1
Introduction

The United States is entering an era of fiscal restraint, and perhaps even more than those in clinical practice, the biomedical research community is likely to be faced with the challenge of doing more with less. This challenge may require the development of innovative strategies to facilitate and enhance the efforts of our talented scientists. One possible 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. Sometimes a telephone call will suffice; other times it may require an extended visit and hands-on training in a new technique or instrument; still other times may require acquiring 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.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 13
--> 1 Introduction The United States is entering an era of fiscal restraint, and perhaps even more than those in clinical practice, the biomedical research community is likely to be faced with the challenge of doing more with less. This challenge may require the development of innovative strategies to facilitate and enhance the efforts of our talented scientists. One possible 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. Sometimes a telephone call will suffice; other times it may require an extended visit and hands-on training in a new technique or instrument; still other times may require acquiring 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.

OCR for page 13
--> Competition for Funds The National Science Foundation (NSF) reports that total federal funding for biomedical research, in inflation-adjusted dollars, has leveled off (National Science Foundation, 1995). The current emphasis on controlling federal spending makes it unlikely that this trend will be reversed in the near future. The federal investment in nondefense research and development (R&D) is projected by the American Association for the Advancement of Science to decrease by approximately 33 percent in real terms by 2002 (Lane, 1996). Universities continue to turn out new Ph.D.s in the life sciences, however, increasing the supply about 5 percent annually (and taking on about 5.5 percent more postdoctoral appointees each year). This has resulted in declining success rates for those seeking traditional investigator-initiated research grants. Such intense competition has not affected publication, but many researchers report that the intense competition has made them think twice about sharing prepublication data, tips on laboratory technique, and important reagents (purified proteins, cloned genes, mouse strains, etc.) with potential rivals (Marshall, 1990; Cohen, 1995). Anecdotes about nonresponsiveness, incomplete sharing, and even deliberate misdirection abound (Werb, in Marshall, 1990; Rensberger, 1994). Young scientists may be tempted to hoard information and materials since unlike more senior researchers, they are most often not able to demand coauthorship or continued collaboration as a quid pro quo and are thus vulnerable to being "scooped" by a more established competitor who has more personnel and funding to exploit a new resource. Senior scientists may be reluctant to permit doctoral and postdoctoral students to take materials or even data with them to an independent position. Incentives for Scientists Stiff competition for dwindling funds would seem to be an incentive for sharing, but the path to success as a scientist lies with individual accomplishments. Grants, publications, and citations are the steps on the ladder of scientific success, and even the order of the authors on a multiple-author paper can be contentious. Promotion and tenure committees often make judgments based on the number of publications authored by a particular investigator, without regard for the role played by this investigator in the overall process of science. There are few mechanisms in place actively encouraging resource sharing or reinforcing it when it appears. Less obvious but just as important is the lack of scientific career incentives for caretakers of the common property generated by sharing. Nothing illustrates this point better than the case of Maynard Olson and his

OCR for page 13
--> colleagues at the University of Washington, who spent two years collecting some 60,000 yeast artificial chromosome (YAC) clones. A strong belief that anything made with the support of the National Institutes of Health (NIH) belongs in the public domain initially led members of the group to encourage other investigators to send them interesting clones, for which they would try to find a match. They reported that at one point they were conducting screening for 85 different investigators and found they had no time for projects of their own. Their solution to this dilemma was to share the entire library of clones, and the associated burden of screening new clones for other investigators, with six other labs. This action could hardly be characterized as selfish, but it reveals the powerful contingencies steering even the best-intentioned scientists away from serving the larger community and toward projects of their own. A recent trend that many feel makes this dearth of incentives for sharing especially important is the successful commercialization of much basic research in biology. The Bayh-Dole Act of 1990 and the U.S. Technology Transfer Act of 1986 contained provisions to stimulate commercial development of basic research conducted by federal agencies and their grantees by encouraging patenting and licensing agreements with private industry, which often showed little interest in developing ideas in the public domain. The incentive for the agencies and grantees is monetary—the individual scientists and their institutions are allowed to share in royalties resulting from their work. The institutions can even accept advance funding from industry partners in return for preferential access to future research findings. As Table 1–1 illustrates, the financial impact on grantees (universities) has been substantial. TABLE 1–1 Fiscal Year 1994 Royalties Received by the Top 10 United States Universities University Royalties ($) University of California (system) 50,210,000 Stanford University 37,700,000 Columbia University 26,746,141 Michigan State University 14,556,761 University of Washington 12,300,000 Iowa State University 9,600,000 University of Wisconsin 8,348,713 Florida State University 6,771,968 Harvard University 5,817,671 University of Florida 5,177,050   SOURCE: Hoffman (1995).

OCR for page 13
--> Blumenthal et al. (1996) provide data from the other side of the ledger. They surveyed private firms conducting or sponsoring research in the life sciences in the United States. More than 90 percent have some relationship with academia. More than half support university research. Extrapolating from their sample, Blumenthal and his colleagues estimate that private-sector companies supported more than 6,000 academic research projects in 1994, at a cost of $1.5 billion. More than 60 percent of companies investing in academic research have reported realizing patents, products, and sales as a result. The Bayh-Dole and U.S. Technology Transfer Acts thus appear to have resulted in mutually profitable partnerships between industry and universities. Another, less propitious consequence has also been quantified by Blumenthal et al. (1996): a survey of life science companies showed that 82 percent of companies supporting research relationships with academic institutions sometimes require keeping information confidential until a patent application is filed. Nearly half of these companies indicated that their agreements with universities required academic researchers to protect confidential proprietary information resulting from company-sponsored research longer than is necessary to file a patent application. Rosenberg (1996) provides several examples, from personal experience, of secrecy in medical research, arguing that it is rapidly becoming a common and accepted practice, to the detriment of science and medicine. Nationalism A second recent trend potentially undermining the culture of sharing is a sort of ''scientific nationalism'' as countries seek to protect or exploit unique resources. Roughly half of all drugs in clinical use stem from a product of nature, and prospectors seeking further potential products in biota all over the world may number in the hundreds. The United Nations Biodiversity Convention of 1992 tried to ensure that profits from such products returned to the place of origin. Despite some successes, huge payoffs remain elusive. Drug companies estimate that on average, 10,000 to 100,000 substances are screened for every profitable drug brought to market. One common result in developing nations however has been resentment and anger toward bioprospectors from industrialized countries, who are suspected of circumventing the convention. In response, several countries have passed laws severely restricting export of native flora and fauna, regardless of the intended use.

OCR for page 13
--> Methods and Goals of This Study A Member Survey Several previous National Research Council (NRC) reports have touched on some of the issues noted above, for example, Sharing Research Data (Feinberg, et al., 1985) and Sharing Laboratory Resources: Genetically Altered Mice (National Research Council, 1994), so the current project began with an informal survey of members of the Institute of Medicine (IOM) and of relevant sections of the National Academy of Sciences (NAS). The survey inquired about members' own difficulties in resource sharing, what kinds of resources could and should be shared, what the scope and mechanisms of such sharing might be, and what specific examples of successful or failed efforts at resource sharing would be worth examining in detail. Responses from NAS and IOM members made it clear that any study of resource sharing would have to recognize the multiple meanings of both "resource" and "sharing." The former, for example, might encompass biological materials (tissue samples, cell lines, bacteria, viruses, antibodies, genes or gene fragments, and plasmids); information (data, databases, patient registries, or recipes and procedures); instrumentation (microscopes of various sorts, synchrotrons, accelerator or magnetic resonance spectroscopes, and other expensive equipment); and experimental subjects (primates, mutant strains of mice or fish, patient registries, or families with known or suspected genetic diseases). Each type of resource presents special considerations for sharing, though all will have to address the costs of production and distribution or the responsibility for maintaining the shared resource. Biomedical, behavioral, and epidemiological data vary in their content, level, form, and structure. Distinctions between the materials and the data themselves are often blurred (Sieber, 1990). In addition, "sharing" could involve large- or small-scale collaborations within or across institutions; scientist-to-scientist exchanges; deposition of resources into regional or national "public domain" repositories; or ''time-sharing" of rare or expensive facilities among collocated staff and visiting "users." Adding still further complexity is the network of interrelationships among the many actors influencing scientists' decisions about when, where, what, how much, and with whom to share (see Figure 1-1).

OCR for page 13
--> Figure 1-1 Potential influences on investigator's decisions to share. SOURCE: Cordray et al. (1990).

OCR for page 13
--> The Committee 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. Specifically, the workshop was to (1) review the current status of sharing in a few particular categories of biomedical resources; (2) identify existing programs, initiatives, and mechanisms in place for sharing these resources; (3) identify future needs, obstacles, and strategies that will promote sharing; and (4) assess agreement within the biomedical research community and relevant funding agencies about the need for advice and recommendations in these areas. The committee was joined by eight representatives from federal agencies and scientific societies in a September 1995 meeting to plan the workshop. The Workshop 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. (See Appendix A for the program.) 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 identify common problems that stand in the way of effective resource sharing, to better understand the roles of different institutions in influencing sharing, to highlight the advantage of sharing for the scientific community, and to stimulate support for sharing from that community. Each presenter was asked to describe the relevant activity or facility, and to specifically address the operations of the activity or facility in terms of the following: How is the issue of ownership addressed? Do the contributors maintain any control over the materials, their distribution, or use? For how long? Do they get credit of any sort, either with the facility or with the scientific community? If not, what is their incentive for contributing? Are any conditions imposed on contributors, (e.g., provide documentation of agreement among all members of a collaboration)? Who can access the shared materials, and how? What mechanisms are employed for disseminating information on availability? Are there any

OCR for page 13
--> conditions or restrictions on use? Any rules for acknowledgment of the original contributor? What is the primary function of the facility? R&D? Distributor of R&D tools and products? Curator? What is your criterion for success? Is the endgame a steady state, or do you foresee a time when the facility, or some functions of the facility, will no longer be necessary? If so, how will you know when that time has arrived? Do you have any plans for disposition of resources or functions in the event the facility has to cease operations involuntarily? What are the costs (nonmonetary as well as monetary) associated with maintaining the shared resources, and how are they covered? What kind of quality control process is employed? Are there financial incentives for contributing or using shared materials? Barriers? What other issues or problems create difficulties for your facility? How would you prioritize among all of these issues? The Report and Its Recommendations This report is a distillation of the resulting talks on the case studies; additional presentations on the roles of government, professional societies and journals, and private industry; and discussions of invited guests from the public, nonprofit, and private sectors. The committee is however solely responsible for the conclusions and recommendations of this report. References Blumenthal, D., Causino, N., Campbell, E., and Louis, K.S. 1996. Relationships between academic institutions and industry in the life sciences--An industry survey. New England Journal of Medicine 334(6):368-373. Cohen, J. 1995. The culture of credit. Science 268(June 23):1706-1711. Cordray, D.S., Pion G.M., and Baruch, R.F. 1990. Sharing research data: With whom, when, and how much? Paper presented at the Public Health Service Workshop on Data Management, Access, Sharing, and Retention in Biomedical, Behavioral, and Epidemiological Research, April 25-26, 1990, Chevy Chase, Maryland. Feinberg, S.E., Martin, M.E., and Straf, M.L., eds. 1985. Sharing Research Data. Washington, D.C.: National Academy Press. Hoffman, D.C. 1995. The AUTM Licensing Survey. Norwalk, Conn.: Association of University Technology Managers. Lane, N. 1996. Thin ice over deep water: Science and technology in a 7-year downsizing. Presentation at the American Astronomical Society Meeting, January 15, 1996, San Antonio, Texas. Marshall, E. 1990. Data sharing: A declining ethic? Science 248:952-957.

OCR for page 13
--> National Research Council. 1994. Sharing Laboratory Resources: Genetically Altered Mice. Washington, D.C.: National Academy Press. National Science Foundation (NSF). 1995. National Patterns of R&D Resources: 1994. Arlington, Va.: NSF/Division of Science Resource Studies, p. 8. Rensberger, B. 1994. Era of transition: Successful science, troubled scientists. Journal of NIH Research. (August 6):29-31. Rosenberg, S.A. 1996. Secrecy in medical research. New England Journal of Medicine 334(6):392-394. Sieber, J.E. 1990. Investigator's concerns about data sharing. Paper presented at the Public Health Service Workshop on Data Management, Access, Sharing, and Retention in Biomedical, Behavioral, and Epidemiological Research, April 25-26, 1990, Chevy Chase, Maryland.

OCR for page 13
This page in the original is blank.