6
Closing Comments and Thoughts About the Future

Section 7 of Public Law 107-84, the MD-CARE Act (Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001), called on the Secretary of Health and Human Services to enter into a contract with the Institute of Medicine for the purpose of conducting a study and making recommendations on the impact of, need for, and other issues associated with extramural center programs funded by the National Institutes of Health (NIH). It further specified six major areas that were to be considered in conducting the study. This report is organized around those six areas, but reflecting the committee’s views of their relative importance, not all are addressed in a chapter or section of their own. The executive summary provides a précis of the report. Rather than repeat that summary here, the remainder of this chapter addresses each of the six congressional concerns in turn, offers a brief summary of the committee’s findings, and refers the reader to the part or parts of the report containing more detail.

1. The current areas of research incorporating Centers of Excellence (which shall include a description of such areas) and the relationship of this form of funding mechanism to other forms of funding for research grants, including investigator-initiated research, contracts, and other types of research support awards.

Chapter 2 is primarily devoted to description and data on the current status of NIH center programs. Center grants have constituted less than 10



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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 6 Closing Comments and Thoughts About the Future Section 7 of Public Law 107-84, the MD-CARE Act (Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001), called on the Secretary of Health and Human Services to enter into a contract with the Institute of Medicine for the purpose of conducting a study and making recommendations on the impact of, need for, and other issues associated with extramural center programs funded by the National Institutes of Health (NIH). It further specified six major areas that were to be considered in conducting the study. This report is organized around those six areas, but reflecting the committee’s views of their relative importance, not all are addressed in a chapter or section of their own. The executive summary provides a précis of the report. Rather than repeat that summary here, the remainder of this chapter addresses each of the six congressional concerns in turn, offers a brief summary of the committee’s findings, and refers the reader to the part or parts of the report containing more detail. 1. The current areas of research incorporating Centers of Excellence (which shall include a description of such areas) and the relationship of this form of funding mechanism to other forms of funding for research grants, including investigator-initiated research, contracts, and other types of research support awards. Chapter 2 is primarily devoted to description and data on the current status of NIH center programs. Center grants have constituted less than 10

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation percent of the NIH budget each year for more than a decade. In February 2003 NIH reported that it was funding 1,209 research center grants at an annual cost of $2.4 billion. Center programs and the centers vary greatly in size, purpose, and organization, reflecting in part different strategies among the NIH institutes and differences among research areas in the state of the science, amount of infrastructure needed for cutting edge research, and nature and burden of the health problem addressed. NIH funds these center programs in a wide variety of ways as well, but there appear to be several broad types of NIH center awards. In the committee’s terms, these are: Center Infrastructure awards, or core grants, which fund a director, core services (administrative and technical), and shared facilities and equipment to focus research on a particular set of questions and to support a group of investigators whose research is funded by independently obtained research project grants. Research Center awards, which fund not only shared services but research projects as well. In some cases, they may also support additional activities, such as community education, screening, and counseling programs, and education of medical and allied health professionals about state-of-the-art diagnostic, prevention, and treatment techniques. Research Resource Center awards, which fund centers to develop and provide research resources and tools to researchers across the country (examples include nonhuman primate centers, mutant mouse and other animal resource centers, islet cell resource centers, proteomics centers, and microbial genome sequencing centers). Centers of Excellence can be found in all three categories. The committee therefore elected to address center programs as a group rather than attempt to generalize about only those center programs using the term “centers of excellence” in their title. NIH envisions these programs, which can be funded by cooperative agreements or contracts as well as by grants, as complementing the investigator-initiated grants that make up the major portion of the research portfolios of the institutes. More information on the interdigitation of different types of award mechanisms is provided in the following section on distinctive aspects of centers, but some extramural scientists argue that these institute-initiated and institute-reviewed center programs are at odds with the highly decentralized initiation and highly centralized review processes that have been central to NIH’s success. The committee believes that both approaches have their roles. 2. The distinctive aspects of Centers of Excellence, including the additional knowledge that may be expected to be gained through Centers of Excellence as compared to other forms of grant or contract mechanisms.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation It should be noted that centers are extramural entities located in a university or an independent research institution. The activities of centers may be supported by many sources in addition to an NIH center grant, and centers typically undertake many activities beyond those required by the terms of their NIH center grant (providing care for patients, for example, paid for by the patients or their insurance). In fact, designation as a center frequently facilitates the conduct of those other activities in a way that leads supporters to describe their center as something greater than the sum of its parts. With that in mind, examination of center program documents published by NIH between January 1, 2001, and March 1, 2003, led to the following synthesis of the major justifications offered for centers or center programs: Centers enable a stable, long-term institutional focus on a complex set of problems that cross disciplinary lines, which is difficult to foster through traditional investigator-initiated grants to individual investigators. Centers can provide a locus for patient-oriented clinical, behavioral, and epidemiological research that typically has not fared well in the discovery-oriented system for review of investigator-initiated research proposals but is necessary for translation of fundamental knowledge into clinical advances. By making expensive resources accessible, centers can enhance quality, facilitate productivity, and promote the cost-effectiveness of other externally supported investigator-initiated research projects. Designation as an NIH-supported research center confers distinction on the area of research and thus helps attract additional competitive funding from private as well as public sources, facilitates fundraising, increases the interest and support of medical school leaders and colleagues, and supplies a valuable incentive in recruiting new faculty, staff, and trainees. Centers in academic medical centers can be important means of facilitating the transfer of clinical research results into community practice by developing and then demonstrating the latest techniques. A network of similar centers can combine their resources to ask questions that no one institution could address alone. The most obvious case is that of large clinical trials, where such a network can take advantage of a greatly expanded patient pool to conduct the trial faster and more efficiently than would be possible in any single site. Center awards are a way to build the infrastructure to promote the institutional development of a field of research (e.g., nursing, population research), develop research capacity at minority-serving institutions or in-

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation stitutions in regions with little NIH research funding, and build research infrastructure to respond to public health emergencies. Many of these points, which are drawn from Chapter 2, are revisited and documented with a number of examples in Chapter 4, where the criteria for initiating a center program are addressed. 3. The costs associated with establishing and maintaining Centers of Excellence, and the record of scholarship and training resulting from such centers. The research and training contributions of centers should be assessed on their own merits and in comparison with other forms of research support. The costs of center programs are documented in Chapter 2. In February 2003, when NIH submitted its fiscal year (FY) 2004 budget request to Congress, it estimated it would fund 1,209 research center awards in FY2003 at a cost of $2.4 billion. Funding for center grants has generally increased in line with the overall NIH budget in recent years, constituting between 8.5 percent and 9 percent of all NIH funding during the 1992 to 2003 period. In FY2002 the average center award was $1.7 million per year. Not surprisingly, given the wide variety of center types, the range spanned three orders of magnitude, from $55 thousand to $56 million per year (the median center grant was $1.3 million per year). To put these costs in perspective, the mean value of the most common individual project award, the R01, was approximately $326,000 per year in FY2002. The record of scholarship and training produced by centers is much more difficult to document. Each institute evaluates the individual centers it funds on a case-by-case basis as the centers apply for renewal awards, but few systematic studies of the center programs themselves have been done. The wide variety of centers is one barrier to sweeping generalizations, but in large measure the difficulty is a consequence of the fact noted above that centers typically draw funding from many sources and undertake many activities not specifically mandated by the NIH center award they hold. In the simplest case, centers supported by what NIH calls core grants use the funds to facilitate the work of independently funded scientists at their institution by providing space, shared services and equipment, and the like. The research itself is funded by other grants from NIH (and often other sources as well). Under such circumstances, sorting out credit for the resulting scholarship is extremely difficult. In addition, center program managers and the peer reviewers who judge renewal applications regularly attempt to sort out the poorly performing individual centers in a program based on their records of scholarship and training relative to other competing centers.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Center programs themselves are seldom analyzed so closely. Comparison of center program achievements with those other forms of research funding has seldom been attempted and will always be problematic because the various forms of funding are employed for different purposes. The committee believes that evaluations of any of the funding mechanisms should be aimed at assessing the degree to which they have met their specific goals. Chapter 5 describes the barriers to evaluation in more detail, recommends a well-designed, periodic program evaluation of all center programs, and offers some guidance for planning and implementing those evaluations. 4. Specific areas of research in which Centers of Excellence may be useful, needed, or underused, as well as areas of research in which Centers of Excellence may not be helpful. Each of the NIH institutes relies on input from a wide variety of sources in determining when a centers program is appropriate, and no one body of observers, including the present committee, is qualified to predict areas of research that would qualify as unique, unexplored opportunities for all center programs. The process and criteria suggested by the committee in Chapters 3 and 4 for initiation of center programs should be the guides in all cases. This committee notes the recently expressed intent of NIH Director Elias Zerhouni to focus more attention on fostering multidisciplinary team approaches to increasingly complex research questions and on accelerating translation of basic science to clinical research and applications, both of them sets of activities in which centers are likely to be useful mechanisms. Ideally, this expanded use of centers would not come at the expense of investigator-initiated grants, which have stood the test of time as a mechanism for new and junior investigators with innovative ideas to reach professional maturity. 5. Criteria that may be applied in determining when Centers of Excellence are an appropriate and cost-effective research investment and conditions that should be present in order to consider the establishment of Centers of Excellence. Chapters 3 and 4 discuss the initiation and adoption of center programs in detail, and Table 4-1 provides criteria for initiating both infrastructure and research center programs. In brief, the criteria focus on the importance of the problem to be addressed by the program, need for shared resources, need to develop a highly visible critical mass of multidisciplinary research, number of researchers working in the field, need for strategic

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation focus, need for interdisciplinary interaction, need for translation of scientific knowledge into clinical or public health practice, and existence of a body of clinical questions in need of scientific research. 6. Alternative research models that may accomplish results similar to or greater than Centers of Excellence. NIH currently employs a number of mechanisms that could be alternatives to centers for fostering and supporting interdisciplinary research, translational research, collaborations among researchers in different places, and shared research resources. In addition, there are or could be alternatives within the center model itself. Chapter 2 describes many of these alternatives, which include the program project (P01) grant to support a small group of investigators conducting research with a common theme, Interactive Research Project Grants, in which related R01 research project grants are submitted together, and mini core grants, in which R24 (or U24) research resource-related grants are used to encourage already-funded investigators to work together on a problem by providing resources not available where investigators are working separately. For clinical research, especially clinical trials, where direct interactions between basic researchers and clinical investigators for translational research purposes are not called for, but coordinated activities by multiple clinical centers are needed, NIH often uses cooperative agreements (e.g., U10, U01, and U19 awards) or contracts. The center model itself has been evolving from a problem-focused organizational structure that cuts across disciplinary department lines within a research institution to an independent component of a network involved in multicenter collaborative as well as center-specific research. Another alternative has been to use existing centers rather than create new ones for a specific disease or other problem. Some emerging research opportunities or health emergencies are met by providing supplements to centers. In another case, centers for research on fragile X syndrome were located at existing centers for research on mental retardation and are, in effect, components of the mental retardation centers. NIH has also been experimenting with Web-based virtual laboratories, also called collaboratories. The National Center for Research Resources (NCRR) has funded seven collaboratories through supplemental awards to some of its existing biotechnology resource centers (NCRR, 2000, 2002). One of these, the Biomedical Informatics Research Network, is developing the network, data-storage, and software tools needed for geographically separated investigators conducting research involving neuroimaging to share

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation and use large sets of data on brain images from the molecular scale to the whole brain. The committee discussed some additional alternatives. One would be to allow individual investigators to apply for support of center projects whose form and structure are designed by the applicant rather than specified in a Program Announcement, Request for Applications, or institute guidelines. This could lead to centers organized differently or addressing problems differently (or different types of problems) than those solicited by NIH. It might encourage collaborative translation, clinical, and population projects that investigators believe are too risky or novel to submit to study sections more oriented toward basic science projects. Another committee alternative would be to broaden initiatives to reduce health disparities to encourage partnerships between centers in research-intensive institutions and rural health facilities. The Alzheimer’s Disease Centers supported by the National Institute of Allergy and Infectious Diseases, for example, are affiliated with satellite diagnostic and treatment clinics that recruit minority, rural, and other underserved patients to increase the diversity of study volunteers. THE FUTURE OF CENTER PROGRAMS Center programs are a small but important element in NIH’s array of responses to its dual mission of pursuing fundamental knowledge about the nature and behavior of living systems and bridging the gap between basic science discoveries and developing better ways to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. For all but four institutes, center programs currently consume less than 10 percent of each institute’s budget. All institutes employ the center mechanism, typically after extensive consultative and review procedures, to promote research and activities that are not well-suited for support through the bell-wether investigator-initiated awards that are the hallmark of publicly funded biomedical science in the United States. Some centers simply focus on making the work of independently funded investigators more efficient, but others, including the disease-oriented centers frequently suggested by Congress, also provide support for multidisciplinary research and other activities aimed at turning important scientific discoveries into clinically useful applications. There is general agreement in the scientific community that the center mechanism has been particularly successful in that sphere. One institute director described the role of centers this way: Continuation of the SCOR [specialized centers of research] program is essential if we are to fulfill our mission as a health-oriented organization. The SCOR is virtually the only mechanism we have available to focus multidisciplinary talent on clinical problems. As the basic science commu-

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation nity relies on the program project mechanism, so the clinically oriented community needs the SCOR if it is to move patient-oriented research to the limits of its frontiers (Lenfant, 2002). More general evidence for the important role played by NIH extramural research centers in supporting clinical research was provided by the NIH Director’s Panel on Clinical Research (NIH, 1997), which concluded that center programs were the only NIH research mechanism predominantly dedicated to the full spectrum of clinical research. The panel’s data are now more than six years old, but current NIH award data show that there has been a continuation of the same proportion of overall funding dedicated to clinical research.1 This present committee believes that centers continue to be leading performers of research that links basic science discoveries with applications in the clinical sciences. The proportion of extramural awards devoted to such institute-initiated center programs has not changed appreciably in the last decade (one of this committee’s recommendations, however, is that NIH revamp its current system for counting and tracking centers to ensure that all center awards are classified as such). Assessments like those expressed above by National Heart, Lung, and Blood Institute Director Claude Lenfant and in the following quote from the National Cancer Advisory Board’s Ad Hoc P30/P50 Working Group suggest that substantial segments of the biomedical research community as well as NIH officials see the centers mechanism as an important, indeed essential, component of NIH’s portfolio of funding mechanisms: The P30/P50 Working Group believes that the P30 centers program should be a centerpiece of the nation’s cancer research investment. The stability and centralized support provided through this funding mechanism allow institutions to conduct a wide array of investigations into the etiology and treatment of cancers. At a time when clinical research is increasingly expensive and difficult to conduct, cancer center support is especially critical in ensuring that there are places where cutting-edge basic, clinical, prevention and control, as well as translational cancer research can be conducted. Cancer centers serve as an essential setting for clinical investigations by providing the critical links between the bench and the bedside (NCAB, 2003). Moreover, judging from the pronouncements of a number of leaders in the field, including the present director of NIH, support for centers and similar mechanisms might well grow significantly over the next decade. Eric Lander, director of the Whitehead Institute Center for Genomic Research 1   The most recent estimate of clinical research funded by NIH is $8.4 billion in FY2003 (Zerhouni, 2003b).

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation and one of the leaders of the International Genome Sequencing Consortium, recently offered his view that biology is in the midst of a transition from trying to discover important individual components and molecules to trying to discover how the pieces fit together and function. He stressed that these integrative projects are going to require collaborative efforts that transcend what can be accomplished in a single lab (Metheny, 2003). The Association of American Medical Colleges, Association of American Universities, and National Association of State Universities and Land-Grant Colleges, together representing the nation’s medical schools, teaching hospitals, leading research universities, and public institutions of higher learning, recently offered answers to several questions posed by the NCRR that resonate with Lander’s views (Cohen et al., 2003). In response to a question about the most important research trends in biomedical research, they cited the: Increasing complexity and sophistication of biomedical research. Much of this research relies on advanced technologies, informatics, and other emerging tools, as well as on shared research resources that often require dedicated professional staff. Growth in multi- and cross-disciplinary research, the emergence of new disciplines, and the growing need for investigative teams with diverse and specialized skills and capabilities. Accelerating translation of basic science to clinical research and applications (and vice versa). Moreover, the horizons of clinical research now extend to public health and health security, the needs of underserved communities, and other areas well beyond the traditional clinical environment. NIH Director Elias Zerhouni voiced a very similar theme in his opening statement to the House Subcommittee on Labor-Health and Human Services-Education Appropriations for the FY2004 Presidents Budget Request (Zerhouni, 2003a). He summarized the results of a series of meetings he had convened to develop a roadmap for NIH, defined as a short list of initiatives that would make the biggest impact on biomedical research. The meetings, which included leading extramural scientists as well as NIH institute directors, resulted in three major themes: New pathways to scientific discovery. For example, vital information about the proteins that make up the human body, molecular libraries, nanotechnology, computational biology and bioinformatics, and molecular imaging. Changing dynamics of the research teams of the future. Because of the complexity and scope of today’s scientific problems, traditional mentor-

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation apprentice models must be replaced by integrated teams of specialists from numerous disciplines that were considered unrelated in the past. Imaging research, for example, requires cell biologists, computer programmers, radiologists, and physicists to work collaboratively on new diagnostics and treatments. Need to reengineer the national clinical research enterprise for optimal translation of our discoveries into clinical reality. This means supporting multidisciplinary clinical research training career paths, introducing innovations in trial design, stimulating translational research, building clinical resources like tissue banks, developing large clinical research networks, and reducing regulatory hurdles. It includes a standard clinical research informatics strategy that will permit the formation of nationwide communities of clinical researchers made up of academic researchers, qualified community physicians, and patient groups. Zerhouni concluded his summary by pointing out that these three thematic areas focus on technologies and systems that will enable researchers of the future to not only solve problems more quickly, but also to ask questions that we have not been able to ask before—questions so complex that without the aid of these efforts, they would be impossible to address. Whether or not one agrees with Zerhouni’s vision of the road ahead in biomedical research, or that center programs will be, or ought to be, key vehicles for the trip, it seems apparent that center programs are not likely to diminish in number or importance in the near future. At least two of the three Roadmap themes—fostering integrated research teams and organizing for translational research—have been driving forces behind the establishment of center programs in the past.2 Whether they will continue to be effective in the future, however, will depend on addressing a number of 2   On September 30, 2003, after this report was drafted, NIH made public the initiatives it is planning to implement the Roadmap for Medical Research (Zerhouni, 2003b). As expected, new center programs will play a prominent role in implementing the Roadmap objectives. In September and October 2003, NIH issued eight Requests for Applications (RFAs) under the Roadmap, five of them for new center programs. They include: National Centers for Biomedical Computing (U54); National Technology Centers for Networks and Pathways (U54); Exploratory Centers for Interdisciplinary Research (P20); Development of High Resolution Probes for Cellular Imaging (P20); and Centers for Innovation in Membrane Protein Production (P50). At least three more center programs are planned: Nanomedicine Centers, Bioactive Small Molecule Library and Screening Centers, and Regional Translational Research Centers. Funding over six years is planned to be $2.1 billion, or $350 million a year on average, although funding in the first year (FY2004) will be approximately $128 million (Kaiser, 2003). According to the five center RFAs, up to $45 million has been set aside for center awards in FY2004.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation potential obstacles that have not yet been resolved. Some of the issues that require careful thought in considering the appropriate role of center programs in the future include: The amount of funds available for new biomedical research supported by the NIH. NIH budget growth is not likely to match the experience of the past five years of near 15 percent annual increases. In the worst case—growth at less than the rate of inflation—the expansion of centers in number or size, or both, would require a redistribution of funding among mechanisms. The importance of expanding the translational aspect of linking basic science funding with clinical research is one of the main justifications of the center mechanism, but it is not apparent that the critical mass of clinical investigators that will be needed to conduct the necessary research is available or now in training. Moreover, the current demands on clinical faculty for patient care and teaching and the academic requirements for promotion and tenure discourage young physician-investigators from entering a research track as a career. Historically, the goal of teaching and training of young scientists for the doctorate has been to prepare them to conduct an independent research program. Although industry frequently states that it needs investigators trained to work in teams, the current method of evaluating the educational and research accomplishments of students in training is antithetical to producing scientists with experience in team research. Current academic recruiting, promotion, and tenure policies are based on individual accomplishment. The inability or reluctance of those who make those decisions to expand their criteria to include contributions to a multidisciplinary team of researchers presents a formidable challenge to expansion of center programs and other team-based large-scale biomedical science (IOM and NRC, 2003). The accommodation in academia of larger and more effective centers carries with it the problems of dedicated space, long-term academic appointments, and administrative issues that must be reconciled with current department-oriented activities. This issue is of importance when considering a policy of sunsetting center programs. In sum, greater emphasis on use of the center mechanism for support of biomedical research will require careful long-term planning and restructuring of many long-held academic traditions.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation REFERENCES Cohen J, Hasselmo N, Magrath P. 2003. “National Center for Research Resources 2004 Strategic Plan, 68 FR 4503-4.” Letter from the presidents of the Association of American Medical Colleges, Association of American Universities, and National Association of State Universities and Land-Grant Colleges to the National Center for Research Resources (NCRR) in response to NCRR’s call for comments on its draft strategic plan. [Online]. Available: http://www.aau.edu/research/Ltr5.9.03.pdf [accessed December 15, 2003]. IOM and NRC (Institute of Medicine and National Research Council). 2003. Large-Scale Biomedical Science: Exploring Strategies for Future Research. Washington, DC: The National Academies Press. Kaiser J. 2003. Speeding up delivery: NIH aims top push for clinical results [News]. Science 2003(5642):28-29. Lenfant C. 2002. Strengthening commitment to clinical research: The National Heart, Lung, and Blood Institute’s Specialized Centers of Research program. Circulation 105(4):400-401. [Online]. Available: http://www.nhlbi..nih.gov/funding/fromdir/circ-1-02.htm [accessed December 15, 2003]. Metheny B. 2003. Science training must embrace teamwork, collaboration, preparation for work outside academia, thought leaders say. Washington Fax, May 13. NCAB (National Cancer Advisory Board). 2003. Advancing Translational Cancer Research: A Vision of the Cancer Center and SPORE Programs of the Future. Report of the National Cancer Advisory Board Ad Hoc P30/P50 Working Group. [Online]. Available: http://deainfo.nci.nih.gov/ADVISORY/ncab/p30-p50/P30-P50final12feb03.pdf [accessed December 15, 2003]. NCRR (National Center for Research Resources). 2000. NCRR Biomedical Collaboratories Workshop Report. [Online]. Available: http://www.ncrr.nih.gov/biotech/btcollabwrkshprpt10-2000.pdf [accessed December 15, 2003]. NCRR. 2002. Data and Collaboratories in the Biomedical Research Community. [Online]. Available: http://www.ncrr.nih.gov/biotech/collabmtg2002.asp [accessed December 15, 2003]. NIH (National Institutes of Health). 1997. Report from the Director’s Panel on Clinical Research to the Advisory Committee to the Director [of NIH]. [Online]. Available: http://www.nih.gov/news/crp/97report/index.htm [accessed December 15, 2003]. Zerhouni E. 2003a. Opening Statement on the FY2004 President’s Budget Request, “FY 2004 Appropriations Overview,” Hearing before the House Appropriations Subcommittee on Labor, Health and Human Services, and Education, April 2, 2003. [Online]. Available: http://www.nih.gov/about/director/budgetrequest/FY2004budgetrequest.htm [accessed December 15, 2003]. Zerhouni E. 2003b. The NIH Roadmap (Policy Forum). Science 302(5642):63-64,72. [Online.] Available: http://www.sciencemag.org/cgi/content/full/302/5642/63?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&author1=zerhouni%2C+e&searchid=1069347433605_6563&stored_search=&FIRSTINDEX=0&fdate=10/1/2003&tdate=11/30/2003 [accessed October 3, 2003].

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