Executive Summary

The United States is entering an era of fiscal restraint, and the biomedical research community is likely to be faced with the challenge of doing more with less. One avenue that could be explored in developing the needed strategies is that of enhanced resource sharing. The public nature of science, emphasizing peer review, confirmation of results, and standardization of methods, would seem to make resource sharing a given. Independent replication provides science with quality control, and few if any laboratory experiments, or even systematic observations, can be duplicated accurately without some contact with the original author or data. Other studies may require specimens or materials obtained or created by the original author. Despite the prospect of more and more talented scientists, chasing dwindling or stagnant research funds and an increasing complexity of both clinical and basic science that would seem to demand more collaboration, a number of contemporary observers have commented on an apparent decline in the openness and willingness to share information and resources that has traditionally been viewed as a characteristic feature of science. The workshop summarized in this report was an initial attempt to examine the status of resource sharing in biomedical research, to identify existing or emerging barriers to effective sharing, and to recommend additional actions.

As an initial step in addressing the issues of whether and how to promote resource sharing, an eight-person committee with expertise in basic and clinical sciences, research administration, drug development, and public policy was charged with planning and conducting a workshop to identify some "best practices" and make the scientific public aware of the most common and most difficult problems in the area of resource sharing. The committee met in



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--> Executive Summary The United States is entering an era of fiscal restraint, and the biomedical research community is likely to be faced with the challenge of doing more with less. One avenue that could be explored in developing the needed strategies is that of enhanced resource sharing. The public nature of science, emphasizing peer review, confirmation of results, and standardization of methods, would seem to make resource sharing a given. Independent replication provides science with quality control, and few if any laboratory experiments, or even systematic observations, can be duplicated accurately without some contact with the original author or data. Other studies may require specimens or materials obtained or created by the original author. Despite the prospect of more and more talented scientists, chasing dwindling or stagnant research funds and an increasing complexity of both clinical and basic science that would seem to demand more collaboration, a number of contemporary observers have commented on an apparent decline in the openness and willingness to share information and resources that has traditionally been viewed as a characteristic feature of science. The workshop summarized in this report was an initial attempt to examine the status of resource sharing in biomedical research, to identify existing or emerging barriers to effective sharing, and to recommend additional actions. As an initial step in addressing the issues of whether and how to promote resource sharing, an eight-person committee with expertise in basic and clinical sciences, research administration, drug development, and public policy was charged with planning and conducting a workshop to identify some "best practices" and make the scientific public aware of the most common and most difficult problems in the area of resource sharing. The committee met in

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--> September 1995 to plan the workshop, a task in which is was assisted by eight invited liaisons from federal agencies and scientific societies. The conclusions and recommendations of this report are however solely those of the committee. The workshop held in Washington, D.C., on January 22–23, 1996, was built around six case studies of large-scale resource sharing, representing models of two very different institutional arrangements: "repository-type" activities and "user facilities" or centers. The resources shared by the case studies include biological materials such as whole animals, information, and instruments or equipment. By analyzing these cases in some detail, the committee hoped to better understand the roles of different institutions in influencing sharing, to identify common problems that stand in the way of effective sharing, and to suggest some approaches to their solution. Case Studies The American Type Culture Collection The American Type Culture Collection (ATCC) was founded in 1925 to serve as a national repository and distribution center for cultures of microorganisms. Since that time, viruses, animal and plant cell cultures, and recombinant DNA materials have been added. A private, nonprofit organization dedicated to the acquisition, preservation, authentication, and distribution of diverse biological materials, ATCC is now the largest general service culture collection in the world, preserving and providing these materials for use by qualified people engaged in science, industry, and education. The Multinational Coordinated Arabidopsis Thaliana Genome Research Project An international scientific effort that began in 1990, the goal of the Multinational Coordinated Arabidopsis Thaliana Genome Research Project is to understand the physiology, biochemistry, growth, and development of a flowering plant at the molecular level. The remarkable collaborative spirit of the participants has made it a successful model of scientific cooperation among about 3,000 participating scientists and scientific administrators in Asia, Australia, Europe, the Middle East, and the Americas. Two Arabidopsis stock centers preserve and distribute seeds, clones, and other biological materials to the large Arabidopsis research community worldwide. Shared databases include a comprehensive collection of many types of information; an on-line system primarily devoted to stock center operations but, like the other information

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--> systems, readily accessible to anyone with a connection to the Internet; and a database of cDNA sequences and expressed sequence tags (ESTs) that periodically sends these data to the National Center for Biotechnology Information at the National Library of Medicine. Thus, it seemed an especially appropriate case with which to examine the ingredients that facilitate the sharing of research resources. The Jackson Laboratory A private, nonprofit, research institution on Mount Desert Island in Maine, The Jackson Laboratory (TJL) has been the major repository for genetically characterized mice for more than 60 years. Although it is a research laboratory focused on providing new information to the scientific community through genetic research with mice, TJL is also recognized internationally as the preeminent source of laboratory mice for genetic research. TJL has developed many mutant strains of mice, which it supplies to researchers, and recently has begun accepting mice with spontaneous or induced mutations from scientists at other laboratories who wish to make them generally available. More than 1.6 million mice are distributed each year. The Washington Regional Primate Research Center The Washington Regional Primate Research Center (WRPRC) is one of seven regional primate research centers established by congressional mandate in the 1960s to develop nonhuman primate models and employ them to examine the underlying mechanisms and processes of human diseases. WRPRC in Seattle is part of the University of Washington Health Sciences Center. The WRPRC core staff is composed of eight doctoral-level researchers. They are joined by approximately 300 other scientists and graduate, medical, dental, and veterinary students in a wide array of research projects. The WRPRC principal breeding colony (about 350 births annually) is the Primate Field Station at Medical Lake, Washington. Additional, smaller, colonies are maintained in Russia and Indonesia. The Primate Information Center of the WRPRC maintains a comprehensive database of publications on nonhuman primates. A second database, the Primate Supply Information Clearinghouse, facilitates efficient use of nonhuman primates by collecting offers from laboratories with available primates and requests from laboratories seeking specific primates. The Tissue Distribution Program is a spin-off of the clearinghouse. It provides fresh, fixed, or frozen specimens prepared in a variety of ways to laboratories throughout the world. About 3,000 tissues harvested from roughly 200 animals will be distributed this year.

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--> The Macromolecular Crystallography Resource at the Cornell High-Energy Synchrotron Source The Macromolecular Crystallography Resource at the Cornell High-Energy Synchrotron Source (MacCHESS), a ''user facility,'' provides support for the collection and analysis of x-ray diffraction data from crystals of biological macromolecules using synchrotron radiation. As such, it is a rich source of information about what works in shared facilities and where problem areas or bottlenecks exist. The overall goal of the MacCHESS research resource is to provide specialized equipment for macromolecular crystallography as well as trained support staff to assist outside users. The MacCHESS staff of two scientists, three technicians, a computer programmer, a machinist, and a secretary has established an active research program designed to advance the frontiers of synchrotron radiation research and structural biology. Collaborators obtain early access to new instruments, techniques, and methods and provide additional impetus for their development and refinement. Mature methods are made available to outside scientists who use the facility on a competitive basis. During 1995, more than 200 scientists from 45 laboratories used the CHESS facilities for macromolecular crystallography experiments. The Human Genome Center at Lawrence Livermore National Laboratory The last of the six case studies examined is neither a repository of scientific community property, like the ATCC, nor a center for visiting scientists, like the Cornell synchrotron. The Human Genome Center at Lawrence Livermore National Laboratory (LLNL) technically is not a shared resource at all, but a federally owned, contractor-operated research and development laboratory that has become, by default, a supplier of valuable materials and information to the international scientific community without specific funding to do so. The center staff has three tasks: creating biological resources useful for genomic research, developing instrumentation and informatics for genome research, and locating genes. The experiences of the LLNL center's scientists, as they have attempted to share locally developed instrumentation and technology, information, and biological materials with the wider scientific community, provided valuable information to the committee.

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--> Conclusions and Recommendations Features of Successful Resource Sharing Strong Scientific Leadership in Agencies and the Research Community Essential ingredients in successful resource sharing are the leadership of program managers in government agencies who identify opportunities and support them; the leadership of senior scientists who establish the norm for the scientific community by example and commitment to sharing resources; the leadership of scientists who direct existing shared resources to provide quality services at moderate costs; and the commitment of scientific institutions such as universities and professional societies that develop policies to facilitate and enforce resource sharing. Adequate Core Funding Many repositories and centers depend on a patchwork of funding from a number of different government funding agencies, industry, and private foundations, to support research or further development of the resource, as well as user fees. Sometimes the different streams of dollars may not be available to support the core administration and quality control necessary for resource sharing. Marketing and Advertising Advertising, marketing, and general knowledge about the availability of a resource are essential to widespread access; many resources are not shared simply because their existence is not known to scientists who require them. Clear Guidelines about Ownership and Access The cases reviewed at the workshop demonstrated the value of clear guidelines concerning access and ownership, although these differ depending on the resource. Planning should include guidelines for sharing—under what circumstances and with whom data and materials will be shared. This is an essential ingredient in preventing later misunderstandings and problems.

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--> User Fees One important source of funding for resource sharing can be user fees. These charges help to subsidize the core operations and maintenance if those research resources that are not currently commercially viable. They also help defray the costs of functions such as authentication and quality control, which are essential, if invisible, elements of first-class science. Clear Policies for Retaining and Discarding Data and Material Policies for the disposition of materials and information that are no longer of value will be increasingly important as the body of resources that need to be shared continues to increase more rapidly than the funding available to support them. Quality Control A critical attribute of a shared resource is that the distributed resource be what it is purported to be. Similarly, mechanisms to ensure the highest-quality research at limited-access resources such as a synchrotron are essential to their ongoing success. Well-Defined Policies for Function of Research and Service at the Facility The balance between service and research by staff is a fundamental question to be considered by all centralized facilities designed to be resource centers for the scientific community. A shared resource is greatly enhanced by the presence of an excellent scientific staff that is conducting research to improve the resource and can ensure the quality of the materials. Sophisticated Information Retrieval and Transfer Systems Rapid exchange of information and widespread access to data are greatly facilitated by sophisticated information retrieval and transfer systems. Rapidly evolving information systems are transforming the way research is conducted and disseminated.

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--> Issues and Problems The case studies, although providing many good examples of "best practices," also provided the committee with a wealth of unresolved issues and emerging problems that any future sharing effort will have to address. One Uniform Policy on Resource Sharing is Not Possible The problems of resource sharing are diverse. Therefore, the solutions will be similarly diverse. There are differences in the resources to be shared, the needs of stakeholders, and the distribution of resources that stakeholders command. In gathering the material for this report, the committee has dealt with the sharing of data, materials (including experimental subjects), and equipment. It is clear that the optimal procedures for sharing these three classes will differ in most cases. The overall guiding principle in such decisions should be scientific merit and the acquisition of information of interest to the scientific community at large. Incentives and Rewards for Resource Sharing are Not Fully Developed The current systems for rewarding academicians or employees in industry do not encourage sharing but rather focus on individual achievements. • Sharing Requires Incentives, Not Disincentives. For academic scientists, incentives are citations or other credit for use of samples made available; another incentive is having the costs of making these samples available covered by the recipient, a third party, or one's grant. Provisions for sharing data, materials, and equipment should be built into research proposals, and the sharing activities should be included as part of the progress report when grants are being considered for renewal. • The Importance of Data and Material Changes Over Time. A key clone at the early stages of an investigation may be worth trading only in an actual scientific collaboration. Later, the clone may be freely available in a public repository or distributed upon request. Finally, the clone may become archaic: it should not be kept or distributed; public repositories should deaccession it. • Technologies and Needs Are Evolving Very Rapidly. Any system of incentives put into place must have sufficient flexibility to evolve as well.

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--> • New Definitions of "Publication" May Have to Evolve to Keep Pace With the New Electronic Information Systems. Ways of providing credit to institutions for resource sharing must be found, or support for the scientific mission of these core activities—which benefit many—will be endangered. Methods for Enforcing Existing Policies on Resource Sharing are Inadequate Although some policies already exist regarding sharing, the enforcement of these policies is inadequate. Although funding agencies may have to take the lead, enforcement of these policies is most likely to be effective if done at the local (university or institution) level. The issues yet to be resolved are the actual mechanism of enforcement and how the costs involved should be paid. There are Many Private and Public Stakeholders in Any Major Resource Sharing Attempt, Often with Conflicting Goals Economies of scale dictate that some activities are better provided as private-sector services as long as actual costs to the users do not inhibit research. However, the issues of credit and ownership go beyond the additional constraints imposed by sharing and are badly in need of clarification and resolution. One example is the status of the research exemption from licensing for university-based investigations in a climate where universities are required by law to protect intellectual property that is potentially valuable commercially. Who Pays and What Do They Pay for? The issues of quality control and quality assurance for shared samples or sample repositories are of major concern, because these activities are a major contributor to the costs of institutions such as TJL and ATCC. Commercial competitors willing to employ less stringent measures on a smaller selection of resources can and do offer apparently similar products at cut-rate prices. High-quality research depends on high-quality materials, and the scientific community will have to recognize that it must pay for quality control, through subsidy if not through user fees.

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--> Regulatory Requirements and Documentation Can Be Unnecessarily Complex and Burdensome Regulations promulgated by government agencies affect resource sharing disproportionately. The regulatory burden on ATCC for shipping biological samples and the various municipal, state, and federal regulations governing animal care and shipping are two examples. Education of Scientists Covers Neither the Ethos of Sharing Nor Intellectual and Tangible Property Issues During training, there is no formal emphasis on the merits of sharing or the benefits of collaborations, and in an increasingly competitive atmosphere where resources are limited, the benefits of sharing may be unappreciated. Resource Sharing Can Have National and International Implications Wherever resources are saturable or irreplaceable, all efforts should concentrate on viewing the scientific utility of such resources from a worldwide perspective. Procedures should be developed for worldwide review of competing applications for limited resources or facilities. There is a Gap in Leadership Sharing of research resources lacks high profile leadership (for example, the president of a major scientific society or the president of the National Academy of Sciences). Academic institutions, government agencies, and industry have failed to focus the scientific community. Partnerships in Resource Sharing May Be Unequal The issue of fairness in access and opportunities to utilize resource sharing is ongoing, because there are typically inequities among those seeking access to saturable resources or costly resources.

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--> Monopolies Can Be Good or Bad Federal funding policies typically require competition for funds, but in some cases this may be an artifice that is unwarranted. The goal should be to identify the most cost effective methods and highest-quality resources for the scientific community. Recommendations Administrators of research institutions, grant administrators, scientists, and industry representatives should meet to develop policies to foster sharing of resources. These policies should explicitly address the following: Sources of reliable funding for provision of materials and services to the research community. Training and education regarding the ethos and the value of sharing and related intellectual property issues, including the merit of patents and licensing Rewards and incentives for researchers who share resources Mechanisms for enforcing agreed-upon resource sharing policies within and across institutions Role of the technology transfer office in facilitating resource sharing Current National Institutes of Health guidelines governing university-industry relationships Federal and private funding agencies and industry should jointly undertake a suitable cost-benefit analysis and explore mechanisms to enhance the efficiency both of funding shared resources and of sharing resources. Because of the growth of economic nationalism and to avoid unnecessary duplication, the world scientific academies should convene to identify barriers to sharing resources across national boundaries and should develop mechanisms to overcome them. Because the private sector will continue to have a major impact on resource sharing, representatives from industry, nonprofit institutions, and funding agencies should be brought together to work toward solutions of current problems such as the following:

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--> Overreaching claims on future ownership of inventions by providers of shared resources and research tools Competition between private-sector activities and public shared resources How to protect the research exemption for licensed intellectual and tangible properties Impediments to biomedical research and education caused by confidentiality requirements A cost-benefit analysis should be conducted to evaluate the possible impediments to resource sharing caused by government regulations.

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