COMMENT BY: National Academy of Sciences
SUBJECT: Against proposed revision to OMB Circular A-110
DATE: April 5, 1999

Dear Mr. Charney:

These comments are being submitted on behalf of the National Academy of Sciences in response to the notice which appeared in the Federal Register for Thursday, February 4, 1999 at pages 5684-85.

As explained in the Federal Register notice, Public Law 105-277 enacted by Congress last year includes a provision (hereinafter sometimes referred to as the "Shelby amendment") that directs the Office of Management and Budget to amend Section _.36 of 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:" Public Law 105-277 further provides that "if the agency obtaining the data does so solely at the request of a private party, the agency may authorize a reasonable user fee equaling the incremental cost of obtaining the data."

As also explained in the Federal Register notice, OMB proposes to satisfy this requirement of Public Law 105-277 by amending Section _.36(c) of OMB Circular A-110 in two ways. First, the introductory phrase "Unless waived by the Federal awarding agency" would be deleted from existing Section __.36(c) so that the first sentence of Section _.36(c) would be revised to read as follows: "The Federal Government has the right to (1) obtain, reproduce, publish or otherwise use the data first produced under an award, and (2) authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes."

Second, the following four additional sentences would be added to Section _.36(c): "In addition, in response to a Freedom of Information Act (FOIA) request for data relating to published research findings produced under an award that were use by the Federal Government in developing policy or rules, the Federal awarding agency shall, within a reasonable time, obtain the requested data so that they can be made available to the public through the procedures established under the FOIA. If the Federal awarding agency obtains the data solely in response to a FOIA request, the agency may charge the requester a reasonable fee equaling the full incremental cost of obtaining the data. This fee should reflect costs incurred by the agency, the recipient, and applicable subrecipients. This fee is in addition to any fees the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A))."

As I stated in my previous letter to the Director of OMB on this subject dated January 26, 1999, the Academy has issued a number of reports through the National Research Council supporting the concept of data sharing, but FOIA is not a reasonable mechanism for achieving that goal. We believe that the Shelby amendment and OMB’s well-intentioned efforts to limit its scope are fatally flawed. Our view is that new legislation will be needed, either to repeal the Shelby amendment or to provide a more reasonable approach for making selected data collected under particular research grants available to the public. In the latter case, Congress should hold hearings and commission objective studies to determine how to write comprehensive legislation without doing damage to the federally funded research enterprise.

Regarding OMB’s proposal, the Academy offers the following comments.

A. OMB's proposal to limit the scope of the Shelby amendment is fundamentally flawed because the phrase "all data" in the Shelby amendment will likely be interpreted by the courts to mean ALL DATA.

I. Legislative Intent

The wording of the Shelby amendment is remarkably clear. OMB has been directed to amend Section _.36 of 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." Yet the OMB proposed revision in the Federal Register notice would transform this requirement into a requirement that applies only to "data relating to published research findings produced under an award that were used by the Federal Government in developing policy or rules." That seems to be clearly inconsistent with the legislative intent embodied in the Shelby amendment.

In commenting on the conference report for the Treasury and General Government Appropriations Act for fiscal year 1999, Senate Majority Leader Lott stated on the Senate floor that the Shelby amendment "requires the Director of OMB to amend OMB Circular A-110 to require Federal awarding agencies to ensure that all research results, including underlying research data, funded by the Federal government are made available to the public through the procedures established under the Freedom of Information Act." 144 Cong. Rec. S12134 (October 9, 1998). Senator Loft also stated that "[t]his provision represents a critical step forward in assuring that the public has access to the research and underlying data used by the Federal government in developing policy and rules." Id. At no point did Senator Lott state that the scope of the Shelby amendment was limited to this purpose or that the scope was any less than what he had already stated it to be—namely "all research results, including underlying research data, funded by the Federal government...."

Senator Campbell, the chairman of the Treasury and General Government Appropriations Subcommittee which reported out the appropriations bill, stated on the Senate floor that "[t]he language included in the Conference Report (i.e., the Shelby amendment) will require Federal agencies to make all Federally funded research data available to the public through procedures established by the Freedom of Information Act....The provision applies to all Federally funded research data...the amended Circular shall apply to all Federally funded research...." Id. He said nothing to suggest that the scope of the Shelby amendment was limited to data used in developing Government policy or rules although, if such a limitation had been intended, it surely would have been an important point for comment on the Senate floor since the actual wording of the appropriations bill contained no such limitation.

It is true that Senator Shelby stated on the Senate floor that his amendment "represents a first step in ensuring that the public has access to all studies used by the Federal government to develop Federal policy." Id. But even Senator Shelby did not state that the scope of the amendment was limited to data used in developing Government policy or rules.

2. Impact on the Application of FOIA

Until the Shelby amendment, it had been clear 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 had received grants from a federal agency are not "agency records" subject to public disclosure under FOIA if the data had not at any time been "obtained" by the agency. 445 U.S. at 178.This was true even if the agency had the unexercised right to obtain such data. 445 U.S. at 185-86.

In reaching this conclusion, the Supreme Court was clearly influenced by its perception of congressional intent. Thus, the Court noted in Forsham v. Harris that "Congress could have provided that the records generated by a federally funded grantee were federal property even though the grantee has not been adopted as a federal entity. But Congress has not done so, reflecting the same regard for the autonomy of the grantee's records as for the grantee itself." 445 U.S. at 180. The Court also noted that "Congress excluded private grantees from FOIA disclosure obligations by excluding them from the definition of "agency," an action consistent with its prevalent practice of preserving grantee autonomy." 445 U.S. at 445 U.S. at 179. To the Court these two factors indicated "that Congress did not intend that grant supervision short of Government control serve as a sufficient basis to make the private records "agency records" under [FOIA], and reveal(ed] a congressional determination to keep federal grantees free from the direct obligations imposed by the FOIA." 445 U.S. at 182.

In assessing congressional intent, the Court was also influenced by its perception of the practical realities of making federal grantee records subject to FOIA. Thus the Court said: "We need not categorize what agency conduct is necessary to support a finding that it has "obtained" documents, since an unexercised right of access clearly does not satisfy this requirement. Government access to documents clearly could not be the central component of the definition of agency records contemplated by Congress since the Federal Government has access to near astronomical numbers of private documents....Even if the Court were to accept petitioners' argument that only contractual access should give rise to "agency record" status, a limitation which does not appear readily supportable, the class of documents subject to FOIA disclosure would still be staggering. The record in this case indicates that (the National Institute of Arthritis, Metabolism, and Digestive Diseases, at the time one of the Institutes of the National Institutes of Health) alone has some 18,000 research grants outstanding." 445 U.S. at 186, n. 17.

The Shelby amendment represents a drastic change in congressional intent. The amendment directs OMB to amend Section _.36 of 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 [FOIA]." In explaining this provision on the Senate floor Senator Campbell, the chairman of the Treasury and General Government Appropriations Subcommittee which reported out the appropriations bill, stated that "[T]he language included in the Conference Report (i.e., the Shelby amendment) will require Federal agencies to make all Federally funded research data available to the public through procedures established by the Freedom of Information Act. The Conferees recognize that this language covers research data not currently covered by the Freedom of Information Act. The provision applies to all Federally funded research data regardless of whether the awarding agency has the data at the time that the request is made. If the awarding agency must obtain the data from the recipient of the award, the provision specifically states that the awarding agency may authorize a reasonable user fee equaling the incremental cost of obtaining the data." 144 Cong. Rec. S12134 (October 9, 1998) (emphasis added). The clear implication is that Congress intended that federal awarding agencies now have a duty to "ensure that all data produced under an award will be made available to the public" under FOIA, even if the awarding agency has to "obtain" the data from the grantee.

The question of whether or not federal grantee records are "agency records" subject to public disclosure under FOIA where a federal agency has a duty to obtain the records was not addressed in Forsham v. Harris. 445 U.S. at 176-77, n. 6. But the Court did make it clear in Forsham v. Harris that FOIA "empowers federal courts to order an 'agency' to produce 'agency records improperly withheld' from an individual requesting access." 445 U.S. at 171. Plaintiffs in FOIA lawsuits may now argue that the Supreme Court's decision in Forsham v. Harris does not prevent the federal courts from ordering federal agencies to obtain and disclose federal grantee records where the agency is improperly withholding them, because federal agencies now have a duty to obtain and disclose such records as a result of the Shelby amendment.

FOIA has been an enormous source of litigation. There have been more than 4000 reported court decisions interpreting and applying FOIA. If OMB directs federal agencies to do anything less in response to the Shelby amendment than make "all data produced under an award" available to the public under FOIA, that directive when converted into agency regulations and applied to specific FOIA requests will surely be challenged in the courts on the ground that "agency records" are being "improperly withheld" in any case where less than "all data" are made available.

Even if OMB's view of the Shelby amendment ultimately prevails, there could be years of litigation before the matter is resolved if Congress fails to intervene. Federal circuit courts of appeal in various regions of the country could arrive at different and even conflicting interpretations of the application of FOIA to federal grantee research data. Different rules might apply to the same kinds of research sponsored by the same agencies depending upon the geographic location of the grantee. In other parts of the country, the validity of agency regulations might be unclear. For federal research grantees, the result would be confusion and chaos.

B. In addition, OMB's attempt to limit the scope of the Shelby amendment to data "used by the Federal Government in developing policy or rules" is not sufficiently defined or developed to be workable.

I. Applicable Only to True Research Grantees

If the scope of the Shelby amendment were limited to grantee data "used by the Federal Government in developing policy or rules" as OMB suggests, the amendment would generally not apply to data that were produced for the principal purpose of being used by a federal agency to develop policy or rules. Under Section 4 of the Federal Grant and Cooperative Agreement Act of 1977, 31 U.S.C. 6303 (formerly 41 U.S.C. 503), procurement contracts must be used when the principal purpose of the funding instrument is the acquisition of property or services for the direct benefit or use of the federal government. See Forsham v. Harris, 445 U.S. at 180. OMB Circular A-110 does not apply to procurement contracts because Subpart A _.2(e) excludes "contracts which are required to be entered into and administered under procurement laws and regulations" from the definition of "award" under Circular A-110.

So if a federal agency wants to use a funding instrument for the principal purpose of acquiring data to be used by the agency to develop policy or rules, the agency must use a procurement contract. For example, the Comptroller General ruled in In Re Council on Environmental Quality and Office of Environmental Quality —Cooperative Agreement with National Academy of Sciences, 65 Comp. Gen. 605 (1986), that the proper funding instrument for a proposed study developed and submitted by the National Academy of Sciences (the institution submitting these comments) to the Council on Environmental Quality for funding at the request of the Environmental Protection Agency was a procurement contract rather than a cooperative agreement, citing the Federal Grant and Cooperative Agreement Act. The purpose of the proposed study was to provide information on risks and benefits of certain pesticides to help federal regulatory agencies such as EPA in analyzing prospective regulations. Since the primary purpose of the study was to acquire information for the direct benefit or use of the federal government, a procurement contract was required. 65 Comp. Gen. at 606-07.

If the Shelby amendment as interpreted by OMB generally would not apply to data that were produced for the principal purpose of being used by a federal agency to develop policy or rules because such data must be developed under a procurement contract, what would the Shelby amendment apply to? The Shelby amendment as interpreted by OMB would apply to data generated by a federal grantee if "published research findings [of the grantee]...were used by the Federal Government in developing policy or rules." Thus, the Shelby amendment as interpreted by OMB would apparently apply only to true research grantees doing basic and applied research if any published research findings of the grantee were subsequently used by the federal government in developing federal policy or rules.

2. What is "Use" in Government Policy Making and Rule Making?

The implications of applying the Shelby amendment as interpreted by OMB to research grantees doing basic and applied research only when published research findings of the grantee were subsequently used in federal government policy making or rule making would be far-reaching and complex. The factual situation addressed by the Supreme Court in Forsham v. Harris, as described in the Court's opinion, provides an interesting real-life model for illustrating the kinds of issues and problems that might arise.

The Forsham v. Harris case involved the University Group Diabetes Program (UGDP). In 1959 a group of private physicians and scientists specializing in the treatment of diabetes formed UGDP to conduct a long-term study of the effectiveness of five diabetes treatment regimens. Two of these treatment regimens involved diet control in combination with the administration of either tolbutamide or phenformin hydrochloride which were both oral hypoglycemic drugs. UGDP's participating physicians were located at 12 clinics nationwide and the UGDP study was coordinated at the University of Maryland. The UGDP study was funded solely by federal grants from the National Institutes of Health (NIH).

The UGDP study generated more than 55 million records. In 1970, UGDP presented the initial results of the UGDP study indicating that the treatment of adult-onset diabetes with tolbutamide increased the risk of death from cardiovascular disease over that present when diabetes was treated by the other methods studied by UGDP. UGDP subsequently reported a similar increased incidence of heart disease when patients were treated with phenformin hydrochloride.

The Committee on the Care of the Diabetic (CCD), a national association of physicians involved in the treatment of diabetics, and others were critical of the UGDP study. CCD requested access to the UGDP raw data in order to facilitate CCD review of the UGDP findings but UGDP declined. Arrangements were subsequently made for a separate assessment of the UGDP study by the Biometric Society under a contract with NIH.

After the Food and Drug Administration (FDA) became aware of the UGDP results, the FDA issued a statement recommending that physicians use tolbutamide in the treatment of diabetes only in limited circumstances. In 1971, after UGDP had also reported its findings with respect to phenformin, the FDA proposed changes in the labeling of both oral hypoglycemic drugs but delayed action pending completion of the Biometric Society study. In 1975 after the Biometric study had been issued, FDA renewed its proposed change in labeling, clearly relying on the UGDP study.

In 1977 the New Drug Application for phenformin was suspended, premised in part on the findings of the UGDP study. The suspension decision was subsequently upheld in administrative proceedings that were not based substantially on the UGDP study. Nearly 400 published articles were included in the record of the phenformin proceedings.

Under the Shelby amendment as interpreted by OMB, when would FOIA have applied? Presumably not for the period from 1959 to 1970 until the initial results were presented. In 1970 FOIA would not have applied simply because the initial results were important and controversial. Would the statement issued by the FDA have triggered the application of FOIA? Was that rule making or policy making? What about the FDA's 1971 labeling proposal? Or would FOIA have applied only in 1975 when the FDA, in the words of the Supreme Court, "clearly relied on the UGDP study" to support the labeling proposal? 445 U.S. at 174.

Perhaps any federal government "use" of the UGDP study results would have triggered the application of FOIA. But what about the phenformin proceeding in which nearly 400 published articles were included in the record. How many of those articles were the result of federally funded grantee research? Would all of the data relating to such articles have become subject to FOIA? Were the research findings in those articles "used" by the Government for rule making or policy making?

It is also interesting to note that OMB is not proposing that FOIA would apply to research grantees doing basic and applied research when published research findings of the grantee "are being used" in federal government policy making or rule making. Under the OMB proposal, FOIA would apply to research grantees doing basic and applied research when published research findings of the grantee "were used" in federal government policy making or rule making. Is the use of the past tense intentional? Would FOIA apply to the grantee's research data only after the federal government rule or policy had been developed? Given the secrecy that often surrounds the deliberation and development of federal government policy, that interpretation seems plausible.

For roughly the first 10 years of the UGDP study, FOIA apparently would not have been applicable under OMB's proposal since apparently (based upon the Supreme Court's recitation of the facts) no research findings were announced until 1970. And during that time it might have been very reasonable to expect that FOIA might never apply because FOIA would apply only if the research findings were used to develop Government policy or rules. Probably no one could predict whether that would happen or not. For one thing, no one knew in advance what the results of the study would be. Perhaps the results would not reveal any significant problems. But when the FDA—an agency separate from NIH, the granting agency—did "use" the results of the UGDP study (whenever that was exactly), perhaps without any notice to or consultation with UGDP, FOIA would have suddenly become retroactively applicable to the 55 million records of the UGDP study. That is apparently the regime that OMB is proposing.

3. What is "Policy"?

One of the confounding aspects of the OMB proposal is that the application of FOIA to research grantees doing basic and applied research would be triggered when published research findings of the grantee were subsequently used in making federal government rules or "policy." But the federal government has many kinds of "policies"--national security policy, economic policy, foreign policy, public health policy, environmental policy, budgetary policy, social welfare policy, energy policy, science policy, etc., etc. The word "policy" in the federal government is amorphous and omnipresent. It would not provide a clear and reliable standard for determining the application of FOIA to grantee research records.

4. No Definition of "Data"

The basic underlying concept of the Shelby amendment seems to be that the public should have access not only to the results of federally funded grantee research (which is already true for the vast majority of federal research grants) but also to the underlying raw data. However, the OMB proposal contains no definition of "data," and under current agency regulations the term "data" may not be limited to information resulting from original observations and measurements, or to similar kinds of raw data. 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, copyrightable 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 peer-reviewed, 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.

If the term "data" is not properly defined by OMB, there will surely be those who will argue that FOIA now applies not simply to underlying federal grantee raw data but rather, like civil discovery, to all recorded information which is relevant. And since "relevance" is not a very meaningful concept within the context of FOIA, this could easily be expanded into an argument that FOIA now applies to virtually all federal grantee information recorded under a grant, including computer programs, email, copyrightable works, drafts of research papers and proposals, etc. Burdensome disputes due to uncertainties over the scope of the term "data" and its application would be inevitable.

5. No Definition of "Published Research Findings"

Under the OMB proposal, the application of FOIA to a federal research grantee's data would be triggered by federal government use of "published research findings" produced under the grant that were used in the development of federal government policy or rules. But what are "published" research findings? Does that mean published in a peer reviewed scientific journal? Could it mean published in the newspapers? Could it mean published on the internet? Would it have to be a written "publication"? Could research findings be "published" orally, for example at a public symposium or in a conversation with a federal government official who then "uses" the information in developing federal government policy or rules?

6. Data "Relating to" Published Research Findings

The OMB proposal would not simply make FOIA applicable to data that are cited in or relied upon in published research findings that are used by the federal government for developing federal government policies and rules. Instead, the OMB proposal would make FOIA applicable to data "relating to" published research findings. The vagueness and potential expansiveness of the phrase "relating to," particularly within the context of a failure to define the term "data," would be especially troubling.

The phrase "relating to" will be used as the basis for arguing for a very expansive interpretation of the application of FOIA to federal grantee research data. For example, assume that the first published research paper under a multi-year grant is immediately used by the federal government to develop policies or rules. All new data developed during the remaining years of the grant would in some sense probably "relate to" that first paper. Would that mean that all such new data would be immediately and continuously subject to FOIA because the data "relate to" published research findings--i.e., the first paper--that were used by the federal government to develop policies or rules?

C. OMB's proposed amendment of Circular A-110 would have serious adverse effects on federally funded grantee research.

1. Impact on Scientific Publication and Peer Review

One of the most troublesome aspects of OMB's proposed 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 (including competitors and foreign countries) under FOIA. This problem results directly from the decision of the U.S. Court of Appeals for the District of Columbia Circuit in Burka v. U.S. Department of Health and Human Services, 87 F.3d 508 (D.C. Cir. 1996).

The Burka case involved a FOIA request for computer tapes recording survey responses about smoking habits and attitudes and whether or not such information could be withheld from public disclosure under Exemption 5 of FOIA. Exemption 5 protects inter-agency and intra-agency memorandums or letters which would not be available by law to a party in litigation with the agency from public disclosure under FOIA. In other words, the parameters of Exemption 5 are determined by reference to the protections that are available to litigants with respect to document and information discovery in civil lawsuits. If material would not be available in civil discovery, it may be withheld under Exemption 5 of FOIA. 87 F.3d at 515-16.

The lower court had ruled that even though some scientific articles had already been published based upon the data, a number of other scientific articles remained to be published based upon those data, and therefore Exemption 5 protected the data from disclosure under FOIA until those remaining articles had been published. The court of appeals reversed, holding that the research data could not be withheld under Exemption 5 of FOIA for the purpose of allowing the researchers to publish the remaining scientific articles 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." 87 F.3d at 521.

Under the OMB proposal, data "relating to published research findings" of a federal grantee—where the research findings were used by the federal government in developing federal policies or rules—would be subject to FOIA. And under the Burka decision, such data could not be protected from public disclosure under Exemption 5 of FOIA, even though additional scientific articles remained to be published describing the results of the research, based upon the data.

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. It would thereby confuse the public, which is against the public interest.

2. Implications for the Performance of Scientific Research

Under the OMB proposal a federal awarding agency, in response to a FOIA request for the data of a particular federal research grantee, would be required to obtain the requested data from the federal grantee and would then process the FOIA request in accordance with standard substantive and procedural FOIA rules, including what constitutes an "agency record" and the statutory FOIA exemptions. Thus, the OMB proposal is premised on the assumptions (1) that when the agency goes to the grantee to obtain the "data," the "data" will be there, and (2) that the important federal function of identifying and maintaining the "data" will be performed by federal grantees and not federal officials. And while the incremental costs of obtaining "data" in response to a FOIA request are addressed, there is no indication of how the costs would be covered that are incurred by federal grantees in identifying and maintaining "data," possibly for years, in anticipation of a possible FOIA request.

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 would 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 which are very important to making the statute work effectively. But these exemptions 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. Department of Health, Education and Welfare, 504 F.2d 238, 244 (D.C. Cir. 1974), cert. 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 are not addressed by FOIA as presently written.

Another major concern would be the impact of the OMB proposal on the privacy and use of individually identifiable grantee data records—e.g., personal medical records. OMB's Federal Register notice specifically refers to the fact that FOIA Exemption 6 exempts "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy." But even if Exemption 6 would fully protect such personal information from public disclosure, such information would still be fully accessible to the federal government. Under OMB's proposal, federal agencies would have the right (which apparently could no longer be waived by the agency) to "obtain, reproduce, publish or otherwise use the data first produced under an award," apparently at any time. That right would, of course, be subject to applicable statutory restrictions, but those restrictions could change over time. The simple fact is that individuals who might otherwise be inclined to participate in important federally funded research studies might decline to do so if their medical or other personal records created during the study would be accessible to and available for use by the federal government at any time. Reasonable people who would willingly cooperate with their local university or hospital or their own physician in a research study might not have the same degree of confidence in the federal government.

D. Instead of a one-sentence policy statement, OMB should develop comprehensive guidance for federal agencies on public access to federal grantee research data in a manner that fully provides for public access but does not damage or infringe upon equally important aspects of performing, and publishing the results of, federal grant-funded research.

1. Federal Agencies Need Real Guidance

The OMB proposal would add only four sentences to OMB Circular A-110, three of which would deal with fees. That is simply not a sufficient response for an issue of this magnitude.

The OMB proposal would make FOIA potentially applicable to a pool of tens of thousands of federal research grants. The National Institutes of Health and the National Science Foundation, for example, have a combined total of about 70,000 research grants outstanding.

Federal research grantees probably possess hundreds of millions of "data" records. And every federal grant would be affected by the OMB proposal to the extent that the grantee must be prepared at any time in the future to respond to a federal agency request for "data" to satisfy a FOIA request.

The OMB proposal reflects no appreciation of the 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, epidemiologists, 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 FOIA to data of such diversity and complexity will be very difficult. The functions of identifying and maintaining such data, possibly for years, are certain to be very costly to both research institutions and the federal government.

OMB cannot simply respond to a one-sentence directive from Congress with a one-sentence policy statement to federal agencies. OMB needs to do what Congress did not do. OMB needs to fully analyze and understand the implications and impact of the Shelby amendment on federal grantee research, report back to Congress, and work with Congress in developing comprehensive guidance for federal agencies on public access to federal grantee research data in a manner that fully provides for appropriate public access but does not damage or infringe upon equally important aspects of performing, and publishing the results of, federal grant-funded research.

2. Some Suggestions

As I stated in my letter to the OMB Director dated January 26, the federal support of scientific research is one of the nation's most important and 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.

There is nothing in the Shelby amendment which suggests in any way that the amendment was intended to damage or diminish the productivity of this research enterprise. The challenge now is to achieve the public access objectives of the Shelby amendment without damaging or diminishing the productivity of federal grantee research. In carrying out this responsibility, OMB and Congress should be guided by at least the following principles:

(1) create a narrow definition of federal grantee research data which makes it clear that the term "data" applies only to underlying raw data and not to preliminary data analyses, drafts of scientific papers, plans for future research, peer reviews, personal communications with colleagues, emails, etc.;

(2) provide that federal grantee research data involving human subjects shall never be made available to the federal government in individually identifiable form;

(3) require that each grant agreement specify at the outset what types of research data are proposed to be collected under the grant and potentially subject to public disclosure so that the grantee will have specific guidance from the outset as to exactly what "data" must be identified and retained under that grant;

(4) except in unique and unusual situations, provide that the grantee be required to send the relevant research data produced under the grant (and specified under (3) above) to the sponsoring federal agency no earlier than when the grant has been completed, so that the grantee will have the uninterrupted period of the grant to complete the research and publish the results;

(5) provide additional safeguards to protect the publication rights, patent rights, rights of industry co-sponsors, and other legitimate interests of federal research grantees while providing for timely public access to appropriate federal grantee research data;

(6) provide guidance on the requirements for, and the reimbursement of costs associated with, identifying and maintaining any federal grantee research data that must be kept by grantees in order to be able to respond to possible requests for public disclosure.

Sincerely,
Bruce Alberts
President