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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the panel responsible for the report were chosen for their special competences and with regard for appropriate balance.
This project was supported by the Robert Wood Johnson Foundation, the U.S. Environmental Protection Agency, the National Academies Endowment Fund, and the Warren L. and Eloise Batts Family Fund. Any opinions, findings, conclusions, or recommendations expressed in this report are those of the authors(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.
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THE NATIONAL ACADEMIES
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chairman and vice chairman, respectively, of the National Research Council.
SCIENCE, TECHNOLOGY, AND LAW PANEL
DONALD KENNEDY, Cochair (NAS/IOM), Editor-in-Chief, Science, and Bing Professor of Environmental Studies and Co-director,
Center for Environmental Science and Policy, Institute for International Studies, Stanford University; President Emeritus of Stanford University, Palo Alto, Calif.
RICHARD A. MERRILL, Cochair (IOM), Daniel Caplin Professor of Law and Sullivan & Cromwell Research Professor of Law,
University of Virginia Law School, Charlottesville, Va.
FREDERICK R. ANDERSON, Partner,
Cadwalader, Wickersham & Taft, Washington, D.C.
MARGARET A. BERGER, Suzanne J. and Norman Miles Professor of Law,
Brooklyn Law School, Brooklyn, N.Y.
PAUL D. CARRINGTON, Harry R. Chadwick Senior Professor,
Duke University Law School, Durham, N.C.
JOE S. CECIL, Project Director,
Program on Scientific and Technical Evidence, Division of Research, Federal Judicial Center, Washington, D.C.
JOEL E. COHEN, (NAS), Abby Rockefeller Mauze Professor and Head,
Laboratory of Populations, The Rockefeller University and Professor of Populations, Columbia University, New York, N.Y.
REBECCA S. EISENBERG, Professor of Law,
University of Michigan Law School, Ann Arbor, Mich.
DAVID L. GOODSTEIN, Vice Provost and Professor of Physics and Applied Physics,
California Institute of Technology, Pasadena, Calif.
BARBARA S. HULKA, (IOM), Kenan Professor,
Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill, N.C.
SHEILA JASANOFF, Professor of Science and Public Policy
at Harvard University’s John F. Kennedy School of Government and the School of Public Health, Cambridge, Mass.
ROBERT KAHN, (NAE), Chairman, CEO, and President of the Corporation for National Research Initiatives,
DANIEL J. KEVLES, Stanley Woodward Professor of History,
Yale University, New Haven, Conn.
DAVID KORN, (IOM), Senior Vice President for Biomedical and Health Sciences Research,
Association of American Medical Colleges, Washington, D.C.
ERIC S. LANDER, (NAS/IOM), Member,
Whitehead Institute for Biomedical Research,
Professor of Biology, MIT, Director,
Whitehead Institute/MIT Center for Genome Research, and Geneticist, Massachusetts General Hospital, Massachusetts Institute of Technology, Cambridge, Mass.
PATRICK A. MALONE, Partner,
Stein, Mitchell & Mezines, Washington, D.C.
RICHARD A. MESERVE, Chairman,
Nuclear Regulatory Commission, Washington, D.C.
ALAN B. MORRISON, Director,
Public Citizen Litigation Group, Washington, D.C.
HARRY J. PEARCE, Chairman,
Hughes Electronics Corporation, El Segundo, Calif.
HENRY PETROSKI, (NAE), A.S. Vesic Professor of Civil Engineering and Professor of History,
Duke University, Durham, N.C.
CHANNING R. ROBERTSON, Ruth G. and William K. Bowes Professor, School of Engineering, and Professor,
Department of Chemical Engineering, Stanford University, Palo Alto, Calif.
PAMELA ANN RYMER, Circuit Judge,
U.S. Court of Appeals for the Ninth Circuit, Pasadena, Calif.
STAFF OF THE SCIENCE, TECHNOLOGY, AND LAW PROGRAM
ANNE-MARIE MAZZA, Director
SUSIE BACHTEL, Staff Associate
KIRSTEN A. MOFFATT, Christine Mizrayan Intern
ALAN H. ANDERSON, Consultant
In 1997, the Environmental Protection Agency (EPA) announced new regulatory standards for airborne particulate matter. These standards were based in large part upon two bodies of scientific evidence. The first was a series of epidemiological studies led by John Dockery of the Harvard School of Public Health that tracked approximately 8,000 individuals from six mid-size cities over a period of 20 years (referred to generally as the Harvard Six Cities Study). Numerous peer-reviewed papers and presentations resulted from these studies. The second was an epidemiological study led by C. Arden Pope of Brigham Young University that reviewed a large body of data of the American Cancer Society (ACS). Both studies showed a correlation between levels of airborne particulate matter and death rates. In developing the standards, the EPA undertook its own assessment of these studies and oversaw peer review of the results by the external Scientific Advisory Board.
EPA then developed proposed new regulatory standards that would limit the release of airborne particulates. Critics of the proposed standards claimed that implementing the new standards would be unreasonably costly, with estimates reaching billions of dollars. They argued further that the standards were not scientifically justified, and they called for access to all of the underlying data so that the results could be verified by other scientists. The Harvard researchers, who had been funded by the National Institutes of Health (NIH) and not the EPA, declined to provide the underlying data. They took this position in large part because of their concern that releasing all data would violate the privacy agreements they
had made with the patients who participated in the study as part of the informed consent process. However, Harvard did indicate a willingness to provide the data to other qualified researchers for confidential analysis and requested that the Health Effects Institute (HEI) conduct an independent review of the data.
The researchers’ refusal to make all their data available led to calls from Congress, industry, and others, requesting access to the data, and was one of the causes of the enactment of a rider, known as the Shelby Amendment, that was attached to the Omnibus Appropriations Act for FY1999, P.L. 105-277. The rider directed the Office of Management and Budget (OMB) to amend Circular A-110 so as to require federal 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 (FOIA).”1 The amendment itself was not discussed in public hearings, however, so that it has virtually no legislative history.2
Enactment of the Shelby Amendment caused a stir in the academic research community as well as among other groups. The academic community, including The National Academies, raised a number of issues and objections: (1) What are data? (2) How will the privacy of human research subjects and the confidentiality of trade secrets that might one day be patentable or publishable be protected? (3) Who will bear the costs? (4) How will agencies handle research data generated with funding from both federal and non-federal sources? (5) How will researchers be protected from groups that try to gain access to data as a way to harass investigators and their institutions in order to hinder or deter the pursuit of specific research topics? and (6) Is FOIA the appropriate mechanism for providing public access to large bodies of complex research information? Defenders of the Shelby Amendment argued that it provided the public with both accountability (taxpayers fund the research—therefore they should be able to see its basis) and transparency (the public should be able to review research data produced with federal funds that is used to support regulatory decisions that affect the public).
The OMB issued proposed revisions to Circular A-110 in February
and August 1999, and issued final revisions in September 1999. The revisions took effect on November 8, 1999. Two years later agencies are still in the process of developing their implementation strategies.
In the years since the Shelby Amendment, scientists, industry, and policy makers have struggled over how the public’s new right of access should be applied to scientific data. There is loose agreement that research data should be accessible, but wide disagreement over the “depth” to which the public has such a right. There is now a new level of demand for data, as more stakeholders claim the right to challenge the basic science that supports regulatory decisions.
The National Academies’ Science, Technology, and Law Program held a one-day workshop to explore the mounting tensions in the federal regulatory process between the need to provide access to research data and the need to protect the integrity of the research process. The workshop provided a picture of the debate arising from passage of the Shelby Amendment and the resulting OMB revisions of Circular A-110. It also took a broad look at the competing interests seeking access to research data by providing various groups with an opportunity to voice their views on public access to research data. In addition, the workshop explored alternative approaches that might be used to improve public access to research data.
The goal of the workshop was not to reach conclusions or recommendations; nor could it address other pressing issues beyond the regulatory process, such as protection of intellectual property, the influence of broader access on scientific competition, the potential for increased administrative burdens and changes in the research process, and the challenge of providing data access in an increasingly electronic world. The STL Panel may address some of these issues in the future. For the present, this report attempts to be faithful to the workshop’s original goal of airing all viewpoints from both legal and scientific leaders. It summarizes the proceedings and organizes them by topic, without drawing conclusions or making recommendations.
The Science, Technology, and Law Panel acknowledges the many fine contributions of the speakers attending this workshop. We especially wish to thank
Bruce Alberts, President, National Academy of Sciences
Frederick R. Anderson, Jr., Partner, Cadwalader, Wickersham & Taft
Wendy Baldwin, Deputy Director for Extramural Research, National Institutes of Health
Joel Cohen, Abby Rockefeller Mauze Professor and Head, Laboratory of Populations, The Rockefeller University and Professor of Populations, Columbia University
E. William Colglazier, Executive Officer, National Research Council
Douglas W. Dockery, Professor of Environmental Epidemiology and Professor of Medicine, Department of Environmental Health, Harvard Medical School
William H. Farland, Acting Deputy Assistant Administrator for Science, Office of Research and Development, U.S. Environmental Protection Agency
Steven Goodman, Associate Professor, Department of Biostatistics, The Johns Hopkins University
Kenneth W. Harris, Acting Director, Research Data Center, National Center for Health Statistics
David G. Hawkins, Director, Air and Energy Program, Natural Resources Defense Council
David Korn, Senior Vice President for Biomedical and Health Sciences Research, American Association of Medical Colleges
William L. Kovacs, Vice President, Environment, Technology, and Regulatory Affairs, U.S. Chamber of Commerce
Barry S. Kramer, Director, Office of Medical Applications of Research, National Institutes of Health
Alan Morrison, Director, Public Citizen Litigation Group
Robert O’Keefe, Vice President, Health Effects Institute
Jim J. Tozzi, Member, Board of Advisors, Center for Regulatory Effectiveness
The Honorable Jack B. Weinstein, Senior Judge, United States District Court for the Eastern District of New York
This workshop report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for quality, objectivity, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report: Cynthia M. Beall, Case Western University; Martin Blume, American Physical Society; Anita K. Jones, University of Virginia; Sylvia K. Kraemer, National Aeronautics and Space Administration; Norine E. Noonan, National Space Science and Technology Center; Sheldon L. Trubatch, Foley & Lardner; and Patrick Windham, Independent Consultant.
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the content of the report, nor did they see the final draft before its release. The review of this report was overseen by Robert M. Hauser, University of Wisconsin-Madison, and R. Stephen Berry, University of Chicago. Appointed by the National Research Council, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring panel and the institution.
We wish to thank the staff of the STL Progam: Anne-Marie Mazza, Susie Bachtel, Kirsten Moffatt, and consultant writer, Alan Anderson.
Donald Kennedy and Richard Merrill