COMMENT BY: U.S. Department of Defense
Office of the Director of Defense Research and Engineering
SUBJECT: Against proposed revision to OMB Circular A-110
DATE: April 4, 1999

Dear Mr. Lew

This letter provides comments on a proposed revision to OMB Circular A-110 [Federal Register; volume 64, page 5684; February 4, 1999]. The revision would implement a provision in Public Law l05-277 that directs the Office of Management and Budget (OMB) to amend the Circular 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" (FOIA).

The Department of Defense (DoD) agrees that the public should have appropriate access to data produced under Federal research grants in order to enhance understanding of results, promote further inquiry, and foster scientific debate, but the DoD is concerned that it is inappropriate to use the FOIA process to provide access to recipient-owned data that is not in a Federal agency's possession. The use of that process, with the requirement to release data to the Federal Government for redaction, would jeopardize government-university-industry partnerships and other research insofar as it raises doubts about the adequacy of safeguards against misuse of data. It also portends large administrative and paperwork burdens for recipients and Federal awarding agencies with corresponding costs to taxpayers and society in dollars and lost research productivity. The enclosure to this letter further explains this concern.

The DoD understands that the current statutory language does not give the OMB the latitude to fully address this concern. Therefore, the DoD urges the OMB to ask the appropriate Congressional committees to conduct hearings on the subject of public access to data produced under grants and agreements. The hearings would enable the Congress to receive input on this matter directly from recipients of Federal awards, Federal agencies, and segments of the public desiring greater access to research data. Hearings also would provide a basis for the Administration to work with the Congress to develop a better approach to addressing the concern that led to the present statute; the enclosure to this letter offers one suggestion for an alternative approach and other ideas likely will arise if there are Congressional hearings.

In the interim, the DoD recognizes that the OMB must continue to develop an implementation of the current statute. Pertinent to that effort, the enclosure to this letter identifies some issues that can be addressed in the revision of Circular A-110 within the constraints of the current statute.

We appreciate the opportunity to comment on the proposed revision to the Circular and look forward to working with you over the coming months on this extremely important matter.

Sincerely,

Delores M. Etter
Deputy Under Secretary of Defense
(Science and Technology)

ENCLOSURE TO DoD LETTER ON PROPOSAL TO REVISE OMB CIRCULAR A-110

This enclosure provides further information in support of the general concerns expressed in the DoD letter on the proposed revision to OMB Circular A-110 concerning access to data [Federal Register; vol. 64, p. 5684; February 4, 1999).

BACKGROUND

The Federal Government is not involved directly in the normal process by which an investigator at a recipient institution shares data and other information. Questions usually come from other researchers who are interested in understanding how well the data serve as the basis for the investigator's stated result or for alternative interpretations. They generally communicate with the investigator rather than asking for raw data because, in many areas of research, the data alone are insufficient. The investigator must also explain the surrounding context of experimental design, conditions, assumptions, and caveats that is essential to understanding how the data led to the stated results. This sharing and questioning is the process by which research generates new knowledge and understanding and the process is the same, with no direct federal agency involvement, whether or not the research has any federal support.

The legislative history of the statute that led to the proposal to revise OMB Circular A-110 describes somewhat different situations in which the Federal Government is directly involved- cases in which research results are used in the development of a Federal policy or rule. If a Federal regulatory agency identifies a research result as a scientific basis for a policy or rule that affects the public, it has a responsibility for ensuring that the public can review the agency's stated rationale for that policy or rule. As part of that review, the public may have questions about the cited research result and answering those questions may require access to some of the underlying data. The statute identifies the FOIA process as the way to ensure access to the data with the Federal awarding agency that supported the research having to obtain the data from the recipient institution and release it to the public.

MAJOR CONCERNS ABOUT THE USE OF FOIA PROCEDURES

Notwithstanding the statute's reference to FOIA procedures, it should be noted that the DoD and other Federal awarding agencies necessarily would use a "FOIA-like" process that is yet to be designed, rather than the current FOIA process. That's because the current FOIA process accommodates only records that are in the possession of a Federal agency, not data that are owned and held by a non-Federal institution. The FOIA-like process would have to enable the DoD to: (a) obtain large amounts of raw scientific and engineering data from a grant or agreement recipient, (b) draw upon technically competent in-house personnel to review the research data for redaction of information that may be protected from disclosure by any FOIA exemptions that apply (assuming that the usual FOIA exemptions apply to the new FOIA-like process), (c) perhaps allow the recipient an appeal phase during which it may challenge the DoD's determinations on what is not protected, and (d) release to requesters the data that are approved for disclosure.

One major concern is that creating and using this FOIA-like process will place new burdens on the DoD's already taxed FOIA resources, as well as on in-house technical personnel. The imposition of these additional administrative requirements without corresponding resources likely will further lengthen the DoD's response time to FOIA requests, increasing the current level of frustration of the Congress and the public with the amount of time required to answer them.

A second major issue is that industrial research partners, researchers, and research subjects may alter their behavior in ways that hurt the research enterprise, due to the possibility that all data would be requested and have to be released to the Federal Government for redaction through the FOIA-like process. This raises significant questions such as:

1. Would non-Federal research partners have confidence that the FOIA-like process would never disclose preliminary data that are not yet fully analyzed and that may underpin future results? This is particularly important due to recent increases in the number of university-industry partnering arrangements, which the DoD sees as a win-win for the Federal Government and industry. A new program, Government-Industry Cosponsorship of University Research, takes this a step further by creating joint funding of university investigators by the DoD and industry in areas where applications critical to national defense can be promoted by leveraging industry investment in long-term research relevant to commercial products and processes. The mere possibility of inappropriate data access could undercut the DoD's ability to attract industrial funding for this program due to concern about the effects of premature data releases on the intellectual property rights of the research performers and sponsors.

2. Would researchers become more conservative in what they document in the research record, due to concern that raw data could be presented out of context? As noted above, data viewed without information about experimental design and caveats can be misinterpreted, intentionally or unintentionally, and misused in ways that disserve the public. That's why the researcher is the best source for understanding how data underpin a stated result. If concerns about misuse of raw data made researchers more conservative in what they documented of their efforts, that would diminish the value of the research record and impede the normal scientific process by which subsequent investigators either reproduce and verify research results or fail to do so and thereby call the results into question. That scientific process is essential if we are to continuing to advance the frontiers of knowledge and understanding.

3. Would human subjects in biomedical and other studies believe that personal information about them would be kept confidential? Biomedical and other research involving human subjects is not a large portion of the DoD's research investment portfolio, but it is an important one because it is oriented toward the special operational needs of the military. Human subjects understandably want and deserve assurances that their privacy will be respected. Some subjects likely will be reluctant or unwilling to participate in research studies if raw data about them might be released to Federal agencies and many may worry that inappropriate data subsequently would be released by the agencies to the public. This ultimately could reduce the pool of potential volunteers and seriously affect the ability of scientists to conduct research dependent on the participation of human subjects.

CONCERNS THAT CAN BE ADDRESSED UNDER THE CURRENT STATUTE

Other issues raised by the proposed use of a FOIA-like process could be addressed by the OMB within its proposed revision of Circular A-110, even if the statute remains unchanged. If there is to be Governmentwide uniformity in the standards used to gather and release data, the proposed revision of the OMB Circular will have to be expanded to clearly address these questions:

1. What types of information qualify as "data" (e.g., do they include all written notes, computer files and other electronic media, photographs, videotapes, and medical records)? Similarly, does the term "publication" include only published reports, articles in refereed journals, and other means of announcing results to the general public, or does it also include oral and poster presentations to other researchers at conferences sponsored by scientific or engineering societies? Finally, what constitutes a Federal "policy" or "rule"?

2. What are the periods for retention of data? How long must recipients keep data, particularly after completion of a research project? Would the Federal awarding agency's authority to require the recipient to deliver the data persist longer than the grant or agreement under which the data were produced? How long must a Federal agency retain data provided to it by a recipient in response to a FOIA request? Is the period for retention by the agency different if the data were properly redacted in accordance with FOIA exemptions, so that they are not releasable to the public?

3. What qualifies as "full incremental cost?" Without guidelines on which agencies may base their estimates of costs for providing data, they later will be subject to charges that they are being arbitrary and capricious and that they are using the fees to discourage requesters. It also should be noted that developing the incremental cost for each data request will be difficult anid in many cases the cost may be prohibitive. Whether or not the requester ultimately wishes to proceed, the Federal agencies and recipients already will have expended considerable technical and administrative resources locating the data and assessing the cost of making it available.

4. How is the recipient to be reimbursed for its incremental costs? Will OMB Circular A-21 be amended to make this an allowable administrative cost for academic institutions, without regard to the current cap on those costs? If not, what vehicle would be used, especially if the award under which the data were originally produced has expired?

5. Finally, what is the range of enforcement actions that are available to a Federal agency should a recipient be unwilling to release all raw data. Paragraph _.62(a) of OMB Circular A-110 currently alludes to suspension or debarment of a recipient only tangentially through subparagraph (5), which states that an agency may "take other remedies that may be legally available." If the provision in Public Law 105-277 now places an implicit statutory onus on the Federal agency to produce the recipient's data through the FOIA-like process, should a recipient's unwillingness to comply be a cause for suspension or debarment? If it is the individual researcher that is unwilling to produce the data, should the action be taken against the individual only or also the institution? Does the answer to that last question change if the individual researcher no longer is employed by the institution at which the research was done?

If there is no change in the current statute, the above questions must be answered in the course of revising OMB Circular A-110 to implement It. Alternatively, if the OMB accepts the DoD's recommendation to ask the appropriate Congressional committees to conduct hearings on the subject of public access to data produced under grants and agreements, the above questions should be raised in the course of those hearings.

ONE SUGGESTION FOR AN ALTERNATIVE APPROACH

A fundamentally different approach than using a FOIA-like process may better address the objective identified in the legislative history. When a Federal regulatory agency identifies certain research as a scientific basis for a proposed policy or rule affecting the public, it has a shared responsibility with the researcher-the investigator must explain the basis for the announced result, which includes sharing of relevant data and identification of any assumptions or caveats, and the agency must explain how the result relates to the justification for the proposed regulatory action. It makes sense in these cases for the Federal regulatory agency to accept responsibility for helping to coordinate the process of answering questions posed to the researcher by the affected public, so that he or she is not inundated by numerous duplicative inquiries and thereby diverted more than is necessary from his or her current work. One way that might be done is for the Federal regulatory agency to work with the researcher before publishing a policy or rule for public comment, in order to identify the underlying data that could be shared with the public to answer questions; if those data could be gathered and made available at a site established in advance by the regulatory agency, it might greatly reduce the disruption of the researcher's work.

The role of the Federal awarding agency in this case would be to include as an award condition, when a project begins, that the recipient cooperate in this way with Federal regulatory agencies if results of the project later are used in developing a policy or regulation. There is no added value in having the Federal awarding agency, as well as the regulatory agency, involved at the time of the policymaking or regulatory action.

In contrast with the FOIA-like process, the approach described in this paragraph may be possible even if the results that the Federal regulatory agency wished to draw upon were from research that had not been Federally supported.