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Historical Perspective

A Washington attorney, Frederick R. Anderson, provided the workshop participants with a brief overview of the events leading up to the Shelby Amendment.3

Important precedents. The Shelby Amendment has several important precedents, including the Freedom of Information Act (FOIA) and the Supreme Court’s decision in Forsham v. Harris. FOIA broadly guarantees citizens access to information gathered by the federal government, including the records of federal agencies. FOIA is subject to exceptions for the purposes of protecting such interests as personal privacy, trade secrets, national security, personnel records, and privileged communications.

The law underlying FOIA-based public access to research data is reflected in the Supreme Court’s 1980 decision in Forsham v. Harris. In this decision, a physician’s group was denied access to physical data that had been gathered by persons working under a grant from the federal government in the course of research on diabetes treatment. The decision excluded from FOIA access to any material that was not physically in the sponsoring agency’s hands.

As explained during Panel I by Dr. David Korn of the American Association of Medical Colleges, much of the science that supports regu

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This chapter essentially summarizes the points made by Mr. Anderson, with additional documentary material that is identified as such.



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Access to Research Data in the 21st Century: An Ongoing Dialogue Among Interested Parties - Report of a Workshop 1 Historical Perspective A Washington attorney, Frederick R. Anderson, provided the workshop participants with a brief overview of the events leading up to the Shelby Amendment.3 Important precedents. The Shelby Amendment has several important precedents, including the Freedom of Information Act (FOIA) and the Supreme Court’s decision in Forsham v. Harris. FOIA broadly guarantees citizens access to information gathered by the federal government, including the records of federal agencies. FOIA is subject to exceptions for the purposes of protecting such interests as personal privacy, trade secrets, national security, personnel records, and privileged communications. The law underlying FOIA-based public access to research data is reflected in the Supreme Court’s 1980 decision in Forsham v. Harris. In this decision, a physician’s group was denied access to physical data that had been gathered by persons working under a grant from the federal government in the course of research on diabetes treatment. The decision excluded from FOIA access to any material that was not physically in the sponsoring agency’s hands. As explained during Panel I by Dr. David Korn of the American Association of Medical Colleges, much of the science that supports regu 3   This chapter essentially summarizes the points made by Mr. Anderson, with additional documentary material that is identified as such.

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Access to Research Data in the 21st Century: An Ongoing Dialogue Among Interested Parties - Report of a Workshop latory action involves research on human beings. Since at least the early 1970s, he said, when the code of federal regulations to protect human participants in research was adopted by the Department of Health, Education, and Welfare, issues of protection, privacy, and confidentiality of participants’ medical information have been paramount. The issue of individual privacy remains a controversial issue nationally, and the DHHS has recently issued a final rule on the privacy of medical information—a long, complicated, and hotly contested rule. Basically, said Dr. Korn, our society continues to place a very high premium on the protection of individuals’ medical information, and this desire stands opposed to unlimited access to information used in research. The wording of the Shelby Amendment. The Shelby Amendment took the form of a two-sentence rider to the Omnibus Appropriations Act for FY1999, Public Law 105-277, which reads as follows: Provided further that the Director of OMB amends Circular A-110 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.4 This amendment, which takes its name from its sponsor, Senator Richard Shelby of Alabama, precipitated a highly charged public debate, but only after it became law. Industry and regulated communities supported the measure as a fair way to challenge scientific studies that support costly regulations, tort suits, and dubious/questionable risk estimates. The scientific community opposed the amendment on the grounds that it would invite intellectual property searches by industry and scientific competitors, jeopardize the privacy of research subjects, decrease the willingness of research subjects to participate in studies, expose researchers to deliberate harassment, and increase costs and paperwork. Revised OMB guidelines. The Shelby Amendment required OMB to modify OMB Circular A-110 so that it became the regulatory expression of the amendment. That section is titled “Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations.” The OMB, as instructed, in early 1999 proposed guidelines for applying the amendment. These stimulated over 9,000 comments from the public to the OMB, which revised the guidelines twice. When the final guidelines were issued in late 1999, the OMB received 3,000 additional comments. 4   The revised Circular became effective November 6, 1999.

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Access to Research Data in the 21st Century: An Ongoing Dialogue Among Interested Parties - Report of a Workshop The wording of the relevant section of the final version is as follows: (d) (1) In addition, in response to a FOIA request for research data relating to published research findings under an award that were used by the federal government in developing an agency action that has the force and effect of law, the federal awarding agency shall request, and the recipient will provide within a reasonable amount of time, the research data so that they can be made available to the public under FOIA. Three additional sentences repeated the guideline’s order to permit an agency to recover any costs associated with compliance. Because Circular A-110 applied only to non-profit institutions, the amendment targeted only universities, teaching hospitals, and non-profit research centers, and did not apply to federally funded research undertaken by for-profit entities. OMB’s final guidelines acknowledged FOIA’s protections—the protection of confidential commercial information and trade secrets, and of personnel and medical information, the disclosure of which would constitute, in the words of the circular, “clearly unwarranted invasion of personal privacy such as information that could be used to identify a particular person in a research study.” The wording of OMB’s guidelines qualified the Shelby Amendment in several ways. First, it limited the data that must be divulged to published or cited research that has been used by the federal government to develop legally binding agency actions. Also, it defined “published” as an appearance in a peer-reviewed scientific or technical journal, and/or use by an agency in support of an action that has the force of law. The OMB also added the provision for a “reasonable amount of time” to assemble and provide the data. In an earlier version the OMB limited the rule to actions with an economic impact of $100 million or more, but this limitation was dropped in the final version. The OMB further defined research data as the factual material commonly accepted by the scientific community as necessary to validate research findings. This definition excluded preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. It did not specifically include laboratory samples or biopsy materials, and left open the question of audio and video tapes of interviews with research subjects. The OMB gave some discretion to the researcher to decide which materials should be provided to a requesting party. No process was specified to resolve disagreements between the principal investigator and the research institution, the federal agency, or the requesting party. The OMB further interpreted the amendment as applying only to new and continuation awards. Some parties, including the U.S. Chamber of

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Access to Research Data in the 21st Century: An Ongoing Dialogue Among Interested Parties - Report of a Workshop Commerce and Public Citizen, disagreed with this interpretation. However, the OMB did not limit the requirement to research that is supported wholly by federal funds. Even if a project has only a relatively small amount of federal funding, all data must still be produced. Notably, OMB did not require access to data produced by privately funded research, even if that research was used by a federal agency as the basis for a legal ruling. The revised guidelines received qualified praise from the research community, but some industry critics contended that the OMB construed the Shelby Amendment too narrowly. The U.S. Chamber of Commerce announced an intention to bring suit to challenge the OMB’s interpretation, but had not yet done so. Thus, the controversy and uncertainty surrounding the Shelby Amendment continues, although reportedly only a few Shelby requests had reached the agencies. Out of almost 20,000 total FOIA requests filed each year, at the time of the workshop the EPA and the NIH had each received only a handful of requests under the Shelby Amendment; of seven such requests to the NIH, the agency had granted four and denied three. The issues of access and reliability. The Shelby Amendment directs our attention to the nature of the science that supports regulation and other policy making: how it is done, who does it, and how reliable it is. Opponents of the Shelby Amendment agreed that, in principle, the more open the science, the more reliable the regulations based on it will be, and the less likely are government regulators, industry, non-profit advocacy groups, and perhaps other stakeholders to obscure the facts and distort the data to serve their interests. Thus, the announced goal of the Shelby Amendment to provide openness was appealing to both sides of the debate. Furthermore, even opponents of the amendment acknowledged that society has interests that legitimately may sometimes counter-balance researchers’ freedom to perform research and handle the data as they see fit, and that the public does deserve access to reliable facts relevant to policy making and dispute resolution. Nonetheless, some participants argued that the Shelby Amendment was too blunt and cursory to fully address an issue as complex as that of data access. One lawyer stated, “. . . many have argued, and I think persuasively, that there must be a better way to provide such access than a two-sentence amendment that simply requires that all data produced be made available under FOIA.”