Controversy over Accessibility of Federally-funded Data

“To alter the rules that the scientific community has operated under for decades without providing them an opportunity to speak to the need for this change or to participate in developing it, is not only unwise, it is unfair.” --Rep. George E. Brown, Jr. (D-CA

Key members of both the scientific and legislative communities are reacting with alarm to a provision added last year to the final, omnibus appropriations bill (H.R. 4328). The provision might result in federally-funded researchers having to make available their raw, prepublication data to anybody who requests it under the Freedom of Information Act (FOIA). The bill language calls on the Director of the Office of Management and Budget (OMB) to revise OMB regulations “to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act.” Currently, only the federal agency funding the research can request raw data from researchers.

The provision was inserted into the nearly 4,000-page catch-all omnibus bill by Sen. Richard Shelby (R-AL). No hearings were held on the need for, or possible consequences of, such a provision. Rep. George Brown (D-CA), Ranking Minority Member of the House Science Committee, calls it “ironic that a provision described as a sunshine provision needed to be tucked into a 4,000-page bill in the dead of night.”

The legislation has prompted concerns over the release and potential misuse of data before it has been peer-reviewed or published, the effect on intellectual property rights, and the possible violation of confidentiality of human research subjects. Additionally, researchers worry about delay and disruption to their work by groups with interests inimical to the results of the research.

Brown has spearheaded legislative opposition to the provision. On the first day of the 106th Congress, he introduced H.R. 88, a bill to repeal the omnibus language. “This provision should be repealed,” Brown stated, “on the basis of both the flawed process through which it was adopted and because of the damage it is likely to do to the publicly funded research structure which we have developed over the past fifty years.... Obviously, some groups feel that an information-sharing problem exists,” he noted. “However, documentation of this problem has been no more than anecdotal.... We should not jeopardize this [scientific] enterprise by taking a hasty, ill-considered approach to remedy an alleged problem.”

Brown was joined by 22 other Representatives in sending a December 7 letter to OMB Director Jacob Lew, expressing their concerns and urging Lew to solicit input from all parties before drafting language to implement the regulation. The letter was signed by 17 Democrats and 6 Republicans. Republican signatories include John Porter (R-IL), chairman of the appropriations subcommittee responsible for NIH; James Walsh (R-NY), the incoming chair of the VA/HUD appropriations subcommittee; and Science Committee vice chairman Vern Ehlers (R-MI). Excerpts from the letter to Lew follow:

“While we all support the free and open exchange of information, we have concerns that there may be a number of negative, unintended consequences for the conduct of research under federal awards if this Circular is amended in haste and without sufficient input federal grant-awarding agencies and grant recipients. An amendment of similar intent was offered and defeated in the House Appropriations Committee one year ago because of Members’ concerns about negative impacts of making this policy change on federally-funded research. At that time, a number of agencies provided comments indicating numerous potential problems associated with making all data from federal awards subject to FOIA. We believe these concerns were and are still valid.”

“One area of concern pertains to research involving human subjects.... Volunteers currently make agreements with researchers and their institutions to divulge personal medical information on the condition that their information will remain strictly confidential.... Although FOIA provides protections for some types of information, the provisions may not be adequate to ensure confidentiality.”

“We are also concerned that this provision could facilitate the theft of intellectual property.... Mandating the accessibility of all data produced under a federal award would undermine the protections for researchers intellectual property rights guaranteed under copyright and other technology transfer laws.”

“We are also concerned about the potential for increases in administrative burdens and costs for granting agencies and for award recipients.... While the language of the Omnibus Bill indicates that agencies could charge a user fee for obtaining data at the request of a private party, there appears to be no mechanism available to award recipients to offset the administrative costs of complying with the required change in policy.”

“The above-mentioned concerns represent a few examples of the problems that we wish to see avoided in implementing this provision. Consequently, we urge you to solicit input from all federal grant-awarding agencies, and from the higher education, hospital, and non-profit grant recipient community before moving forward with this change.”

The letter was signed by the following Members of the 105th Congress:

Howard L. Berman (D-CA) Sherwood L. Boehlert (R-NY) George E. Brown, Jr. (D-CA) Lois Capps (D-CA) Vernon J. Ehlers (R-MI) Bob Filner (D-CA) Maurice D. Hinchey (D-NY) Steven C. LaTourette (R-OH) Nita M. Lowey (D-NY) Carolyn McCarthy (D-NY) Constance A. Morella (R-MD) Major R. Owens (D-NY) John Edward Porter (R-IL) David E. Price (D-NC) Lynn N. Rivers (D-MI) Jose E. Serrano (D-NY) Louise M. Slaughter (D-NY) Edolphus Towns (D-NY) James A. Traficant, Jr. (D-OH) James T. Walsh (R-NY) Henry A. Waxman (D-CA) Lynn C. Woolsey (D-CA) Albert R. Wynn (D-MD)

It is not clear how much discretion Lew has in developing an OMB regulation that would be acceptable to all parties. Also unknown is how much support Brown can raise for his bill to repeal the legislation.