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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences 2 Crosscutting Issues This chapter addresses some training issues that cut across disciplines and that pertain generally to the National Research Service Award (NRSA) and other training mechanisms. The committee considered a number of these issues and identified the following as ones that require attention: financial support of the trainees, cost recovery by educational institutions, participation by underrepresented minorities, responsible conduct of research, National Institutes of Health (NIH) data systems the emerging role of biomedical informatics, workforce data requirements, and international workforce. FINANCIAL SUPPORT OF THE NRSA PROGRAM The National Research Council (NRC) in the report, Addressing the Nation’s Changing Needs for Biomedical and Behavioral Scientists (2000), recommended “that stipends and other forms of compensation for those in training should be based on education and should be regularly adjusted to reflect changes in the cost of living.” In 2001 the NIH concurred with this recommendation and set a target of $45,000 per year for new postdoctoral scholars, with the expressed intention to raise the then-current stipends by 10 to 12 percent per year until this target was reached. Additionally, the NIH pledged to budget for annual cost-of-living increases to keep pace with inflation and to prevent the loss of buying power seen as stipends had remained largely flat over the previous decade. However, stipend levels at both the predoctoral and postdoctoral levels have not kept pace with the NIH targets. There were increases in 2000, 2002, and 2003 at all levels that conformed to the goals set by NIH in 2001, but in 2004 the increase was less than half the recommended level, and from 2006 to2008 there were no increases (see Table 2-1). Of course, from fiscal year 1999 to 2003 the NIH budget was doubling, but from fiscal year 2004 to 2008, the budget was essentially unchanged, and, in fact, during this interval it lost nearly 13 percent of its purchasing power. In fiscal year 2009, there was a small increase of about 1 percent in the NIH appropriation, and a similarly modest increase was enacted for fiscal year 2010. These modest increases, well below the levels of biomedical research inflation (as measured by the Biomedical Research and Development Price Index in the respective years), were independent of the nearly $10 billion of American Recovery and Reinvestment Act (ARRA) funding that was awarded in fiscal year 2009 for NIH research. The ARRA initiative was driven by the goal of creating or saving jobs, and the funding for NIH was explicitly a one-time infusion of “stimulus” funds that were to be entirely obligated within 2 years for primarily short-term research projects. None of the ARRA funds were to be used to address structural problems in research training programs. The President’s NIH budget request for 2011 contains a 6 percent increase for NRSA trainee stipends, but at the cost of a 1 percent decrease in the number of training slots. In addition to supporting the originally targeted stipend increases, the 2005 NRC report also recommended that NIH develop a mechanism for support such that postdoctoral fellows receive the employee benefits of the institution in which they are located. It is clear that all postdoctoral fellows should be supported in terms of receiving appropriate benefits at each institution. However, the fact that there are two categories of postdoctorates—NRSA trainees and postdoctoral employees—is a consequence of a federal decision to pay trainees a stipend (as opposed to a salary). As such, following the requirements of the Internal Revenue Service imposes different tax liabilities on the two groups of post-doctorates. Trainee postdoctorates cannot be categorized as employees, they do not pay Federal Insurance Contribution Act (FICA), and they cannot receive benefits in the same fashion as employees. However, this should not mean that they cannot receive parallel support systems. To demand then that all postdoctorates be treated identically becomes the training equivalent of trying to put a square
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences TABLE 2-1 NRSA Stipends Years 2001 Percent 2002 Percent 2003 Percent 2004 Percent Predoctorate $ 16,500 10 $ 18,156 10 $ 19,968 10 $ 20,772 4 Postdoctorate Level 0 $ 28,260 5 $ 31,092 10 $ 34,200 10 $ 35,568 4 Postdoctorate Level 1 $ 29,832 5 $ 32,820 10 $ 36,108 10 $ 37,476 4 Postdoctorate Level 2 $ 35,196 5 $ 38,712 10 $ 40,920 6 $ 41,796 2 Postdoctorate Level 3 $ 36,996 5 $ 40,692 10 $ 42,648 5 $ 43,428 2 Postdoctorate Level 4 $ 38,772 5 $ 42,648 10 $ 44,364 4 $ 45,048 2 Postdoctorate Level 5 $ 40,560 5 $ 44,616 10 $ 46,404 4 $ 46,992 1 Postdoctorate Level 6 $ 42,348 5 $ 46,584 10 $ 48,444 4 $ 48,852 1 Postdoctorate Level 7 $ 44,412 5 $ 48,852 10 $ 50,808 4 $ 51,036 0 Years 2006 Percent 2007 Percent 2008 Percent 2009 Percent Predoctorate $ 20,772 0 $ 20,772 0 $ 20,772 0 $ 20,976 1 Postdoctorate Level 0 $ 36,996 4 $ 36,996 0 $ 36,996 0 $ 37,368 1 Postdoctorate Level 1 $ 38,976 4 $ 38,976 0 $ 38,976 0 $ 39,360 1 Postdoctorate Level 2 $ 41,796 0 $ 41,796 0 $ 41,796 0 $ 42,204 1 Postdoctorate Level 3 $ 43,428 0 $ 43,428 0 $ 43,428 0 $ 43,860 1 Postdoctorate Level 4 $ 45,048 0 $ 45,048 0 $ 45,048 0 $ 45,504 1 Postdoctorate Level 5 $ 46,992 0 $ 46,992 0 $ 46,992 0 $ 47,460 1 Postdoctorate Level 6 $ 48,852 0 $ 48,852 0 $ 48,852 0 $ 49,344 1 Postdoctorate Level 7 $ 51,036 0 $ 51,036 0 $ 51,036 0 $ 51,552 1 SOURCE: NIH Stipend Levels, http://grants.nih.gov/nrsa.htm. peg into a round hole. The simplest solution is to create a square hole, which offers all the advantages of a round one. With increasing awareness of this contradictory issue, many institutions have devised creative solutions aimed at maintaining parity between the two groups of postdoctorates. Thus, although trainee postdoctorates cannot usually be included on employee health coverage, highly competitive insurance can in fact be purchased, usually more cheaply than the employee plan and offering better coverage because the postdoctorates tend to be younger than the general employee population. It is true that postdoctorate trainees cannot get university retirement benefits, but the cash value lost is in fact less than the gain in income from not paying FICA. Not being on the human resources list of employees may cause frustration with issues such as parking and child care. However, payment of a very nominal sum to the trainee as salary solves this problem without jeopardizing his or her status as primarily a stipend-receiving trainee. Recommendation 2–1: 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 should 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 4 years, the $20 million dollar annual 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. The committee notes that the Obama administration has recently proposed a 6 percent increase in stipends for 2011 over the 2010 level. This is a positive step on the way to the recommended stipend levels. INDIRECT COST RATES It is debatable whether training grants lead to a superior or better trained individual in the long run. The rather limited amount of data and related evaluations are certainly consistent with this conclusion, although the degree of significance is not high. Of course, institutions tend to put their best students on training grants, and the outcomes likely should be better. However, to a degree this is immaterial. The key role of NRSA training lies in the fact that the applications are scrupulously peer reviewed. This, in turn, drives institutions to review their approaches to graduate education on a regular basis and encourages them to establish best practices that can then be honed through the peer-review system. As a result, in the competition to recruit graduate students, even non-NRSA schools will feel the pressure to create an excellent training environment. In this sense, over the past decade or so the training grants have served as major drivers of innovation in
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences graduate education, and this may be their greatest contribution to the biomedical research training environment. Thus, the many requirements and expectations for support activities centered on training grants, such as minority recruiting, education in the responsible conduct of research (RCR), and professional development, have improved the overall tenor of graduate education immensely over the past decade. These expectations have come at a considerable price, however, and this price has largely been covered by institutional funds. The current 8 percent indirect cost allowance (which is not applied to tuition and fees, health insurance, and expenditures for equipment) is insufficient to cover the university’s costs. Similarly, the K awards, which have served a tremendously important role is fostering the early career development of both basic and clinical biomedical researchers, use the same facilities as funded researchers and generate their own significant administrative costs, yet they have the same 8 percent indirect cost allowance, which as best one can determine is arbitrary and is based on no carefully argued rationale. The indirect cost rate has varied over time. Prior to 1958, the rate for training grants was set at 8 percent by the Department of Health, Education and Welfare, and the rate has remained at this level to this day. The rate on non-training grants was increased to 15 percent in 1958 and to 20 percent in 1963. In 1966 the ceiling on indirect costs was removed, but in 1991 OMB Circular A-21 imposed a cap of 26 percent on the recovery of administrative costs from research grants, and the cap has remained unchanged in spite of compelling documentation by the Council on Governmental Relations that these costs in all the top research universities sampled were significantly greater than could be recovered under the 26 percent cap. As a result, many of the improvements in graduate education and early career development, such as special skills courses, increased focus on interdisciplinary studies, increased diversity, RCR training, and career advising and outcomes research, have all come through resources provided by the institutions applying for NRSA support. The committee finds that the institutional commitment of resources for training grants and K awards is no different from that for research grants. Graduate and postdoctoral trainees require the same facilities in the laboratory as their counterparts in the same laboratory who are supported on a research grant that carries the institution’s negotiated rate. Likewise, individuals on K awards act in a capacity similar to that of a researcher on an R01 or other research project grant. The committee was not unanimous with regard to the NRSA part of the following recommendation because of concerns about costs and the reduction in program size that could result from a stagnant NIH budget, but it did endorse the increase for the K awards. Recommendation 2–2: 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, for example, by increasing the rate by 8 percent each year until the negotiated rate is reached. Implementing this recommendation 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. 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. RESPONSIBLE CONDUCT OF RESEARCH NIH’s NRSA grants require awardee institutions to establish specific curricula in the responsible conduct of research. Indeed, in late 2009 NIH issued a detailed policy statement outlining its expectations along with recommendations on how to approach these expectations (NIH policy statement NOT-OD-10-019). It is worth noting that National Science Foundation (NSF) has issued similar requirements for all personnel participating in NSF-funded research, including undergraduate students. The requirement of RCR training within the T32 mechanism has led to the development of curricula and educational practices for NRSA that would benefit all students and postdoctorates being trained in biomedical and health sciences research and should be required in all graduate and postdoctoral education programs supported by the NIH. Since with relatively few exceptions the majority of this training takes place in laboratories supported by NIH research program grant (RPG) mechanisms, this leads to the expectation that all students supported by the NIH (i.e., including those students supported by R01 grants during their education) should be required to benefit from such training. Recommendation 2–3: All graduate students and postdoctoral fellows who are supported by the NIH on 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. NIH DIVERSITY INITIATIVES WITHIN THE NRSA PROGRAM Minorities1 now account for 50 percent or more of the population in several states, and at some time within 1 Minorities are defined as Blacks, Hispanics of Puerto Rican , Cuban, or Mexican extraction, American Indians, and Pacific Islanders. Does not include Asian.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences the foreseeable future the demographics of the country will have changed to the point where current minority groups will be approaching a majority of the citizenry. The NIH is committed to increasing the diversity of the biomedical workforce. There is no doubt that over the past 15 years NIH-supported training programs have driven major changes in trainee diversity. Leadership from the Minority Opportunities in Research (MORE) division of the National Institute of General Medical Sciences should be acknowledged in this regard. As a result, the number of minority students in biomedical graduate programs has increased from 2 percent in 1980 to 11 percent today (and, relative to U.S. nationals, the percentage is actually a little higher since the denominator for this calculation includes international graduate students). We should bear in mind that the current participation level is not far from the 14 percent of underrepresented minorities students among all students receiving a B.S. degree in biological sciences. Comparable results are seen in the U.S. citizen component of postdoctoral programs in the biomedical sciences. Sadly, however, the minority representation of 2 percent on tenure-track medical school faculties has not changed significantly since 1980. Unfortunately, there are essentially no data on what careers prove to be attractive to minority graduates after they leave postdoctoral training and why on average they choose careers other than academic research. The following recommendations pertain to strengthening diversity within the educational system supported directly or indirectly by NIH grants. Recommendation 2–4: Graduate student and postdoctoral training programs that educate and train students who are funded by RPGs2 should be subject to expectations for diversity of U.S.-native trainees similar to those expected of training grants. Such programs should be required to provide assurance on R01 grant applications that efforts are being made. The K24 mentoring award has been successful in developing the careers of clinical scientists. The committee views this program as highly valuable and would like to see this approach applied to the basic sciences; in addition, a mechanism may be developed to this end that also serves to support diversity at the faculty level. The impact of this type of mid-career career development award would enable faculty members to incorporate mentoring of other junior and early-stage investigators in order to enable their success in leading and managing a research team. The basic science faculty member, particularly in today’s system where faculty members need to generate protected time much like clinicians, would also serve to acknowledge and reward best mentoring practices that can support the success of a diverse array of new investigators including K01 , R00, and first-time R01 recipients. Broadening the K24 program to include basic biomedical studies is both feasible and readily achievable. Recommendation 2–5: The K24 mentoring award mechanism should be expanded to include the basic sciences. Use of the K24 award to enhance efforts to recruit diverse faculty should be a component of the award criteria. NIH DATA SYSTEMS Any discussion of the merits of NRSA training, both at the level of T32 and of F31/32 awards, invariably includes the question: Are the individuals educated in this fashion more successful and productive in their future careers? Although the competitive initial and renewal applications for these programs contain an enormous amount of information, no systemic approach has been developed to capture this information for rigorous scrutiny, and, as a result, no critical, data-driven analysis can be applied to the wealth of information that institutions have provided for more than 30 years. This problem will become all the more acute if trainees supported on R01 grants become a part of the overall database. The availability of such data would be enormously helpful to the NIH in the development of sound future policy. Accordingly, a modern data recording and management system is needed desperately and should be implemented without delay. Newly instituted data collection procedures at the NIH will provide data on graduate students and postdoctorates with NIH support, as long as the data are input into a database or a tabular file and not simply recorded as unformatted electronic files. These data will be useful in estimating the numbers and research areas of individuals in training, but the lack of data on the career outcomes of NRSA- and R01-funded trainees makes it difficult to produce an informed comparative assessment of the research training programs. Moreover, this lack of information hinders the development of those training mechanisms and strategies that will best ensure a talented and productive research workforce. Recommendation 2–6: To assist future assessments of the research training more effectively, 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 include important components of the training grant tables as well as retention and subsequent outcomes. Recommendation 2–7: The applications for training grant support require many detailed data tables. Some of these are very important and essential for the review; some are merely compendia of largely irrelevant data that could equally well be summarized briefly. The committee recommends that the data tables be reviewed and a determination made, in consultation with the awardee 2 Research Project Grant (RPG).
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences community, as to which are really essential for reviewing the proposal and which should be incorporated into the databases described in Recommendation 2–6. In addition, one aspect of the outcomes of training programs that has not been evaluated to date is how the value of the research training is perceived by the program director and by the trainees themselves. In no sense should collecting such data be a popularity contest or, worse, a complaint session against individual training-grant principal investigators. Rather we believe that broad anonymous surveys, in which the only identifier would be the fact of having been an NIH supported trainee, can be quite valuable. The NIH institute or office funding the training might be identified, but the institution offering the training would be confidential. Recommendation 2–8: We recommend that a training evaluation questionnaire 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. INTERDISCIPLINARY FIELDS AND THE EMERGENCE OF NEW KINDS OF TRAINING PROGRAMS With the evolution of team science and the increasing dependence of research on interdisciplinary activities, new breeds of scientists have emerged in recent decades. Initiation of new kinds of formal training programs has occurred as a natural consequence, but these programs are too often neglected when NIH-funded NRSA training is considered and measured. Perhaps the most obvious examples can be found in the quantitative and computing sciences—areas that are now heavily represented in the research portfolios of the categorical institutes but that generally, other than a modest effort at National Institute of General Medical Sciences and at the National Library of Medicine (NLM), are not extensively supported by them as areas for focused research training. For example, the increasing interest in, and importance of, biomedical informatics—as reflected in the mandated biomedical informatics core resources for all clinical and translational science awards—has created a need for trained scientists in this field. The principal extramural funding source for research and training in biomedical informatics has been the NLM, which is both a significant research institute at the NIH and the largest and most innovative medical library in existence. Its role as an NIH institute is often overlooked because its name conjures up images of a library facility, but its intramural and extramural research have played key roles in advancing the infrastructure for modern biological science as well as electronic health records, decision-support systems, and online access to the biomedical literature. NLM programs all deal with information and knowledge management used to support biomedical research and clinical care along with the development and promotion of standards that allow the integration of biomedical and clinical data from diverse resources. Its training programs in biomedical informatics, which have supported graduate degree programs and postdoctoral fellowships since the early 1970s, are responsible for producing a generation of leaders who now head academic programs in health science institutions, perform today’s cutting-edge informatics research, fill major leadership roles in the government’s commitment to healthcare information technology, and staff or lead the companies that produce, sell, and implement today’s burgeoning clinical information systems. The NLM training grants (see Table 2-2) are administered as T15 programs, but although they are not formally designated as NRSA programs, they do follow NRSA guidelines for funding and training requirements and are in this sense indistinguishable from the other programs emphasized in this report. Because NLM’s programs are not formally designated as NRSA programs, they are not monitored or measured in the same way that NRSA programs are, and the existence of its training programs is often overlooked. This has constrained the programs’ growth despite the burgeoning national demand for trained research scientists in the field of biomedical informatics (which spans bioinformatics, clinical informatics, and public health informatics). It is shortsighted for HHS to fund current implementations of health information technology (as the Office of the National Coordinator for Health Information Technology has done with ARRA stimulus funds) without a concomitant investment in the basic research and graduate training needed to develop the concepts and innovations that will TABLE 2-2 Number of Full-time Pre- and Postdoctoral Research Training Slots Awarded FY 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009a Postdoctoral 60 84 105 103 130 109 110 99 82 94 Predoctoral 38 56 97 118 169 162 160 179 186 189 aThe training slots for 2009 include those awarded with ARRA and other supplemental funds. SOURCE: NIH National Library of Medicine, 2009.
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Research Training in the Biomedical, Behavioral, and Clinical Research Sciences drive progress in the future. Computer science in general has been a major stimulant to the U.S. economy and has had a remarkable influence on our quality of life, but the biomedical world cannot rely on the general engineering community to develop the solutions that health care and medical research require. The biomedical informatics community can fill that pipeline, as it has in the past, but this requires a program of funding and training that will produce both the ideas and the scientists that are needed to restore the momentum that we need in these important disciplines. The NLM is the only agency that has consistently supported such education, and it needs the resources to continue its important programs. There may be other similar interdisciplinary programs at NIH that have been overlooked because they do not use the NRSA or T32 mechanism. All such programs need to be considered explicitly in the guidelines and recommendations offered in this report. Recommendation 2–9: The unique graduate training programs of the NLM, plus its postdoctoral fellowships in biomedical informatics, should receive gradually increasing support with incremental dollars over 5 years to produce a 50 percent increase in the number of funded training programs and a doubling of the number of funded training positions. COORDINATION WITH NIH When a new workforce committee is constituted, it spends a considerable amount of time reviewing the previous recommendations and the response by the NIH. This is often quite difficult to do in a satisfying manner since the exact implementation can be piecemeal, and, indeed, sometimes there may be very sound reasons for non-implementation. It is not easy for the new committee to triangulate how things have evolved in the four years since the previous recommendations were first presented. This committee was helped by a small number of individuals who had sat on the previous committee and were able to offer a valuable extended perspective. Clearly, better communication between the NRC review committees and the NIH could speed up the overall review process. The committee debated this issue for some time and eventually decided to make a recommendation that the NIH establish a review group that would analyze and collate the NIH responses to the committee recommendations and report its findings to the director’s advisory committee. In this way the director of the NIH would be apprised of the relevant issues, and the appropriate components of the minutes could be used to inform the next NRC review committee four years from now. Recommendation 2–10: The committee believes that subsequent workforce committees would greatly benefit from continuity in terms of crafting recommendations and following and monitoring the implementation of those recommendations 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. 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. INTERNATIONAL CONTRIBUTION TO THE BIOMEDICAL WORKFORCE Chapter 3 documents the contributions of foreign-educated scientists, particularly at the postdoctoral level, to the U.S. biomedical research workforce. Indeed, in the biomedical postdoctorate pool more than 60 percent of the fellows are foreign trained. In addition, typically 60 to 65 percent of these individuals indicate that they hope to stay in the United States after they have completed their fellowship. Without this component of the workforce, U.S.-educated Ph.D.s, at the current level of production, would not be able to provide the amount of human capital needed to meet the demands for research in this area. Over the past two decades the number of foreign-trained individuals in the postdoctoral workforce has steadily increased. However, we are now faced with a highly uncertain future in this regard. This is a direct consequence of two powerful forces, the effects of which are impossible to determine at present. On the one hand, the enormous growth of the Chinese and other Asian economies—and their explicit intentions to invest in the biomedical and life sciences and become “research powerhouses”—has already begun to attract their nationals to return and conduct research at their home institutions, a phenomenon that seems likely only to increase over the next decade. On the other hand, the pressing economic situation in the United States, especially the uncertainty of job availability in the future, may lead to a decreasing attractiveness of U.S. biomedical research careers to Ph.D.s from these foreign countries. Although there is a great deal of uncertainty about how these phenomena will affect the contributions of international scientists to the U.S. biomedical research enterprise, our leaders at the NIH and in the Congress should be aware of this committee’s concerns. It is probably not yet time to suggest that U.S. production of biomedical Ph.D.s should be increased, but clearly this issue needs to be carefully and continuously monitored.