1
Introduction

The age at which scientific investigators receive their first research grant from the National Institutes of Health (NIH) has been increasing in recent decades. The number and percentage of grants awarded to younger researchers has been decreasing (Figures 1-1 and 1-2), and the number of awards made to researchers age 35 and younger declined by over 75 percent since 1980, even as the overall number of grants has increased (Figure 1-3). For example, in 2002, the median age for new research grant recipients was 42. Moreover, the percentage and absolute number of awards made to new investigators—regardless of age—has declined over the last several years (Figure 1-4). At a June 16, 2004, National Academies workshop on this issue, NIH Director Elias A. Zerhouni identified his major concern that creative young scientists might choose other careers to avoid the uncertainty of basic academic research: “[It] is not manageable … [to have] a culture where young investigators are discouraged from either entering the field or, when in the field, get discouraged about taking risks and bringing science into the new directions that it needs to go.” Many people, including Nobel laureates, share the concern that scientists at the beginning of their research careers who are unsuccessful at obtaining initial grant support may leave the academic research enterprise altogether (Jenkins, 2003).

New investigators are particularly vulnerable to difficulties in obtaining research funding since they are less likely to have other grants or the protection of tenure than more established investigators. Thus funding difficulties and discouraging prospects for independence have especially high stakes for new investigators. This “crisis of expectation” has severe



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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research 1 Introduction The age at which scientific investigators receive their first research grant from the National Institutes of Health (NIH) has been increasing in recent decades. The number and percentage of grants awarded to younger researchers has been decreasing (Figures 1-1 and 1-2), and the number of awards made to researchers age 35 and younger declined by over 75 percent since 1980, even as the overall number of grants has increased (Figure 1-3). For example, in 2002, the median age for new research grant recipients was 42. Moreover, the percentage and absolute number of awards made to new investigators—regardless of age—has declined over the last several years (Figure 1-4). At a June 16, 2004, National Academies workshop on this issue, NIH Director Elias A. Zerhouni identified his major concern that creative young scientists might choose other careers to avoid the uncertainty of basic academic research: “[It] is not manageable … [to have] a culture where young investigators are discouraged from either entering the field or, when in the field, get discouraged about taking risks and bringing science into the new directions that it needs to go.” Many people, including Nobel laureates, share the concern that scientists at the beginning of their research careers who are unsuccessful at obtaining initial grant support may leave the academic research enterprise altogether (Jenkins, 2003). New investigators are particularly vulnerable to difficulties in obtaining research funding since they are less likely to have other grants or the protection of tenure than more established investigators. Thus funding difficulties and discouraging prospects for independence have especially high stakes for new investigators. This “crisis of expectation” has severe

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research FIGURE 1-1 Age distribution of principal investigators receiving competing R01, R23, R29, and R37 research awards, by number of awards made to each age cohort. Source: Office of Extramural Research, NIH. FIGURE 1-2 Age distribution of principal investigators receiving competing R01, R23, R29, and R37 research awards, by percentage of total awards made to each age cohort. Source: Office of Extramural Research, NIH.

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research FIGURE 1-3 Number of NIH research awards made to PIs 35 years of age and younger. Source: Office of Extramural Research, NIH. FIGURE 1-4 NIH awards made to new investigators. The histogram shows the percentage of NIH research awards that have been made to new investigators (left axis), while the line shows the total number of awards made to new investigators (right axis). Source: http://grants1.nih.gov/grants/award/trends/icfund9803.html.

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research and troubling implications for the future of biomedical research in the United States (NRC, 1998). A 1997 survey conducted by the American Society for Cell Biology (ASCB) provides evidence for further concern. When a sample of its membership was asked if they would pursue their doctoral degree if they had it do over again, 31 percent of those who received their degrees in the 1990s would “probably” or “definitely” not do it again. This compares with only 16 percent of those who received degrees in the 1970s (Marincola and Solomon, 1998a; http://www.ascb.org/survey/survey.htm). In addition, data from 2001—the most recent year for which data are available—show a decline in the number of U.S.-trained PhDs in biomedical postdoctoral appointments across all employment sections. Among the reasons cited for this decline are long periods of training with few benefits, the perception that postdoctoral appointments are more like low-paying jobs than training experiences, and poor prospects for independent follow-up positions (NRC, 2005). Many of the greatest contributions in science were made by those who were independent investigators at an early age. Marshall Nirenberg, for instance, had his own independent lab at NIH when he was just 27 after only 2 years of postdoctoral training, unraveled the genetic code when he was 31, was an NIH section head at 35, and received a Nobel Prize at 41. He was doing risky independent research with intramural support from the NIH in his 20s. In today’s climate, Nirenberg might have received his Nobel Prize before his first NIH grant. Nirenberg is not unique; Stephan and Levin (1993) examined the age at which Nobel laureates in physiology or medicine performed their critical experiments, finding a median age of 38 years. Further, the highest honor in mathematics—the Fields Medal—is awarded only to individuals under age 40. Thus, a researcher in mathematics might reach a career pinnacle before a biomedical researcher has first established independence. As National Academy of Sciences President Bruce Alberts related in his 2003 President’s Address, During a period when the total amount of federal funds available to support science at the National Institutes of Health has doubled, it is incredible to me that the average age at which scientists first become funded continues to rise. [In the early 1970s,] many of my colleagues and I were awarded our first independent funding when we were under 30 years old. We did not have preliminary results, because we were trying something completely new. [Now] almost no one finds it possible to start an independent scientific career under the age of 35. Moreover, whereas in 1991 one-third of the principal investigators with NIH funds were under 40, by the year 2002 this fraction had dropped to one-sixth. Even the most talented of our young people seem to be forced to endure several

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research years of rejected grant applications before they finally acquire enough “preliminary data” to assure the reviewers that they are likely to accomplish their stated goals. (Alberts, 2003). These challenges are likely to be even more pronounced in the near future. An NIH budget expected to be nearly constant for the next several years will especially constrain the amount of resources available for new awards. If new investigators were finding it difficult to secure research support in a time of NIH budget expansion, how much more difficult will it be when the budget is flat and many of the resources allocated to continuing awards? The years in which one might be establishing or waiting for independence coincide with marriage and family life for many new investigators, placing additional personal costs on the delay of independence. As these issues affect men and women differently, it is essential to disaggregate data on biomedical careers by gender. There are also significant financial costs in which additional time spent in low-paid postdoctoral positions comes at the expense of possibilities for greater compensation in industry or in other career endeavors. COMMITTEE STATEMENT OF TASK Because of concerns about the effect of this increasing age of first grant on the careers of new investigators and their ability to undertake high-risk research, the NIH asked the National Academies to recommend some mechanisms to foster the independence of new investigators in biomedical research. The complete committee statement of task is in Appendix A and is summarized in Box 1-1. In his remarks at a June 16, 2004, workshop convened by the committee, Dr. Zerhouni added additional requests for the committee to consider: “come up with pragmatic recommendations that the agency [NIH] can follow, that might, in fact, propel us to try new models, and to try to encourage new thinking in terms of who we bring into the scientific enterprise, and when do we bring them in, and how do we encourage them to stay in, and to be productive.” “come up with testable pilots—not just wishful pilots—pilots that can lead to a tangible measurement of whether or not we are accomplishing what we want to accomplish…. The hope is that, instead of general principles, that we come up with very specific action steps that the agency can implement, but that can lead also to more knowledge about the issues that we are dealing with.”

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research BOX 1-1 Summary of the Committee Statement of Task The National Academies will convene a workshop as the principal data-gathering event of a study to explore issues related to fostering the independence of early-career scientists (postdoctoral researchers and young faculty) in order to enhance the vitality of the biomedical research enterprise and its workforce. This workshop will build upon an October 23-24 (2003) meeting held at the National Institutes of Health (NIH) that addressed training and opportunities for postdoctoral scientists and on previous reports on postdocs and young faculty issued by the National Academies and others (e.g., Enhancing the Postdoctoral Experience for Scientists and Engineers [2000] and Trends in the Early Careers of Life Scientists [1998]). The proposed workshop will focus on the transition to independence of postdoctoral researchers and entry-level faculty with particular emphases on mechanisms to enhance the quality and effectiveness of postdoctoral training and the ability of young faculty to receive independent research funding. Previous recommendations from other studies will be considered and participants will be asked to identify and consider means to address the impediments that have prevented many of these recommendations from being put into practice. The workshop will consider whether existing programs within NIH could be expanded (e.g., K awards) and will include discussion of some of the successful programs and models being used outside NIH and to determine which features of these programs might be transferable to NIH and other large research-sponsoring organization settings. A report will be prepared identifying the challenges and presenting ideas for enhancing the opportunities for young investigators to gain independent research funding. The report will also make recommendations on those topics where consensus can be reached. The study will focus on mechanisms for fostering independent funding in the life sciences, but it may also identify challenges or recommend solutions for dealing with the larger biomedical research and academic structures. “create pathways for physical sciences to enter biomedical sciences, to work within scientific teams—mathematicians, physicists, chemists.” “… and last but not least, let’s not be shy. It may be that, in fact, NIH needs to work with the academic institutions and the National Academies and everybody else to redefine career pathways.” Simply put, there are not enough tenure-track academic positions for the available pool of biomedical researchers. Very little that the committee can recommend will cause a sudden explosion in the number of such

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research positions and consideration of the appropriate size of the pool is beyond the scope of this committee (cf. NRC 2000, 2005). As such, the report focuses on other mechanisms to enhance the quality of training and foster opportunities for independence. In many ways, the biomedical research enterprise is not designed to support the establishment of independence. The structure of academic biomedical research training is largely a byproduct of funding mechanisms and reward structures, not one with specifically identified goals to foster the development of independent researchers. NIH has significant responsibility for the current state of affairs, but also a significant ability to help reverse the increasing age of independence. Lengthy graduate student and postdoctoral training periods—and the massive growth in the number of such positions—result largely from the availability of NIH funding. Moreover, the increasing dependence on non-tenure-track “soft-money” researchers would not have happened without available soft money from the NIH. In considering its charge, however, the committee recognizes that one cannot isolate the role of NIH from that of other stakeholder groups. Universities, research institutions, professional societies, public and private funding agencies, academic administrators, senior faculty, junior faculty, staff scientists, postdoctoral scientists, and others have a responsibility for working together to address these issues. The committee provides its report and recommendations for all of these groups in addition to the NIH itself. In fact, the report explicitly calls upon action by universities and research institutions in several places (e.g., Recommendations 4.6, 6.2). Further, grant funding from the NIH interconnects with a collection of many other issues related to the process of science, the scientific workforce, and the settings in which researchers work. The availability of academic positions, requirements for tenure, retirement policies and rates, start-up costs, research infrastructure, indirect cost recovery, university budgets, postdoctoral scientist stipends and benefits, visa and immigration policies, and overall economic forces are just some of the many issues that have a significant impact on new investigators. The preparation of scientists striving to establish independence also reaches back through postdoctoral and graduate student periods, into undergraduate years, and back to K-12 education. The committee has tried to keep the focus on the issues that are most central to fostering the independence of new investigators. The report, therefore, may not fully explore all of the related issues, many of which The National Academies and others have previously addressed and will continue to address. For example, the committee was not asked to consider the appropriate number of biomedical researchers; in fact, the “supply” of available scientists has been considered by a number of committees in detail (NRC 1998, 2000, 2005). This report does not

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research assume that, at present, there is necessarily a shortage—or surplus—of biomedical researchers. However, today’s new investigators are finding greater difficulties achieving their independence than in the past: they are spending longer periods in mentored positions, choosing to pursue more conservative research directions, and being discouraged about their prospects for independence. Rather than argue for a greater number of independent positions, the report considers that the current career structures and opportunities for independence adversely affect the future of the biomedical research workforce as well as the success, productivity, and research directions of individuals who do pursue such careers. The increase in age of independence for new investigators has largely coincided with the growth of the biotechnology and pharmaceutical industries. Even though this report focuses on academic biomedical research, the increase in industrial opportunities may have effects on the academic research environment as well. Many promising young scientists may have been opting for careers in industry where financial compensation, research funding, and opportunities for directing research programs can be more plentiful. For example, it is estimated that the percentage of biological sciences PhDs pursuing careers in industry was approximately 35 percent in 2001, up from approximately 25 percent in 1991 and 15 percent in 1981 (C. Kuh, unpub., with data from Survey of Doctorate Recipients, NSF). It could be that the recent declines in the number of grants to new investigators, the number of postdoctoral researchers, and the duration of postdoctoral positions are due, in part, to the migration of researchers to industry. With a slowdown in biotechnology in the last few years, it is possible that there might be a renewed influx of researchers into academic careers and a worsening of the prospects for independence. While the committee realizes that some of the recommendations will require dedication of resources, it has not proposed specific programs that should be reduced to provide the necessary funds—except when the proposed programs are meant to replace existing ones. For the most part, however, the individuals who would be supported on the proposed programs are already supported by existing programs. So the budget considerations are generally modest redistributions of existing resources that would support the same investigators but in a way that contributes to their own career development. For example, independent support for postdoctoral researchers or staff scientists could be shifted from the mechanisms currently used to support them to the targeted independent programs described here. The committee also recognizes that implementation of some recommendations may require action outside of the NIH. While most of the recommendations can be implemented by NIH leadership and advisory councils, a few require Congressional action.

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research The committee has considered previous recommendations from earlier studies (many of which are outlined below) and successful programs and models from within and outside of NIH (many of which are described in Chapter 2). The contents of this report have been influenced by the general themes, issues, and recommendations from those other sources. In many cases, explicit reference is made to other work, but other reports and programs may have inspired aspects of this report even without mention of a specific connection. The committee has proposed pragmatic recommendations related to several different stages of a biomedical research career. The various programs discussed in the report are meant to complement each other and provide opportunities for members of a diverse scientific workforce with varying career objectives. In most cases, the pragmatic recommendations provide a framework for a new policy or program, discussing the salient characteristics but without stipulating every detail; the committee feels that the NIH staff, with appropriate backing and resources, is well positioned to use its reasoned discretion in determining the appropriate implementation. In some instances when previous recommendations have not proved successful, however, the committee has found it helpful to specify how its recommendations should be implemented and to provide a rationale for those details. The committee has suggested mechanisms for assessing the effectiveness of these recommendations once implemented. The various challenges described in the report have existed for far too long, and many previous recommendations for improving the situation have not been implemented. The NIH Director has expressed his commitment to act and the committee anticipates that the policies and programs recommended here will be put into effect as soon as possible. The methods of evaluation suggested here can provide formative data on the new programs that can assess their effectiveness while new investigators have the opportunity to take advantage of them. The committee has not been able to fully define pathways for physical scientists to move into biomedical research. In many ways, this issue is not specific to new investigators since the challenges and difficulties of switching fields apply to new and experienced investigators alike (COSEPUP, 2004). While the committee appreciates the need for developing these pathways into biomedical research, it feels that this topic would not have gotten the attention it deserves had it been more fully explored here. Therefore, this topic needs further investigation focusing explicitly on the similarities and differences between fields and requires a broader charge than only considering new investigators. The present committee recognizes that experienced researchers in the physical sciences likely need different mechanisms and programs for entering biomedical research than those without an established track record, even in the physi-

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research cal sciences. Thus, this report discusses and recommends the programs and procedures that might be especially useful for those making an early-career transition from the physical to biomedical sciences. However, it does not explore the issue fully for the reasons stated above. Finally, as to the issue of “shyness” mentioned by Dr. Zerhouni, the committee—and the workshop participants—have done a lot of “out of the box” thinking. The committee considered a number of radical possibilities, including reconfiguring entire biomedical funding and career structures. Overall, the committee found it important to make recommendations that are not only appropriate, but also practical and possible. The committee has also been careful not to offer recommendations that might endanger the enormous success of the biomedical research enterprise and the groundbreaking research that NIH supports. Moreover, none of the recommendations contained in this report are intended to threaten the autonomy or independence of established investigators or to make it any more difficult for them to obtain research funding (though tight budgets necessarily mean that funds spent on one program will not be available elsewhere). The focus on new investigators does not mean that the continuing challenges faced by previously funded investigators are not also of concern. Rather, the focus is on the overall research enterprise, whose future relies upon attracting and supporting new investigators who will become the established researchers of the future. A TIME FOR ACTION Despite a long history of concern on these issues, progress has been slow. Previous recommendations have been offered but, in many cases, not even attempted. Since ignored previous recommendations were offered, the situation has worsened for new investigators. The time for action is now. Every year of delay in implementing change affects tens of thousands of scientists already pursuing biomedical careers and an untold number of those who might have pursued such a career. Scientists who have the creativity to cure disease and advance biomedical research significantly are being discouraged from pursuing that research. Fortunately, the time is right to take action. The personal concern for this issue by leaders at the highest levels of NIH and of science in general provides a reason for optimism. But it is not only the leaders of NIH who must be convinced of the urgency. Advisory Councils, study sections, and staff members at NIH must all play their part in enacting these recommendations now. University administrators, department chairs, and faculty must recognize that the biomedical research enterprise is not the same as it was when they were new investigators and take steps to acknowledge this new reality. New faculty members, postdoctoral researchers,

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research BOX 1-2 NIH Definition of New Investigator “Applicants are considered new investigators if they have not previously served as the principal investigators (PI) on any Public Health Service-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or certain research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research career (K01, K08, and K12). Current or past recipients of Independent Scientist and other nonmentored career awards (K02, K04) are not considered new investigators.” Source: http://grants2.nih.gov/grants/guide/notice-files/not97-231.html staff scientists, and graduate students must also recognize these realities and be proactive and realistic about their own careers. DEFINITIONS The meanings of “new” and “young” investigator blur. The major issue addressed in this report is moving new (i.e., previously unfunded) researchers into the ranks of funded independent scientists, regardless of age. Even though not all new investigators are “young,” many of the relevant data are based on the age of the applicant.1 Thus, various types of data are cited in the report; although chronological or even professional age data may not always present an accurate picture of all new investigators, in many cases, those are the only data sources available. The focus of this report and its recommendation is on new investigators. (See Box 1-2 for NIH’s definition of new investigator.) The traditional view of “independence” in academic biomedical sciences as being listed as a Principal Investigator (PI) on a traditional NIH investigator-initiated research award—the R01 grant2—does not accurately reflect what it means to be independent. Box 1-3 includes the 1   Some data sources use the “professional age” of an applicant, i.e., years post-PhD. 2   The list of abbreviations in Appendix C defines each of the NIH grant award types discussed in this report.

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research BOX 1-3 Independence An “independent investigator” is one who enjoys independence of thought—the freedom to define the problem of interest and/or to choose or develop the best strategies and approaches to address that problem. Under this definition, an independent scientist may work alone, as the intellectual leader of a research group, or as a member of a consortium of investigators each contributing distinct expertise. Specifically, we do not intend “independence” to mean necessarily “isolated” or “solitary,” or to imply “self-sustaining” or “separately funded.” committee’s interpretation of “independence.” The committee seeks to broaden the concept of independence beyond that of a tenure-track professor to include other career trajectories such as a staff-scientist track of highly trained and talented individuals engaged in independent research but without necessarily having their own laboratory. Moreover, increasingly collaborative research projects with multiple investigators and the growth in non-tenure-track positions necessarily alter what independence means. Even those working in large research groups who have overall goals set by others can and do exercise independence by developing the strategies in pursuit of those goals. The research environment of the future will likely incorporate both large collaborative teams and individual investigators with small research groups, and both models will be necessary for advances in biomedical research. Individuals will need to be able to direct their own research and pursue independent directions within both of these contexts—and be skilled at moving between them. The committee also recognizes that independence means not only initially establishing independent research funding, but also sustaining it. Any programs explicitly for new investigators should be designed to help put researchers in a position to subsequently compete for funding with established investigators. Finally, the committee has affirmed the interconnectedness of scientific research and research training. For those engaged in mentored research as postdoctoral researchers and graduate students, research cannot be separated from the training and mentorship offered to them. Even if a postdoctoral or graduate trainee is supported by a research grant, the principal investigator, institution, and granting agency have a responsibility to ensure that the trainee receives the appropriate guidance, mentoring, and training.

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research CONTEXT AND BACKGROUND This committee is not the first to explore issues of fostering the independence of new investigators in biomedical research. Several National Academies reports are among those that have explored this or closely related issues (e.g., NRC, 1994, 1998, 2000; COSEPUP, 2000; Institute of Medicine, 1990); additional recommendations have been made by private funding agencies, professional societies, advocacy groups, and researchers (e.g., ACS/BWF/HHMI, 2000; FASEB, 1998; National Postdoctoral Association, 2003; Petsko, 2001). But there has been disappointingly little progress in improving the situation confronting new investigators or in implementing previous recommendations. In formulating its recommendations, the present committee has considered the earlier recommendations and the challenges that have prevented them from being implemented or in producing the desired effect. One crosscutting message is that NIH has not implemented most of the previous recommendations. The committee did not have an opportunity to fully investigate the reasons for the slow progress in implementing previous recommendations. Several of the recommendations to support new investigators rely upon devoting significant resources to individuals who have not already demonstrated their abilities in the specific areas they seek to address. The reliance on preliminary results as one of the most important criteria for peer review necessarily disadvantages those who have not been in a position to already conduct the research for which they are applying. While study sections may feel that focusing resources on individuals and projects that are already proven is responsible, there is also a need to provide support for more “risky” research and researchers. Responses to more specific concerns have generally only been addressed indirectly—if at all. For example, almost all attention to postdoctoral researchers has been focused on the NRSAs, ignoring the far larger number of postdocs who are supported on research awards. And the earlier recommendation to establish career transition awards provided a set of very focused programs designed to meet specific institute goals, rather than the more general program suggested. While the committee appreciates the need to meet a variety of objectives, fostering the independence of new investigators has not been a significant NIH-wide goal addressed in a coordinated fashion. The committee feels that NIH action on issues related to new investigators and on the issues mentioned in this report should have a coordinated response so that the 27 NIH institutes and centers work together. The NIH Roadmap3 provides a helpful framework for such unified actions on issues of concern across NIH. 3   http://nihroadmap.nih.gov/

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research Career Transition Awards Career transition grants, which support a period of mentored postdoctoral tenure followed by the first several years of independent research support, have been recommended by the National Research Council (1998), COSEPUP (2000), and the National Postdoctoral Association (2003) among others. Although a number of private funding agencies—including the Burroughs Wellcome Fund, the National Multiple Sclerosis Society, and the discontinued Markey Charitable Trust—have established such awards, the total number of them is quite small (less than 40 annually across several private foundations). The NIH awards fewer than 100 each year, and many of these are quite restrictive. In particular, the NIH’s K22 career transition award program is actually not one program, but many. Each of the 12 NIH institutes that offers the award has a different set of requirements and expectations, several of which require that the mentored postdoctoral fellowship be conducted in an intramural NIH laboratory. Further, not all the institutes award the K22, and the National Institute of General Medical Sciences, one of the most important supporters of basic biomedical research, does not have a K22 program. It is clear that the K22 awards are designed to fulfill specific research goals of the institutes that offer them, rather than provide the more general career development function advocated in the previous recommendations. The Federation of American Societies for Experimental Biology (FASEB) (1998) has recommended that NIH establish a program of “NIH Scholars Awards,” which would competitively select individuals to start faculty appointments at geographically diverse host institutions. The program would provide salary and start-up costs for the most outstanding postdoctoral researchers across the country as they launch independent research careers. Petsko (2001) goes even farther in suggesting that NIH designate three starting faculty from each biomedical sciences PhD-awarding institution to receive $175,000 for each of the first three years of their career without need for a proposal or review. Neither of these ideas has been tried. Review of Grant Applications A 1994 National Research Council (NRC) committee and others have recommended that a grant application from a new investigator should be “judged on its merits and on its likelihood of providing new information, without a requirement for extensive evidence that it will succeed” (NRC, 1994, p. 87). The 1994 committee even suggested that letters of recommendation from past preceptors could replace preliminary data to provide the evidence of success. The difficulty new investigators have in obtaining

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research preliminary data further discourages new investigators from trying new ideas and pursuing novel areas of research. That committee also recommended the separation of review of new investigator applications from that of more established PIs (NRC, 1994). At NIH, applications from new investigators are identified as such, and study sections are advised to follow modified guidelines for them, but these applications are still reviewed in the same pool as those from established researchers and are generally not considered en bloc at study section meetings. Separately constituted study sections to consider new investigator applications might solve one problem but create others because there are relatively few applications from new investigators during any one review cycle. Thus, new investigator study sections would either have to review very broad ranges of proposals—risking insufficient scientific expertise in some areas—or pool applications over longer periods of time—delaying the consideration of proposals from new investigators. Finally, reviewing all the proposals from both new and previously funded investigators together allows study sections to better sense the direction of research in their respective fields. The emphasis on the new investigator status of certain applications and how to consider them is at the discretion of the Center for Scientific Review (CSR) scientific review administrator and the study section, so the treatment of new investigators is not consistent across study sections. There are anecdotal reports of special consideration for new investigators being almost completely disregarded or even actively discouraged. Even though these instances may be specific to individual study sections and not a general phenomenon, new investigators whose proposals are considered by those study sections are not getting the intended consideration. It should be noted that CSR sees the review process as solely to determine scientific merit, with decisions about whether to fund proposals and programmatic decisions on funding priorities the purview of individual institutes. For example, “select pay” mechanisms may allow for funding of proposals whose scores do not fall within the range of those that would normally be funded but that are relevant to the overall mission of an institute (see Boxes 2-4 and 2-5 for discussion of policies benefiting new investigators in two institutes). Sufficient Resources and Funding Policies R03 (small research projects) and R21 (exploratory or developmental research) awards do not require preliminary data, but are not generally targeted specifically to new investigators. Rather, they are meant to achieve certain programmatic aims of an institute and to stimulate research in new areas. The level of funding is generally not sufficient for

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research supporting an entire research laboratory, leading new investigators attracted to such programs—because of the lack of preliminary data—scrambling to find funding from many different sources. Previous reports have strongly recommended providing sufficient levels of funding for new investigator awards. For instance, before the R29 program was eliminated, the National Research Council (1994) recommended that the maximum level of support for this new investigator award increase by over 75 percent. Although new investigators are unlikely to have large research teams of many postdoctoral scientists, graduate students, and technicians, they do have additional costs associated with establishing a research program and laboratory and training personnel. In addition, a new investigator’s laboratory is likely to grow quickly over the award tenure as projects become established and new personnel join the group. This increases the need for programs intended to support independent research groups—including those overseen by new investigators—to have the necessary resources. In addition, some researchers, especially at medical schools, are often expected to pay for a fraction of their own salary out of grants, putting additional demands on the size of awards. New investigators face particular challenges as they establish labs and train personnel, all while trying to collect enough data to apply for continued funding, publish their research, and possibly prepare for tenure consideration (NRC, 1994). Shorter award tenures may exacerbate these difficulties and discourage investigators from pursuing novel, more risky research, because of the need to publish results before the grant comes up for renewal. Protected Time It has been suggested that grants should reward institutions for limiting the administrative, clinical, and teaching responsibilities of new investigators, allowing them to focus time on research (NRC, 1994). Many of NIH’s programs—including all of the K awards—stipulate a minimum percentage of time a PI must devote to research. Many of the career transition and other new investigator grants in the private sector require a similar commitment to dedicated research time. However, protected research time must not disengage the scientist from other activities essential for other aspects of their career development. For example, scientists engaged in clinical research may benefit from clinical responsibilities. And teaching may help beginning faculty to recruit graduate and undergraduate students to work in their laboratory. In any case, teaching often helps faculty to generate new ideas. Further, new faculty may be some of the

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research most innovative teachers and best able to relate to undergraduate and graduate students. The Faculty Early Career Development Program (CAREER) grants of the National Science Foundation take this into consideration, and CAREER awards are specifically intended for teacher-scholars who plan to integrate research and educational activities. Feedback A 1990 Institute of Medicine (IOM) committee recommended that the R29 new investigator award program include a formalized assessment of progress by a scientific panel in the third year of the 5-year award (IOM, 1990). This mid-course review would help ensure that new investigators are moving in the right programmatic direction to be competitive for the “normal” R01 grant system. For the most part, no such interim review exists for NIH-funded grants. While most PIs are required to file annual progress reports, the vast majority of these reports have little consequence. In fact, only in the rare situation of extremely serious concern is any feedback provided (generally by discontinuing funding). For some of the K awards, the mentor files the report. This may encourage the mentor’s involvement with and feedback to the trainee, but does not help the mentee receive feedback from NIH. In the private sector, most grants require formal annual progress and financial reports, but again, without substantive feedback. However, grant programs administered by private funding agencies are more likely to have annual meetings and other networking functions that create informal communities of awardees and, sometimes, representatives of the funding organization can provide informal feedback. Career Guidance The Committee on Science, Engineering, and Public Policy (COSEPUP, 2000), National Postdoctoral Association (NPA), and others have called for increased attention to substantive career guidance, career planning, and training enhancement opportunities by advisors, institutions, disciplinary societies, and funding organizations. While institutions and some disciplinary societies have had some success in implementing such programs, much more progress is needed. With this in mind, one recommendation coming out of the October 23-24, 2003, NIH meeting on postdoctoral issues was to provide seed money to assist institutions in establishing postdoctoral offices to help coordinate and conduct such career development and training activities (Henry, 2004; Jenkins, 2004).

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research Need for Data Finally, there have been many calls for increased data collection and reporting on the biomedical workforce. As identified by COSEPUP (2000), many institutions have very little idea how many postdocs and “soft-money” scientists are in residence. And very few reliable national data exist on the number of postdoctoral researchers. In fact, NIH cannot provide anything more than an educated guess when asked about the number of postdocs it supports on extramural research grants. Clearly, there is a problem with data collection and reporting. The NRC (2000), NPA (2003), the October 2003 NIH postdoc meeting (Henry, 2004), and even the NIH (2001) itself are among those who have called for increased data collection for all NIH-funded postdocs. The growing population of staff scientists and other non-tenure-track researchers (see Chapter 2) must also be reflected in appropriate data about all career stages of the biomedical workforce. Moreover, data collection strategies should also be constructed to allow for disaggregated information to detect different trends between sub-populations of the biomedical research workforce. WORK OF THE COMMITTEE As outlined in its charge, the committee’s data-gathering efforts centered on a daylong public workshop dedicated to exploring issues related to fostering the independence of new investigators in the life sciences (Appendix B). Approximately 150 individuals attended the June 16, 2004, workshop held at the Keck Center of the National Academies in Washington, D.C., and about 100 listened on a live audio Webcast. (A list of registered attendees is included in Appendix B.) In addition to speakers and committee members, workshop participants included representatives from the NIH—ranging from postdoctoral researchers to institute directors—and other government agencies, professional scientific societies, university researchers and administrators, tenured faculty, untenured faculty, staff scientists, postdoctoral researchers, and others interested in and knowledgeable about the issues confronting new investigators. Through a series of presentations, discussions, and breakout sessions, the committee heard about data regarding new investigators, challenges facing new investigators and institutions, and some promising programs and efforts designed to address those challenges. Much of what was discussed at the workshop (agenda in Appendix B) is summarized in Chapter 2 and referenced throughout the report. Audio files and presentations are also archived on the project web site.4 4   http://dels.nas.edu/bls/bridges.html

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research The committee received and reviewed additional information, including sections of previous studies from the National Academies and others, relevant articles, material provided by NIH officials and others, grant announcement and review guidelines, and additional background research conducted by National Academies staff. The committee also requested and received analyses of personnel and grant award data from the Office of Extramural Research at the NIH and the National Academies Board on Higher Education and Workforce. The committee met in person immediately following the workshop to plan the structure and scope of the report and to begin work on recommendations. Committee members worked to develop, discuss, and refine their findings and recommendations by teleconference over the next several months. ORGANIZATION OF THE REPORT Chapter 2 describes the current patterns and data for biomedical research careers and highlights some of the present challenges. Chapter 3 presents a vision for the future and offers a roadmap for where we want to be in 5 years. The next three chapters walk through various career stages and the steps needed to foster scientific independence at each of those steps: Chapter 4 focuses on the postdoctoral experience, Chapter 5 on the transition to a first independent position, and Chapter 6 on establishing stable research programs. Finally, Chapter 7 offers the committee’s conclusions.