FINDING THE PATH

Issues of Access to Research Resources

Summary of a Conference Held at the National Academy of Sciences January 27–28, 1999

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.



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FINDING THE PATH: Issues of Access to Research Resources FINDING THE PATH Issues of Access to Research Resources Summary of a Conference Held at the National Academy of Sciences January 27–28, 1999 Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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FINDING THE PATH: Issues of Access to Research Resources NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C.20418 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 committee responsible for the report were chosen for their special competences and with regard for appropriate balance. 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 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. William 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, 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. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council. This study was supported by Grant No. DBI-9819600 between the National Academy of Sciences and the National Science Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-06625-5 Additional copies of this report are available from the Commission on Life Sciences, Rm. 353, 2101 Constitution Avenue, N.W., Washington, D.C. 20418; (202) 334-1238; fax (202) 334-1687 Copyright 1999 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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FINDING THE PATH: Issues of Access to Research Resources CONFERENCE ADVISORY COMMITTEE DAVID J. GALAS, (Chairman), Keck Graduate Institute of Applied Life Science, Claremont, CA PAUL BERG, Stanford University, Stanford, CA DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, CA ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena, CA RONALD R. SEDEROFF, North Carolina State University, Raleigh, NC SHIRLEY M. TILGHMAN, Princeton University, Princeton, NJ Science Writer ROBERT POOL, Arlington, Virginia NRC Staff ROBERTA SCHOEN, Project Officer JENNIFER KUZMA, Staff Officer MIMI ANDERSON, Project Assistant ANNE POND, Program Assistant MARK RIVERA, Intern NORMAN GROSSBLATT, Editor

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FINDING THE PATH: Issues of Access to Research Resources COMMISSION ON LIFE SCIENCES MICHAEL T. CLEGG, (Chairman), University of California, Riverside, CA PAUL BERG, Stanford University, Stanford, CA FREDERICK R. ANDERSON, Cadwalader, Wickersham, & Taft, Washington, DC JOHN C. BAILAR III, University of Chicago, Chicago, IL JOANNA BURGER, Rutgers University, Piscataway, NJ SHARON L. DUNWOODY, University of Wisconsin, Madison, WI DAVID EISENBERG, University of California, Los Angeles, CA JOHN L. EMMERSON, Eli Lilly and Co. (ret.), Indianapolis, IN NEAL L. FIRST, University of Wisconsin, Madison, WI DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, CA DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, CA ARTHURO GOMEZ-POMPA, University of California, Riverside, CA COREY S. GOODMAN, University of California, Berkeley, CA HENRY W. HEIKKINEN, University of Northern Colorado, Greeley, CO BARBARA S. HULKA, University of North Carolina, Chapel Hill, NC HANS J. KENDE, Michigan State University, East Lansing, MI CYNTHIA J. KENYON, University of California, San Francisco, CA BRUCE R. LEVIN, Emory University, Atlanta, GA OLGA F. LINARES, Smithsonian Tropical Research Institute, Miami, FL DAVID M. LIVINGSTON, Dana-Farber Cancer Institute, Boston, MA DONALD R. MATTISON, March of Dimes, White Plains, NY ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena, CA ROBERT T. PAINE, University of Washington, Seattle, WA RONALD R. SEDEROFF, North Carolina State University, Raleigh, NC ROBERT R. SOKAL, State University of New York, Stony Brook, NY CHARLES F. STEVENS, The Salk Institute for Biological Sciences, La Jolla, CA SHIRLEY M. TILGHMAN, Princeton University, Princeton, NJ JOHN L. VANDEBERG, Southwest Foundation for Biomedical Research, San Antonio, TX RAYMOND L. WHITE, University of Utah, Salt Lake City, UT Staff WARREN MUIR, Executive Director

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FINDING THE PATH: Issues of Access to Research Resources Priority Issues of Access to Research Resources A Letter Report from the Commission on Life Sciences Advancement of scientific research in the life sciences is possible only with access to physical, biologic, and information resources. Such resources include plant and animal tissues, microbial cultures, monoclonal antibodies, reagents, animal models, combinatorial chemistry and DNA libraries, drug targets, clones and cloning tools, methods, laboratory equipment, databases, and software. Nearly every field of biology is experiencing problems in the transfer of research resources among members of its research community. While science continues to bring forth research resources of great potential, their dissemination often gets bogged down in issues of ownership, equity, availability, cost, appropriate use, value, and maintenance. Many of those issues were aired on January 27-28, 1999, at the National Research Council's conference “Finding the Path: Issues of Access to Research Resources ”. Sponsored by the Subcommittee on Biotechnology of the National Science and Technology Council's Science Committee, the conference convened over 300 participants from academe, government, and industry to discuss research-resource issues that affect numerous scientific disciplines. The purpose of the conference was to identify common issues and to place the challenge of access to research resources in a larger frame of reference—the entire scientific enterprise, but not to reach consensus on solutions to these challenges. A summary of the conference is published in this volume. In March 1999, the Commission on Life Sciences met to discuss the issues further. We observed that many of the problems raised at the conference are important to the health and future of the scientific enterprise and the effective application of science. Some of the problems are not fundamentally difficult to overcome but will require the collective thought, organization, and

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FINDING THE PATH: Issues of Access to Research Resources consensus of members of the scientific disciplines affected. Others are much more difficult and will require new approaches. At the request of Dr. Mary Clutter, Chairman of the Subcommittee on Biotechnology, the Commission has identified priorities from among the issues raised in the conference summary. Based on that document and the collective experience of the Commission in the life sciences, we believe the following issues are particularly important and require attention by the federal government, and in some cases, by various sectors of the scientific community. Policies on the patenting of biological materials. Material transfer agreements and licensing. International material transfer. Database development and use. Access to data in the private sector. This is not necessarily a comprehensive list of all the important issues of access to research resources. Indeed, all the issues raised at the January conference were important. We believe these issues are priorities because they affect research across the full spectrum of subdisciplines in the life sciences, and because they impact scientists in academe, government, and industry. International material transfer is included as a subclass of material transfer agreements with slightly different dimensions that warrant a separate discussion. In the near term, the issues of patent policies, material transfer agreements, and access to privately held data are the most time-critical, and should be addressed sooner rather than later, because proposing and adopting solutions to them now is likely to have the greatest chance of success. Stakeholders involved in these problems are beginning to take actions—defensive patenting, excessive demands in exchange for access, increasing use of trade secrets—that will be difficult to reverse and that will have lasting effects on scientific progress. The life sciences are in a revolutionary period of discovery, so identifying research resources and barriers to their development and dissemination should be a continuing part of the management of our scientific enterprise in the long term. The variety of barriers —in such forms as the high cost of a single piece of equipment, a bottleneck in software distribution, and competitive secrecy—requires constant monitoring and creative response. This effort must be the shared responsibility of the federal government, the academic scientific community, and corporations. Policies on the Patenting of Biologic Materials In the relatively new, rapidly unfolding field of biotechnology, scientists and companies have envisioned future products of gene research for human health, agriculture, and many other fields. The realization of these products will depend, in part, on the accumulation of knowledge about the

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FINDING THE PATH: Issues of Access to Research Resources functioning of a genome as a whole; this collective effort is proceeding quickly in the public and private sectors. As the sequencing of the human genome and the genomes of plants and other organisms are completed, there is a danger that the intellectual property rights afforded to new genetic constructs will be so broadly drawn that future scientific investigation and commercial development will be inhibited. Since the Supreme Court opened the door to the patenting of genetically modified organisms in 1980, patenting has accelerated commercial development and complemented the progress of basic research in genetics. Recently, however, the award of broad proprietary rights to a new category of DNA sequences has had a dampening effect on academia and industry. In 1999, the first patent on an expressed sequence tag (EST) was issued. ESTs are small pieces of DNA that are part of complete, but as yet uncharacterized genes. Such gene fragments are potentially valuable research tools: they are used as probes and markers in the genomes of humans and other organisms. There is concern that the scope of the patents will be so broad as to interfere with basic research on the function of genes that are associated with a patented EST. In addition, the number of ESTs that might be eligible for patenting is potentially in the hundreds of thousands. When companies began to identify huge numbers of ESTs mechanically and to apply for patents on them, the US Patent and Trademark Office found it necessary to issue a policy to limit the number of ESTs per application to 10. The award of the first EST patent is fueling speculation about the possibility that patents will be sought on other types of genetic information, such as single-nucleotide polymorphisms (SNPs), which are variations in DNA that provide insight into the genetic basis of disease, among other things. Many research scientists, particularly those in the academic community, consider SNPs to be research tools; like ESTs, SNPs are being identified rapidly and methodically in the genome. The question of what scope of intellectual property rights protection best balances the public interest in creating, stimulating, and rewarding invention with the needs of the scientific community for access to research resources is urgent and important. When scientific material or information qualifies as the “door” through which all research must pass, its encumbrance by intellectual property rights, such as patents, has the potential to inhibit advances in a field. Moreover, applications to patent ever-smaller pieces of the genomes of a wide variety of plants and animals are pouring into the Patent and Trademark Office. If rapid progress in basic science and commercial development is to be fostered, protection of intellectual property should be carefully applied. A balance of interests is necessary between the stimulation of research and innovation through the open exchange of research resources and the promotion of innovation and commercialization of new technologies through patenting.

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FINDING THE PATH: Issues of Access to Research Resources Such a balance in the life-science context might or might not be consistent with the legal interpretation and implementation of existing patent law. Recommendation: An analysis of the potential effects of different types of patent protection and the breadth of patent rights on basic research and commercial interests in the life sciences should be undertaken, taking into account societal goals in granting intellectual property rights. Priority should be placed on examining options for protecting inventions that contain nucleic acid sequences, before forthcoming decisions on patents of biologics set precedents that make consideration of alternatives difficult. Material Transfer Agreements and Licensing Research scientists have a long tradition of sharing research findings and experimental materials with one another in the interests of collegiality and furthering the scientific research enterprise. However, since the 1980 enactment of the Bayh-Dole Act to foster technology transfer, nonprofit organizations like universities have been obliged to promote the utilization, commercialization, and public availability of inventions that arise from their federally funded research. As a financial incentive, they are permitted to seek and hold rights to the intellectual property embodied in inventions made with public funding. Research resources, including those described in the scientific literature, are disseminated to interested investigators or organizations through direct transfer or via a third party, usually a licensee that produces and sells the resources to others. These transfers are typically accompanied by material transfer agreements or licensing agreements that are negotiated by the technology transfer offices of the transferring and receiving institutions. As a result, what was formerly a free, open, and rapid exchange of research resources has become an often uncertain, restricted exchange that is subject to protracted negotiations. Most research resources are innovations of value for scientific investigation, and some have the potential for commercial uses beyond research. By attempting to protect an institution's future financial and other interests in a biologic research resource, the above negotiations can hinder the pace at which the resources are available for use in research. University research faculty's attempts to acquire materials from other academic institutions are hindered by the material transfer process, which requires agreement to assurances that are difficult to monitor in any case, and university officials have not yet resolved these issues. Faculty attempts to acquire access to resources owned by business organizations can be especially thorny, because commercial operations are bound to the interests of investors, not to the public good. Time-consuming negotiations over access to proprietary research resources are detrimental to academic research, but a private firm cannot usually accept a no-strings agreement. If industry and academe have a compelling interest in sharing their

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FINDING THE PATH: Issues of Access to Research Resources resources, a genuine effort to develop a mutually recognized and accepted set of minimum requirements could help to expedite future negotiations on research resources. Tensions that arise during the transfer of research resources can be attributed, in part, to the financial incentives provided to universities by the Bayh-Dole Act. By exercising their right to patent and license their inventions, including research resources, universities generate income for themselves and their researchers. As potential sellers of innovations in the marketplace, however, universities can be viewed as commercial competitors by the business sector—the same business sector whose research resources are sought “without strings” by federally funded, university investigators. The image of the university as a player in the commercial world, and therefore one with which private resources cannot be freely shared, is strengthened by the increasing number of university partnerships with individual companies that often compete with each other. Finally, as recognized in the National Institutes of Health (NIH) proposed principles and guidelines for sharing biomedical research resources, the financial incentive provided by the Bayh-Dole Act can work against its own objectives and inhibit the dissemination of research resources when universities inappropriately capitalize on the value of a resource. The guidelines note that “restrictive licensing, especially when coupled with indiscriminate use of the patent system, can be antithetical to the goals of the Bayh-Dole Act, such as where these are employed primarily for financial gain ” and add that such practices “are likely to thwart, rather than promote utilization and public availability of the invention.” The principles and guidelines proposed by NIH seem to be a constructive step in the right direction. The principles emphasize academic freedom and publication, the appropriate treatment of research tools under the Bayh-Dole Act, and the need to minimize administrative impediments to the transfer of research resources. They also exhort institutions to be mindful of potential conflicts between their obligations to NIH and to other parties that provide research resources, and to establish clear and unyielding policies on acceptable conditions for importing research resources. The guidelines provide specific examples of appropriate language for agreements that accompany the transfer of research materials into and out of universities. If implemented, they could speed the development of material transfer agreements and add certainty to the outcome of such agreements. A copy of the proposed principles and guidelines can be found at http://www.nih.gov/od/ott/RTguide.htm. Recommendations: All federal agencies should examine the proposed NIH principles and guidelines and participate in the development of strong and consistent policies across the federal government on acceptable terms for transferring and accepting research resources.

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FINDING THE PATH: Issues of Access to Research Resources University recipients of federal funds should develop, with input from scientific faculty and university leadership, policies for the identification, valuation, and dissemination of research resources. Business concerns should recognize their long-term interests in supporting scientific progress and work with universities to determine basic terms of agreement for sharing resources. An independent and balanced review of the extent to which the financial incentives created by the Bayh-Dole Act affect, favorably and unfavorably, the technology transfer process and the conduct of science should be carried out, taking into consideration the purpose of the Act and the different values and interests of stakeholders involved in and affected by the process. International Material Transfer At the international level, an issue of concern to scientists who study different aspects of the life sciences is the increasing difficulty of gaining access to wild materials, especially from the tropics, where most of the world's biologic resources exist. The Convention on Biological Diversity, to which many developing countries in the tropics are signatories, recognizes the rights of nations to control access to and to participate in the use of biodiversity resources, particularly the commercial exploitation of native germplasm or local knowledge. Restrictions on exploration of, collection of, and access to information on wild resources have become common, and they affect not only the field work of US scientists, but also the work of local scientists and research institutions. In many nations, there is no clear differentiation between the collection of biologic materials and information for academic purposes and for commercial applications. As a result, every research project (ecologic, systematic, ethnobiologic) is treated as a potential “bioprospecting” agreement. The US government has sponsored research aimed at involving biodiversity-rich countries in the development of commercial applications derived from native resources, but its ability to negotiate access to biodiversity resources for academic research is inhibited by the fact that the United States is not a signatory to the convention. The creation of joint, basic research programs in which resources can be shared through material transfer agreements that appropriately restrict their distribution or the scope of their application is one approach to this problem. The joint development of mechanisms to document germplasm and other information so that its appropriate and legitimate use can be traced is another. Recommendation: The federal government should seek discussion with other countries' science agencies to find appropriate terms, which could be applied generally, for the transfer of biodiversity materials for academic research.

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FINDING THE PATH: Issues of Access to Research Resources Database Development and Use Databases are increasingly critical as research resources, not only for geneticists and molecular biologists, but also for computational and structural biologists, chemists, ecologists, anthropologists, zoologists, botanists, crystallographers, social scientists, and people in many other disciplines. The contents of such databases are as varied as information about rare resources (such as museum and biodiversity specimens and culture collections), DNA sequences, and sensitive identifiers of human subjects. Computer-accessible databases are in increasing demand by researchers of all types. New scientific discoveries are often based on previously published findings, but data in many fields can be generated so quickly that data “mining” and reanalysis are often as important for the advancement of scientific understanding as data collection in the next experiment. In pharmacology and ecology and in academe, government, and business, the pace of advancement in the life sciences will depend in many ways on access to existing databases as much as the generation of new data. Indeed, a new and exciting field of scientific inquiry has developed: bioinformatics—the use of computers to manipulate biologic information. With software that permits investigators to query databases in flexible and creative ways, bioinformatics facilitates the rapid and expansive analysis of data. The development of bioinformatics will be a key to using databases fully in the future. If databases constitute a major leap forward in how scientific information can be viewed and analyzed, new strategies to embrace and take advantage of this power are warranted. Establishing and getting the most out of databases will require investment in the following: Their conceptual and physical development Data-quality assurance Data acquisition and maintenance The software needed to operate them. If a database is to be of maximal value, its potential uses must be reflected in its design. For example, databases need structure and consistency in the variables to be used for sorting or compiling. Inconsistencies in nomenclature (such as species name, symptom, and pathologic condition) make it difficult to analyze large databases that use such characteristics. Even numbers, dates, and geographic locations must be consistent in a database if its utility is to be maximized. Such structure and consistency must be incorporated into the database from the start. The data quality and quality assurance needed for a database depend on the nature of the analyses being performed. For example, trying to match billions of fragments of DNA to elucidate the human genome requires that there be very few errors in the data. But a few misidentifications of individual

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FINDING THE PATH: Issues of Access to Research Resources members of fairly common species in a regional database are likely not to affect studies of ecosystem health. To determine the most useful structure and format of a database, and to establish mechanisms for quality assurance or peer review, potential data contributors and users should be involved in database design. Often it takes a dedicated effort to obtain, via experimentation or monitoring, data with the structure and consistency required by the design of the database, so the community should determine how credit should be assigned to data contributors and whether they have any rights to the use of the data, once deposited. Similarly, rules for the appropriate use of data need to be established, especially to protect sensitive information and personal privacy related to data on human subjects. The value of a database will also be determined by the nature and extent of the data that it contains. Once a database is created, considerable effort is often needed to maintain it through curation and the addition of data, provision of user support, and the development of software updates. Finally, being able to glean knowledge from databases requires analytic software. Indeed, the field of bioinformatics involves the development of many sophisticated analytic software tools. Recommendations: Databases and the bioinformatics tools needed to analyze them offer an opportunity to gain new insights in the life-sciences and should be considered for increased government and private support. Before a database is established, data acquisition and maintenance, user support, quality assurance, and analytic software development needs should be carefully considered. Access to Data in the Private Sector Many important databases are being developed by private organizations, especially in the business sector. These databases are often held confidentially and are not available to other scientists except through individual arrangements, some of which restrict investigators' ability to share the results of later work freely; confidentiality is intended to keep competing commercial interests from exploiting investments made in creating the data. Because of the strong tradition of federal support of the collection and distribution of basic scientific information, access to proprietary data has not been a major issue for publicly funded scientists in the past. But in fields in which scientific and commercial interests overlap, the relevance and importance of the data to new breakthroughs is increasing. Thus, there is a tension between the scientific researchers ' need for access to databases and the private database owners' need for confidentiality. That tension is evident in the development of DNA-sequence databases, in which both the nonprofit and business sectors have invested. For example, in agricultural research, the private sector is far ahead of

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FINDING THE PATH: Issues of Access to Research Resources the public sector in collecting DNA-sequence information about important field crops. Databases of that information could be a great asset to academic researchers studying plant physiology, growth, and resistance to disease and pests. Although the federal government generally seeks to make public the results of research that it sponsors, it faces a daunting decision between expensive duplication of the efforts that went into obtaining the valuable information that is already in privately held databases and paying substantial costs and acceding to the terms of access to the private data. Public funding in some fields of research is tightly constrained, so it is often questionable whether scarce funds should be used to recreate private-sector databases. Arguments to support an independent, federal database effort or to rely on private data providers should be developed for a variety of data types; scientific considerations and access must be weighed against cost and other factors, such as the effect of intellectual property rights on the material that underlies the data. Options include the outright purchase of access to the data, perhaps leveraged through a public-private database effort; the creation of public-private consortia to develop bioinformatics tools; and the establishment of incentives to share private data with the public. A mixture of approaches that depends on the values and tradeoffs identified might be proposed. Thus, the issue of how best to balance the needs for access to scientific databases and for recognition of the proprietary value of the investments that created them is important and challenging. Recommendation: Continuing discussion between the various scientific, public, and private interests on the subject of access to and use of scientific databases should be established to promote agreement on approaches that represent the best balance of interests. A candidate for an early topic for such a discussion is access to agricultural genomic data.

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FINDING THE PATH: Issues of Access to Research Resources Preface In the fall of 1998, staff of the National Research Council met with the National Science and Technology Council's Subcommittee on Biotechnology 1 to discuss concerns about the scientific community's ability to obtain and share “research resources”. Research resources, broadly defined, include plant and animal tissues, reagents, animal models, combinatorial chemistry libraries, drugs and drug targets, clones and cloning tools, methods, laboratory equipment and machines, databases, and computer software. Despite the efforts of federal agencies to promote the efficient dissemination of research tools, problems in accessing resources are increasing in many different fields of science. Some of the problems arise from the fact that many desirable resources are in private hands, have proprietary rights attached to them, or are perceived as having commercial potential even if they are not yet developed; public and private holders of such resources are unlikely to share them freely. Other resources, like databases, are the collective products of individual scientific contributors, who have a personal stake in how their data are used by others; these resources also face social, cultural, logistical, and financial obstacles that dampen their potential to be used widely as scientific tools. Earlier in 1998, the National Institutes of Health (NIH) Working Group on Research Tools, chaired by Professor Rebecca Eisenberg, released its report describing the difficulties of biomedical scientists in obtaining research resources. Included in its recommendations were the establishment of a research tools forum, and the development of guidelines for recipients of NIH funds as to 1   Office of Science and Technology Policy, National Science and Technology Council, Science Committee, Subcommittee on Biotechnology

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FINDING THE PATH: Issues of Access to Research Resources reasonable terms in licensing and material transfer agreements. These draft guidelines were posted on the NIH web site for public comment in June 1999. Scientists in disciplines other than biomedicine, with research funding from other federal agencies, are equally affected by issues of access to research resources, especially in obtaining information held in databases of the private sector, and in some cases, by their colleagues in academia. Each scientific field seems to exhibit its own unique hurdles to resources. Recognizing the need to approach the question of access more broadly, the Subcommittee on Biotechnology, chaired by Dr. Mary Clutter, encouraged the National Research Council (NRC) to hold a public meeting on the spectrum of issues affecting several different research fields. On January 27-28, 1999, the NRC Commission on Life Sciences organized “Finding the Path: Issues of Access to Research Resources”, a conference to explore the breadth of problems and opportunities related to obtaining and transferring research resources. Scientists, entrepreneurs, corporate representatives, university administrators, and government officials attended the conference, which was organized around three panel discussions: Issues in Biotechnology and Genomics. Issues at the Interface of University, Industry, and Government Policy. Issues of Access to Research Resources Across the Disciplines. The following summary of the 2-day meeting lays out the problems concerning access to research resources as discussed by 2 dozen speakers and members of the audience. Some topics on the conference agenda prompted more discussion than others. The first section of the summary is entitled Material Transfer Agreements because this subject dominated discussion in Panel 2, Issues at the Interface of University, Industry, and Government Policy. The frustrations of bench scientists and industry representatives with university technology transfer offices were voiced strongly by individuals like Harry Klee and Tony Hugli. A group of university representatives collectively articulated how different universities view their institutional responsibilities regarding the transfer of innovations, and Joan Leonard explained federal efforts to study and address the problems. But the long-term implications of federal programs and policies on the multiple roles of universities as educators, research institutions, and users, producers, and commercializers of innovations begged for further discussion. The second section of the summary is entitled Patents, based on the underlying theme of Panel 1, Issues in Biotechnology and Genomics. Craig Venter, Tom Caskey, and Steve Holtzman engaged in a lively debate on the appropriateness of recent Patent and Trademark Office decisions and their effects on the behavior of industry stakeholders. But Mike Synder made a plea for attention to the issues affecting the “little guy”, such as the financial cost of access to critical proprietary and public technologies. Finally, the subject of

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FINDING THE PATH: Issues of Access to Research Resources access to large genomic databases owned by companies like Celera and DuPont was raised. The discussion was somewhat tentative, because the commercial strategies of these information holders are uncertain, and the impact on scientists in academia and industry, who will most certainly want access to this data in the future, is unclear at this time. Clarification of the stakes of information ownership and access will be critical to the future of biology. The final major section of the summary, Data Collection and Informatics, captures the individual presentations of scientists from a variety of fields. Many subjects discussed in the context of these fields are novel and reflect recent changes in the organization of how scientists work and how they hope to capitalize on the information and resources they collectively produce. The resolution of at least some of the issues raised in this session hinge on the ability to develop consensus within the respective scientific communities. In all of the sessions, some speakers offered suggestions for improvement, and their suggestions are included. But if any common theme emerged, it was only that access to resources is indeed a major problem that will take much time, creative thought, and effort to ameliorate. The elucidation of these issues at the conference represents an initial step on the path of identifying first, the challenges, and later, the mechanisms and policies that can produce the rapid and equitable dissemination of research resources on which scientific progress depends.

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FINDING THE PATH: Issues of Access to Research Resources Contents     Introduction   1  Chapter 1:   Material Transfer Agreements   4  Chapter 2:   Patents   12  Chapter 3:   Data Collection and Informatics   19      Protein Crystallography,   20      The Protein Data Bank,   22      Culture Collections,   23      Museums and Botanic Gardens,   24      Ecology,   26      Developmental Psychology,   27      Human-Population Databases,   28     Epilogue: Chairman's Remarks   30     Appendixes    A.   Program and Discussion Questions   33  B.   Participant Biographies   41 Boxes  1:   A Model for University Industry Collaboration,   10-11  2:   The High Cost of High Technology,   18

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