Dear Appropriations Committee Colleague:

During the past few weeks, a lot of misinformation has been released regarding a provision which increased the public's access to federally funded research data. This provision was signed into law as part of the 1999 Omnibus Appropriations bill. There have been many inaccurate statements made regarding this data access provision and we believe these inaccuracies need to be rightfully addressed.

Enclosed for your review is a document which addresses the concerns made by the Association of American Universities. We hope that this information is useful as you continue on with your Appropriations work.

Thank you for taking the time to consider the enclosure.

Sincerely,

Jo Ann Emerson

Tom DeLay

Robert Aderholt

John Peterson

Court Challenge to OMB Interpretation
Q: Isn't OMB's limitation on data access to "findings used by the Federal Government in development of federal policies or rules" subject to court challenge? What if it's reversed?

A: The new statute should not be repealed just because OMB's interpretation may be open to challenge. Such fears could result in a halt to all regulatory or legislative progress and would consign society to the status quo in perpetuity.

Patient Confidentiality Concerns
Q: Won't threats to confidentiality discourage human subject participation in research?

A: They shouldn't, because:

1. FOIA prohibits disclosure of private medical and other personal data.
2. Existing strict ethical rules on protection of human subject confidentiality will continue to apply. These include stripping all personal identifiers.
3. Agencies already exempt disclosure of confidential human subject data.

Intellectual Property Concerns
Q: Won't industry be afraid to support, or share data with, federal researchers?

A: They shouldn't be. FOIA protects against disclosure of trade secrets and confidential business information. Additional assurances to private industry regarding protection of such data is under consideration at OMB.

Q: Won't OMB's changes to A-110 interfere with the goals of the Bayh-Dole Act?

A: No. As a practical matter, data that are used by the federal government in "developing a policy or rule" are unlikely to include the patent-related intellectual property protected under the Bayh-Dole Act.

Cost/Burden on Researchers
Q: Won't responding to the FOIA requests impose a new, expensive burden on researchers?

A: No. The statute and OMB's interpretation provide for payment of user fees from the FOIA requester to the researcher. In addition, researchers already must maintain data in a format that allows the data to be turned over to the agency upon request.

Q: Won't researchers be open to harassment through repetitive FOIA requests?

A: No. Researchers will be required to produce the data only once -- to the government. Additional FOIA requests will be handled by the awarding agency.

Definition of "Data"
Q: How will "data" be defined, and how will grantees know what "data" are "produced under an award"?

A: Only those data from studies that have been published and are used in the development of federal rules or policies need be disclosed. OMB has not defined "data" yet, and may leave this up to individual agencies, which have particular familiarity with the kinds of research at issue.

Definition of "Published"
Q: How will "published" be defined so as trigger data release under the OMB rule?

A: OMB has not yet defined the term "published" and should be given an opportunity to respond to the many comments received on this issue. Researchers favor a definition that would require that only peer reviewed studies be disclosed, while other groups favor a more inclusive definition. One factor might be considered is whether agencies have relied upon the data prior to peer reviewed publication.

Retroactivity
Q: Will the statute apply retroactively?

A: This is unclear from the statute, and OMB should be given an opportunity to address the issue. Reasonable arguments for and against retroactive application can be made, and Congress has vested OMB with sufficient authority to interpret the statute to resolve the question.

Data Retention
Q: How long will researchers be required to retain data? What if the researchers change institutions?

A: A-110 currently requires certain records be held for three years, but OMB may elect to modify this provision with respect to the new data access policy. The awardee institution, not the individual researcher, would be subject to the data retention obligation, and the institution could discharge that obligation by turning the data over to the government upon completion of the research study.