March 16, 2001

Data Access: No Foreseeable Compromise with Industry Groups

The responsibility of scientists to make research data accessible to peers or the public continues as a topic of concern in Washington, most recently in a March 12 forum at the National Academy of Sciences (NAS). The discussion focused on Senator Richard Shelby's (R-Ala.) 1998 legislative provision requiring that data generated under federal research grants to universities and other non-profit organizations be made available to the public under the Freedom of Information Act. Representatives of industry who back the Shelby law and new legislation on "data quality" were featured speakers at the NAS meeting.

In the meeting's first panel, moderated by David Korn, M.D., AAMC Vice President for Biomedical and Health Sciences Research, Dr. Steven Goodman of Johns Hopkins University provided an overview of the types and variety of data employed in the scientific process. Dr. Goodman objected to the notion, perhaps underlying the layman's view, that all data fall into three categories: true, false, and unproven. Rather, the truth validity of data may lie at varying levels of certainty between false and true. Dr. Goodman recounted the ways the scientific community improves the reliability of its findings, by re-examination, replication, and further research.

Dr. Douglas Dockery of Harvard University then reviewed the "Six Cities Study," an epidemiologic study of particulate air pollutants. Industry, objecting to Environmental Protection Agency regulations based in part on the study, tried to obtain the Six Cities data for separate examination but was declined because of confidentiality agreements accorded to participants in the study. The case purportedly motivated Sen. Shelby to pass the law requiring access to such data through FOIA.

Although the Six Cities findings have been extensively re-examined (and supported) by the independent Health Effects Institute, William Kovacs of the U.S. Chamber of Commerce insisted that the Chamber and other groups should have the right to examine the data for themselves. "This is [a matter of] civics," he stated. But David G. Hawkins of the National Resources Defense Council argued that industry's intent is to obstruct and undermine the authority of federal agencies to effect environmental or other regulations, comparing industry's questioning of research data as an "O.J. Simpson defense" of its practices.

Wendy Baldwin, M.D., NIH Deputy Director for Extramural Research, said that NIH promotes and continues to seek better ways to ensure access to research data. The Shelby statute, by its reliance on FOIA, she noted, is not an effective mechanism for data access. FOIA does not provide for structure or documentation of the records released. It is difficult for agencies to know how thoroughly to redact data to protect the privacy of individuals, nor do the provisions of FOIA protect the confidentiality of individual clinics, schools, or other organizations. And, as others noted, data access under Shelby/FOIA is strictly one-sided, requiring release of university data to anyone for any intent, but does not correspondingly require sharing of data from private firms or individuals with the scientific community. Moreover, because the Shelby statute amends Office of Management and Budget (OMB) Circular A-21, which governs the management of federal grants and cooperative agreements to academic and non-profit institutions only, the law does not apply to for-profit institutions, even when they receive federal funds.

Although the Office of Management and Budget (OMB) and federal agencies recognized university concerns in implementing the statute , which became effective last year, the U.S. Chamber of Commerce made clear that it intends to sue the federal government to overturn the OMB's restrictive interpretation of the statute. No suit has been filed at this time. William Kovacs believes that industry may concede to confining the reach of the statute to data used to support federal policies and regulations (the Shelby statute does not explicitly make such distinction).

Jim Tozzi representing the Center for Regulatory Effectiveness (CRE), supporting the Shelby provision, also supports the "daughter of Shelby," a provision in last year's appropriations bill that requires OMB to implement procedures for ensuring "data quality" [see Washington Highlights, Jan. 19]. OMB must implement the data quality regulation by Sept. 30, 2001.

The forum, "Seeking Access to Research Data in the 21st Century: An Ongoing Dialogue Among Interested Parties" was moderated by Donald Kennedy M.D., editor of Science and co-chair of the Science, Technology, and Law Program of the National Academies.

Information: Steve Heinig, AAMC Division of Biomedical and Health Sciences Research, 202-828-0488.

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Originally published in AAMC Washington Highlights