences study the issue of federal data sharing policy to determine how best the objective of reasonable access to data by interested parties can be achieved without threatening patient confidentiality, premature release of sensitive data, licensing/patent agreements and the increase of litigation due to vague definitions regarding ownership of data.

Sincerely,

William R. Brody