Arguments Against The Price-Walsh Amendment For House Appropriations Committee FY 2000 Treasury Appropriations Bill "Markup"
Patient Confidentiality Concerns
Q: Won't threats to confidentiality discourage human subject participation in research?
A: They shouldn't, because:
- FOIA prohibits disclosure of private medical and other personal data.
- Existing strict ethical rules on protection of human subject confidentiality will continue to apply. These include stripping all personal identifiers.
- 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.
- Limiting disclosure to only "published" research will significantly lessen interference with public-private partnerships.
- Intellectual property created under many agreements ("CRADAs") between private parties and federal agency government laboratories is protected from disclosure pursuant to the National Technology Transfer Act of 1995.
- Additional assurances to private industry regarding protection of joint research data are under consideration at OMB.
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. Finally, as under the present structure, researchers will be required to provide the data only one time -- to the agency.
Q: Won't researchers be open to harassment through repetitive FOIA requests?
A: No. Researchers will be required to produce the same 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.
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.