WASHINGTONThe Office of Management and Budget (OMB) has issued a final rule that defines what research data the public can demand to see under the Freedom of Information Act (FOIA). To the relief of many in the biomedical sciences, the White House agency did not include data from research in progress or any information that could be used to identify particular persons in a research study.
The new rule took effect Nov. 6. It requires that data from a published study must be provided within a reasonable time when the information is requested under the FOIA. To OMB, a published study is one that has appeared in a peer-reviewed journal or one that a federal agency has officially cited to support an action that has the force and effect of law. [See below for definitions.]
Narrowing the FOIA Target
Scientific organizations expressed considerable concern about what OMB would designate as research data. In its final ruling, the agency spelled out what is and isnt fair game under its new access rule:
Research data is defined as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This recorded material excludes physical objects (eg, laboratory samples).
Research data also does not include: trade secrets, commercial information, materials that must be held confidential by a researcher until they are published, or similar information that is protected under law; and personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.
Published is defined as either when research findings are published in a peer-reviewed scientific or technical journal, or a Federal agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law.
Anyone who makes a request for research data can be charged a reasonable fee to cover the costs incurred in providing the data.
The new rule is a revision to OMB Circular A-110, which governs the administration of federally funded research grants. OMB was required to make the revision by a two-line amendment inserted into the 1999 Omnibus Appropriations Bill by Sen. Richard C. Shelby (R-Ala). His amendment, which passed both houses of Congress, called on OMB to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through FOIA procedures.
Sen. Shelby acted after researchers at the Harvard School of Public Health refused to release data they had gathered and which the Environmental Protection Agency relied upon to justify its decision to create a standard for ultrafine ambient air particles. The Harvard scientists said that releasing the data would violate the confidentiality of people they studied.
When word of the Shelby amendment spread, the research community responded with vigorous protests. For example, National Cancer Institute director Richard D. Klausner, MD, said the Shelby amendment has very disruptive, if not paralyzing implications for research. And the National Cancer Advisory Board responded with a letter strongly expressing its concerns.
When OMB published a first draft of its proposed revision, it received more than 9,000 letters of comment. Its second draft drew another 3,000 comments. In issuing its final rule, OMB said it recognizes the importance of ensuring that the revised Circular does not interfere with the traditional scientific progress. As such, we have not construed the statute as requiring scientists to make research data publicly available while the research is still ongoing.
OMB said it also agreed with the suggestion that all appropriate data be protected. Thus, it changed its initial wording to replace the word files in the phrase personal and medical files with the word information so as to protect such things as videotapes or audiotapes of research subjects.
OMB made clear that the responsibility for identifying requested material remains with the researchers, and that staff of federal funding agencies would not search investigators files. However, the federal awarding agency would retain its right to ask the recipient for additional information, if it believed the recipients submission was not complete.
As for research data already available to the public through data archives or other means, OMB agreed that researchers could answer an FOIA request by providing information on how to obtain the sought data.
The cost of responding to an FOIA request concerned many in research. In its rule, OMB said that when information is obtained solely in response to an FOIA request, the federal agency could charge a fee to cover the full incremental cost of obtaining the research data. This fee should reflect cost incurred by the agency, the recipient, and applicable subrecipients, the agency noted.
OMB also dealt with the situation in which a data request is made after a federal grant or contract has expired. Under FOIA procedures, a request for data would go to the funding agency, which would then ask the grantee for an estimated cost of complying. With cost in hand, the federal agency would then apply existing standards for requesting appropriate prepayments from the requester. And once the requested data are received, the federal awarding agency will then seek reimbursement from the person or organization making the FOIA request.