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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences 1 Context and Issues STUDY CONTEXT AND HISTORICAL DEVELOPMENTS Advances in biomedical, clinical, and behavioral research have significantly contributed to increased human life span and well-being over the past century, and the support and guidance of the National Institutes of Health (NIH) has had a significant role in enabling this research. Among the major benefits of this research have been vaccines for polio, measles, mumps, Streptococcal pneumonia, Hemophilus meningitis, and a host of other infectious diseases; insulin treatment for diabetes and sophisticated instruments for monitoring glucose levels in the blood; medications to control blood pressure and serum cholesterol; medical and surgical procedures for the treatment of heart disease, including cardiac valve and whole organ transplants; antiretroviral drugs for the treatment of AIDS; and increasingly successful treatments for cancer. The successful completion of the Human Genome Project has led to a plethora of new insights and experimental strategies for understanding major, chronic human diseases at the most fundamental levels and has led to continuously growing numbers of diagnostic tests based on genome, proteome, and metabolome arrays as well as to new types of powerful and targeted treatments. These advances are already transforming our understanding of human physiology and pathophysiology and redefining with far greater specificity and precision our understanding of, and approaches to, complex human diseases. Not only are these advances transforming the practice of medicine, but also they have enabled new, quantitative whole-organism approaches to the study of health and disease by providing the scientific and technological foundation for the burgeoning new discipline of systems biology. The behavioral and social sciences in recent years have benefited from a tremendous leap in the sophistication of methods and tools, leading to a realistic expectation that useful and effective answers to fundamental questions central to disease prevention and health promotion will result from investing in research training in these areas. At the level of human behavior, the behavioral and social sciences produce knowledge about health issues such as drug and alcohol abuse, obesity, violent behavior, smoking, maintenance of drug treatment regimens, stress management, ability to cope with illness, and health decision-making. At the level of society, the economics of maintaining health and delivering health care can significantly benefit from the research that is carried out in this area. As these sciences have been maturing, our society has come to realize the absolute necessity of the research findings they produce for the understanding and the treatment and prevention of its health problems. To capitalize on these often-transformational changes requires a highly trained work force that is capable of contributing in increasingly multidisciplinary teams that span scientific domains from biology, chemistry, and physics to engineering, informatics and mathematics. Continuing to invest in the training of this workforce is to invest in the health and well-being of this country. RESEARCH TRAINING AT THE NATIONAL INSTITUTES OF HEALTH The history of clinical and research training at the NIH dates back to the naming of the NIH in 1930, when Congress also authorized the first research fellowships in the biological and medical sciences. The ensuing decades have witnessed dramatic growth not only in the NIH budget but also in the number of institutes, the disciplines encompassed, and the mechanisms for funding. From 1975 to 2008 the National Research Service Award (NRSA) program has provided traineeship and fellowship support at the predoctoral level for about 40,000 graduate students in the biomedical, behavioral and social, and clinical sciences. At the postdoctoral level, during this period about 31,000 trainees and fellows were supported across the same broad fields.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences BOX 1-1 Research Training at the National Institutes of Health The origins of research training at NIH date to 1930, when the Ransdell Act changed the name of the Hygienic Laboratory to the National Institute of Health (a single institute at that time) and authorized the establishment of fellowships for research into basic biological and medical problems. While the harsh economic realities of the Great Depression imposed constraints, this legislation marked a new commitment to public funding of medical research and training. The National Cancer Act of 1937, which established the National Cancer Institute (NCI) within the Public Health Service (PHS), funded the first training programs targeting a specific area. This legislation supported training facilities and the award of fellowships to outstanding individuals for studies related to the causes and treatment of cancer. In 1938, 17 individuals received fellowships in cancer-related research fields, such as biochemistry, physiology, and genetics. NCI became part of NIH with the passage of the Public Health Services Act of 1944—the legislative basis for NIH’s wartime and postwar expansion of research and training programs and, more generally, for a major federal commitment to support biomedical research. This expansion was supported by legislative actions that converted existing divisions within NIH to institutes and centers and the establishment of new institutes or centers, each with field-specific training and research missions. In particular, the first of these laws—the National Heart Act of 1947—established the National Heart Institute and changed the name of the National Institute of Health to the National Institutes of Health. Throughout the 1940s, 1950s, and 1960s there was substantial growth in the NIH budget, with annual increases averaging 40 percent from 1957 to 1963 (with dollar increases ranging from $98 million to $930 million). This funding raised the number of grants to academic institutions and enabled greater federal assistance in both the construction of research facilities and the establishment of fellowship and training programs for research personnel; it even allowed for limited investment in the support of research in foreign countries. The growth in research and training support slowed in the late 1960s, to about 6 percent annually, with a consequent decline in the number of research grants, both foreign and domestic, and a curtailment of facilities construction. Support in the 1970s reflected public and congressional interest in specific diseases. Legislation provided increased funding for such research areas as cancer and pulmonary and vascular disorders, and the eleventh institute on the NIH campus, the National Institute on Aging (NIA), was established in 1974. The NIA also brought a new perspective to NIH in that it was authorized to support not only biological research but also social and behavioral research. While funding for research in targeted areas was welcomed at NIH, this also meant that research in less visible areas tended to decline. Institutes such as the National Institute for General Medical Sciences and the National Institute of Allergy and Infectious Diseases saw annual average reductions of about 10 percent. By the early 1970s, training support was authorized through the different institutes and centers by 11 separate pieces of legislation. However, in its fiscal year 1974 budget recommendations, the administration proposed the phasing out of research training and fellowship programs over a five-year period by making no new awards and honoring only existing commitments. The reasons it cited for this proposal were that the need for such programs and the manpower trained by them had never been adequately justified, people trained in these programs earned incomes later in life that made it reasonable to ask them to bear the cost of their training, large numbers of those trained did not enter biomedical research or continue their training, alternative federal programs of support for this training were available, and the programs were not equitable because support was not available equally to all students. The administration’s proposal met with virtually universal opposition by members of the nation’s biomedical research community. As a result, the administration revised its position and proposed a new, but smaller, fellowship program at the postdoctoral level. This proposal also met with objections, and in 1974 Congress enacted the National Research Act (P.L. 93-348), which amended the Public Health Services Act by repealing existing research training and fellowship authorities and consolidating them into the National Research Service Award (NRSA) program. The legislation authorized support for individual and institutional training grants at the predoctoral and postdoctoral levels, with the stipulation that an individual could be supported for no more than 3 years. Moreover, to safeguard against some of the cited abuses of the former programs, it restricted training support on the basis of subject-area shortages and imposed service obligations and payback requirements. In the years since the National Research Act was signed, the law governing the NRSA program has been modified several times in order to include new areas of research training and to establish funding levels for selected disciplines. The first change came in 1976, when Congress extended the program to encompass research training in nursing. Then, in 1978, Congress expanded the NRSA program to cover training in health services research. In 1985 the program was enlarged once again to include training in primary care research. Specific funding targets for training in health services and primary care research were established with the Health Research Extension Act of 1985, when Congress required that 0.5 percent of NRSA funds be allocated to each of the two fields. The same law directed that funds for training in health services research be administered by the Agency for Health Care Policy and Research and its successor, the Agency for Healthcare Research and Quality. Research training in primary care originally came under the purview of NIH but in 1988 was delegated to the Health Resources and Services Administration by Congress after concerns were raised that NIH was interpreting the meaning of “primary care” too broadly. Funding levels for training in health services and primary care research were increased to 1 percent of the NRSA budget with the passage of the NIH Revitalization Act of 1993, and these two fields remain the only ones for which specific funding levels have been established by law. SOURCE: NRC. 2005. Advancing the Nation’s Health Needs: NIH Research Training Programs. Washington, DC: The National Academies Press, pp. 5-7.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences Career Development Programs While the education and training of graduate students and postdoctoral fellows prepares individuals to do research, the NIH recognized the need for programs that would help such individuals go on to establish strong and productive research careers. In the 1980s they initiated programs (the K awards) to facilitate the transition from trainee to research scientist and to give established scientists the opportunity to pursue new research directions. These programs had two goals: (1) to provide Ph.D. scientists with the advanced research training and additional experiences needed to become independent investigators, and (2) to provide holders of clinical degrees with the research training needed to conduct patient-oriented research. Dual Degree Training The Medical Scientist Training Program (MSTP) was established by the National Institute of General Medical Sciences (NIGMS) in 1964 to fund research training leading to the M.D./Ph.D. degree in order to better bridge the gap between basic science and clinical research.. Graduates complete the dual degree in about 8 years. Composing only about 2.5 percent of medical school graduates, M.D./Ph.D.s annually receive about 33 percent of the NIH grants made to physician-scientists—attesting to their impressive level of research productivity. Indeed, by 2004 the number of first-time M.D./Ph.D. applicants for NIH R01 grants approximately equaled the number of M.D. first-time applicants even though the total populations of M.D.s and M.D./Ph.D.s are vastly different. In 2009, 10.5 percent of tenured or tenure-track faculty held dual degrees, and they made up 11.1 percent of the clinical department faculty and 8.7 percent in basic sciences department faculty. The dual-degree program started in 1964 with three M.D./Ph.D. programs—at the Albert Einstein College of Medicine, Northwestern University, and New York University—with 66 trainees; by 2009 the program had grown to include more than 2,000 M.D./Ph.D. trainees at more than 75 institutions nationwide, supported by a complex mix of federal plus diverse institutional and extra-institutional funding sources. MSTP graduates receive training in a diverse set of fields, including not only the biological sciences but also the chemical and physical sciences, social and behavioral sciences, economics, epidemiology, public health, computer science, bioengineering, biostatistics, and bioethics. Although the fact that the program is expensive has repeatedly led to concerns about whether it is justified in terms of the overall outcome, several reports suggest that the MSTP has delivered on its promise to create a strong workforce of physician scientists. In 1998 NIGMS published a matched sample study that compared individuals who completed a MSTP program with those who had an M.D., Ph.D., or M.D. /Ph.D. from a non-MSTP program and found that MSTP recipients were more likely both to publish and to apply for and receive grants from the NIH.1 Graduates from a non-MSTP dual-degree program were also found to be highly productive. Most recently, a report by Brass et. al. has provided strong evidence for the success of this approach in supplying a dedicated and well trained cadre of clinician biomedical scientists.2 This report examined the graduates of 24 M.D./Ph.D. programs including 4 that were not receiving NIH MSTP support. Twenty of the programs were among the 42 receiving MSTP support. Their finding that 82 percent of the program graduates are doing research and have funding is consistent with that of the NIH study of MSTP graduates. An important observation was that program graduates pursue a broad range of research areas and that many are conducting translational and patient-oriented research as well as basic research. Already such individuals are making major contributions both in terms of new discoveries and also in infusing research strength into major clinical departments in medical schools across the country. By any criteria this program can now be judged a success. In Chapter 3 we recommend an expansion of the program and encourage that it be diversified to a degree into non-bench-oriented disciplines. Minority Programs at the NIH NIH has been active in the recruitment of underrepresented minorities into careers in research for nearly 40 years, working through a constellation of support mechanisms targeted at specific populations under the Minority Access to Research Careers (MARC) program and the Minority Biological Research Support (MBRS) program. Both the MARC and the MBRS programs are housed in NIGMS, which encourages cooperation with the other parts of the institute and regularly promotes MARC and the MBRS program activities through conferences and other events. In addition, there are special initiatives that promote training and career development for minorities, such as the Bridges to the Doctorate Program, which provides support to institutions to help students make the transition from master’s to Ph.D. programs. Minority graduate students working toward the Ph.D. or M.D./Ph.D. degree are also supported through the MARC program by F31 fellowship awards. The full range of minority programs for graduate students and post-doctorates housed in NIGMS and other institutes is described in detail in Chapters 4 and 5 of the 2003 National Research Council (NRC) report3 Assessment of NIH Minority Research and Training Programs, Phase 3. 1 National Institute of General Medical Sciences, 1998. Available at http://publications.nigms.nih.gov/reports/mstpstudy/. 2 Brass, L. F., M. H. Aabas, L. D. Burnley, D. M. Engman, C. A. Wiley, and O. S. Andersen. 2010. Are MD-PhD Programs Meeting Their Goals? An Analysis of Career Choices Made by Graduates of 24 MD-PhD Programs. Academic Medicine 85(4):692-701. 3 NRC. 2005. Assessment of NIH Minority Research and Training Programs, Phase 3. Washington, DC: The National Academies Press.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences BOX 1-2 History of Minority Programs at the NIH In 1972, at about the same time that the NRSA program was established, the Minority Schools Biomedical Support program—under the administration of the NIH Division of Research Resources—began awarding grants to faculty and students at minority institutions. That same year research awards were made to minority faculty under the Minority Access to Research Careers (MARC) Visiting Scientist and Faculty Fellowship program, and in 1974 MARC was officially established within NIGMS as a formal program to stimulate undergraduates’ interest in biomedical research and to assist minority institutions in developing strong undergraduate curricula in the biomedical sciences. In 1977 the MARC Honors Undergraduate Research Training (HURT) program was established, and in 1981 the MARC Predoctoral Fellowship program was created to provide further incentive for graduates of the HURT program to obtain research training in the nation’s best graduate programs. These programs continue today with some modifications, such as the replacement of the MARC HURT program with the MARC Undergraduate Student Training in Academic Research program, which is designed to help meet the need for continual improvement in institutional offerings. Other additions have included the Post-Baccalaureate Research Education Program Award, MARC Faculty Predoctoral Fellowships, MARC Faculty Senior Fellowships, MARC Visiting Scientist Fellowships, and MARC Ancillary Training Activities. As the MARC programs have been growing, the Minority Schools Biomedical Support program also has been evolving. When eligibility for the program was expanded in 1973, it was renamed the Minority Biological Support program; its name was changed again in 1982 to the Minority Biological Research Support (MBRS) program in order to reflect its research scope. This MBRS program was transferred to NIGMS from the Division of Research Resources in 1988, and the NIGMS established the Minority Opportunities in Research (MORE) program branch to serve as the focal point for efforts across NIH to increase the number and capabilities of minority individuals engaged in biomedical research and teaching. In 1996 the MORE Faculty Development and Initiative for Minority Student Development awards were established, and in 1998 the Institutional Research and Academic Career Development Award was announced to encourage postdoctoral candidates’ progress toward research and teaching careers in academia. SOURCE: NRC. 2005. Advancing the Nation’s Health Needs: NIH Research Training Programs. Washington, DC: The National Academies Press, p. 7. NATIONAL RESEARCH SERVICE AWARD PROGRAM In its almost 40-year history, the National Research Service Award (NRSA) program has provided more than 160,000 training slots in the biomedical, behavioral, and clinical sciences to students and young investigators. This has been accomplished through a combination of individual fellowship awards and institutional training grants. Over the 10-year period from 1998 to 2007, trainees were to be found in some 258 universities, research institutes, and teaching hospitals. As the NIH and the Public Health Service (PHS) have grown over the past quarter of a century, the NRSA program has evolved to include new fields in the basic biomedical sciences, such as genome research and neuroscience, and has expanded to support training in such clinical sciences as communication disorders, health services, primary care, oral health, and nursing. Institutional training grants, which fund the education of about 83 percent of NRSA participants, are widely regarded as one of the best avenues for learning the theories and techniques of biomedical and behavioral research.4,5 These programs are overseen by awardee institutions rather than by individual research mentors, and this allows for the implementation of trans-institutional standards for trainee stipends and benefits, mandated instructional programs in such foundational areas as the responsible conduct of research (RCR), the ethical conduct of human and animal subjects research, and sundry career development and counseling programs addressing such topics as grant writing and reviewing, publication practices, mentorship, laboratory management, and preparation of resumes. Institutional training grants assure institutional ownership of, and responsibility for, the quality of trainees and their training programs as well as making available professional and career development services that may not otherwise be accessible to trainees on individual fellowships. In other words, in order to gain support for a training grant application, each institution has to review and strengthen all of its approaches to graduate education, a process from which all students benefit, not just those specifically supported by the training grant. Individual fellowships, which support almost 18 percent of NRSA recipients at the predoctoral level and 35 percent at the postdoctoral level, are also awarded on a competitive basis and provide what is often a first step toward professional independence. Fellows develop their own proposals and, once an 4 NRC. 1995. Reshaping the Graduate Education of Scientists and Engineers. Washington, DC: National Academy Press. 5 NRC. 1998. Trends in the Early Careers of Life Scientists. Washington, DC: National Academy Press.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences award has been made, are generally accorded a great deal of autonomy in pursuing their educational and research goals. In the years since the NRSA program was established, funding for research training has grown overall much more slowly than the NIH budget. In 1975, when the NRSA program began, it supported 3,752 graduate students and postdoctoral fellows, and this grew to 11,565 slots by 1980. Thirty-two years after this, when the NIH budget had grown by more than 1300 percent (in nominal dollars), the NRSA program supported only 13,790 slots per year. The level of support has been approximately stable since 1995. It is important to note that these numbers refer to available “slots” on the grants, and since a given student is often appointed for more than one year, this measure of level of support overestimates the actual number of students supported by this mechanism, possibly by as much as two-fold. The NRSA provides but a small part of NIH’s total support for graduate education—about 22 percent—while roughly two-thirds of the nation’s graduate student support is in the form of Research Assistant-ships funded directly by NIH research grants. The relative numbers of trainees at the predoctoral and postdoctoral levels have varied over the life of the program. More training was initially provided at the postdoctoral level, but by 2008, 55 percent of the trainees were predoctoral. The training mechanisms (i.e., trainee vs. fellow) have also changed. Although the growth in predoctoral training has predominantly been at the individual fellowship level, in absolute terms the trainees still far outnumber fellows. In contrast, the decline in postdoctoral training has been all at the fellowship level (see Table 1-1). These numbers do not reflect the actual number of predoctoral and postdoctoral trainees and fellows since an individual may receive support for up to 3 years. In recent years the average median time for a trainee has been 2 years, which implies that the actual number of graduate students who have received predoctoral support is less than the total in the table by a factor of about two. The average period for fellows is slightly longer at 2.2 years. In summary, this means that about half of the 6,641 trainees in 2008 and a little over half of the 1,537 fellows in 2008 should be counted as also TABLE 1-1 NRSA Trainees and Fellows, by Broad Field, 1975-2008 FY 1975 1980 1985 1990 1995 2000 2005 2006 2007 2008 Basic Biomedical Sciences Predoctoral Trainees (T32) 1,009 4,184 4,026 4,701 5,095 4,628 4,845 4,516 4,937 5,390 Predoctoral Fellowship (F30, F31) 27 21 80 123 411 400 862 962 1,074 1,154 Postdoctoral Trainees (T32) 474 2,200 2,128 2,232 2,191 2,310 2,598 2,463 2,386 2,475 Postdoctoral Fellowship (F32) 1,106 1,982 1,583 1,483 1,679 1,598 1,365 1,374 1,291 1,284 Total 2,616 8,387 7,817 8,539 9,376 8,936 9,670 9,315 9,688 10,303 Behavioral and Social Sciences Predoctoral Trainees (T32) 208 655 501 619 505 451 506 522 421 416 Predoctoral Fellowship (F30, F31) 125 74 41 58 101 207 214 183 154 147 Postdoctoral Trainees (T32) 32 368 392 398 411 465 460 401 350 301 Postdoctoral Fellowship (F32) 146 131 86 78 112 114 104 77 50 50 Total 511 1,228 1,020 1,153 1,129 1,237 1,284 1,183 975 914 Clinical Sciences (Excluding Health Services) Predoctoral Trainees (T32) 65 284 379 385 830 558 633 602 711 807 Predoctoral Fellowship (F30, F31) 3 2 8 153 108 123 190 209 222 228 Postdoctoral Trainees (T32) 346 1,408 1,714 1,287 1,553 1,467 1,893 1,930 1,872 1,968 Postdoctoral Fellowship (F32 ) 211 250 180 99 75 93 140 131 137 143 Total 625 1,944 2,281 1,924 2,566 2,241 2,856 2,872 2,942 3,146 Health Services Research Predoctoral NIH Predoctoral Trainees 0 3 10 11 6 0 20 27 28 28 NIH Predoctoral Fellows 0 0 1 1 4 8 14 7 8 8 AHRQ Predoctoral Trainees 0 0 8 22 19 3 71 67 76 71 AHRQ Predoctoral Fellows 0 0 0 0 0 0 1 2 1 2 Total 0 3 19 34 29 11 106 103 113 107 Health Services Research Postdoctoral NIH Postdoctoral Trainees 0 3 5 31 16 0 31 39 29 40 NIH Postdoctoral Fellows 0 0 1 2 1 1 4 3 3 5 AHRQ Postdoctoral Trainees 0 0 5 5 1 3 40 35 37 40 AHRQ Postdoctoral Fellows 0 0 0 3 0 0 2 2 3 2 Total 0 3 11 41 18 4 77 79 72 85 Total All Fields 3,752 11,565 11,148 11,691 13,118 12,429 13,993 13,552 13,790 14,555
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences supported in a previous year, which indicates that the actual number of trainees is about 3,700 individuals per year. This is consistent with NIH data on the number of Ph.D.s with some form of NRSA support, which, allowing for attrition, stands at about 3,000 Ph.D.s. The relative distribution of trainee support between the biomedical sciences (70 percent) and all the other areas supported by the NRSA mechanism has changed little over the years. However, the number of NRSA-supported trainees in the social and behavioral sciences has declined recently. Until 2000 the percentage of trainee slots in this area was almost constant at 10 percent, but by 2007 it had fallen to 7.1 percent. In contrast, during this interval the number of supported trainee slots in clinical training increased from 18 percent to 21.3 percent. Evaluation of the NRSA Program A number of attempts have been made to quantify the value of NRSA training. In 1984, NIH conducted an extensive evaluation of the program, with a follow-up evaluation in 1998. These evaluations showed that NRSA trainees and fellows graduated 3 months sooner than those without NRSA support at the same institutions and 7 months sooner than their counterparts at institutions without any NRSA grants. In addition, nearly 58 percent of the NRSA trainees and fellows had received their doctorate by the age of 30, as compared with 38.9 percent and 32.3 percent for the non-supported doctorates from NRSA and non-NRSA institutions, respectively. One factor that may play a role in the difference is that if students are not NRSA supported, they may have significant teaching assistantship responsibilities, which may contribute to a longer time to degree. Following graduation, NRSA predoctoral trainees and fellows were more likely to move quickly into research positions. In fields where postdoctoral study was common, 93 percent of the trainees and fellows reported having definite postdoctoral commitments, compared to 80 percent of graduates in the same fields at non-NRSA institutions. It is difficult to report career path progression accurately, since people move in and out of positions and postdoctoral appointments tend not to be for fixed time periods, but NRSA trainees and fellows appeared to be more likely to move into faculty or research positions. About 37 percent of the NRSA recipients held faculty positions 7 to 8 years past the doctorate, compared to 16 percent from non-NRSA institutions. Also, 87 percent of previous NRSA trainees and fellows, compared to 72 percent from non-NRSA institutions, were in research-related positions in academia, industry, or other research settings. If one examines research grants and publications as measures of research productivity, one finds that the NRSA trainees and fellows were more likely to have grants and more publications. For example, among the 1981-1988 Ph.D.s who had applied to NIH by 1994 for research grant support, the success rate for NRSA recipients was 67 percent, compared with 47 percent for non-NRSA institution graduates. With regard to publications, NRSA predoctoral trainees and fellows in the 1981-1982 cohort had a median number BOX 1-3 NIH Evaluations of the NRSA Program A 1984 evaluation of formal NIH-sponsored research training (which included programs existing before the establishment of the NRSA) found that a larger percentage of participants in NIH training programs completed their doctoral programs and went on to NIH-supported postdoctoral training than among their counterpart trainees. Furthermore, those supported by the NIH during their predoctoral studies were more likely to apply for and receive NIH research grants, authored more articles, and were cited more often by their peers. At the postdoctoral level, both those appointed to institutional training grants and recipients of individual fellowship awards were more likely to pursue research careers than their colleagues without formal NIH research training, and the former were more successful by such measures of achievement as obtaining research funds, publication, and citations by their peers. These differences were true for M.D.s with postdoctoral research training as well as for Ph.D.s. A follow-up to the 1984 evaluation of the NRSA Predoctoral Program was conducted in 1998, and many of the findings from the earlier study were found to still hold true. The 1998 study examined the characteristics of NRSA-supported doctorates between FY 1981 and 1992 against their Ph.D. counterparts at institutions with NRSA training grants who did not receive this type of support and at another group at institutions without NRSA grants.a The study found that 80 percent of the NRSA trainees or fellows received their Ph.D. from 50 institutions that ranked in the top quarter of all biomedical sciences programs, and nearly 60 percent received their degree from the top 25 institutions. The completion rate for students supported by the NRSA program was an estimated 76 percent and was comparable to that of other merit-based, national fellowship programs and of students in high-quality doctoral programs. a National Institute of General Medical Sciences, 1998. Available at http://publications.nigms.nih.gov/reports/mstpstudy/.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences of publications twice that of doctorates from institutions without NRSA grants, 8.5 publications as compared to 4. Non-NRSA-supported Ph.D.s at NRSA institutions also had fewer publications by almost as large a margin, 5 publications as compared with 8.5. Such studies do not, of course, indicate whether the success of former NRSA trainees and fellows reflects the training they received, the selection process, or a combination of factors. In addition, as alluded to above, these data have to be viewed with caution because a non-NRSA student in other funded positions such as an assistantship may have to spend additional time in activities not directly related to his or her research. Nonetheless, these findings do suggest that there are significant strengths and achievements within the NRSA program at the predoctoral level. In assessing the needs for training support in the biomedical, behavioral, and clinical sciences, it is important to understand the role of NRSA awards. Although, as indicated above, NRSA awards support only a small fraction of the total number of trainees, the role of these awards in the training process is extremely important for the following reasons: First, they serve to attract highly qualified people into biomedical research. As discussed above, a good example of this is the Medical Scientist Training Program (M.D./Ph.D.), which has a well-established track record for launching physicians into productive—and often outstanding—research careers. Second, they have served over the years to direct training into specific research areas, which have often been emerging areas for which other mechanisms may not be available, such as molecular medicine, biophysics, and bioinformatics, and, as such, they have stimulated cross-disciplinary research. Third, they establish innovative training standards not only for NRSA awardees, but also for all trainees, regardless of their mechanisms of support. This last point is of great importance, and, indeed, over the past decade this may have been one of NRSA program’s most important contributions. A report published in 2006 by ORC Macro for the NIH examined the career achievements of NRSA postdoctoral trainees and fellows from 1975 to 2004. The results of this study were inconclusive. By some measures the trainees had an advantage, and by other measures they did not. Most tellingly, the study concluded that after 12 years the postdoctorates who received NRSA support were largely indistinguishable from those who did not. Unfortunately the study is flawed: The postdoctoral pool is radically different from the predoctoral pool in that more than 50 percent of the postdoctorates are internationals and thus unable to become NRSA trainees because of the citizenship restrictions. Presumably, the international pool contains a significant number of equally talented and creative individuals who are well equipped to compete with the U.S.-trained postdoctorates, thus rendering any relative performance conclusions moot. NATIONAL RESEARCH COUNCIL ROLE IN ASSESSING PERSONNEL NEEDS The Study’s Origins Since 1975, the NRC has issued regular reports on the supply of biomedical and behavioral researchers in the United States and the likely demand for new investigators. This con- BOX 1-4 National Research Service Award Act of 1974 (P.L. 93-348) Sec. 472. (a) (3) Effective July 1, 1975, National Research Service Awards may be made for research or research training in only those subject areas for which, as determined under section 473, there is a need for personnel. Sec. 473. (a) The Secretary shall, in accordance with subsection (b), arrange for the conduct of a continuing study to— (a) establish (A) the Nation’s overall need for biomedical and behavioral research personnel, (B) the subject areas in which such personnel are needed and the number of such personnel needed in each such area, and (C) the kinds and extent of training which should be provided such personnel; (b) assess (A) current training programs available for the training of biomedical and behavioral research personnel which are conducted under this Act at or through institutes under the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration, and (B) other current training programs available for the training of such personnel; (c) identify the kinds of research positions available to and held by individuals completing such programs; (d) determine, to the extent feasible, whether the programs referred to in clause (B) or paragraph (2) would be adequate to meet the needs established under paragraph (1) if the programs referred to in clause (A) of paragraph (2) were terminated; and (e) determine what modifications in the programs referred to in paragraph (2) are required to meet the needs established under paragraph (1). (c) A Report on the results of the study required under subsection (a) shall be submitted by the Secretary to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate at least once every four years.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences tinuing series of reports was initiated by the U.S. Congress with the passage of the National Research Service Award Act of 1974,6 which consolidated the variety of research training activities then sponsored by the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration into a single, inclusive program: the National Research Service Awards. In the same legislation, Congress decreed that National Research Service Awards be made only in areas for which “there is a need for personnel” and directed that the National Academy of Sciences be asked to provide periodic guidance on the fields in which researchers were likely to be needed and the numbers that should be trained (see Box 1-1). The present study is the twelfth completed by the NRC, the operating arm of the National Academy of Sciences, the Institute of Medicine, and the National Academy of Engineering. Past Reports To date there have been 12 assessments of the “national need” for research personnel in the biomedical and behavioral sciences conducted by the NRC, and while the purpose of these assessments was to provide NIH and the Congress with information that could be used to make budget decisions, the manner in which the assessments should be conducted or the scope of the investigation has been left to the discretion of the NRC. Those who conducted the first assessment in 1974 chose to limit its study to the demand for faculty, as shaped by federal support for university-based research and enrollments in higher education. It interpreted the faculty research areas broadly to include the basic biomedical sciences, the behavioral sciences, the clinical sciences, and health services research. In their first full-length report, issued the following year, committee members concluded that Ph.D. production in the biomedical and behavioral sciences was more than adequate to meet existing demand. In studies conducted from 1977 to 2002, subsequent committees incorporated employment trends in industry, government, teaching hospitals, and similar settings in their assessments of the demand for biomedical research personnel. In 1985 and 1989, the committees recommended additional research training in the basic biomedical sciences, due in part to increased demand from the biotechnology industry. The 1994 committee advised that training in the biomedical sciences be maintained at existing levels but called for an increase in research training in the behavioral sciences. The 1994 report also redefined the scope of its investigation by highlighting a number of issues that were of particular concern to the administrators of the NRSA program. These included the growth of the Ph.D. population in the biomedical sciences, the decline in the number of physician researchers, the recognition that the behavioral sciences should play a more important role in health care, the decline in the relative share of graduate students funded by training grants, and the lack of promising research career options for young scientists, among other concerns. These and other issues related to the state of the nation’s research workforce have to this day been the focus of considerable attention and discussion and the subject of numerous national meetings, public policy studies, and congressional hearings. Some of this activity was prompted by the 1994 “national needs” report itself and the subsequent response to it by the NIH, the Agency for Health Care Policy and Research (AHCPR), and the Health Resources and Services Administration.7 Of the eight major recommendations put forth by the 1994 committee, the agencies focused on two: increasing the stipends for trainees and fellows, and evaluating the NRSA program. Although they did not require any new steps, the suggestions put forth in the 1994 report for maintaining training levels in the basic biomedical sciences and for increasing the numbers of underrepresented minorities were also adopted. At the same time, however, recommendations for increasing the number of NRSA training grants and fellowships in the behavioral and clinical sciences, oral health, nursing, and health services research were not acted upon, prompting a congressional inquiry in the fiscal year 1997 appropriations for the NIH. In explaining their actions to Congress, the NIH and the other agencies indicated that they had focused on the highest priority recommendations and were likely to continue to direct additional research training monies to stipends until NRSA stipend levels were comparable to other sources of research training support. In the meantime, other reports on clinical research and training were being issued. In its 1994 report Careers in Clinical Research: Obstacles and Opportunities,8 the Institute of Medicine (IOM) recommended (a) further evaluating clinical research training programs, (b) redirecting funds to the most effective forms of clinical research training, (c) emphasizing training programs that provide an opportunity to earn an advanced degree in the evaluative sciences, (d) increasing the number of M.D. /Ph.D. and D.D.S./Ph.D. programs that train investigators with expertise in patient-oriented research, and (e) expanding initiatives that reduce educational debt, either through tuition subsidies, as in the case of M.D. /Ph.D. programs, or loan forgiveness. In 1997 an NIH panel produced a report on the status of clinical research in the United States, including the recruitment and training of future clinical researchers.9 The panel recommended: (a) initiating clinical research training programs 6 National Research Service Award Act of 1974, Public Law 93-348. 93rd Congress, June 28, 1974. 7 NIH. 1997. Implementing the Recommendations in the 1994 Report from the National Academy of Sciences: Meeting the Nation’s Needs for Biomedical and Behavioral Scientists. Unpublished report to Congress. Washington, DC: NIH. 8 IOM. 1994. Careers in Clinical Research: Obstacles and Opportunities. Washington, DC: National Academy Press. 9 NIH. 1997. Director’s Panel on Clinical Research. Report to the Advisory Committee to the NIH Director. Washington, DC: NIH.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences aimed at medical students, such as M.D./Ph.D. programs for clinical research, (b) ensuring that postdoctoral training grants include formal training in clinical research, (c) providing new support mechanisms for young and mid-term clinical investigators, and (d) taking steps to reduce the educational debt of clinical investigators. Some of these recommendations had already been put in place at NIH before the panel report was completed. These included: (1) a program to bring medical and dental students to NIH’s Maryland campus for a one to two years of clinical research training; (2) new NIGMS guidelines for its M.D./Ph.D. program to encourage research training in fields such as computer sciences, social and behavioral sciences, economics, epidemiology, public health, bioengineering, biostatistics, and bioethics; and (3) three new career development awards for young and mid-career investigators focused on careers in clinical research. This current report will again stress the value of additional training in informatics, social and behavioral sciences, epidemiology and biostatistics, and bioethics. In a related area, another Institute of Medicine committee published the results of a study on the training and supply of health services researchers. In its 1995 report, Health Services Research: Workforce and Educational Issues, the IOM committee endorsed the number of training positions in health services research that had been recommended in the 1994 “national needs” study. The committee also encouraged the AHCPR to focus its training funds on areas in which researchers were reported to be in short supply, such as outcomes measurement, biostatistics, epidemiology, health economics, and health policy, and to set aside a number of institutional training grants for innovative research training programs. In response, the Agency for Healthcare Research and Quality made “innovation awards” to 10 institutions in 1998 to support the design and implementation of new models of health services research training. Just as clinical research training has been the subject of multiple studies since the 1994 NRC report, so too has doctoral training in the basic biomedical sciences; some of these studies have also encompassed the behavioral sciences. In a 1995 study commissioned by the National Science Foundation, the NRC’s Committee on Science, Engineering, and Public Policy reviewed graduate education across the biological, physical, and social sciences and engineering. The report, Reshaping the Graduate Education of Scientists and Engineers, urged universities to provide a broader range of academic options and better career guidance for their students and called for federal agencies to encourage this trend through training grants. Partly in response, new NIGMS training grant guidelines encouraged graduate programs to provide opportunities for trainees to take internships in industry and gain experience in teaching as well as to provide them with information on the career outcomes of graduates and with seminars on employment opportunities and career counseling. Shortly after Reshaping the Graduate Education of Scientists and Engineers was published, William Massy and Charles Goldman published a paper using mathematical modeling to demonstrate that U.S. universities were overproducing Ph.D.s in fields such as engineering, mathematics, and the biological sciences, thus creating a group of Ph.D.s that was chronically underemployed. They concluded that increases in research funding would be likely to worsen job prospects for Ph.D.s and urged academic departments to bring the production of Ph.D.s into balance with the demands of the labor market—not just the demand for research and teaching assistants. In 1996 the Federation of American Societies for Experimental Biology convened a conference to discuss these topics, which concluded with participants opposing any national regulation of the size of graduate programs. Instead, the participants called for data on employment trends to be made available to students and for universities to “self-regulate” the size of their graduate programs. Institutions were urged to refrain from admitting graduate students in order to meet needs for teaching or research assistants. Information about institutions that have aggressively reduced the size of their biomedical graduate programs is lacking. Subsequently, an NRC committee examining the career paths of young investigators issued a report in the fall of 1998 that also called for restraining the rate of growth in the number of graduate students in the life sciences. In Trends in the Early Careers of Life Scientists, the NRC committee noted that the number of Ph.D.s awarded annually might already be too high and called for prospective students to be better informed about research careers. The committee urged the government to consider restricting the numbers of graduate students supported by research grants and to emphasize research training via training grants and fellowships, acknowledging at the same time that the number of Ph.D.s produced is ultimately determined at individual and campus levels. Although universities control the influx of graduate students into their programs, experience shows that they (unsurprisingly) tend to include their specific workforce needs in their calculations, and the data clearly indicate that they have not collectively restricted the growth of the graduate student pool. The fact of the matter is that the bulk of the creative work and discovery in the biomedical sciences is driven by R01 grants to individual faculty members. These faculty members are under immense pressure to be productive, and a workforce composed of trainees is vastly more effective than one composed of technical assistants. The trainee workforce is also much less expensive to the individual grant than senior research personnel such as instructors or research faculty. It has to be recognized that this system has been enormously successful over many years; it also has to be acknowledged that if R01 support increases, then the number of trainees will ineluctably increase in lockstep, as happened during the recent doubling of the NIH budget. And if there are insufficient U.S. national trainees, then faculties will aggressively look to international Ph.D.s to fill the gap. No
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences amount of well-intentioned urging of institutions to self-correct will change this equation. The important question to be asked is, If this is such a successful model in terms of scientific progress and return to the taxpayers’ investment, then what responsibility do we have to these young men and women as they complete their contributions to research during their training period? This will be addressed in the recommendations below. The 2000 assessment of the need for research personnel, which was begun in 1997, concentrated on the three broad fields of biomedical, behavioral, and clinical research, with dental, nursing, and health services research included in the third category. A major change from earlier reports was the movement away from detailed recommendations on the number of individuals who should be trained under the NRSA program and the use instead of a demographic life-table model, proposed in the 1994 report, to estimate the size of the workforce each year up to 2005. The life-table model was adopted because previous models of supply and demand had proved unreliable for valid forecasts. The life-table-based analysis considered such factors as the average age of current investigators in the biomedical and behavioral sciences, the number of Ph.D.s expected to join the workforce in the years ahead, and the likely effect of retirements and deaths. The committee supplemented this analysis by reviewing such indicators of short-term demand as trends in faculty and industry hiring and perceptions of the job market by recent Ph.D.s. The model was implemented for the biomedical and behavioral sciences and showed that the supply of doctorates, even if at a low level, would be much greater than the need for researchers during the projection period. This finding prompted the committee to recommend that degree production be maintained at current levels in all three broad fields. It did, however, make recommendations for increases in clinical research training related to patient care and in interdisciplinary research in the biomedical and behavioral fields. Many of the committee’s recommendations concerned the administration of the NRSA program; the NIH, in response to the report, established new guidelines for stipends at the predoctoral and postdoctoral levels, supported the recommendation on early completion of doctoral and postdoctoral education and training, and supported limitations on the period of NRSA support at the predoctoral and postdoctoral levels. The study immediately preceding this one was begun in late 2002, and the study report was published in 2005. That study built on the 2000 assessment and used the same life-table analysis to make projections from 2005 to 2011 in each of the main fields. Individual chapters in the report were devoted to oral health, nursing, and health services research, but no projections of the workforce were made in these areas since there were insufficient data. Because the numbers of individuals working in these areas are less than in the three major fields, a life-table model was considered impractical. In terms of workforce projections, the study committee concluded that training in the biomedical, clinical, and behavioral and social sciences should remain at least at the 2003 level, and training after 2003 should be commensurate with the rise in the total NIH extramural research funding in the three fields. There were several reasons for the committee’s recommendation concerning the level of NRSA support and for not changing the mechanisms for support. The committee members examined the workforce from the perspective of its size, composition, and age distribution and concluded that it had been fairly stable over recent years. In addition, a life-table analysis of the workforce in each of the three fields showed no signs of over- or under-employment during the period from 2005 to 2011. Degree production, specifically in the biomedical sciences, had leveled off, and the size of the postdoctoral pool was declining. All of these factors led the committee to believe that no change in the level of NRSA support was necessary. It did recommend an expansion of the MSTP by 20 percent and the greater involvement of clinical, health services, and behavioral and social sciences in the program. Other recommendations were made concerning the structure of the NRSA program—in particular, to provide postdoctoral fellows with the normal employee benefits of the institution and to use NRSA awards to target emerging and interdisciplinary areas of research. The committee made a strong recommendation to restructure the career development grants (K awards) to have fewer mechanisms and to implement them consistently across the NIH. The recommendation also called for more flexibility in the management of K grants to allow for transition awards from senior postdoctoral status to independent research positions and for awards to allow individuals to maintain research careers during periods when personal demands prevent full employment status. The recommendations were generally not acted on by NIH. This may in part be due to a set of recommendations that came from another NRC committee concerning the long duration of postdoctoral training in the biomedical sciences and the time it takes to become an independent researcher. This issue was of prime importance at the NIH, and in response to the recommendations from this report the NIH introduced the K99/R00 award, aimed exclusively at Ph.D.s, to provide 5 years of support during the transition from postdoctoral to faculty status. The aim of this program was to maintain and increase a strong cohort of new, well-trained, NIH-supported independent investigators capable of competing for NIH support. THE CURRENT STUDY The current study began in 2008 with the selection of an expert committee to guide the study. The first meeting was in the late spring of that year and was followed by six more meetings, with the last taking place in early 2010. The
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences committee was charged, as were the past few, with the task of examining the current workforce and projecting the need for additional personnel in the biomedical, behavioral and social, and clinical sciences as they pertain to the research mission of the NIH. Individual chapters of this study report are devoted to these fields, and special attention was given to the clinical fields of oral health, nursing, and health services research, with the inclusion of separate chapters, as required in the Statement of Task. In assessing the characteristics of the past and current workforce, datasets from the National Science Foundation and the Association of American Medical Colleges were used. An additional dataset that became available near the end of the study came from the National Research Council Study of Research Doctorate Programs. The value of these datasets depended on whether the study fields were included in their taxonomy or data were collected on degree types. In particular, the clinical sciences posed a problem, since data are not readily available on researchers with medical degrees, and it is difficult to distinguish between basic and clinical research in medical school departments. Projections for the size of the future workforce are provided in Appendices D and E using a life-table model and a systems dynamics model, respectively. The projections were based on different estimates of researchers entering the workforce from doctoral programs and through U.S. immigration and emigration. The task of projecting the workforce was particularly difficult because of the state of the current economy and the unknown future demand for researchers. RECENT DEVELOPMENTS When the study committee first met, the economy was showing the first signs of a downturn that would deepen to a recession and eventually dramatically affect employment and economic development around the world. As the committee reviewed the state of research training in subsequent meetings, it became clear that a projection of the future research workforce in the biomedical, behavioral, and clinical sciences would be difficult to develop from available data and would furthermore be risky, given the uncertain duration and severity of the recession. The workforce was contracting with a decline in industrial employment, especially in the pharmaceutical area, and academic institutions had slowed their expansion of faculty and research facilities in response to the reduced values of endowments and state appropriations as well as the overall economic uncertainty. At the same time, faculty members were delaying retirement, and this in turn was reducing the hiring of junior faculty members. These and other conditions might call for a reduction in research training, even though enhancements to training programs would be of great benefit. Given the current economic realities, the committee recognized that the NIH budget would not allow for the implementation of recommendations that would require new funds. The only possibility was the reallocation of existing resources, and NIH was in the best position to realign their agenda. The committee debated how it could nevertheless fulfill its charge and assist NIH in its decision making, and it concluded that in order to maintain the high standards of the programs and continue to attract the best students into research careers, it would go forward with its recommendations to improve training programs but would prioritize the most important ones and identify the costs. The committee was unanimous in its recommendations and prioritization except for the one recommendation that called for an increase in the indirect cost rates for NRSA awards (see below). RECOMMENDATION ON NRSA POSITIONS The primary task of this committee is to recommend the number of NRSA positions for 2010-2015. Based on the need to maintain a strong research workforce, we recommend that the total number of NRSA positions in the biomedical and clinical sciences should remain at least at the fiscal year 2008 level and that in the behavioral sciences they should increase back to the 2004 level. This increase will require the addition of about 370 training slots at a cost of about $15 million. The committee also recommends that future adjustments in the number of NRSA positions be closely linked to the total extramural research funding in the biomedical, clinical, and behavioral sciences. In recommending this linkage, the committee realizes that a decline in extramural research would imply that there should also be a decline in training. PRIORITIES FOR OTHER RECOMMENDATIONS WITH LARGE COSTS IMPLICATIONS In addition to the recommendation on the number of NRSA positions, there are several other recommendations in this report that require additional resources. Most call for modest increases and could be accomplished by a shifting of resources within an institute or center. Three, however, would require significant additional funds. They are listed below in order of priority. In prioritizing these actions, the committee considered both their costs and their merits as well as likely future constraints on the NIH budget. First, NIH should reinstitute its 2001 commitment to increase stipends at the predoctoral and postdoctoral levels for NRSA trainees. This should be done by budgeting regular, annual increases in postdoctoral stipends until the $45,000 level is reached for first-year appointments, and stipends should increase with the cost of living thereafter. Predoctoral stipends should also be increased at the same proportional rate as postdoctoral stipends and revert to cost-of-living increases once the comparison postdoctoral level reaches $45,000. The estimated annual cost when fully implemented would be about $80 million, or 10 percent of the NRSA budget. If phased in over four years, the $20 million dollar annual
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences increase would be about 2 percent of the NRSA training budget. This should not be implemented by reducing the number of individuals supported by the NRSA program. Second, the size of the MSTP should be expanded by at least 20 percent—and more, if financially feasible—with an emphasis on clinical, behavioral, and social sciences in the expansion. This program has been highly successful in producing researchers in basic biomedical, transitional, and clinical research.10 Again, recommendations to increase MSTP training were made in previous NRSA reports, and an increase was endorsed by NIH following the 2000 NRSA report. Currently there are 911 MSTP slots at an average cost of $41,806 per slot. An increase by 20 percent to about 1,100 slots would increase the MSTP budget by about $7.6 million, or 1 percent of the NRSA budget. Phasing it in over 4 years would not have a significant impact on the budget. Third, NIH should consider an increase in the indirect cost rate on NRSA training grants and K awards from 8 percent to the negotiated rate currently applied to research grants. The increase in the rate could be phased in over time. This would require a five- or six-fold increase in indirect costs, or $191 million for the NRSA program at its current size, assuming that stipends amount to about half of the awards, and $338 million for K awards. There was not unanimity within the committee on this recommendation because of concerns about costs and the reduction in program size that could result with a stagnant NIH budget. An increase of $529 million is significant, even in light of the reasoning that NIH should share the full cost of administrating these programs, but the committee wanted to record its support for the measure and its hope that it could be implemented at some point. The committee had the option of putting forth recommendations without prioritization, but it believed that guidance in these difficult economic times would add to the weight and credibility of the recommendations. 10 The National Institute of General Medical Sciences. 1998. Available at http://publications.nigms.hix.gov/reports/mstpstudy/,