10 Funding Opportunities at the National Institutes of Health James E. Everhart & Judith M. Podskalny Key points The National Institutes of Health (NIH) fund intramural and extramural research in digestive disease epidemiology. Funding opportunities exist, based on career stage, for training grants, career transition grants, and independent investigator grants. Numerous resources regarding study funding are available at the NIH that are accessible by phone or online. This chapter is a guide for investigators seeking training, career development, and research support from the National Institutes of Health (NIH) of the USA to study the epidemiology of gastroenterological diseases. The chapter begins with early postdoctoral research training opportunities and proceeds through obtaining independent investigator initiated research grants. This path to independent investigator can be seen in Fig. 10.1. Table 10.1 provides the codes and internet resources used to support training and research applicable to gastroenterological epidemiology. Background Twenty years ago, it would have been difficult to find the breadth and depth of expertise to write this book. Fewer than a dozen persons in North America would have characterized themselves as digestive disease epidemiologists. Since that time, there has been an increasing recognition of the value of epidemiologic methods applied to the clinical problems of gastroenterology. As a result, major contributions have been made to our knowledge of many important disorders. Government support in the USA and many other countries has contributed to much of this progress. In the USA the majority of public funding for biomedical research comes from the NIH. Nearly 20 of the expert authors of this book have received NIH funding for training or for clinical and epidemiologic research. Twenty-four of the 27 institutes and centers that make up the NIH fund research, as detailed on the NIH website (http://www.nih.gov/icd/). Many of the institutes provide funding for gastroenterological or for epidemiologic research, or for both. For example, liver disease research is funded by 18 institutes (http://www2.niddk.nih.gov/aboutniddk/research AndPlanning/Liver_Disease/Action_Plan_For_Liver_ Disease_Intro.htm The institutes that provide substantial support for gastroenterological epidemiology (including clinical trials) include the National Cancer Institute (NCI), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). GI Epidemiology: Diseases and Clinical Methodology, Second Edition. Edited by Nicholas J. Talley et al. C 2014 John Wiley & Sons, Ltd, with the exception of original artwork which is C Mayo Foundation for Medical Education and Research. Published 2014 by John Wiley & Sons, Ltd. Companion website: www.wiley.com/go/talley/giepidemiology 77
CHAPTER 10 National Institutes of Health Training, career development, and research opportunities Medical/grad school Postgraduate Transition Independent (Students) (Postdocs, fellows) (Junior faculty) investigator (Faculty) Medical students: short term training via T35s; F30 for MD/PhD students; MSTP* for MD/PhD students Graduate students: predoctoral fellowships; T32 slots Fellowships (NRSA support) Training grant slot (T32) or individual fellowship (F32) K-awards: MDs: K08, K23, K99/R00 PhDs: K01, K25, K99/R00 Research project grants: R01, R21, R03 Others: K24, Networks, etc. *MSTP = Medical Scientist Training Program, administered by NIGMS Figure 10.1 Path to independent investigator through support by the National Institutes of Health. The NIH funds what is termed intramural and extramural research. Intramural research is conducted at the laboratories and offices of the NIH and constitutes about 10% of the research budget. The NCI funds much of the intramural research conducted on the epidemiology of gastroenterology, which focuses on gastrointestinal malignancies. The extramural NIH budget is much larger and provides funding for training and research across the USA and internationally. The bulk of funding goes toward investigator-initiated research (described later). Essentially all extramurally funded training and research proposals undergo peer review, by study sections organized by either the Center for Scientific Review (CSR) or by the funding institute. Training opportunities Individual predoctoral (F30 and F31) and postdoctoral (F32) fellowships and institutional training grants (T32) are available as part of the National Research Service Awards (NRSA) program. Only US citizens or permanent residents are eligible for NRSA support. At the predoctoral level, this program provides opportunities for students to obtain up to 5 years of funding toward a graduate research degree (F31) or the combined MD/PhD degree (F30). The fellowship award provides an annual stipend to help meet the fellow s living expenses, an allowance for tuition and fees and health insurance in accordance with NIH policy, and an annual institutional allowance. At the postdoctoral level, up to 3 years of mentored postdoctoral support is allowed. The first year of postdoctoral NRSA support is subject to a service payback obligation, while months 13 and beyond serve to fulfill the payback requirement. This payback system was adopted because studies have shown that fellows who participate in two or more years of postdoctoral research training are more likely to continue in a research career. Predoctoral students do not incur any payback obligation. Peer review of predoctoral fellowship applications focuses on the potential of the applicant for a research career, the quality of the doctoral program in which the applicant is enrolled, the experience and suitability of the sponsor and the environment, and the quality of the proposed dissertation project. Peer review of individual postdoctoral fellowship applications focuses on the following elements: the applicant, the mentor(s), the research project, and the training potential. Many institutes use the F31 for students who are from minority groups that are 78
FUNDING OPPORTUNITIES AT THE NATIONAL INSTITUTES OF HEALTH Table 10.1 National Institutes of Health Grant Programs for Training, Career Development, and Research. For entire list, see Types of Grant Programs (http://grants.nih.gov/grants/funding/funding_program.htm) under the NIH Office of Extramural Research (http://grants.nih.gov/grants/oer.htm). For a complete list of all current parent program announcements, see http://grants.nih.gov/grants/guide/parent_announcements.htm Activity code or acronym Title Website Training NRSA National Research Service Award http://grants.nih.gov/training/nrsa.htm T32 Institutional Research Training Award (NRSA) PA-11-184.html F30 Individual predoctoral awards for MD/PhD fellowships PA-11-110.html F31 Individual predoctoral fellowship PA-11-111.html F32 Individual postdoctoral fellowship (NRSA) PA-11-113.html LRP Loan Repayment Program http://www.lrp.nih.gov/ Career development awards http://grants2.nih.gov/training/ careerdevelopmentawards.htm K01 Mentored Research Scientist Development Award PA-11-190.html and http://grants.nih.gov/ grants/guide/pa-files/par-12-020.html K08 Mentored Clinical Scientist Development Award PA-11-193.html K23 Mentored Patient-Oriented Research Career Development Award PA-11-194.html K24 Mid-Career Investigator Award in Patient-Oriented Research Award PA-11-195.html K99/R00 Pathway to Independence Award PA-11-197.html K25 Mentored Quantitative Research Development Award PA-11-196.html Research grant programs R01 Research Project Grant Program PA-11-260.html R03 Small Grant Program PA-11-262.html R21 Exploratory/Developmental Research Grant Award PA-11-261.html R34 Clinical Trial Planning Grant Program http://grants.nih.gov/grants/funding/r34.htm Other resources RePORTER NIH Research Portfolio Online Reporting Tools: RePORT Expenditures and Results (RePORTER) http://projectreporter.nih.gov/reporter.cfm NIH Guide NIH Guide to Grants and Contracts http://grants.nih.gov/grants/guide//index.html New Investigators http://grants.nih.gov/grants/new_investigators/ 79
CHAPTER 10 underrepresented in the biomedical sciences. Fewer institutes use the F30 mechanism, which is for combined MD/PhD training. Appointments of predoctoral students, postdoctoral fellows, or both to an institutional training grant (T32) are made at the discretion of the training grant director, who is also its Principal Investigator. T32 applications are competitively reviewed and awarded for five-year periods for a set number of pre- and/or postdoctoral positions. As for the individual awards, NRSA positions on institutional awards are only available to US citizens or permanent residents. The review criteria for T32s include: the availability of a high-quality faculty to provide mentors; the past record of the faculty in successfully training fellows; a strong pool of potential trainees; a plan for organizing and overseeing the training program; the training environment. The National Institute of General Medical Sciences (NIGMS) supports the vast majority of predoctoral training for the NIH via institutional training grants, as detailed by the NIGMS website (www.nigms.nih.gov/training), while most postdoctoral programs are supported by the other institutes and centers whose missions are more focused on specific organ or disease areas. For more information on training awards see the NIH Office of Extramural Research website (http://grants.nih.gov/training/ extramural.htm) and for electronic submission of all grants see the relevant webpage (http://era.nih.gov/ ElectronicReceipt/). Career development awards Several career development, or K-series, awards are available. The purpose of most K awards is to protect the time of the applicant in order to further his or her career from the postdoctoral or, for physicians, postclinical training period to the independent stage of his or her research career. The awards most used at the NIH for early career development, providing 3, 4, or 5 years of salary and research support to individuals with a doctoral degree, are the K01 (Mentored Research Scientist Development Award), K08 (Mentored Clinical Scientist Development Award), K23 (Mentored Patient-Oriented Research Career Development Award), and K25 (Mentored Quantitative Research Development Award). The K24 (Mid-career Investigator Award in Patient-Oriented Research) targets clinical or translation researchers at the associate professor, or higher, level. Only US citizens or permanent residents are eligible for most K awards, and only US institutions are eligible. The exception is thek99/r00 (Pathway to Independence) Award. This award, begun in 2005, is aimed at shortening the time a research scientist spends in a postdoctoral position by providing a two-phased funding period: the first (K99) with mentor(s) and the next (R00) independently after securing a faculty appointment. Non-US citizens are eligible to apply for the K99/R00, but all work for both phases must be done in the USA. All K awards are peer-reviewed with the following general categories included: qualifications of the candidate; the suitability and credentials of the mentor(s); and the quality of the research plan, the career development plan, and the environment. The support provided by training and career development awards has proven useful for funding coursework in epidemiology and biostatistics that would qualify the trainee for a master s or higher degree, even if an official degree is not granted. There are essentially two converging training paths for researchers in gastroenterological epidemiology. Physicians require the statistical and epidemiologic training that is available from departments within schools of public health or within other academic divisions or centers devoted to these quantitative methodologies. PhD or equivalent candidates who are not physicians will usually go further in methodologic coursework. They also need exposure to anatomy, physiology, mechanisms of disease, nutrition, and other areas necessary to grasp the clinical aspects of digestive diseases. A dissertation that focuses on a digestive disease is most helpful in such training. Successful training in either path should confer a high level of competency in biostatistics, epidemiology, and research design. Loan repayment The NIH encourages applications for educational loan repayment from qualified health professionals and researchers who have made a commitment to pursue a research career. The Loan Repayment Program 80
FUNDING OPPORTUNITIES AT THE NATIONAL INSTITUTES OF HEALTH is an important component of the NIH s efforts to recruit and retain the next generation of researchers by providing for the potential for developing a research career unfettered by the burden of student loan debt. Since 2002, the NIH has provided more than $20 million a year to repay educational debts for promising clinical and pediatric researchers who can demonstrate a commitment to pursuing a research career in these areas. To be eligible, an applicant must owe more than 20% of his or her yearly salary as a bona fide educational debt, agree to pursue 2 years of research for at least 50% of their time while the loan is being repaid, and be a US citizen or permanent resident working in the USA. Applications are submitted electronically via the Loan Repayment website (www.lrp.nih.gov) each fall and decisions reported after external, as well as program staff, reviews are completed in the following summer. Research project grants The largest portion of the NIH budget goes to investigator-initiated research, commonly known as the R-series grants. Institutions eligible for investigator-initiated research funding may be public (but not federal), private or commercial. Application is not limited to US institutions, although applications that propose to conduct research in other countries must discuss why that research cannot be conducted in the USA and may require clearance by the US Department of State before funds can be released. Principal Investigators for R-series grants are usually not required to be US citizens. Generally, awards are limited to $500,000 direct research costs per year for a maximum of 5 years. The most common R-series grant is the R01. The purpose of an R01 is straightforward: to support a hypothesis-driven, circumscribed project in an area representing the investigator s specific interest and competencies, based on the mission of the NIH, as detailed on the NIH R01 webpage (http://grants.nih.gov/grants/funding/r01.htm). R01s require that the applicant be considered, by virtue of past research productivity, training and reputation, an independent investigator. Writing a successful R01 requires more than a sound and innovative research idea. Insight into the complexity of creating an R01 application can be obtained from the examples posted on the NIAID website (http://www.niaid.nih.gov/ researchfunding/grant/pages/appsamples.aspx). In recent years, three smaller and shorter-duration R awards of particular interest to epidemiologists and clinical researchers have grown in popularity. The R03, or Small Research Grant, provides 2 years of support for projects that can be carried out in this period of time, with the allowable maximum of $50,000 per year in direct costs. Two of the common uses of the R03 award of interest to digestive disease epidemiologists are to fund pilot or feasibility studies and to support secondary analysis of existing datasets. Not all NIH institutes accept unsolicited R03 applications; see the NIH Small Grant Program webpage (http://grants.nih.gov/grants/funding/r03.htm). The R21, or Exploratory/Developmental Grant, provides support for the early, conceptual stage of a research idea. The research proposed should test a hypothesis and thus provide preliminary data that can be used for a subsequent R01 application. R21 support is limited to 2 years with a combined budget for direct costs for the 2-year project period of no more than $275,000. Some institutes only accept R21 applications in response to their specific program announcements; see the NIH Exploratory/Developmental Research Grant Award webpage (http://grants.nih.gov/ grants/funding/r21.htm). Introduced in 2003, the clinical trial planning grant, or R34, provides support for the development of phase III clinical trials; see the NIH Clinical Trial Planning Grant Program webpage (http://grants.nih.gov/grants/funding/r34.htm). This program supports the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and other essential elements of the study included in a manual of operations/procedures. The R34 is not designed for the collection of preliminary data or for the conduct of pilot studies to support the rationale for a clinical trial. A project period of one year and a budget for direct costs of up to $100,000 per year are permitted. Other resources and opportunities There are additional online resources available to investigators interested in research funding. The NIH Research Portfolio Online Reporting Tools (RePORT) system, via the RePORT Expenditures & Results (RePORTER) function, is a searchable database 81
CHAPTER 10 (http://projectreporter.nih.gov/reporter.cfm) that provides the abstracts of grants funded by NIH, and several other government entities, such as the Food and Drug Administration and the Centers for Disease Control and Prevention. The NIH Guide for Grants and Contracts is the repository for all NIH program announcements (PAs), requests for applications (RFAs), and Notices that provide relevant information for current or potential grantees. Each PA and RFA lists the Institute contacts most knowledgeable about the specific funding opportunity. The Guide for Grants and Contracts maintains a list-serve available to any investigator see the Funding Opportunities and Notices webpage (http://grants.nih.gov/grants/guide/) which supplies a weekly listing of newly released PAs, RFAs, and Notices. Also, each NIH institute maintains its own website where unique resources for researchers can be found. In addition to investigator-initiated research awards, the NIH also funds multi-institutional networks that are grounded in epidemiologic principles, including clinical trials and observational cohort studies. These networks originate through RFAs for cooperative agreements or through Requests for Proposals (RFPs) for contracts (http://oamp.od.nih.gov/ contracts/rfps/mainpage.htm). Cooperative agreements and contracts involve NIH staff members in a substantive way as regards organization and technical assistance. Networks are supported by a data coordinating center that provides overarching data management and biostatistical expertise. Participation of junior researchers through attendance at investigator meetings and serving on study committees provides on-the-job training in the design, methodology, and execution of large-scale clinical studies. Another opportunity that all investigators should consider is serving as a reviewer for grant applications. A number of NIH study sections require and welcome investigators with clinical and epidemiologic expertise in gastrointestinal diseases. Often an investigator will be asked to serve as an ad hoc reviewer for one or more grants during a given review cycle. Because all NIH-funded research passes through peer review, this is a unique opportunity to learn what constitutes successful research applications. It is also a service to the research community that does not go unnoticed by one s peers. Finally, it should be noted that a main function of NIH program staff is to see that the best research gets funded. They are here to help investigators, and consultation with the appropriate program staff is strongly encouraged prior to submitting any application. Note: Websites cited in this chapter were last accessed August 2013. 82