I.3.1 U.S. Government Executive Branch Policies

In examining federal branch policy on data access, it is important to understand that the federal government currently has the right to access data produced under a federal award. As existing Circular A-110 states:

Unless waived by the Federal awarding agency, the Federal Government has the right to . . . (1) Obtain, reproduce, publish, or otherwise use the data first produced under an award . . . [and/or] (2) Authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes.

OMB Circ. A-110 § ___.36(c).

The new data access law makes information access and information dissemination a mission of the agencies comparable to their basic enabling statutes. Currently, we have a patchwork of varied agency policies on data access. To the extent that these assorted policies can be made more uniform through OMB's revisions to Circular A-110, we believe that is exactly what Congress intended in enacting the data access law.

As noted in the Introduction above, OMB Circular A-110's directive to the agencies on data sharing should serve as a delimiting framework within which the separate agencies will develop conforming data access rules within the next six months. OMB's next revisions to the Circular should therefore explicitly mandate that each agency must issue such rules. The revisions should also clarify that these agency revisions will be issued in accordance with Executive Order 12866, with review by OMB, and that an opportunity for public comment will be afforded in that process.

The revised Circular A-110 should provide individual agencies with flexibility to tailor their own rules, however, consistent with the OMB guidance. This approach will allow each agency to address concerns specific to that agencies' federal awardees and the research programs the agency oversees.

I.3.1.a Presidential Executive Order on Children's Health

On April 21, 1997, President Clinton signed Executive Order No. 13045, which sets forth requirements for access to research on children's health effects that is funded by the federal government. The policy calls for liberal sharing of and access to federally funded data. The Executive Order provides, in part:

4-401. Within 6 months of the date of this order, the Task Force [on Environmental Health Risks and Safety Risks to Children] shall develop or direct to be developed a review of existing and planned data resources and a proposed plan for ensuring that researchers and Federal research agencies have access to information on all research conducted or funded by the Federal government that is related to adverse health risks in children resulting from exposure to environmental health risks or safety risks. The National Science and Technology Council shall review the plan."

4-402. The plan shall promote the sharing of information on academic and private research. It shall include recommendations to encourage that such data, to the extent permitted by law, is available to the public, the scientific and academic communities, and all Federal agencies.²

I.3.1.b Food and Drug Administration

The Food and Drug Administration ("FDA"), pursuant to its FOIA regulations, routinely provides wide and early access to most types of data, including research and testing data produced with federal funds. FDA's regulations regarding public access to data provide:

(c) The results of all testing or research conducted by or with funds provided by the Food and Drug Administration, such as toxicological testing, compliance assays, methodological studies, and product testing, are available for public disclosure when the final report is complete and accepted by the responsible Food and Drug Administration official, after deletion of any information that would reveal confidential investigative techniques and procedures. . . . If such results are disclosed in any manner to the public before the final report is available, they are immediately available for disclosure to any member of the public that requests them.

(d) Access to all raw data, slides, worksheets, and other similar working materials shall be provided at the same time that the final report is disclosed.

21 C.F.R. § 20.105(c), (d). (Emphasis added.) These regulations are in keeping with FDA's general policy on disclosure of records, which states:

(a) The Food and Drug Administration will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade secrets and confidential commercial or financial information, and the need for the agency to promote frank internal deliberations and to pursue its regulatory activities without disruption.

21 C.F.R. § 20.20(a).

I.3.1.c National Science Foundation

The statement of grant conditions³ of the National Science Foundation ("NSF") provides that:

37. Sharing of Findings, Data, and Other Research Products

a. NSF expects significant findings from research and education activities it supports to be promptly submitted for publication, with authorship that accurately reflects the contributions of those involved. It expects investigators to share with other researchers, at no more than incremental cost and within a reasonable time, the data, samples, physical collections and other supporting materials created or gathered in the course of the work. It also encourages awardees to share software and inventions or otherwise act to make the innovations they embody widely useful and useable.

b. Adjustments and, where essential, exceptions may be allowed to safeguard the rights of individuals and subjects, the validity of results, or the integrity of collections or to accommodate legitimate interests of investigators.

The NSF has also taken the position that the researcher institution's retention of intellectual property rights "does not reduce the responsibility of researchers and institutions to make research results and supporting materials openly accessible."⁴

I.3.1.d National Center for Health Statistics of the Centers for Disease Control and Prevention

The Staff Manual on Confidentiality of the National Center for Health Statistics ("NCHS")⁵ provides:

The primary purpose of the NCHS is to develop statistical information on health matters in the United States and to provide that information as quickly and in as useful form as possible to all who desire it. Therefore, it is Center policy that whenever a staff member receives a request for information, the staff member will be as helpful as possible to the requestor. Within the bounds of the law, the information is provided without delay, together with any appropriate and necessary explanation concerning the character of the data provided.

I.3.1.e Public Health Service of HHS

The Grants Policy Statement ⁶ issued by the Public Health Service ("PHS") states that:

It is the policy of PHS to make available to the public the results and accomplishments of the activities that it funds. Restricted availability of unique resources upon which further studies are dependent can impede the advancement of research and delivery of medical care. Therefore, when these resources are developed with PHS funds and the associated research findings have been published or after they have been provided to the agencies under contract, it is important that they be made readily available for research purposes to qualified individuals within the scientific community.

I.3.1.f National Institutes of Health

Guidelines issued by the National Institutes of Health ("NIH") for the conduct of extramural research⁷ state that "[i]t is expected that the results of research will be carefully recorded" and that "[r]esearch data, including the primary experimental results, should be retained for a sufficient period to allow analysis and repetition by others of published material from those data. In some fields, five or seven years are specified as the minimum period of return, but this may vary under different circumstances."

On June 4, 1998, the Working Group on Research Tools presented a report to the Director of NIH addressing the problem of underlying data access in connection with medical "research tools," a term which includes both data and reagents.⁸ The Working Group recommended that:

NIH should promote free dissemination of research tools without legal agreements whenever possible, especially when the prospect of commercial gain is remote.

NIH should develop and disseminate guidelines for recipients of NIH funds as to reasonable terms in licenses and MTAs [materials transfer agreements] addressing both importing of research tools owned by other institutions and exporting of research tools created with NIH funds.

NIH should review its policies with regard to dissemination of research tools generated under its intramural and extramural funding, and revise and strengthen those policies. . . .

. . . NIH's should consider . . . replacing the current 'encouragements' to recipients to disseminate unique research resources with stronger requirements to the same effect . . . .

NIH should promote the establishment of a research tools forum for the biomedical research and development community.

I.3.1.g National Aeronautics and Space Administration

NASA's policy on data access, which covers human research, has been as follows since 1996 ⁹ :

Ready access to data from NASA research programs and missions (via modern data archiving and communications technologies) by researchers not directly involved in the program increases the return on NASA research investments. It is therefore NASA policy that non-proprietary scientific data obtained from NASA programs and missions will be made publicly available in usable form as quickly as possible. (Non-proprietary data are data that may be distributed without violating patent, trade secret, or copyright laws or NASA's ability to obtain and protect U.S. government intellectual property rights.) Such data constitute a national resource that can be used by scientists, policy makers, and the public throughout the country to undertake new scientific studies, permit wider assessment of the validity of the results and conclusions from NASA missions, and facilitate broader public understanding of the value of NASA programs and missions. (Emphasis in original.)

It is NASA policy that all non-proprietary scientific mission data be made publicly available after the shortest reasonable time in forms which permit a wide range of users to derive scientific, technical, and other benefits." Id. (Emphasis in original.)

In keeping with this Policy, NASA announced in 1997¹⁰ :

Investigators sponsored by the Office of Space Science no longer have exclusive use of their data for any proprietary period. Therefore, selected PI's [principal investigator awarded grants] are expected to release data for public access as soon as feasible. After a short period for verification and validation, not to exceed six months, the PI must deposit the validated data in the PDS [Planetary Data System].

I.3.1.h National Institute of Justice of the Department of Justice

The Institute's current guidelines for research it sponsors state¹¹ :

Public Release of Automated Data Sets
NIJ is committed to ensuring the public availability of research data and, to this end, established its Data Resources Program in 1984. All NIJ award recipients who collect data are required to submit a machine-readable copy of the data and appropriate documentation to NIJ prior to the conclusion of the project. The data and materials are reviewed for completeness. NIJ staff then create machine-readable data sets, prepare users' guides, and distribute data and documentation to other researchers in the field. . . .

² E.O. 13045, "Protection of Children from Environmental Health Risks & Safety Risks", April 21, 1997, 62 Fed. Reg. 19,887 (April 23, 1997)

³ Grant General Conditions (GC-1) (Oct. 1998).

⁴ Important Notice to Presidents of Colleges and Universities and Heads of Other National Science Foundation Grantees Organizations, Notice No. 106, §2 (Apr. 17, 1989).

⁵ NCHS Staff Manual on Confidentiality, U.S. Dept. of Health and Human Services, Public Health Service (Sept. 1997), p. 9.

⁶ PHS Grants Policy Statement, §8, "Postaward Distribution of Unique Research Resources Produced with PHS Funding."

⁷ Guidelines for the Conduct of Research in the Intramural Research Programs at NIH (Jan.1997).

⁸ National Institutes of Health, Report of the National Institutes of Health (NIH) Working Group on Research Tools Presented to the Advisory Committee to the Director, Recommendations (June 4, 1998).

⁹ Science in Air and Space: NASA's Science Policy Guide, § VI.B (July 1996)

¹⁰ Announcement of Opportunity, Mars Surveyor Program - 2001 Orbiter, Lander, Rover Missions: Science Investigations and Characterization of Environment §6.4, "Data Records Requirements and Data Validation" (June 19, 1997).

¹¹ "Guidelines for Submitting Proposals for National Institute of Justice-Sponsored Research".