Who Owns Your Research?

One Senator, stung by a refusal to allow access to raw research data from a published study, inserted a relatively small provision into last year’s omnibus appropriations bill that has the scientific community in a giant uproar. The provision would make all data produced under a federal grant available through the Freedom of Information Act, or FOIA.

If implemented, this could have far-reaching effects on both the pragmatic and philosophical dimensions of federally-funded science, raising the specter of enormous administrative burdens for research institutions and individual investigators, and prompting fundamental questions of intellectual property rights. For behavioral researchers and others who conduct research involving human subjects, it also raises significant questions about confidentiality and protection of sensitive information.

“There is no question that this would have a profoundly chilling impact on research in our field,” said Alan Kraut, APS Executive Director. “It’s not a matter of legitimate issues about access to data, or sharing information. Parties with vested interests could use this as a way to shut down projects on issues they disagree with, or intimidate research participants with the threat of exposure. The potential for abuse is enormous.”

The sponsor of the provision, Sen. Richard Shelby (R-AL), first became involved when researchers from the Harvard School of Public Health would not release data from a study that was the basis for an Environmental Protection Agency (EPA) regulation. Invoking the public’s right to know, and claiming that data underlying a federal rule or policy should be accessible, Shelby tucked his seemingly-punitive measure into the massive, 4,000-page legislative package that Congress used to wrap up all of its unfinished must-do business before adjourning prior to last year’s election.

Critics of the omnibus measure both inside and outside of Congress feared exactly this scenario, that legislators would be able skirt the usual process of open hearings and public comment by hiding their pet projects or peeves in the giant bill.

Legislation (H.R. 88) to repeal the Shelby provision has been introduced by Rep. George Brown (D-CA), a leading Congressional supporter of science, who said that it was passed without being considered by Congressional science committees and without consulting the scientific community. Brown and others in Congress also have told federal regulators that this provision would compromise sensitive data and would result in enormous legal and administrative costs. APS strongly supports H.R. 88.

Some proponents of the Shelby measure claim that the federal government uses junk science to justify regulations, and that opposition to Shelby is an attempt to hide bad science. The American Association for the Advancement of Science (AAAS), the National Academy of Sciences, and the National Science Board (the governing body for the National Science Foundation) have all issued statements opposing the Shelby provision.

Despite the concerns that have been raised by Congress and the scientific community, the regulations to implement the FOIA changes are proceeding apace. The Office of Management and Budget (OMB) has issued draft regulations that would amend OMB Circular A-110 to include the requirement that all data produced under a federally-funded award will be made available to the public through FOIA procedures. OMB Circular A-110, which has been in effect since 1976, governs the management of federal grants by universities.

Based on statements concerning the legislation by Shelby, Senate Majority Leader Trent Lott (R-MS) and Sen. Ben Nighthorse Campbell (R-CO), OMB has indicated that the requirement will pertain to: Research that is the basis for any federal policy or rule; all underlying data, not just published data; all federally-funded research, regardless of the level of funding or whether the investigator is also using non-federal funds.

This provision has raised questions about who owns the data from federally-funded research.

The FOIA is intended to provide public access to government records, and FOIA requests are made of federal agencies. But data technically are the property of universities, which are the recipients of federal award money. So under the proposed regulations, the federal agency, for example the National Institutes of Health (NIH) or the National Science Foundation, would be required to get the data from the university.

Let’s assume for a moment that federal agencies could do this (and that is a big assumption, given the legal challenges that would arise). The prospect of handling such FOIA requests raises many concerns for federal research agencies, ranging from the definition of data to who pays the administrative costs of complying with the request, said Wendy Baldwin, NIH deputy director for extramural research.

“What do we mean by data?” she asked. Does it include individual laboratory notebooks, videotapes of families interacting? And what’s covered by “published?” Does it include a poster or a presentation of preliminary data at a scientific conference?

The administrative costs of complying with FOIA requests would also be considerable, said Baldwin. Beyond just getting the raw data, she asked: Who would pay for the analysis that would make the data understandable? And even if costs are recoverable, she pointed out that under current law, recovered FOIA costs go to the U.S. Treasury, not to the agency incurring the costs.

Mary Ellen Sheridan, assistant vice president for research at the University of Chicago, echoes Baldwin’s concerns, noting that “premature data are fragile,” and their release would be “devastating.” At the worst, she envisions private sector companies using the FOIA to raid federal research, which she believes would hamper leading-edge, high-risk research. She also believes early interception of data would have the potential to wreck promising scientific careers.

Both Baldwin and Sheridan point out that there are mechanisms to ensure appropriate transfer of data from universities to agencies, and there are no protections for the confidentiality of information in such transfers. Imagine the reaction of a potential research participant who is told that the information they give may be available under the FOIA, said Sheridan.

Shelby says that existing FOIA exceptions and protections are adequate to protect this and other kinds of information, such as personnel records and medical history. It appears that the scientific community disagrees.

The message to OMB, said Sheridan, is that “you can’t have good implementation of a bad statute.”

A scientist from the private sector sees this as an opportunity for the scientific community to improve access to data. Speaking along with Baldwin and Sheridan at a briefing sponsored by the AAAS, Roger McClellan, president of the Chemical Industry Institute of Toxicology, said that scientists can have differing interpretations of data. He believes it is the scientific community’s responsibility to develop procedures that allow access to critical data, particularly those bearing on public health rules and regulations. Such data should be open to re-analysis, he said.

OMB’s proposed regulations were published in the Federal Register on February 4th, and are currently open for comment. (They can be accessed online at www.access.gpo.gov/su_docs/fedreg/a990204c.html.) The comment period ends on April 5, 1999. APS’s response to the proposed regulations will be available on the APS Website.