THE GOVERNMENT-UNIVERSITY-INDUSTRY RESEARCH ROUNDTABLE

Openness and Secrecy in Research: Preserving Openness in a Competitive World

The Research Roundtable, sponsored by the National Academies of Sciences and of Engineering and the Institute of Medicine, was created to foster strong American science through effective working relationships among government, universities, and industry. The Research Roundtable provides a unique forum for informal dialogue among top government, university, and industry leaders of the nation’s science and technology enterprise. However, the Research Roundtable does not develop advice or recommendations on specific policies or programs within the range of responsibility of participating government officials.

The Government-University-Industry Research Roundtable seeks to identify and to illuminate issues at the forefront of the nation’s science and technology enterprise. This brochure summarizes ideas exchanged at the October 1997 Roundtable Council meeting, which examined issues of openness and secrecy in the conduct and culture of science and technology. It does not represent the views of individual participants nor a consensus view of the Roundtable Council. For information on the Roundtable, consult our home page at: http://www4.nationalacademies.org/pd/guirr.nsf

You may contact us directly via email at: GUIRR@nas.edu.

Preserving Scientific Openness in a Competitive World

“The right to search for truth implies also a duty: one must not conceal any part of what one has recognized to be true.” Albert Einstein

Progress in science in premised on the free and open exchange of uncensored information.

Research and graduate education benefit from the widest possible sharing of knowledge; openness also lends public legitimacy to a pursuit sometimes seen as the province of a remote elite. The culture of collegial exchange among scholars and investigators sets a tempo for both progress through cooperation, and for competition. It forms the foundation of a seamless transfer of ideas among generations of scientists. Still, scientists may need to withhold information in many circumstances -- to protect privacy of experimental subjects, for example, or to ensure that a finding is replicable before announcing it.

Recently, observers have noted signs of greater secretiveness among scientists. The Research Roundtable, seeking to better understand trends in scientific openness, convened a meeting to explore them. The Roundtable invited several outside speakers to join this discussion, including: David Blumenthal, Chief, Health Policies Research and Development, Massachusetts General Hospital; Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Gary Guzy, U.S. Environmental Protection Agency; Roger McClellan, President, Chemical Industry Institute of Toxicology; Douglas Hanahan, Professor of Biochemistry and Biophysiology, University of California at San Francisco; David Cox, Professor of Genetics, Stanford University; and Alan Williamson, Vice President for Research Strategy, Merck & Co.

BALANCING THE PUBLIC AND PRIVATE INTERESTS IN INFORMATION

Scientific information has great value both publicly and privately. Scientific tradition and the law of intellectual property have evolved to recognize both public and private interests: protecting trade secrets and other private value encourages entrepreneurship, while keeping the flow of information free enough to promote discovery is in the public interest. The traditions of open exchange have been challenged by changes in technology and in our economy, and by increasing collaboration between those with differing value systems. Information technology, on the one hand, makes it possible for information to flow more freely than ever, opening collaborative opportunities that were unavailable a few years ago. use. Against this backdrop, however, several other trends act to restrain scientific communication. These include the increasing intimacy of industry’s involvement in academic research, an increasingly competitive environment for research funding and career advancement, and myriad legal and regulatory concerns.

Preserving a balance between openness and proprietary control is vital. Constraining the flow of scientific information too much would retard scientific progress, making it harder to repeat or to confirm research in a timely way, and perhaps harder even to extend research in valuable new directions. Conversely, inadequate protection of intellectual property would choke off incentives for innovation and for bringing scientific results to new market.

RISING STAKES OF RESEARCH

Traditional academic research is growing more competitive as federal funding fails to match growth in the number of grant applicants and in the costs of modern research. Industry is relying more on a base of academic research. Legal and regulatory decisions of great public moment hinge increasingly on questions at the cutting edge of science. For these reasons both scientists and society as a whole have rising stakes in the recognition and use of research results. Thus there is a growing perception that the norms of research communication must be clearly defined and widely understood.

This sentiment gives rise to concerns about the erosion of scientific openness and sharing. To protect their positions in competition for funding or in the race for scientific primacy, some researchers withhold results and techniques that are of general interest and utility. Others succumb to pressure from university administrators to maximize patent royalties, or from industrial sponsors trying to protect trade secrets. Some universities and their faculty view research results increasingly as potential intellectual property that must be developed and protected, rather than freely disseminated.

Beyond anecdotal reports and preliminary surveys, there is little hard evidence about the extent of these trends. Some of them are results of the very success of research: it is no coincidence that concerns are greatest in fields -- such as biomedical science, electronics, and information technology -- that are among the most vital sources of both public and private benefits.

Secrecy to Protect Intellectual Property

Industry’s links with academe have grown stronger and more pervasive in the past decade. The private sector in many industries has come to rely on academic researchers for long-range research that it once did in-house. Industrial sponsors of academic research typically restrict publication of research results and apply other controls on information.

Universities are helping build these links as they are called upon by government to serve as agents of economic growth. The Bayh-Dole University and Small Business Patent Act of 1980, for example, allows federally sponsored researchers to retain title to patents derived from their work and encourages universities to license the patents to industry. Universities have responded by encouraging faculty to patent research results, so that both researchers and their institutions may share in licensing royalties.

The engagement of universities with industry has great benefits, but it also has risks. One risk is the demand by sponsors for undue control of information. Among today’s sources of concern are:

Publication delays. Academic researchers funded by industry typically agree to delay publication, if asked, to allow the sponsor to fill patent applications. The National Institutes of Health and other agencies generally regard a 60-day delay as acceptable (although there are no rigorous policies); surveys suggest that many agreements sanctioned by universities permit longer withholding periods.

Censorship. In rare cases, companies may take steps to impede publication of company-funded research findings, or even to block dissemination of publicly funded research results, when they consider those findings damaging to their market positions.

Nondisclosure agreements. Companies also may bar disclosure of information on their products. Suppliers of some chemicals used widely in biochemical research, for example, require users to sign nondisclosure agreements to protect information about dosages and other factors from competitors. These demands could force researchers to withhold information they know could have a direct and profound impact on public health, yet some researchers sign them without protest.

Patent Protection and the Licensing of Research Tools

When secrecy affects widely used basic tools of research, it raises stronger objections than when it involves the results of research. Increasingly, biological research tools and techniques are being patented or otherwise protected. Some of the licensees of the patents have imposed sweeping controls on the use of these tools, including “reach-through” provisions that claim rights to all future inventions made with the use of the tools, veto rights on licensing of subsequent investigations, and other forms of encumbrance.

Many scientists believe that applying patents to research tools (as distinguished from research results) is inherently unwise, since it places “tollbooths” in the path of science and lowers incentives to innovate. Others believe that patent protection should be reserved for technologies, and not permitted for discoveries about nature. But distinguishing a tool from a research result, or a discovery from a technology, is not a trivial problem scientifically, legally, or philosophically.

Though they have never been tested in court, some have questioned the legality of reach-through agreements themselves, contending that this is a use of patent licenses for restraint of trade. There is more common concern about the wisdom of entering into such agreements, and fear that academic institutions or individual investigators are signing such agreements without considering their full ramifications.

Secrecy in the Competition for Research Primacy

Some believe researchers themselves have grown more likely to withhold information and materials from one another. Career pressures are rising, and the race to achieve breakthroughs has grown ever more intense. Several celebrated cases of highly productive scientists who resisted sharing research materials and results with colleagues have led some to conclude that the traditional ethic of cooperation in science is being degraded.

Most agree that an investigator may have legitimate reasons to withhold raw data for some reasonable period of time, in order to digest, explore, and confirm data. In many fields, investigators put considerable time and effort into creating data bases, and they need time -- even years -- to explore and to analyze that information and to prepare publications. In such cases, premature public release of such information could deprive researchers of the benefits of their own labor.

OPENNESS AND THE REGULATORY TRADITIONS OF GOVERNMENT

Health and environmental regulations often hinge on the empirical results of scientific inquiry, and questions about public access to the science behind government regulations have sparked controversy. Typically, regulators notify the public of scientific studies underlying proposed new regulations; this lays the foundation for consensus by securing agreement about the underlying facts. If the facts themselves are disputed, however, regulators labor under a handicap in establishing public credibility.

The Environmental Protection Agency’s announcement of standards on small airborne particulates (soot), issued in July 1997, is an illustration of the importance of the empirical foundation of the federal regulatory process. The new standards-–based largely on epidemiological studies correlating death rates with levels of tiny particulates in several middle-sized cities–drew protests from those who believe they are not scientifically justified. Opponents called for disclosure of the detailed underlying data.

The EPA had based its analysis on studies published in the peer reviewed literature; its assessment of these studies and of their scientific information was itself peer reviewed by an external scientific advisory panel. To further address the concerns of critics, however, EPA wrote to the original investigators and asked that they make the raw data available to interested parties. The research team indicated their willingness to do so to qualified researchers but not to the general public, arguing that this was essential to protect patient privacy rights. This decision ignited controversy in the media, and further calls by Congress and others to release the underlying data. Partly as a result, the EPA has committed to conducting a full scientific review of available data within five years.

Achieving a wise balance of public and private interests in such a case is difficult. Clearly, complex statistical studies can be subject to various interpretations and deserve the widest possible scrutiny to justify costly regulations. Can traditional peer review be relied on in such cases to ensure credibility and consensus? Should parties with stakes in the outcomes of regulatory decisions, such as industry, be accorded greater access in planning the research underlying those decisions? Can the scientific community devise a credible test to determine when a substantial portion of those in the field agree that an interpretation of an observed phenomenon is “at least likely” to be correct? Are these sufficient approaches to government regulation?

SHAPING FLEXIBLE POLICIES AND STANDARDS OF OPEN EXCHANGE

The tradition of openness in science is evolving in response to changes in government roles, markets for technology, and intellectual property law and practices (such as university use of the Bayh-Dole Act). There is no algorithm for determining the balance of public and private good, and traditional assumptions and arrangements will not always prevail. Efforts must be made to develop information practices that suit today’s circumstances, and all stakeholders should be involved in this process.

Certainly, universities are on the front lines of any response: their technology transfer policies need to acknowledge both commercial pressures and the traditions of open research and graduate education. Their officers need to be creative and flexible when tensions arise between interested parties in a commercialization approach. Research funding agencies, too, will need to develop and promulgate policies on a broad front to provide safeguards for the public’s interests -- including recognition of government support of the underlying research -- while still allowing entrepreneurial energy to drive rapid application of new discoveries. Some legislative action may be appropriate, but few call for immediate Congressional intervention. The impacts of the Bayh-Dole Act could perhaps be reviewed, and the reach of patent protection to scientific findings and techniques might be reconsidered.

Ultimately, though, no single standard, protocol, or policy can be flexible enough–or rigorously enough enforced–to meet the needs of all parties, in all cases. The answers in many cases will be up to individuals. Graduate students must receive adequate training in the ethical and legal challenges that they will face in their careers, and working scientists must acknowledge that their private privilege to seek the truth implies a personal duty to serve a broader public interest.

FURTHER READING

Blumenthal, David, Eric G. Campbell, Melissa S. Anderson, Nancyanne Causino, and Karen Seashore Louis, Withholding research results in academic life science: Evidence from a National Survey of Faculty. Journal of the American Medical Association, vol. 277, no. 15 (Apr. 16, 1997), pp. 1224–1228..

Cohen, Jon, Share and share alike isn’t always the rule in science: American Association for the Advancement of Science, Conduct in Science Research Materials.

Kaiser, Jocelyn, Showdown over clean air science: Science, vol. 276 (July 25, 1997) pp. 466–469.

Marshall, Eliot, The mouse that prompted a roar, Science, vol. 277 ( July 4, 1997), pp. 24–25.
National Research Council, Resource Sharing in Biomedical Research. Washington, D.C.: National Academy Press, 1996.

Government-University-Industry Research Roundtable: Background and Purpose

The Government-University-Industry Research Roundtable was created just over a decade ago to provide a forum for dialogue on science and technology issues among top government, university, and industry leaders. The purpose is to facilitate working relationships and the exchange of ideas about emerging trends, problems, and promising opportunities facing those charged with developing and deploying scientific resources.

The Roundtable also seeks to stimulate new approaches to issues by disseminating the product of its deliberations, and by actively fostering contact and collaboration with other organizations able to build further on the ideas developed.

The Roundtable is sponsored by the National Academies of Sciences and of Engineering and the Institute of Medicine.

Funding

Core financial support for the Roundtable comes from federal R&D agencies and from our university-industry partnerships. Supplemental funding for specific activities comes from foundations, states, and other sources.

The Roundtable Council

Members

RICHARD F. CELESTE, Roundtable Chairman; Former Governor, State of Ohio; and Partner, Celeste and Sabety, Ltd.

BRUCE ALBERTS, ex officio, President, National Academy of Sciences

D. JAMES BAKER, Under Secretary for Oceans & Atmosphere, U.S. Department of Commerce

EVAN BAYH, Former Governor, Indiana; Law Firm of Baker and Daniels

ROBERT BERDAHL, Chancellor, University of California, Berkeley

JEAN BONNEY, Director of Education\Research Business, Digital Equipment Corporation

CAROL M. BROWNER, Administrator, U.S. Environmental Protection Agency

LYNN CONWAY, Professor of Electrical Engineering and Computer Science; Director UMTV Demonstration Project, The University of Michigan

MORTIMER L. DOWNEY, Deputy Secretary, U.S. Department of Transportation

ROBERT V. EDWARDS, Chairman Computer Sciences and Engineering, Case Western Reserve University

BRAN FERREN, Executive Vice President, Creative Technology, Walt Disney Imagineering

CHARLES GESCHKE, President, Adobe Systems Incorporated

JACK GIBBONS, President’s Science Advisor; Director, Office of Science and Technology Policy, Executive Office of the President

DANIEL GOLDIN, Administrator, National Aeronautics and Space Administration

I. MILEY GONZALEZ, Under Secretary for Research, Education and Economics, U.S. Department of Agriculture

STEVEN JAY GOULD, Professor of Geology and Zoology, Museum of Comparative Zoology, Harvard University

ROBERT HEBNER, Acting Director, National Institute of Standards and Technology, U.S. Department of Commerce

FREEMAN A. HRABOWSKI, President, University of Maryland Baltimore County

BOBBY R. INMAN, Admiral (Retired), U.S. Navy

DEAN KAMEN, President, DEKA Research and Development Corporation

MARTHA KREBS, Director, Office of Energy Research, U.S. Department of Energy

NEAL LANE, Director, National Science Foundation

JAMES MCGRODDY, Vice President (Retired), IBM, Advanced Network & Services, Inc.

MAYNARD V. OLSON, Professor, Department of Molecular Biotechnology, University of Washington

KENNETH SHINE, ex officio, President, Institute of Medicine

WILLIAM J. SPENCER, President and Chief Executive Officer, Sematech

DANIEL VAPNEK, Senior Vice President, Research and Development, Amgen

HAROLD VARMUS, Director, National Institutes of Health

WILLIAM WULF, ex officio, Interim President, National Academy of Engineering

JOE B. WYATT, Chancellor, Vanderbilt University

ED ZSCHAU, Senior Lecturer of Business Administration, Harvard University

Roundtable Staff

Thomas A. Moss, Executive Director

Allison A. Rosenberg, Associate Executive Director

Anne-Marie Mazza, Senior Program Officer

Wanda London, Research Associate

McAlister Clabaugh, Project Assistant