COMMENT BY: National Academy of Sciences
SUBJECT: Against proposed revision to OMB Circular A-110
DATE: January 26, 1999

Dear Mr. Lew:

On behalf of the Council of the National Academy of Sciences, I am writing to you concerning the new legislation that directs you to amend OMB Circular A-110 "to require 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...."

It has been clear since 1980, as a result of the U.S. Supreme Court's decision in Forsham v. Harris, 445 U.S. 169 (1980), that data generated by a privately controlled organization that has received grants from a federal agency are not "agency records" subject to public disclosure under the Freedom of Information Act (FOIA) if the data have not at any time been "obtained" by the agency, even if the agency has the unexercised right to obtain such data. However, as a result of the new legislation, you seemingly have been directed to ensure that now all data produced under all federal grants must be made available to the public through the procedures established under FOIA. This is an enormous change in federal policy regarding federally funded research. We are convinced that the new legislation will have serious, unintended consequences for the nation's research enterprise.

The federal support of scientific research is one of the nation's most important arid enduring public policies. As we stand on the threshold of the 21st century, a moment of reflection on the past one hundred years will call to mind the tremendous impact of science and technology on the 20th century here in the United States and around the world. The continuing importance to this country of federally funded research in developing new knowledge that can lead to new products and services, new industries, new treatments for disease, new weapons for national defense, new means of communication, and so on, is widely accepted. It is from this vantage point that we address the new legislation and its implementation.

While the Academy has issued a number of reports through the National Research Council supporting the concept of data sharing, the public disclosure of grantee research data under FOIA called for by the new legislation is not a carefully designed way of achieving data sharing in the public interest but rather a very bureaucratic, legalistic and expensive mechanism for disclosing research data to the public. The serious problems that the new legislation is likely to cause for federal grantee research include the following.

One of the most troublesome aspects of the application of FOIA to federal grantee research data is the possibility that FOIA may not allow a federal research grantee to publish the results of his or her research in scientific journals before the underlying research data must be made available to the public under FOJA. This problem results directly from the holding in Burka v. U.S. Dept. of Health and Human Services, 87 F.3d 508. 521 (D.C. Cir. 1996), that research data could not be withheld under FOIA so that researchers could publish their results because there is no "established or well-settled practice of protecting research data in the realm of civil discovery on the grounds that disclosure would harm a researcher's publication prospects."

Publication of research results in peer-reviewed scientific journals is one of the most critical elements of the research process. it is the means by which new discoveries are communicated to others in the scientific community and to the public at large. Permitting the researcher who actually collected the data to be the first to analyze and publish conclusions concerning the data is an essential motivational aspect of research. Requiring public release of data prior to publication in scientific journals would seriously short-circuit the scientific research process that has been so effective in the United States. Moreover, it would severely disadvantage federally funded scientists while providing unreasonable advantages to their competitors, both in the United States and internationally. Premature release of research data before careful analysis of results, and without the independent scientific peer review that is part of the normal process of publication of scientific research, would also increase the risk of public disclosure of erroneous or misleading conclusions and confuse the public, which would not be in the public interest.

The application of FOIA to all federally funded research grantee data will also be greatly complicated by the fact that there are currently tens of thousands of federally funded research grantees engaged in tens of thousands of research projects. One cannot overemphasize the staggering volume, complexity, and variety of federal grantee research data being generated by astronomers, molecular biologists, atmospheric chemists, high energy physicists, geoscientists, clinical investigators, plant biologists, materials scientists and engineers, etc. The complexities of individual scientific fields are often so great that only scientists working in those fields will really understand the details of their particular field of research and the data being generated. The effective application of FOJA to data of such diversity and complexity will be very difficult, if not impossible, to achieve. It is certain to be very costly to both research institutions and the federal government.

This situation is further exacerbated by the fact that the term "data" in the new legislation is not defined. Under current agency regulations, the term "data" may not be limited to information resulting from original observations and measurements The definition of "data" under some agency regulations is very broad, encompassing not only data in the conventional sense but all recorded information in all media including such items as computer programs, copyrightabIe works, and procedural manuals. Under an expansive definition of "data," drafts of research papers, for example, might be available to the public under FOIA even before the drafts are finalized and published, potentially confusing the public and unfairly penalizing the researcher. Important legal rights in certain kinds of "data" might be altered or impaired. Burdensome disputes and uncertainties over the scope of the term "data" and its application are inevitable.

It is also unclear whether the new legislation is retroactive. Is FOIA now suddenly to be made applicable to all existing federal grantee research data? And if not, how will "new" data be distinguished from "old" data in research projects that are currently ongoing?

The new legislation seemingly transforms all federal research grantee data into "agency records" for purpose of FOLA. But federal research grantees are generally not well-equipped by inclination, training or experience to deal with the legal and definitional subtleties of "data" and the bureaucratic responsibilities that go with being custodians of "agency records" nor with the very substantial financial and administrative burdens of doing so. The net result will be a major shift of valuable intellectual and financial resources away from Scientific research and into disruptive paperwork production. Frequent FOIA requests for data by particular interest groups and individuals might even be used as an effective means to discourage certain research, attack ongoing research, or delay the publication of research results.

FOIA contains a number of exemptions from its public disclosure requirements which are designed to balance various legitimate interests in confidentiality of information with the public's right to know and arc very important to making the statute work effectively. It is unclear, however, whether these exemptions will apply to federal grantee research data under the new legislation since the legislation refers only to "procedures established under [FOIA]" and not to FOIA itself and the FOIA exemptions. But even if the exemptions do apply, they are seriously inadequate for protecting the legitimate interests of federal research grantees.

For example, as noted above, FOIA may not allow a federal research grantee to publish the results of his or her research in scientific journals before the underlying research data must be made available to the public under FOIA. In addition, although FOIA protects certain trade secrets and commercial or financial information from public disclosure, this provision may have only limited application in the case of federally funded grantee research. See Washington Research Project v. Dept. of Health. Education and Welfare 504 F.2d 238, 241 (D.C. Cir. 1974), cerr. denied, 421 U.S. 963 (1975) ("a noncommercial Scientist's research design is not literally a trade secret or item of commercial information, for it defies common sense to pretend that the scientist is engaged in trade or commerce"). Thus, legitimate interests of federal research grantees regarding the confidentiality of certain kinds of information may not be respected because these issues simply arc not addressed by FOLA as presently written

FOIA protects the confidentiality of personnel and medical files and similar files if the disclosure of such tiles would constitute a clearly unwarranted invasion of personal privacy. But regardless of whatever legal protection this may provide for the confidentiality of such information, individuals who now provide invaluable personal information for medical and other forms of federal grantee research may be disinclined to continue to do so in the future if such information will now be subject to even the possibility of public access under FOIA.

All of these factors underscore the serious limitations of FOLA as a mechanism for making federal grantee research data available to the public. We understand that the new legislation originated at least in part from concern that research data developed by federal grantees that arc used as a basis for federal agency policies and regulations should he available to the public for analysis. Hut we also understand that the particular research data at the Hariard School of Public Health that generated much of the public controversy have now been made available to an independent group for a separate, independent re-analysis of the data. Thus, there are other mechanisms for addressing these problems without resort to FOIA.

A bill has been introduced in Congress to repeal the new legislation making FOIA applicable to federal grantee research data, and we hope that the Administration will support such repeal. In the meantime to the extent that the application of FOIA to federal grantee research data under the existing legislation is addressed by OMB, we urge your thoughtful consideration of the issues set forth in thi5 letter. We must not allow the entire federally-funded research establishment in the United States to be seriously burdened by compliance with new bureaucratic requirements that are intended to address a legislative concern that is irrelevant to the vast majority of federally ally funded research projects.

We urge your thoughtful consideration of these issues.

Sincerely,