Proposed changes to the Office of Management and Budget’s (OMB) Circular A-110, a regulation governing research grants to universities and non-profit institutions, are moving closer to a final promulgation. The orginial directive in Public Law (P.L.) 105-277 required OMB to amend the circular to allow underlying data produced through federal funds be made available through procedures established under the Freedom of Information Act (FOIA). As a result of the first comment period, OMB redrafted changes to the circular and opened a second comment period (see Federal Register, August 10). OMB continues to seek clarity of four key concepts that were problematic in the first proposal: the definition of “data” and “published”, clarification of “used by the Federal Government in Developing Policy or Rules,” and how to reimburse costs.

The original language in P.L. 105-277 would allow the public to request access to “all data.” OMB, however, did not clearly define the term and received numerous comments asking for clarification since “data” could comprise all the components of research including phone logs, physical equipment, financial records, private medical information, or proprietary data. In the August 10 notice, OMB defines data 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 (e.g., laboratory samples).” Furthermore, OMB restricts the definition of data to omit proprietary trade secrets or private information such as medical files.

Concerns regarding the definition of “published” stemmed from fears that requests for data would occur before an investigator completed a study. This could cause the release of incomplete data and possibly hamper the scientific process if scientists had to answer to criticism of preliminary findings. Therefore, OMB has defined published as “either when (A) research findings are published in a peer-reviewed scientific or technical journal, or (B) a Federal agency publicly and officially cites the research findings in support of an agency action.”

Perhaps the most significant change involved OMB’s definition of a federal regulation. OMB’s initial proposed change to Circular A-110 cited that only data “used by the Federal Government in Developing Policy or Rules” would be available through FOIA. This statement, however, is and hence, any action taken by an agency that was influenced by a research study would place that study under scrutiny. OMB, in its new proposal, argues that too broad a definition would prove to be a burden for agencies and proposes to narrow the phrase to “used by the Federal Government in developing a regulation.” OMB cites the definition of “regulation” as it has already been defined in the Administrative Procedures Act. Also, OMB goes further by requiring that the regulation meet an $100 million economic impact threshold, a precedent set by other laws.

Finally, OMB is requesting comments on the cost structure of the new proposal. P.L. 105-277 mentions that agencies can charge a “reasonable fee” for the cost of obtaining data. The cost of retrieving data, for what some anticipate to be a deluge of FOIA requests, could be problematic for grant recipients, their institutions and federal agencies. OMB would like comments on potential costs incurred by the agencies and other parties that will have to be used to release data, and whether grant recipients can charge these costs to their federal grants.

The new proposal seems to have leaned more towards the concerns of the scientific community than proponents of the original amendment introduced by Sen. Richard Shelby (R-AL). Supporters of the Shelby amendment have long argued for a broad interpretation where access to all forms of data culminating from federally funded research is possible so that the complete scientific process can be scrutinized. Science magazine quotes a representative of the U.S. Chamber of Commerce, Louis Renjel, calling the new OMB interpretation, “unacceptable.” Senators Richard Shelby (R-AL), Trent Lott (R-MS), Ben Nighthorse Campbell (R-CO) and Phil Gramm (R-TX), submitted a joint letter to OMB in early September expressing disagreement with the new changes. The letter states that “the August 11th proposal represents a significant retreat from OMB’s original February 4th proposal as to render the provision potentially meaningless in its ability to improve the public’s access to federally funded research data.”

Meanwhile, some opponents of the Shelby amendment still see the use of FOIA as an unfair mechanism for disclosure of scientific data. In its response to the second proposal, the Association of American Universities (AAU) characterizes the Shelby amendment as “misguided and represents bad policy.” AAU, however, was generally pleased with OMB’s second proposal but submitted comments recommending that the economic impact threshold be raised to $500 million, and that the revised circular only affect future research and not studies that have already been completed. The National Academy of Sciences in its response to OMB states, “within the constraints of the existing wording and limited scope of the Shelby amendment, OMB has done a masterful job of listening to public concerns and trying to craft an amendment… in a fair and reasonable way.” Thus if FOIA is used, the science community, on the whole, seems to be amenable to the new proposal.

While this new proposal clearly shows that OMB listened to the science community’s concerns, several issues still need to be meted out. Issues such as allowing access to research done by institutions other than nonprofit grantees, the trigger needed for FOIA action, and the proposal’s effect on public/private partnerships are not addressed. If it were to move forward as it is currently written, it is highly likely that the differences between P.L. 105-277 and OMB’s proposal will be argued in the courts.