Chapter 2 chronicled the challenges that early-career investigators face as they transition to and sustain research independence. In this chapter, the committee identifies a series of reforms to the existing biomedical1 ecosystem designed to create stronger and more easily navigable pathways to independent research opportunities for investigators regardless of gender, race, ethnicity, sexual orientation, socioeconomic background, visa status, or degree. If adopted, these reforms would provide stable and supportive platforms for success at each stage in a researcher’s career, while ensuring that the most promising candidates proceed to the next stage of training and mentorship and that robust exit opportunities exist for those who choose not to progress to an academic appointment. An ideal ecosystem would strike a balance between low-risk and high-risk lines of research, between basic and applied research, and between opportunities to work independently or as part of a team of independent investigators. It would also provide appropriate mentoring and financial support in a manner that does not place an arbitrary and undue burden on young scientists from any background, but instead creates equitable opportunities for all qualified investigators to succeed.
As highlighted in commissioned papers by international contributors,2 the U.S. biomedical research ecosystem is not unique in the challenges facing younger investigators or in its desire to attract and retain the best and the brightest in rewarding research careers. Canada, for example, has been working to rejuvenate its biomedical research workforce in the face of declining federal research funds and increasing pressures on entry-level academic positions resulting from
1 In this report, “biomedical” refers to the full range of biological, biomedical, behavioral, and health sciences supported by the National Institutes of Health.
an end to mandatory retirement in universities and colleges. The European Union is grappling with its own misalignment between the supply of and demand for trainees, availability of faculty positions, and the need to train young scientists for diverse careers. The countries that provided input to the committee are addressing many issues similar to those experienced in the United States:
- whether to allocate additional funds set aside for early-career investigators;
- whether to increase the size and duration of funding for these investigators;
- how to avoid unintended consequences for mid-career investigators seeking follow-on funding; and
- how to monitor success of these populations in systems under stress.
The committee strongly endorsed the urgent need to solve the persistent and severe structural issues described in Chapter 2 that impact early-career investigators. These issues command deliberate attention from and action by all stakeholders, including the federal government, academic and research institutions, and industries in the biomedical space. The committee’s recommendations are predicated on the strong belief that collaboration from all stakeholders will be required to strengthen the system in the manner envisaged by this committee.
The National Institutes of Health (NIH) should invest in strengthening the research funding landscape for the next generation of investigators.
- To promote innovative research with high potential for groundbreaking discoveries, NIH should expand the number of NIH Director’s New Innovator Awards (DP2) and similar programs funded by individual NIH Institutes and Centers.
- NIH should ensure that the duration of all R01 research grants supporting early-stage investigators (ESIs) is no less than 5 years to enable the establishment of resilient independent research programs. NIH Institutes and Centers should monitor the effect of this change on the availability of funds for other research project grants and should experiment with further extensions of the duration of R01 awards for ESIs.
- To avoid dis-incentivizing research collaboration, those ESIs who participate in multi-principal investigator (PI) submissions prior to receiving their own R01 grants should retain their ESI status unless serving as a co-PI on a funded multi-PI award provides them with R01-equivalent funds for their own research.
- NIH should expand the Pathways to Independence (K99/R00) award, with a priority on fostering independence through career development, including the development of an innovative and independent
- research project originally conceived of and executed by the applicant, rather than additional or new training.
The committee strongly supports NIH’s recent announcement of the Next Generation Researchers Initiative (NGRI) and encourages Congress to allocate new funds to support this initiative. NIH should evaluate on a regular basis its new programs with the goal of expanding those that prove effective at addressing the challenges that ESIs and early established investigators (EEIs) face as they attempt to become independent investigators. The committee also commends NIH’s support of ESIs who pursue R01 awards through previous ESI-specific policies, including preferential paylines and segregated review. These efforts have had a positive impact on the success rates for the intended applicant pools (see Figure 2-4).
In the past, most R01-equivalent grants were funded for 5 years, but the duration and number of R01 awards have decreased as the number of applicants has increased out of proportion to the NIH budget. Initial NIH funding for ESIs should be long enough in duration and large enough in amount to support establishment of new, independent research programs. We recommend 5 years and at least $250,000 per year of direct cost. Furthermore, NIH should consider exempting the first R01 for ESIs from administrative cuts after the grant is awarded so that those investigators are not penalized as they establish their programs.
In 2007, NIH unveiled the DP2 to support highly innovative research from exceptionally creative ESIs. DP2 applicants can request up to $1.5 million in direct costs over the 5-year grant period. Although the DP2 award appears to be an excellent mechanism to support ESIs who plan innovative projects, NIH expects to make only 33 awards in 2018, depending on the availability of funds in the NIH Common Fund.3 Given that the DP2 award has successfully motivated early-career investigators to propose and conduct innovative, high-risk, and impactful biomedical and bio-behavioral research, NIH should encourage Institutes and Centers to implement similar mechanisms, such as the National Institute of Mental Health (NIMH)’s Biobehavioral Research Awards for Innovative New Investigators (R01) award. Many organizations that responded to the Dear Colleague Letter (Appendix C) strongly urged expansion of the DP2 program. The committee requests that NIH expand the number of DP2 awards and mount a pilot project to determine whether there are tangible advantages to increasing the duration of the DP2 and similar awards, such as the National Institute of Neurological Disorders and Stroke’s Research Program (R35) award with an 8-year duration, the National Cancer Institute (NCI)’s Outstanding Investigator Award (R35) with a 7-year duration, and the National Institutes of General Medical Science’s MERIT (R37) award with a potential 8- to 10- year duration. The benefits could include, but are not limited to, higher success rates for securing subsequent NIH
3 See http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-17-006.html (accessed March 21, 2018).
awards, increased publication and citation rates, or increased willingness to undertake higher risk research.
In 2006, NIH established the NIH K99/R00 award to “help outstanding postdoctoral researchers with a research and/or clinical doctorate degree complete needed, mentored career development and transition in a timely manner to independent, tenure-track or equivalent faculty positions.”4 Recipients of the K99/R00 award have been found to have a higher success rate for subsequent R01-equivalent awards compared to new ESIs and are more persistent in obtaining subsequent grant support (Carlson et al., 2016). In addition, a 2014 analysis by Grantome found that close to 60 percent of 2007 K99 awardees became the PI on a research project grant (RPG), compared to less than 20 percent for postdocs supported on F32 awards (Grantome, 2014). The committee commends NIH for developing a program that artfully connects training and independence, and recommends that NIH consider expanding this program with some modifications, such as extending the length of the R00 portion of the grant beyond 3 years, ceasing funding of applicable indirect costs from the R00 portion of the grant,5 and decreasing the emphasis on the new/additional training component of the K99 proposal.
The National Institutes of Health (NIH) should continue to improve the peer review process to optimize the evaluation of applications submitted by early-stage and early experienced investigators in the Next Generation Researchers Initiative. This action would especially benefit investigators from underrepresented groups. NIH should revise the biosketch requirement to focus peer review on recent contributions and accomplishments and should continue to test effective practices to reduce the effects of implicit bias on the review process and to increase the diversity of reviewers.
Traditionally, a young investigator’s receipt of an initial R01 or equivalent award has been viewed as a marker of early independence and success. However, data suggest that ESIs experience difficulties in the peer review process that may disadvantage them compared to established investigators (Azoulay et al., 2013). In 2008, NIH issued a report that addressed many issues surrounding peer review (National Institutes of Health, 2008). In that report, NIH assessed that some policies, such as the single resubmission policy, disproportionately disadvantage newer investigators because they tend to have smaller research programs and facilities. The committee supports the need for additional action to reduce the barriers that ESIs face in the grant review process. Although adjustment of paylines has assisted, other measures can improve the review and success of ESI applications.
4 See https://grants.nih.gov/grants/guide/pa-files/PA-16-077.html (accessed March 20, 2018).
5 The current R00 award is up to $249,000 total costs per year, including salary, research support, and indirect costs.
To improve the review process for ESIs, NIH identifies ESI applications when they are assigned to a study section so that appropriate consideration of career stage can be applied during review. To facilitate this effort, ESI applications are clustered, or reviewed together, to enable evaluation as a group, and NIH instructs peer reviewers to focus more on the proposed approach than on the track record and to expect less preliminary data than might be provided by an established investigator.
NIH requires a standardized biosketch to accompany every grant application. The biosketch highlights an individual’s qualifications for the proposed research project. In the current application format, applicants describe their major contributions and list four to five publications that reflect each contribution. Since the current biosketch format focuses on the totality of the researcher’s career, and places less emphasis on recent productivity, it could advantage more established over younger investigators in the review process.
Revising the biosketch requirement to emphasize recent productivity could help to level the playing field for ESIs. Canada adopted a similar approach, whereby applicants for Natural Sciences and Engineering Research Council (NSERC) grants are assessed on the quality and impact of their contributions to research over the past 6 years instead of the duration of their careers.6
All investigators, but particularly ESIs, would benefit from increased diversity on the review panels. The committee also recommends that NIH expand the number of junior investigators who serve as ad hoc members on review committees and afford them an opportunity to learn more about the peer review process. In addition, NIH should continue to develop training strategies to address implicit biases in peer review. Data reveal that grants submitted by members of underrepresented minority groups (Ginther et al., 2011) receive lower priority scores than those submitted by their white counterparts. The committee applauds NIH for its current efforts and notes that current studies are under way to identify effective remediation strategies.7 The committee requests quick dissemination of these studies’ findings and full funding of any additional research needed to promote equity during the peer review process.
Research institutions and the National Institutes of Health should develop mechanisms to increase the number of individuals in staff scientist positions to provide more stable, non-faculty research opportunities for the next generation of researchers. Research institutions should experiment with providing career tracks with clearly defined review and promotion processes, as well as opportunities for professional development. Individuals in a staff
6 See http://www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/assesscontrib-evalcontrib_eng.asp (accessed December 10, 2017).
7 See https://acd.od.nih.gov/documents/presentations/06082017Valantine.pdf (accessed December 10, 2017).
scientist track should receive a salary and benefits commensurate with their experience and responsibilities.
Relatively few established paths exist for researchers who pursue research at academic institutions as non-faculty researchers, often referred to as staff scientists. These positions often do not include clear opportunities for career advancement, and they rarely allow access to the professional resources available to faculty and trainees. In many cases, staff scientists work in the laboratories of individual PIs and are not encouraged to secure independent research support. In addition, few funding mechanisms are dedicated to supporting professional, non-faculty researchers in academia, and staff scientists who receive an NIH grant find it difficult to sustain their careers because of federal prohibitions against spending time writing grants when they are supported by a federal grant (Carpenter, 2012).
The lack of clarity around established career paths at many universities other than academic faculty positions is a flaw in today’s academic biomedical enterprise. This flaw contributes to many of the issues discussed in this report, including the backlog of postdoctoral researchers and confusion and frustration on the part of trainees and PIs. Promotion of a staff scientist track as an attractive and viable research career choice in academia—one with stability and professional recognition and status as well as opportunities for progressive advancement—would provide a career path for individuals who are interested in academic research but are not interested in an academic faculty position. This action would help to bring the biomedical system into greater equilibrium, though it is possible that the increased use of staff scientists could impact the downstream availability of faculty positions, a possibility that will require careful monitoring to avoid.
At many institutions, it is staff scientists who manage the sophisticated research technologies located in core and other shared facilities. These services and technologies are essential to the success of biomedical investigators’ endeavors and therefore the overall biomedical research enterprise. Therefore, programs to support a unique class of independent or semi-independent staff scientists are needed. Many will be leaders of scientific core facilities or shared resources, and while they will enjoy a degree of independence, they will nearly always focus on providing collaborative support and making critical research technologies accessible. This recommendation is intended to further the development of a cadre of staff scientists, provide research-based opportunities for academic scientists beyond a faculty research appointment, and support advancement of the nation’s biomedical research.
Recognition of the role for staff scientists in the research enterprise is growing. Academic institutions such as the University of Wisconsin-Madison, the Howard Hughes Medical Institute’s Janelia Research Campus, the Salk Institute of Biological Sciences, NIH Clinical Center, NIH intramural laboratories, and
the Allen Institute for Brain Science have developed formal programs for staff scientists. The Broad Institute is notable for its Institute Scientist initiative and for employing more than 400 staff scientists (Hyman, 2017). In recognition of the key role that staff scientists can play in advancing complex scientific projects, the NCI launched in 2015 a new Research Specialist Award (R50) pilot program for exceptional scientists who want to pursue research within the context of an existing cancer research program, but not serve as independent investigators. The R50 is intended to provide desirable salaries and sufficient autonomy so that individuals are not solely dependent on grants held by PIs for career continuity.
However, meaningful evaluation of the potential impact of staff scientist or equivalent positions will depend on the design of new programs that extend beyond NCI and can fund more than a few dozen positions. This area is well suited for funding experimental pilot projects, and NIH and universities alike should explore development of programs that provide support for original research projects conducted by staff scientists. These programs should be open to qualified scientists regardless of visa status. In addition, institutional leadership will need to nurture an environment that supports staff scientists and attracts high-caliber investigators who want to work in non-faculty academic positions. The nature of pilot projects differs from that of RPGs; therefore, the metrics for their evaluation should be considered carefully. Evaluation criteria should aim to capture the holistic contributions of the scientist and could include contributions to published work noted in authorship, contributorship (Rennie et al., 1997; Sauermann and Haeussler, 2017) or acknowledgement, contributions to data that result in successful grant funding, and the breadth and numbers of different independent researchers that are assisted. In addition, NIH or the National Science Foundation (NSF) should track the career paths of staff scientists in the same ways that this report recommends they track the career paths of postdoctoral researchers (see Recommendation 3.3).
Many of the responses to the Dear Colleague Letter (Appendix C) highlighted the need to better support staff and professional scientists given their contributions to the biomedical research enterprise. Based on the findings of its working group to study the issues confronting staff scientists, the American Society for Biochemistry and Molecular Biology (ASBMB) is planning a study to collect data on the cost, efficiency, and productivity of staff scientists as a means to develop guidance for the research community on how best to incorporate staff scientists into its operations. The ASBMB working group proposed that institutions create individual development plans for staff scientists to ensure they receive some degree of professional development and career advice. In a 2015 report, Sustaining Discovery (FASEB, 2015, p. 5), the Federation of American Societies for Experimental Biology (FASEB) called for the research community to employ more staff scientists and to consider more extensive use of career technicians, as have others (Pickett et al., 2015).
The National Institutes of Health (NIH), research institutions, and principal investigators should share responsibility for increasing diversity and promoting inclusion of early-career researchers.
- To promote diversity and inclusion at the junior faculty level, NIH should require an institutional diversity and inclusion plan as a component of the institutional resources reported on research grants supporting trainees.
- To promote diversity and inclusion of research trainees, principal investigators should provide a diversity and inclusion plan in their grant proposals and should provide updates in progress reports, if funded.
The ability of science to promote worldwide health and prosperity requires a culture that supports and sustains a diverse and innovative biomedical workforce, but recent studies suggest that women—particularly women of color—and individuals from underrepresented populations (Hispanic or Latino, African American, American Indian and Alaska Native) experience higher rates of attrition in the transition from Ph.D. to academic faculty positions (Gibbs et al., 2014, 2016). Research into why improvements in gender, race, and ethnicity representation at the doctoral level are not reflected at the postdoctoral researcher and faculty career stages is ongoing, as is research on how best to restructure training, mentoring, and faculty hiring practices to reverse this trend.
One obvious priority is to address concerns about the effect of current hiring, tenure, and promotion policies on diversity and inclusion. These concerns arise from evidence-based observations about the enduring challenge of increasing faculty diversity. The first observation from recent studies is that the improved diversity in the ranks of trainees has not carried forward to the ranks of tenured professors (Finkelstein et al., 2016; Gibbs et al., 2016; Li and Koedel, 2017). At most academic medical centers, for example, promotion rates for African American and Hispanic faculty were lower than those for their non-Hispanic white peers (Nunez-Smith et al., 2012). In one set of studies in European countries, where faculty tenure and promotion decisions are made by randomly assigned committees, the promotion chances of female candidates for faculty promotion were diminished if they were assigned to an all-male review committee rather than a mixed-gender review committee (De Paola and Scoppa, 2015; Zinovyeva and Bagues, 2010).
Establishing institution-wide and laboratory-specific diversity and inclusion plans would go a long way in encouraging research institutions and their PIs to participate actively in addressing underrepresentation in the scientific research workforce. The committee applauds the National Institute of General Medical Sciences’ recently announced plans to require institutions to report evidence--
based diversity and inclusion approaches in all T32 proposals and to include these plans as part of scored review criteria. Such initiatives would encourage institutions to develop their own official diversity and inclusion plans and strategies that investigators can leverage when recruiting and training students and postdoctoral researchers.
The National Institutes of Health should allocate funds from its Next Generation Researchers Initiative to expand the number of Research Supplements to Promote Diversity in Health-Related Research (PA-16-288). These should be awarded to underrepresented minority (URM) early-stage investigators and URM investigators who have not been awarded a research project grant and seek to collaborate with funded investigators on new but related research projects. Proposals must clearly detail how the collaboration will result in a grant proposal by the URM investigator. To best support this career stage, awards should be enhanced with funds for supplies, equipment, professional development, and mentoring. The eligibility criteria for these diversity supplements should reflect only the URM populations specified by the National Science Foundation for the biomedical research enterprise.
In response to the 21st Century Cures Act of 2016,8 NIH launched the Next Generation Research Initiative (NGRI). This policy established ESIs and EEIs as two classes of scientists that would be prioritized for funding. In replacing the 2007 NIH New Investigator policy, the NGRI increases the possibility of unintended consequences from enhancing workforce diversity specifically within the biomedical research enterprise as called for by the 21st Century Cures Act. The NIH Research Supplements to Promote Diversity in Health-Related Research program can be utilized as part of the NGRI to counterbalance these potential unintended consequences.
Currently, only 10 percent of all diversity supplements are used to support faculty-level investigators (Valantine et al., 2016). As part of an NIH-wide program, PIs on RPGs may request supplemental funds to support and recruit eligible investigators from underrepresented racial and ethnic groups and with disabilities. Individuals who meet the criteria for “Investigators Developing Independent Research Careers” as specified in the solicitation can receive up to 2 years of funding and $10,000 for travel and supplies. As part of the NGRI, this support should be increased to provide up to 3 years of salary support ($75,000/year maximum) and $50,000/year for supplies and travel.
The National Institute of Neurological Disorders and Stroke (NINDS), responding to its assessment of its diversity supplement program, instituted
8 21st Century Cures Act, P.L. 114-225 § 2021, 130 Stat. 1051, 1052 (2016). Available at https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf (accessed January 19, 2018).
rigorous review criteria and now requires the student or fellow supported by a diversity supplement to write an individual proposal within 2 years of receipt of support from this program. This approach should be extended to Next Generation Researchers Initiative-Diversity Supplements (NGRI-DS).
The eligibility criteria for administrative supplements has been the subject of debate. The committee recommends limiting the eligibility for underrepresented racial and ethnic groups to those groups underrepresented in science, technology, engineering, and mathematics (STEM) fields as defined by NSF. The committee also recommends that eligibility for the NGRI-DS should not extend to individuals from economically or educationally disadvantaged backgrounds unless evidence demonstrates that this group is at a competitive disadvantage during the ESI and EEI stages.
The National Institutes of Health (NIH) should make the Loan Repayment Programs available to all individuals pursuing biomedical physician-scientist researcher careers, regardless of their research area or clinical specialty. NIH should increase the monetary value of loan repayment to reflect the debt burden of current medical trainees. NIH should also continue implementation of the recommendations laid out in the 2014 NIH Physician-Scientist Workforce Working Group Report. NIH should test new strategies and expand effective approaches to increase the pool of early-stage physician-scientists.
Physician-scientists function as a critical segment of the biomedical research workforce because they bridge the clinical and research enterprises and thus help to accelerate the translation of basic discoveries into medical advances. In addition to the challenges that all ESIs face, physician-scientists face some unique challenges early in their research careers. For example, the training required to obtain competency in clinical and scientific research is extensive, and, not surprisingly, achieving proficiency in both can require a long overall training period. In addition, physician-scientists face increasing clinical demands, thereby decreasing their time for investigative work. In the face of these challenges, additional incentives are needed to support clinicians interested in either pursuing or sustaining their research programs (NIH Physician Scientist Workforce Working Group, 2014).
Initiatives such NIH’s Loan Repayment Programs (LRP) for physician-scientists are helpful in encouraging research activity by physician-scientists, but the program has not kept pace with the increasing cost of medical school and is only available in some biomedical fields. As of 2017, NIH’s LRP will pay 25 percent of the eligible education debt up to a maximum of $35,000 of loan repayment per year, with an option for a 1- or 2-year renewal. However, the median medical school debt in 2016 was $190,000, a nearly $20,000 increase
since 2011,9 and the loan repayment amount is considered taxable income. Division of Loan Repayment at NIH pays federal taxes for the LRP recipient on a quarterly basis at 39 percent of the loan repayment. However the LRP recipient may be subject to other taxes such as state taxes. In fiscal year 2017, this program made 1,283 awards totaling $68,185,910. With 74 percent of medical school graduates from 2016 with education debt,10 physicians are less likely to pursue biomedical research and become physician-scientists than they were in the past (Garrison and Deschamps, 2014).
In 2016, the 21st Century Cures Act authorized increases in the amount of loan forgiveness to a maximum of $50,000 per year and granted the NIH Director authority to expand the number of repayments to reflect workforce and research needs. However, NIH has not yet expanded LRP access for physician-scientists beyond the current programs for which they are eligible: clinical research, pediatric research, health disparities research, contraception and infertility research, and clinical research for individuals from disadvantaged backgrounds. Therefore, the committee recommends that NIH make the LRP available to all individuals pursuing biomedical physician-scientist researcher careers, regardless of their research area or clinical specialty, and that NIH increase the dollar amount of loans forgiven to reflect the debt burden of current medical trainees to incentivize talented physicians to pursue independent biomedical research careers.
Ensuring that physician-scientists have dedicated time for research, as well as adequate mentoring, is perhaps the most effective intervention to retaining young academic medical faculty in the NIH workforce. Time devoted to clinical care and financial pressures are strong predictors of attrition (Dzirasa et al., 2015; Lingard et al., 2017; Milewicz et al., 2015; Turner, 2012). Career mentoring and peer support have been identified as effective measures for supporting young physician-scientists, particularly among women and underrepresented minorities (Byington et al., 2016; Chen et al., 2016; Dzirasa et al., 2015; Gotian et al., 2017).
Prompted by the 2014 NIH Physician-Scientist Workforce Report, NIH has begun to explore several approaches to support physician-scientists, such as decreasing the length of training, reducing educational debt, and encouraging earlier mentored-research experiences. One example of such a program is the new National Heart, Lung, and Blood Institute Stimulating Access to Research in Residency R38 research program.11 This program funds qualifying institutions to provide outstanding mentored research opportunities to resident-investigators and to foster their ability to transition to individual career development research awards. The program enables institutions to provide support for up to 2 years of
9 See https://news.aamc.org/medical-education/article/taking-sting-out-medical-school-debt/ (accessed December 15, 2017).
11 See https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-023.html (accessed December 15, 2017).
research conducted by resident-investigators in structured programs for clinician-investigators with defined program milestones.
In 2017, NINDS established the Neurosurgeon Research Career Development (K12) Award,12 with the goal of expanding the cadre of neurosurgeon investigators trained to conduct research into neurological disorders. The K12 award provides 5 years of funding to research organizations to support a national research career development program. Although this K12 award is housed at the program director (PD)’s or PI’s institution, it is not intended to support scholars solely at that institution. The PD/PI can solicit applications from eligible candidates at institutions from across the country, and selected scholars will proceed with their career development and research plan at their home institution, with a local mentor. The committee encourages NIH to continue piloting programs and institutions to not only participate actively in these programs but also develop and test their own innovative programs. When successful, NIH should encourage every Institute and Center to adopt such programs.
Some academic institutions have established innovative programs to help researchers dedicate more time to research and increase their productivity. Harvard Medical School’s Office for Diversity Inclusion and Community Partnership Faculty Fellowship,13 for example, provides junior faculty with 2 years of fellowship support in the amount of $50,000 per year to release time from clinical work to conduct an individual, mentored research project. NIH could incentivize these types of efforts by providing matching flexible funds to institutions that are exploring ways to retain physician-scientists. The funds could be used to protect research time or to provide mentoring services.
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13 See https://mfdp.med.harvard.edu/DICP_Faculty_Fellowship (accessed February 9, 2018).
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