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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences Summary The importance of research for the improvement of health and health care has been recognized both nationally and internationally for many decades. In the United States the most visible sign of this recognition is the strong and enduring support for the National Institutes of Health (NIH). The creation of a research establishment that supports research ranging from very basic to applied has yielded incredible dividends in terms of improving the health care of the nation. Many of these improvements have a common theme: Very fundamental basic research provided an understanding of human physiology that ultimately resulted in improved health care. In many cases, the basic research occurred decades before its application and with no apparent application. Thus, the benefits of research to the health care of the nation are quite clear. To continue to derive and extend these benefits, we require a highly trained workforce. This workforce must have an infusion of new people with new approaches on a steady basis if it is to be successful. An investment in the training of this workforce is an investment in the health of this country. The introduction of the National Research Services Award (NRSA) program in 1973 was a significant step in maintaining this workforce, and while it supports only a small fraction of the predoctoral and postdoctoral scientists in the biomedical, behavioral, and clinical sciences, it has set the standard for training, regardless of the sources of support. The legislation establishing the NRSA program also called for periodic review by the National Research Council of the program and evaluation of the national needs for research personnel, and this report is the thirteenth in the resulting series. The task of assessing and predicting the status of research personnel is complicated by the need for accurate and complete data on the supply and demand of personnel and by the effects of external forces. Examples of the latter are downturns in the economy, the effect that national health care legislation will have on the clinical profession, and possible changes in the flow of international talent in the biomedical sciences with the development of world-class research institutions in foreign countries. The statement of task for the committee is: A committee will advise the National Institutes of Health (NIH) and the Agency for Healthcare and Quality Research (AHRQ) on issues regarding research personnel needs as they relate to the administration of the National Research Service Awards (NRSA) program. The committee will gather and analyze information on employment and education trends of research scientists in the broad fields of the biomedical, behavioral, and clinical sciences, and in the subfields of oral health, nursing, and health services research. The analysis will take into consideration the demographic changes in the United States, changes in disease pattern, and changes in scientific opportunity. The committee will deal broadly with the training needs and direction of the NRSA program as they relate to relevant federal research training policies, the impact of changes in the level of support for research and training, and the emergence of cross-disciplinary research areas. The analysis will include an estimate of the future supply of researchers from the current and future population of graduate students and postdoctorates, and the committee will make recommendations on the overall production rate of research personnel in the biomedical, behavioral, and clinical sciences for the period 2010 to 2015 as it relates to the NRSA program. Separate consideration will be given to training with respect to NIH dual-degree and career development programs, and NIH programs that are designed to address diversity in the research workforce. Reflecting the broad fields identified in the statement of task, the committee divided the research enterprise into three major areas: basic biomedical, behavioral and social sciences, and clinical research. These areas are discussed in detail in individual chapters in this report. Additional chapters are devoted to dentistry, nursing, and health services research, even though these can be thought of as subfields of the major areas. An additional chapter addresses training
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences issues that cut across the above fields. Recommendations are found in the individual chapters and are referenced here by number following the recommendation. FUTURE WORKFORCE PROJECTIONS For each of the three major areas considered—biomedical sciences, behavioral and social sciences, and clinical sciences—the committee commissioned contractors to develop workforce models using two different methods. One is a life-table model, similar to that used in the past two studies, and the other is a new approach that relied on a systems dynamics model. Each model includes estimates of the numbers of new Ph.D.s and M.D.s entering the workforce and of the size of the workforce through 2016. The results of this modeling should be taken as approximations, because the data available to analyze the past and current status of the workforce are incomplete, the career trajectories of new doctorates are not predictable, and most importantly, it is impossible to judge the effects of the current major stresses on the world and national economies, on the budget available for research, and on the state of the world in general with regard to war, disease, and immigration policies. The models predict substantial growth in the biomedical and clinical sciences and little growth in the behavioral and social sciences. The role that foreign scientists will play in influencing the size of the job market in the biomedical and clinical sciences is significant, and changes in the level of participation among these foreign scientists could reduce the predicted growth. The life-table model estimates a larger biomedical workforce in 2016 than does the systems dynamic model for scenarios with the greatest projected workforce entrance. The differences in the workforce projections among the different scenarios are substantial, and it is difficult to predict which scenario will provide the best estimate, considering the status of the economy, the national debt, and research support. Unemployment among trained researchers should remain low; however, in 2006 there was an increase in the number of postdoctorates in all sectors, and this may reflect a weakening of the job market as the NIH budget, after its doubling, was essentially kept constant. ECONOMIC REALITIES When the study committee began its deliberations, the economy was showing the first signs of a downturn that would deepen to a recession and dramatically affect employment and economic development around the world. Spending over the past decade and the cost of the stimulus package have significantly increased the debt of the federal government, and reports such as that from the U.S. Deficit Commission predict massive reductions in U.S. spending. The extent of any future cuts in the NIH budget—and, in particular, the extent of cuts that affect training—is unknown. As the committee reviewed the state of research training, however, it became clear that recommendations that call for increases in the NIH training budget are important and should be made for the health of the current and future research workforce in the biomedical, behavioral, and clinical sciences. Given the current and projected future economic environment, it is unlikely that the NIH budget will allow for the implementation of recommendations that require new external funds. A more realistic possibility is the reallocation of existing resources. It is not within the committee’s charge, nor did we have the information to recommend how funds within the NIH might be reallocated. The NIH is in the best position to realign its agenda. Recognizing that reallocation of existing funds is nearly inevitable, however, we have identified the three most costly recommendations and placed them in priority order. RECOMMENDATION ON THE NRSA POSITIONS The primary task of recommending the number of NRSA positions for 2010-2015 was complicated by the inconclusive results from the two models for projecting the future workforce combined with the existence of major economic uncertainties. Based on the ongoing need to maintain a strong research workforce, the committee recommends that the total number of NRSA positions in the biomedical and clinical sciences should remain at least at the fiscal year 2008 level and in the behavioral sciences should increase back to the 2004 level. Furthermore, future adjustments should be closely linked to the total extramural research funding in the biomedical, clinical, and behavioral sciences (3–1, 4–3, and 5–1). In recommending this linkage, the committee realizes that in the case of a decline in extramural research, a decline in training would also be appropriate. The year 2008 is the last year for which the most complete data are available and represents the highest level of support in recent years in the biomedical and clinical sciences. In contrast, 2008 support in the behavioral sciences declined from the 2004 level. Bringing the level of support in the behavioral and social sciences in 2008 up to the level in 2004 would require the addition of about 370 training slots at a cost of about $15 million. Considering the importance of research in this area, a return to the previous level is essential. The highest quality of workforce is necessary for a successful research enterprise. The NRSA program is important in this regard. Even if it trains only a small fraction of all the students and postdoctoral fellows involved in research, these training programs set the standards for the entire research training establishment. In addition, they attract high-quality students into research and into fields of particular need. The record of success of NRSA award holders in obtaining research funding is impressive, and the results of the nation’s training efforts are self-evident: The United States continues as a world leader in research.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences PRIORITIES FOR OTHER RECOMMENDATIONS WITH LARGE COST IMPLICATIONS In addition to the recommendation on the number of NRSA positions, there are several other recommendations in this report that will 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 priority order. In prioritizing these actions, the committee considered both their cost and their merits, along with likely future constraints on the NIH budget. 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 at 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 (2–1). When fully implemented, the estimated annual cost of this recommendation would be about $80 million, or 10 percent of the NRSA budget. If phased in over four years, the $20 million dollar annual increase would be about 2 percent of the NRSA training budget. This increase should not be accomplished by reducing the number of individuals supported by the NRSA program. Despite the cost, the committee thought this increase to be sufficiently important to give it the highest priority. It has been almost 10 years since NIH endorsed the recommendation from the 2000 National Research Council (NRC) report and subsequently instituted a plan to increase the minimum postdoctoral stipend to $45,000 with proportional increases at the predoctoral level. But after a few years of implementation, there were no compensation increases, and in the past two years the increases were 1 percent. By returning to its targeted minimum, the NIH would allow NRSA stipends to be competitive and would retain the best trainees in the program. The quality of the workforce cannot be maintained without an appropriate level of support. The President also sees this as an issue, and the 2011 budget request for NIH included a 6 percent increase in stipend levels, although it was at the expense of a 1 percent decrease in the number of training slots. The size of the Medical Science Training Program (MSTP) should be expanded by at least 20 percent, and more if financially feasible (3–4). 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. If phased in over time, the impact would be less. The MST Program has proved remarkably successful in attracting outstanding physicians into research. Although the program is expensive, we believe that a modest expansion would serve the nation well. A recommendation to increase the size of the program was made in the previous NRSA study but was not implemented. The committee also recommends, strongly, that this increase in the size of the MST program be accomplished by increasing the total number of MST programs and thereby the number of students trained, and not by expanding the size of existing MST programs. Broadening the scope of MSTP training responds to the current national commitment to improve the effectiveness, efficiency, and accessibility of health resources, while controlling costs. 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 (2–2). This would require a five- or six-fold increase in indirect costs, or $191 million for the NRSA program at its current size 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 to have NIH 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. Many of the requirements and support activities centered in training grants—such as minority recruiting, education in the responsible conduct of research, and professional development—have improved the overall tenor of graduate education immensely over the past decade. However, these activities cannot be covered by the current 8 percent indirect cost allowance and therefore must rely on institutional funds. Similarly the K awards, which have served a tremendously important role in fostering the early career development of both basic and clinical researchers, utilize the same facilities as funded researchers and generate their own significant administrative costs, yet have the same 8 percent indirect cost allowance. OTHER RECOMMENDATIONS Training in Responsible Conduct of Research NIH in 2009 issued a detailed policy outlining the agency’s expectations for training in the responsible conduct of research (RCR), along with recommendations on how to establish specific curricula. The requirement of RCR training within the T32 mechanism has led to the development of curricula and educational practices that should benefit
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences all students and postdoctorates being trained in biomedical, health sciences, and behavioral research. Accordingly, all graduate students and postdoctoral fellows who are supported by the NIH on Research Program Grants (RPGs) should be required to incorporate certain additional “training grant-like” components into their regular academic training program. These should include RCR training, exposure to quantitative biology, and career guidance and advising (2–3). Diversity The demographics of this country are changing, and underrepresented minorities (URMs) are approaching a majority of the citizenry. The NIH is committed to increasing the diversity of the health sciences workforce through many programs, such as the Minority Access to Research Careers and Minority Opportunities in Research programs in the National Institute of General Medical Sciences (NIGMS), and the number of URM students in biomedical graduate programs has increased from 2 percent in 1980 to 11 percent today. However, in 2009 minority representation was 2 percent for tenured and tenure-track medical school faculty in basic science—the same as in 1980—and was 4 percent for non-tenured or non-tenure track faculty. Graduate student and postdoctoral training programs that educate and train students who are funded by RPGs should be subject to the same expectations for diversity of trainees that are expected of training grants. Such programs should be required to provide assurance on R01 grant applications that efforts are being made to increase diversity, though they will likely have to be at an institutional level (2–4). K24 Mentoring Awards The K24 mentoring award has been successful in developing the careers of clinical scientists and should be expanded to the basic sciences. In addition, this mechanism could also be used to support diversity at the faculty level. The NIH should expand the K24 mentoring award mechanism to include the basic sciences and adapt the K24 mechanism to provide the opportunity for established mid-career faculty to mentor early-stage investigators in the basic sciences, including recipients of the the new R00 awards (Phase 2 of the Pathways to Independence Award-K99/ R00 Award). Additionally, the K24 award mechanisms for both basic and clinical mid-career faculty should be utilized to enhance institutional efforts to recruit and develop a diverse faculty. Specifically, the NIH should develop a new category of K24 awards targeted to enhance the success of early-stage basic and/or clinical investigators, or reserve a fraction of existing K24 awards for mid-career applicants whose mentees will include one or more URM faculty members (2–5). Data Management Are NRSA awardees more successful and productive in their subsequent careers than others? Competitive initial and renewal applications for these programs contain an enormous amount of information, but no systemic approach has been developed to capture this information for rigorous, data-driven analysis. This problem will become all the more acute if trainees supported on R01 grants become a part of the overall database. The need for a modern data recording and management system is desperate, and such a system should be implemented without delay. The NIH should collect reliable data on all of the educational components that it supports in such a manner that this information can be stored in an easily accessible database format. Such data might consist of important components of the training grant tables, as well as retention and subsequent outcomes (2–6). In the same vein, applications for training grant support require many detailed data tables, some of which are largely irrelevant to the proposal award process. The committee recommends that the data tables be reviewed and a determination made, in consultation with the awardee community, as to which are really essential for reviewing the proposal and which should be incorporated into the databases (2–7). Program Evaluation and Future Coordination One aspect of training programs that has not been evaluated to date is how the value of the research training was perceived by the program director and the trainees themselves. This information should be collected by an anonymous survey, where the only identifier would be the particular institute or center at which the NIH trainee was supported. Specifically, a training evaluation questionnaire should be created so that all participants in the full range of NIH-funded training vehicles can provide a confidential, unbiased evaluation of the program in which they were trained. The intent of this recommendation is not to provide additional information for the competitive renewal of a particular program, but rather to allow the NIH to evaluate the merit of all of its training approaches broadly (2–8). There should also be better communication between the NIH and the NRC during the periods when the NRSA program is not in review. Such coordination would enhance the information-gathering process and allow the committees at the start of the review to complete their work more rapidly and efficiently. Greater continuity would benefit subsequent NRC committees in crafting recommendations and in monitoring their implementation by the NIH. Accordingly, it is recommended that the appropriate office at the NIH involved in analyzing these recommendations should issue an annual report to the Director’s Advisory Committee on the status of review and implementation. After
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences approval, such a report should be forwarded to the NRC to be made available to the subsequent review committees. In addition, the NIH may wish to invite external experts to provide added insight into the analysis. There are a number of ways that this could be done, but the exact mechanism is left up to the NIH (2–10). Nontraditional Outcomes Traditionally, a successful career in the biomedical sciences was defined as a research position in a university with grant support from NIH or other funding organizations. While many trainees still aspire to this career goal, many others use their biomedical training to provide other societal benefits—as researchers in the private nonprofit sector or in the pharmaceutical, biotechnology, and medical device industries; by inventing and developing new products; by teaching science in the secondary schools; and with careers in intellectual property law, in finance, and in government service. To recognize these career paths, peer reviewers in evaluating training grant applications, especially competing renewals, should be instructed to broaden their conception of “successful” training outcomes to recognize nontraditional outcomes that meet important national priorities and needs in the biomedical, behavioral, and clinical sciences (3–2). Similarly, in light of chronic and escalating concerns about the uneven quality of precollege science education and its effect on students’ career choices, one highly needed and extremely valuable outcome is for biomedical and behavioral sciences trainees to teach middle and high school science. The NIH and the Department of Education should work to provide incentives that would attract trainees into these teaching careers and lead a national dialogue to accelerate the processes of teacher accreditation controlled by the individual states (3–3). M.D./Ph.D. Training Programs In addition to having their funding increased by 20 percent (3-4), MSTPs should be encouraged to include basic behavioral and social sciences training relevant to biomedical and health sciences research (3–5). This is consistent with the recommendations below to increase training programs in basic behavioral and social sciences across NIH centers and institutes (4–1, 4–2, 4–4). MSTPs should also be encouraged to intensify and document their efforts to identify and recruit qualified nontraditional, underrepresented groups (women and minorities). These efforts should be a factor in the evaluation of all requests for MSTP funding increases and should be conditions for receipt of any MSTP funding increases. Success depends on having a critical mass (rather than isolated examples) of underrepresented trainees in any given MSTP (3–6). Furthermore, the F30 awards have proven to be an effective way for students in M.D./Ph.D. programs to gain NIH support for their activities. They also provide a means of support for students at institutions that do not have an MSTP. Consequently, all institutes should be encouraged to make F30 fellowships accessible to qualified M.D./Ph.D. students (3–7). Behavioral and Social Sciences The behavioral and social sciences receive considerably less training support than the other two major fields, but their role in the nation’s health has become increasingly important. The lack of support may in part be due to the lack of an NIH institute that focuses exclusively on basic behavioral and social sciences research. Much of the current funding is oriented toward the research areas of the categorical institutes, and this should continue since it links behavioral and social sciences research to the missions of the institutes. However, training programs in basic behavioral and social sciences that cut across disease categories and age cohorts should be housed at NIGMS, which would be consistent with the NIGMS congressional mandate. Given its disciplinary expertise, the Office of Behavioral and Social Sciences Research (OBSSR) should cooperate in this effort. NIGMS will need funds and appropriate staff dedicated to this new effort (4–1). In addition, training programs in basic and traditional behavioral and social sciences that bear specifically on particular diseases and specific age cohorts should be housed in all the relevant institutes and centers. Given both its disciplinary expertise and its role in connecting institutes and centers (ICs), OBSSR should cooperate in this effort (4–2). An earlier recommendation calls for expanding the MSTP to the behavioral and social sciences. In parallel, the F30 program should also be extended to clinical behavioral scientists in M.D./Ph.D. programs (4–4). Clinical Sciences The earlier recommendation for the MSTP applies with equal force to the clinical sciences, since part of the training occurs in this area. However, the hope that M.D./Ph.D. programs would provide the transitional and clinical research workforce has not been completely fulfilled. On the other hand, medical students and residents might be attracted to research in these areas if they are exposed to the principles of clinical research and given the training to carry out such research effectively. The NIH, in consultation with academic medical leadership, should identify better training mechanisms for attracting medical students into translational and clinical research and should fund pilot programs designed to implement promising new approaches to accomplishing that objective (5–2). While the areas of oral health and nursing are considered subfields
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences of the clinical sciences, and while health services research is at least partially a subfield, these areas were considered separately in this study. Dentistry While dentistry is primarily practice-oriented, there is another career path that brings strong science to the problems of oral, dental, and craniofacial health. There is a need for a critical mass of investigators with a long-term commitment to research in the oral health sciences. Consistent with the 2009 National Institute of Dental and Craniofacial Research (NIDCR) strategic plan, the committee recommends several actions to increase the biomedical research workforce in the oral health sciences. First, efforts should be made to achieve closer integration between schools of dentistry and the broader biomedical and health sciences research, practice, and education communities with the goal of generating new and vibrant research pathways and partnerships for students and faculty (6–1). Second, financial support of dental students and post-doctorates with an interest in research is critical. NIDCR should establish research fellowships, including K awards, and individual research awards to provide greater opportunities for independent NIH research support for dentists, as well as programs to fund non-dentists in Ph.D. programs in subject areas relevant to oral health and also programs for internationally trained non-U.S. citizen dentists seeking Ph.D. and postdoctoral fellowships. To accomplish this may well require that NIDCR rethink its current priorities and may require additional funding. Partnerships between NIDCR and other components of the academic health system need to be developed and maintained based on recognition of the value added by the oral health sciences. The NIH-sponsored Clinical and Translational Science Awards and Practice-Based Research Networks should explicitly identify a collaborative role for oral health research (6–2). Third, it is essential that some form of debt relief be available to dental students who commit to pursue research careers. Most students graduate with debt well over $100,000 and not unreasonably view dental practice as the only way to pay that debt. The committee recommends the development of programs that offer supplements for full or partial coverage of tuition or that offer loan forgiveness, or both, for the dental school component of combined D.D.S./D.M.D./Ph.D. programs. This would allow most of the burden of the D.D.S./D.M.D. tuition to be covered for students who commit to long-term careers in dental research. Enhanced stipends for graduate students should be provided if fiscally feasible without causing students to lose eligibility for low-interest student loans. In conjoined D.D.S./D.M.D./Ph.D. programs, when the clinical degree is awarded prior to the Ph.D., the NIH should permit postdoctoral stipend levels to apply during the post-D.D.S. phase (as opposed to the lower, predoctoral stipend levels). The feasibility of adaptations of the existing Medical Science Training Program (M.D./Ph.D.) model to dental education—including full funding for eight or so years—should be explored (6–3). Nursing The nursing profession shares the same shortage of research personnel as dentistry, but for different reasons. Because of the structure of their profession and their education process, nurses begin doctoral study at a much later time in life and take longer to complete the degree than in other fields with more NRSA support. In response to the graying of the profession, the T32 programs in nursing should emphasize a more rapid progression into research careers. Criteria for application should include predoctoral trainees who are within eight years of high school graduation, streamlining the requirement for a nursing master’s degree in passing to the Ph.D. and providing support for postdoctoral trainees who are within two years of completion of the Ph.D. (7–1). To increase research capacity for the existing workforce, the National Institute of Nursing Research (NINR) should (1) increase the number of mid- and senior-career awards to enhance the number of nurse scientists capable of sustaining programs of research, and (2) increase the length of support for K awards to five years to be consistent with other institutes and centers (7–3). The NINR budget is less than half that of any other institutes that provide NRSA support and, because of that, has difficulty balancing training and research support. In consideration of the size of the NINR budget and the acute need for nursing faculty, NIH should request additional support from Congress to allow NINR to more closely meet this acute need (7–4). As described elsewhere, the MSTP has proven to be beneficial in attracting and sustaining a research workforce. In this regard, NINR should develop and pilot test a MSTP-like program to support clinical training at the Master of Science in Nursing (MSN) or Doctor of Nursing Practice (DNP) level for those nursing students wishing to be clinician scientists (7–5). Health Services Research Considering the critical need for health services research at a time when the nation’s health-care system is undergoing extraordinary changes, the NRSA support for such training at NIH is modest, less than half a percent at the predoctoral level and less than half of that at the postdoctoral level. Health services research training should be expanded and strengthened within each NIH institute and center (8–1). Also, the 1 percent of the NRSA budget that is now set aside is not sufficient for the training supported by the
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences AHRQ; AHRQ training programs should be expanded, commensurate with the growth in total spending on health services research, including comparative effectiveness research (8–2). CONCLUSION In general, over the past 40 years the NRSA program has been of enormous benefit in training the workforce responsible for the dramatic advances in the understanding of disease and has provided insights that have led to more effective and targeted therapies. The NRSA program has been an important component of the biomedical research enterprise in the United States—the standard that other nations measure against. To sustain this preeminence, NIH training mechanisms must be nimble in responding to changes in U.S. immigration policy, changes in global employment opportunities for international graduate students and postdoctorates, growth in U.S. minority populations, profound changes in the health-care system, severe financial problems in U.S. higher education systems, chronic inadequacy of science education in K-12, and other conditions that may arise. Strengthening the NRSA and related training programs will help them meet these challenges.
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