Keys to Writing A Competitive Grant

INTRODUCTION “Press on: nothing in the world can take the place of perseverance. Talent will not; nothing is more common than unsuccessful men with talent. Genius will not; unrewarded genius is almost a proverb. Education will not; the world is full of educated derelicts. Persistence and determination alone are omnipotent.” Calvin Coolidge (1872–1933) The 2001 meeting of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition concluded with a half-morning session entitled “Transition from Trainee to Successful Academician: Tips, Strategies and Sage Council from Those Who Have Traveled the Path Before You”. Dr. Philip Sherman from The Hospital for Sick Children in Toronto organized the session, the purpose of which was to give trainees and junior academic gastroenterologists insight into several of the key areas required for a successful academic career. Presentations were entitled: “Preparing Your Curriculum Vitae” (1); “How to Prepare and Deliver a Smashing Oral Presentation” (2); and “Keys to Writing a Competitive Grant”. The session was well attended and well received. As a consequence, related sessions are planned for the 2002 NASPGHAN meeting in San Antonio. In the early stages of planning this presentation, I questioned Dr. Sherman's decision to invite me to speak on the topic of competitive grant writing. Many accomplished national colleagues would surely be able to give a more credible presentation. Ultimately, I concluded that Dr. Sherman had likely reasoned that valuable insights could be gained from the experience of a joe-average gastroenterologist with a persistent, workman-like approach to grant writing. In fact, the quote at the top of this page precisely summarizes my personal formula for success in extramural funding: Perseverance. Four general topics relating to competitive grant writing are discussed herein. First, the critical importance of “laying the groundwork” for a successful research career is highlighted. A brief review of common sources of funding available to junior investigators is then provided. The importance of preliminary data and general points about actually writing a grant application follow. The presentation ends with a final comment about perseverance. It must be pointed out that there are many paths to success and other national colleagues might configure this presentation differently. LAYING THE GROUNDWORK In my experience, the careers of junior physician scientists are often not properly configured to optimize chances for research success. If one intends to write a competitive grant, a great deal of preparatory work is required, beginning with investigating faculty opportunities and accepting a faculty appointment structured to ensure success. Although this is as much a Department's as an investigator's responsibility, concrete measures that a junior investigator can take to help ensure success are discussed below. An important initial consideration is a candidate employer's history, tradition, and vitality in research. The NIH and the National Association of Children's Hospitals and Related Institutions (NACHRI) annually collate national rankings of NIH awards to Departments of Pediatrics and Children's Hospitals. There are two lists, one for free-standing Children's Hospitals and one for Departments of Pediatrics affiliated with a parent university. This information can be accessed at http://grants.nih.gov/grants/award/award.htm or via a departmental administrator. Obviously, programs with the most research prowess are ranked highest. NIH rankings are a reasonable initial objective measure of an institution's overall commitment and experience with research, although other important variables should also be evaluated and may supervene, as discussed below. The NIH rank list also likely reflects an institution's history of successful mentoring and overall culture of support for junior investigators. Thus, particular care should be exercised if one considers beginning a research career at an institution ranked in the bottom tier of NIH funding or at an institution with a deteriorating ranking. However, it is important to realize that there are individual careers that are outstanding exceptions to this general rule and floundering research careers are common at top-tier institutions. Notwithstanding, NIH funding is an excellent starting point in the assessment of an institution's overall research milieu. During a job interview, a prospective research faculty member will want to inquire regarding specific examples of mentoring relationships that have been successful in the Department. One should also inquire regarding intramural granting programs such as the NIH center grants and CHRCs discussed below. Other measures of the vitality of research culture might include participation of faculty in NIH study sections, since mentors who participate on study sections are likely adept at advising junior faculty on grantsmanship. Finally, late in the stages of recruitment, well-delineated support packages should be provided to prospective new research faculty. A support package is not a vague, behind-the-scenes agreement between a Division Director or Department Chair and a junior faculty member. It should exist as a document that delineates, on a year-by-year basis, support for investigator's salary, research assistants, supplies, and equipment. At Columbus Children's Research Institute, a “start-up” package is provided in a five-year matrix with actual dollar amounts of support shown in detail. Thus, there is never ambiguity regarding level of support and commitment by the institution to the investigator nor is there ambiguity in the expectation of future independence from institutional support. Financial commitments in start-up packages are substantial. A recent survey of Departments of Pediatrics estimated that the average level of support for the first three years of a laboratory investigator's career is $650,000 (3). Another important criterion is the overall structure and composition of the Division of Gastroenterology, Hepatology and Nutrition. The importance of critical mass in faculty numbers cannot be overstated. A traditionally clinical academic group with a burgeoning patient volume and a history of faculty attrition may have a difficult time supporting a primary research position. On the other hand, a stable Division with a balance between clinical faculty numbers and successful research faculty numbers is likely better suited to support a research commitment to a junior faculty member. If one is serious about independence as a funded investigator, research time must be jealously protected. The general formula that most academic Divisions use is an 80% commitment of time for research and 20% commitment to clinical activities. Calculation of this percent effort can be tricky and it is useful to identify how the calculation is conducted in advance of one's faculty appointment. GRANTING MECHANISMS If one intends to write a competitive grant, it is important to know potential funding sources and to target the application to the most appropriate agency. Some of the most common funding sources available to pediatric gastroenterologists are listed in Table 1. Arguably, the most prestigious and generous funding sources are the National Institutes of Health (NIH). These are desirable for a number of reasons, not the least of which is the generous level of financial support and the significant indirect (administrative) costs awarded with NIH funding. Hospital and research institute administrators are especially interested in indirect costs, usually calculated at a negotiated percentage of the total direct costs of doing the research, since these moneys are targeted in support of research infrastructure.TABLE 1: Potential research funding sources for junior scientistsAlthough there are multiple potential NIH funding mechanisms and institutes from which research funding might be obtained, the most common source of funding for pediatric gastroenterologists is the National Institute for Diabetes, Digestive and Kidney Diseases (NIDDK). The three most common NIDDK funding mechanisms available to junior faculty are K08 (Mentored Clinical Scientist Development Award), K23 (Mentored Patient-Oriented Career Development Award) and R01 (Investigator-Initiated Research Grant) awards. A K08 award is designed to provide physician-scientists with up to five years of support to begin a laboratory research project. This is a mentored award and requires supervision and support from an experienced investigator. Similarly, the K23 award provides clinician-scientists with up to five years' support to pursue clinically oriented, mentored research projects that must directly involve patients. Both K awards are attractive because the competition for funding is relatively less intense. A potential disadvantage of K awards is the modest level of support for both direct and indirect costs. Fortunately, supplemental funds (R03 award) can be obtained in the final two years of K funding such that the total level of support approximates R01 funding, thereby facilitating transition to independent R01 support. An R01 is generally considered the most desirable type of NIH grant for an individual investigator and is the most widely used NIH mechanism for research support. A well-designed R01 provides generous support to the investigator in the form of direct costs, and also generous support to the institution for indirect “administrative” costs. A number of junior investigators at my institution, Columbus Children's Research Institute, have moved directly from post-doctoral fellowship training to full R01 funding. This is a path that should not be undertaken casually and senior mentors should assist in making this decision. Other federal funding sources are available to junior investigators. Large NIH center grants such as Clinical Nutrition Research Units or Digestive Disease Centers are especially useful sources of funding for junior investigators. These large grants typically set aside funds to support one to two years of pilot funding for junior investigators. Pilot project funding is an excellent vehicle by which one can accrue preliminary data for NIH applications. The National Institute of Child Health and Human Development (NICHD) funds Child Health Research Centers (CHRCs). Based exclusively in Departments of Pediatrics, these center grants support career development awards for junior investigators and core facilities for the institution. Over the past ten years, more than 28 CHRCs and 355 junior investigators have been supported by this program, which has an excellent track record in advancing junior investigators to independent funding. For example, a recent review of the overall CHRC program reported a 70% funding rate for CHRC scholars from centers funded for at least 8 years (4). Non-federal funding sources are also available. These include American Gastroenterological Association (AGA)/Industry Scholar Awards. It is worth noting that applications from pediatric gastroenterologists for AGA/Industry Scholar Awards have been particularly successful. Entities such as the Children's Digestive Health and Nutrition Foundation (CDHNF), Nestle, the March of Dimes, and the Crohn's and Colitis Foundation of America all sponsor awards for junior investigators. Finally, well-established Departments of Pediatrics and Children's Hospitals often set aside intramural funds for junior investigators. PRELIMINARY DATA AND WRITING A GRANT The NIDDK Web pages at http://www.niddk.nih.gov/fund/fund.htm#7 contain an especially well-crafted discussion of the entire granting process, including advice for first-time applicants. Most of this information is applicable to writing a grant to other funding agencies as well. The discussion below is based on the general concepts outlined on the NIDDK Web site. It is recommended that inexperienced applicants for NIH funding refer to the NIH Web site early and often in the grant writing process to prevent loss of perspective in the laborious process of actually writing the proposal. First and foremost, one should select a novel project in an area of high current scientific interest. Innovative grants will always be favored over ideas that are not at the forefront of modern day biomedical science. The significance and the applicability of the work to clinical medicine should be clearly emphasized in the background section of the application. It is extremely important to clearly state a testable hypothesis. Although it seems naive to state this, it is amazing to see how some grants are written without a clearly stated hypothesis. Preliminary data must be provided that demonstrates viability of the grant application. Good preliminary data demonstrates that the investigator is able to conduct the type of work proposed and provides early evidence that the hypotheses have merit. It is understandable that first-time applicants, especially for K awards, may have less preliminary data and fewer publications than more seasoned investigators. For first-time applicants, more emphasis is placed on the applicant's true independence of former mentors, the availability of space and resources, institutional support, and ability to independently lead a laboratory in the case of an R01 application. The proposed study design and methodology should be described in sufficient detail that a reviewer clearly understands the design of the experiment along with contingency plans, alternative strategies, and methodological strengths and weaknesses should be described. Most seasoned investigators include this latter information under a separate heading for each proposed experimental approach. Finally, it is important that an investigator provide letters of support and collaboration from experienced colleagues to demonstrate institutional commitment and show an environment of collegiality and synergy exists. The NIH Website also lists advice for the first-time applicant. Prior to writing a proposal, advice from experienced colleagues should be sought regarding appropriate funding sources. It is appropriate to suggest a specific NIH study section or an institute in a cover letter that accompanies the grant. Again, the advice of experienced colleagues will be helpful in making this decision. NIH Program Directors or grant administrators should be contacted if there is any concern about eligibility criteria. NIH deadlines are true deadlines and there is no latitude in modifying the deadline for an NIH application. It is also emphasized that one should not abandon a grant after an initial application has been rejected. Applications may be resubmitted twice and the peer review process is designed such that each grant can be improved based on reviewer's comments. Finally, it is common that first-time applicants propose far more work than what can be reasonably done in the allotted time frame. It is often helpful to clearly delineate a timetable for conduct of proposed experiments in the body of the grant. This makes the work look more realistic. Finally, one should plan on completing the proposal well in advance of the deadline to allow time for an experienced colleague to review. Although junior investigators are often reluctant to ask an experienced colleague to read and critique a proposal, this is critically important in successful grant writing. It is important that one “think like a reviewer” as the grant application is being written. Reviewers are typically selected because of a depth of knowledge and experience in a wide variety of scientific areas. A reviewer can understand a clearly written proposal even though he or she may not be an expert in specific area proposed for study. The application should convince the reviewer of the investigator's general level of independence, knowledge of the field, and ability to design well-controlled experiments. Finally, it is important that grant applications be clear, error-free, concise, and precise. Basically, the grant should be easy to read. This goes a long way toward providing a reviewer a pleasant reading experience and emphasizes your ability to clearly and carefully articulate the research plans. PERSEVERANCE The quote by Calvin Coolidge should be the mantra for junior faculty applying for research funding. Statistically, it is unlikely that an application will be funded after the initial review. The peer review process should be appreciated as one of continuous improvement based on constructive review, rather than a source of frustration. To understand the perseverance required, it is useful to consider the timeline required for submission of a successful NIH grant. As shown in Figure 1, the minimum timeline for a “perfect” grant approaches two years. One must allow at least a year to develop a cogent hypothesis and generate preliminary data in support of this hypothesis. An additional two to three months is consumed by actually writing the grant application. It takes approximately five months for review by the study section and one to two months to receive a summary statement from the NIH. This summary statement provides a grant's priority score and detailed constructive feedback. Even if a grant is funded there is an additional three-month interval before money is received. Thus, an absolutely minimum timeline for federal funding of a new idea is approximately two years. Success on the first application is unusual; thus one can reasonably expect at least a three-year turnaround to achieve federal funding. One should bear this in mind as a support package is designed, as discussed above.FIG. 1.: Minimum timeline for funding of a “perfect” grant application to the national Institutes of Health.A few additional comments about success rates are relevant. First, a common misconception is that M.D. scientists are competitively disadvantaged when compared with Ph.D. scientists at the NIH level. This is simply not true. NIH data clearly show the success rate for applications from M.D. and Ph.D.s are equivalent and have been for many years. NIH data also show the success rate for applications originating from Departments of Pediatrics are approximately 30%. SUMMARY Pediatric gastroenterology fellows and junior faculty genuinely interested in gaining research funding should be optimistic about ultimately receiving funding of their research ideas. Immersion in a supportive intellectual and administrative milieu, combined with motivation, energy, and persistence, will likely result in success. Identification of experienced mentors and senior colleagues who are willing to be involved in career development is an integral step in writing a successful grant application.

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