New Rules on Access to Research Data Excite Controversy

By Mary R. Anderlik
Health Law & Policy Institute

A two-sentence provision buried in the 4,000-plus-page Omnibus Consolidated and Emergency Supplemental Appropriations Act (P.L. 105-277) may have a major impact on the scientific community.

The federal Office of Management and Budget (OMB) establishes uniform standards for grants and agreements awarded to institutions of higher education, hospitals, and other non-profit organizations by federal agencies. P.L. 105-277 directs OMB to add a requirement that federal agencies make all data produced under an award to a non-profit organization available to the public through Freedom of Information Act (FOIA) procedures. As interpreted by the U.S. Supreme Court, the FOIA itself only applies to data in the files of a federal agency—P.L. 105-277 reaches into the files of researchers. On February 4, 1999, OMB issued a Notice of Proposed Revision (of OMB Circular A-110) and solicited comments. OMB received over 9,000.

If openness is one of the first principles of science, why this controversy? The concerns voiced by commentators are diverse. The primary ethical concern relates to privacy. Research records may contain health and other sensitive personal information, and the term "data" might extend to things like DNA samples. Some researchers assert that they will no longer be able to promise confidentiality to subjects. It is important to note that records in the possession of researchers are not absolutely inviolable under existing law. For example, in the 1980s courts ordered production of research records in a number of high-profile product liability suits, finding redaction of records to remove names and other identifying information sufficient to protect confidentiality. In any event, the clarifying changes proposed by OMB on August 11, 1999 should go a long way toward reassuring researchers and research subjects. The new, improved definition of "research data" expressly excludes physical objects such as laboratory samples and "personnel and medical files and similar files 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," This expands on an exemption in the FOIA.

Commentators also put forward scientific concerns, such as the concern that findings will make their way to the public prematurely, before they have been validated and subjected to the peer review process. Linked to that is a commercial concern. Researchers, and private companies collaborating with researchers and federal agencies on research projects, fear that competitors will use this new mechanism to access proprietary information. To meet these concerns, the clarified definition of "research data" also excludes "trade secrets, commercial information, materials necessary to be held confidential by a researcher until publication of their results in a peer-reviewed journal, or information which may be copyrighted or patented." Again, this expands on an exemption in the FOIA.

A final concern might be labeled democratic. According to the New York Times, the impetus for the new legislation was an extended industry battle to gain access to data from a pollution study that served as a basis for tougher regulation. Some fear that the new mechanism will be used to harass regulators and researchers outside industry and to hinder the regulatory process. In other words, private interests may use the access provision against the public interest. To discourage fishing expeditions and the like, OMB has clarified that access rights extend only to research data relating to published research findings "used by the Federal Government in developing a regulation," meaning that "an agency publicly and officially cites to the research findings in support of a regulation [subject to notice-and-comment rulemaking]." Also, those requesting data are responsible for the "full incremental cost" of obtaining it.

The text of the August 11 notice, published at 64 Fed. Reg. 43786, is available via the Internet at http://www.whitehouse.gov/OMB/fedreg/2ndnotice-a110.html. Comments on this document are due September 30, 1999.

08/17/99