6
Establishing Stable Research Programs

Over the past 20 years, scientists have been receiving their first grants from the National Institutes of Health (NIH) at increasingly older ages, as discussed earlier. The proportion of NIH grant recipients under age 35 has fallen dramatically, down to 4 percent in 2001; the average age of award of an investigator’s first independent NIH grant is now 42 for PhD recipients and 44 for MD and MD/PhD recipients (see Chapter 2). The general lengthening of graduate and postdoctoral training periods, the scarcity of faculty positions in biomedical research, and NIH’s policies and practices all contribute to this trend. New investigators are held to the standards of established scientists and are expected to have already obtained preliminary results that show they can perform a particular set of experiments at a high-quality level. As a consequence, many new investigators—who have not had time to “establish” themselves independently despite perhaps brilliant postdoctoral work—must wait for NIH funding.

The number of traditional tenure-track assistant professorships has remained level or even declined, while the number of PhDs competing for these positions has increased substantially (see Chapter 2). Consequently, the number of research positions outside normal tenure-track faculty appointments has grown. As such, the fastest-growing categories of post-postdoctoral appointment academic scientists are non-tenure-track positions, with titles such as staff scientist, research associate, lecturer, and research assistant professor. Scientists in these positions no longer work as trainees under a mentor’s supervision, yet many of them have not yet obtained independent financial support.



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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research 6 Establishing Stable Research Programs Over the past 20 years, scientists have been receiving their first grants from the National Institutes of Health (NIH) at increasingly older ages, as discussed earlier. The proportion of NIH grant recipients under age 35 has fallen dramatically, down to 4 percent in 2001; the average age of award of an investigator’s first independent NIH grant is now 42 for PhD recipients and 44 for MD and MD/PhD recipients (see Chapter 2). The general lengthening of graduate and postdoctoral training periods, the scarcity of faculty positions in biomedical research, and NIH’s policies and practices all contribute to this trend. New investigators are held to the standards of established scientists and are expected to have already obtained preliminary results that show they can perform a particular set of experiments at a high-quality level. As a consequence, many new investigators—who have not had time to “establish” themselves independently despite perhaps brilliant postdoctoral work—must wait for NIH funding. The number of traditional tenure-track assistant professorships has remained level or even declined, while the number of PhDs competing for these positions has increased substantially (see Chapter 2). Consequently, the number of research positions outside normal tenure-track faculty appointments has grown. As such, the fastest-growing categories of post-postdoctoral appointment academic scientists are non-tenure-track positions, with titles such as staff scientist, research associate, lecturer, and research assistant professor. Scientists in these positions no longer work as trainees under a mentor’s supervision, yet many of them have not yet obtained independent financial support.

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research As each institution submits grant applications on behalf of its researchers, institutional policy plays an important role in deciding who may apply for a grant. Receipt of research funding is an essential credential in the scientific community and is necessary for even continuation of most “soft-money” positions. NIH permits grant applications from scientists without tenure-track positions, but it also requires that their proposals have institutional backing. One indicator of the problematic status of most non-tenure-track scientists is the fact that many universities are reluctant to allow them to apply for their own research funding. Some institutions do not allow certain classes of non-tenure-track researchers to apply for external funding at all, refusing to commit the laboratory space and resources necessary to conduct the proposed research to individuals outside the tenure track. Non-tenure-track positions that depend solely on “soft money” are not always considered desirable careers, given their almost complete dependency on uncertain federal research dollars and the resultant job insecurity. But this does not necessarily differ from the situation for tenure-track faculty, especially in medical schools. For example, a study by the Association of American Medical Colleges (AAMC) indicated that tenure did not carry any financial guarantee for basic science appointments at 30.8 percent of medical schools in 2002, up from 24.4 percent just three years earlier (Liu and Mallon, 2004). Clarifying the roles and possibilities available to non-tenure-track academic scientists and finding ways to make the best use of their talents and training presents a challenge to the leadership of the nation’s research enterprise. This chapter makes recommendations on creating more stable research opportunities for new investigators, both tenure-track and non-tenure-track. R01s FOR NEW INVESTIGATORS For some time, NIH and the broader biomedical research community have been concerned about the ability of new investigators to obtain research grants, even those researchers who have attained tenure-track positions. The application and interview process for most tenure-track academic positions is so competitive that the successful applicant is not only an “above-average” scientist, but one near the very top of early-career-stage scientists. Given this level of vetting, the best interests of U.S. biomedical science require funding more of these individuals. The special mechanisms instituted by NIH over the past 15 to 20 years did not increase the number of new investigator applicants and these programs were eliminated (see Chapter 2), in part because promotion and tenure committees only value the “R01” designation. Creating opportunities for

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research increased scientific independence therefore requires a variety of arrangements that do not stigmatize a particular type of award and that are palatable not only to the investigator but also to his or her institution. After NIH abolished the R29 award, it developed a one-page sheet that provides guidelines for reviewing applications from new investigators (see Box 2-3 and related discussion). If these guidelines were followed in a robust and uniform manner, some of the problems faced by new investigators in applying for funds would be ameliorated. But the distribution of study section scores to new investigators (see Figure 2-12) and the experience of reviewers show otherwise. As explained in Chapter 2, study sections currently review an application in terms of the significance of the project, its approach or methods, the innovation of its concepts, the investigator’s qualifications, and the probability of success due to environment. Applications can be deferred (rarely), unscored, or scored. An unscored application is one that is deemed noncompetitive, and a scored application is one that has enough likelihood of funding that it merits further discussion. Having a proposal unscored (“triaged”) appears to be a particularly discouraging event, as evidenced by the lower rates of resubmission for unscored proposals than for unfunded—but scored—proposals. This may be especially discouraging for new investigators who do not have a history of grant applications and grant success. Leaving a new investigator’s application unscored deprives him or her of valuable feedback on the proposal and harms morale. Data provided by the National Institute of General Medical Sciences (NIGMS) suggests the importance of allowing new investigators the opportunity to revise and resubmit their applications after complete feedback, including assignment of a priority score (see Box 2-5). U.S. biomedical science would benefit if beginning PIs were encouraged to follow opportunities distinct from the area of their postdoctoral project, and even important areas not much pursued by anyone. Yet the current reliance on preliminary results further discourages branching out into high-risk, high-reward areas. 6.1 NIH should establish and implement uniformly across all of its institutes a New Investigator R01 grant. The “preliminary results” section of the application should be replaced by “previous experience” so as to be appropriate for new investigators and to encourage higher-risk proposals or scientists branching out into new areas. This award should include a full budget and have a 5-year term. NIH should track new investigator R01 awardees in a uniform manner including success on future R01 applications.

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research This award should have the following characteristics: The grant should be designated an “R01,” with the “new investigator” status indicated by a checkbox on the first page of the application. The “Preliminary Results” section should be replaced by “Previous Experience.”1 Previous experience need not necessarily be in the same subfield as the proposed research. The budget should be in the same range as for other R01s, currently $250,000 per year. The term of these grants should be 5 years, allowing investigators the opportunity to establish a laboratory and train personnel without concern about renewing research support immediately. In addition, short duration awards further discourage investigators from pursuing new areas of research (NRC, 1994). The receipt of a New Investigator R01 should not prohibit additional NIH funding, although additional R01 applications would not be eligible for “new investigator” status. As an R01, these grants should be reviewed by regular study sections, which have the appropriate depth of expertise, but evaluated in a contiguous “new investigator session” and introduced with clear instructions from staff. A previous NRC committee (1994) proposed this mechanism for review of R29 awards. All of these applications should be given full review and priority score, with none unscored. Applicants could also benefit from prompt return of reviews to enable them to prepare a resubmission in the next study section round. Funding for this program should be allocated separately from those of previously funded investigators so that new investigators do not compete against those with more experience. This will assure that an appropriate number of new investigators will be funded in each study section. Considering the modest number of new investigator proposals currently left unscored by a typical study section, the additional workload entailed by the implementation of this recommendation is not onerous. An open issue is eligibility for these awards: Who is considered a “new investigator”? The preferred policy would exclude those with significant 1   This is consistent with an earlier NRC committee’s recommendation for consideration of new investigator proposals without requiring preliminary data from new investigators (NRC, 1994).

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research renewable sources of funding. As such, receipt of career transition awards (e.g., K22, BWF) would not disqualify an applicant, because they are nonrenewable. However, being the sole PI on a renewable grant from another source (public or private) would disqualify the applicant. NIH institutes must have the same definition of eligibility. To allow evaluation of the impact of this program, NIH should track applicants for this New Investigator R01 with respect to their success in future R01 applications and in competitive renewals of their first R01. SUPPORT FOR NON-TENURE-TRACK SCIENTISTS Independent Grant Support for All Researchers Very few postdoctoral scholars obtain a tenure-track position in academia, and the number of tenure-track positions has been constant over time. However, many postdocs still remain in the academic sector; the number of postdocs who pursue other academic positions has dramatically increased, from approximately 1,000 in 1985 to nearly 17,000 in 2001 (Garrison et al., 2003). Some of these individuals work as part of a team in big science projects, and it is appropriate to fund them through grants awarded for these projects. Others might work alone as independent investigators. The career track of staff scientists/research track faculty should be legitimized (Marincola and Solomon, 1998a, 1998b; Gerbi, et al. 2001) by offering salaries appropriate to the position and the opportunity to compete for federal grants. Although biomedical research is entering an era of increasingly big science, a broad platform of independent research projects will still yield benefits. 6.2 NIH should establish a new renewable R01-like grant program for small science projects (e.g., $100,000 direct costs per year), open to researchers who do not have PI status on another significant research grant, including “soft-money” staff and research-track scientists. This program should receive its own set-aside funding from the NIH budget. The committee has chosen to spell out details of this new award program to ensure that it meets the desired aim of fostering the independence of new investigators rather than serving as another source of funds for already-funded researchers. Applicants for these grants should provide a statement describing their independence (especially if housed within the laboratory of a mentor). These funds would go to applicants who work as independent investigators but have positions other than the traditional tenure-track faculty appointments. By recommending this grant program, the committee does not intend to encourage the creation

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research of additional “soft-money” positions; rather, the grant recognizes the reality of the growing number of these researchers and provides them with increased opportunities for independence. Scientists with PI status on another research grant would normally not be allowed to apply. NIH staff could determine whether scientists with a small amount of funding as a result of Co-PI status on another research grant, participation in a training grant, or other small amounts of support remain eligible. Funds from the small grant would allow the staff scientist/research-track faculty member to have a salary commensurate with their training and experience, thereby endorsing the career track they are pursuing as honorable and independent and one that contributes to the research enterprise. While other small grants are available (for example the R03 award), they are normally nonrenewable and often too restricted in funding levels. Moreover, those other awards are available to all researchers, while the proposed new award would be restricted to those without other significant sources of support. As research awards, sponsoring institutions could recover indirect costs. Providing for Enhanced Job Security The number of tenured and tenure-track faculty in research universities and institutions has remained approximately constant over the last decade, while the ranks of non-tenure-track scientists have swelled. These investigators have many titles, including research assistant professor, senior scientist, lecturer, research associate, and instructor—and, in a few cases, they are still called postdoctoral associates. It is time to develop policies to protect the careers of these individuals, who provide a valuable resource to the current and future research enterprise. In recent years, universities increasingly have used non-tenure-track positions to expand their faculty without making a permanent commitment. At research universities, faculty-level jobs lacking the possibility of tenure have risen from 55 percent of new hires in 1989 to 70 percent today (presented by Paula Stephan, using data from National Center for Educational Statistics). The large number of applicants for each position offers a “buyer’s market” and allows institutions to attract talented researches to non-tenure-track positions. These trends have intensified job competition among young scientists. Such non-tenure-track scientists are generally completely dependent on external grant support. They rarely have any job security or protection and may have to take on teaching or clinical responsibilities that further inhibit their chances at independence. Nonetheless, these individuals have made a commitment to research and to their institutions; their institutions

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research should return that commitment by providing some means of job security and protection against a single unfunded grant proposal. Moreover, NIH should provide bridge support for the most highly deserving applicants who do not have additional funding. 6.3 Non-tenure-track “soft-money” researchers should have a budgetary “safety net” that provides time to reapply for grant support if their funding lapses. This safety net should be a joint responsibility of the NIH and the host institution: NIH should expand the Shannon Award to provide merit-based bridge awards for those without other sources of support and host institutions should offer multi-year renewable contracts to its staff scientists that guarantee space, salary, and minimal research support even in the absence of external funding. NIH’s James A. Shannon Director Award (R55) currently provides a small number of PIs whose grant applications fall just below the payline with $100,000 of bridge funding over 2 years to allow them to strengthen the proposal for resubmission. This program should be expanded to incorporate a special program of merit-based bridge funding that will be awarded to the most promising researchers who do not have other means of support. That is, NIH should examine whether applications that fall just below the payline are submitted by “soft-money” researchers who have no other source of support. Since the positions held by these applicants may be put in jeopardy by a funding lapse, a small bridging award will allow them to revise and strengthen a grant proposal for resubmission. This recommendation is not intended to establish a de facto form of tenure for non-tenure-track researchers, but to provide a minimal means of job security. At present, institutional commitment to “soft-money” researchers seems almost entirely tied to external funding; that is, if the funding is lost, so is the position, often before the applicant has the chance to even submit a revised proposal. If the institution is willing to commit to the individual by sponsoring their funding application, it should honor some level of commitment even if the grant application is not funded. The committee encourages institutions to offer multi-year renewable contracts to its non-tenure-track researchers so that they have some means of security and are protected from a single unfunded proposal. The committee has found it difficult to find examples of institutions that have an announced, transparent policy to provide a safety net to “soft-money” researchers. While many institutions and departments will assist individual researchers, they seem reluctant to publish a policy that would commit them to any action. The university may have pages of regulations for tenure-track researchers, but barely a mention of non-tenure-track,

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Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research even as these scientists are becoming increasingly prevalent in the research community. Recommendation 6.3 is very far removed from the current situation, but one that is vital to the continued success of the research enterprise. Non-tenure-track scientists and physicians should be eligible—by both institutions and the NIH—to apply for grants, including the New Investigator R01, and the NIH should review such applications without prejudice regarding their “soft-money” status. One challenge will be to ensure that these applications really do represent an independent research project from the applicant and not merely an opportunity for an established investigator to extend his or her funding through a junior colleague. Finally, to allow evaluation of the impact of such grants, NIH should monitor non-tenure-track applicants for R01 grants with respect to their funding rate and their success in future R01 applications—both new grants and competitive renewals. DATA COLLECTION As with postdoctoral and other researchers, NIH needs informative data on all segments of the scientific workforce, including tenure-track and non-tenure-track researchers. 6.4 NIH should develop enhanced data collection systems on all NIH-supported researchers, regardless of specific funding mechanism. This will allow NIH to track the effectiveness of its programs, make more informed programmatic decisions, and monitor the career progression of supported researchers. These data should include information about position, responsibilities, and support on those receiving NIH support. For instance, what percentage of time do funded investigators spend on research? Teaching? Clinical responsibilities? Is salary support provided by the host institution or is some of it obtained through external grants? How does this distribution correlate with the position held by the investigator? Moreover, data should be disaggregated to detect different trends among different demographic and other groups. In sum, creating a more stable environment for new investigators will encourage productivity and innovation early in their careers as they choose a long-term path. Great uncertainty is non-productive and can lead to risk-averse behavior, an anathema to good science.