Grant Writing, Grantsmanship , & Grant Submission Jared B Jobe, PhD, FABMR

1. Grant Writing, Grantsmanship, & Grant Submission Jared B Jobe, PhD, FABMR Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Department of Health and Human Services

2. Acknowledgements • Susan Czajkowski, PhD, NHLBI • Ellen Werner, PhD, NHLBI • William Elwood, PhD, CSR • Mary Horlick, MD, NIDDK • Tom Pearson, MD, MPH, PhD, Univ of Rochester • Charlotte Pratt, PhD, NHLBI • Julia Rowland, PhD, NCI • Lorraine Silsbee, MS, NHLBI

3. Learning Objectives • Understand new NIH policies on New & Early Stage PIs. • Understand the increased importance of the Specific Aims page. • Consider steps needed in organizing and writing an effective research grant application.

4. Initial Step: Become Familiar with Relevant NIH Institutes • Identify the several most likely Institutes for funding based on your specialty/scientific interests . • See who funds your mentor’s research. • See what Institutes are issuing FOAs in your area. • See what Institute staff attend the same meetings you do. • Become familiar with the websites of those Institutes who might fund you. • Review funding agencies priorities and review FOAs.

5. Next Steps in Applying for an NIH Grant • Sign up for the NIH Guide ListServe • The Guide is emailed once a week, and contains Table of Contents with ‘links’ to PAs, Notices, and RFAs http://grants1.nih.gov/grants/guide/listserv.htm • Review recently funded grants (RePORTER) • http://projectreporter.nih.gov/reporter.cfm • http://nexus.od.nih.gov/all/DiscNIHReport/index.htm • Review model grants on the NIH website • Discuss your ideas with colleagues. • Consider a consultant.

6. Next Steps in Applying for an NIH Grant (continued) • Contact program officers (POs) to obtain info on: • Mechanisms supported by that Institute; • Institute-specific policies & procedures; and • Other relevant program information. • Write a concept paper with your specific aims (1-2 pages). • Send concept paper to a Scientific Review Officer (SRO) at the Center for Scientific Review to discuss possible study section assignment.

7. Determine the Institute’s Interest and Receive Feedback on Your Idea • Share your concept paper/prospectus with an NIH Institute program officer(s) & request feedback: • Is your Institute interested in funding research like this? • Are others currently funded doing similar work? • Does this fall within a priority area of research for your institute? • What study section group would likely review the application? • How can I improve this concept?

8. Institute Specific Policies and Procedures • Payline (the percentile at which an Institute will provide funds for an application) • New Investigator payline at NHLBI • Paylines vary across institutes • Budgetary policies • Grants> $500 K direct costs/year require prior Institute approval • Across the board funding cuts, decreases in duration of funding

11. New NIH Policies:New & Early Stage Investigators NIH Definition of New Investigator (NI) • A principal investigator (PI) is considered a New Investigator (NI) if he/she has not previously competed successfully as a PI for a significant NIH independent research award • May have received funding as PI on small, early stage, training and mentored career awards including: • Small Grant (R03) • Academic Research Enhancement Award (R15) • Exploratory/Developmental grant (R21) • Training & Research Career Awards (F awards, K awards)  • If multiple PIs, to obtain “New Investigator” status, all PIs must conform to New Investigator criteria

12. New NIH Policies: New & Early Stage Investigators (cont’d) NIH Definition of Early Stage Investigator (ESI) • A PI who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if, at the time of submission, he/she is: • within 10 years of completing his/her terminal research degree or • within 10 years of completing medical residency (or the equivalent)

13. NIH Approach to New/Early Stage Investigators - 1 • Applications will be more effectively evaluated when judged against applications from individuals at the same career stage. • Whenever possible, CSR will cluster applications from New Investigators for discussion during initial peer review. • Reviewers are asked to focus more on the research proposed and less on the track record and preliminary studies of the New Investigators.

14. NIH Approach to New/Early Stage Investigators - 2 • Priority processing and release of summary statements have been established for New Investigators. • Special Receipt dates have been established for New Investigators who resubmit their applications in consecutive rounds (see NOT-OD-07-083 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html)

15. NIH Approach to New/Early Stage Investigators - 3 • Small Grant (R03) and the NIH Exploratory/ Developmental Research Grant (R21) applications have increased over the last few years. • A smaller proportion of individuals with initial R21 or R03 grant support subsequently apply for and obtain R01-equivalent funding than those who first apply for an R01. • The initial success rate for R21 applications often is lower than for R01 applications.

16. NIH Approach to New/Early Stage Investigators - 4 • Because R03 and R21 grants are limited in scope and period of support, they may not be the most effective way to launch an independent research career. • NIH encourages New Investigators, particularly ESIs, to apply for R01 grants when seeking first-time funding from the NIH (excepting mentored career awards of course). • NIH’s partners--Institutions--must continue to look for ways to reduce the duration of graduate and postdoctoral training and to find new ways to enable new investigators to compete successfully for extramural funding. • For more details, see: http://grants.nih.gov/grants/new_investigators/

17. Allowable Grants for New PIs • Pathway to Independence Award-Research Phase (R00) • Small Grant (R03) • Academic Research Enhancement Award (R15) • Exploratory/Developmental Grant (R21) • Research Education Grants (R25, R90, RL9, RL5) • Clinical Trial Planning Grant (R34) • Dissertation Award (R36) • Shannon Award (R55)

18. Allowable Grants for New PIs (Cont) • Small Business Technology Transfer Grant-Phase I (R41) • Small Business Innovation Research Grant-Phase I (R43) • NIH High Priority, Short-Term Project Award (R56) • Competitive Research Pilot Projects (SC2, SC3) • Resource Access Award (X01) • All Fellowships (F awards) • All mentored individual and institutional career awards (K awards). Some K grants are not mentored.

19. Allowable Grants for New PIs (Cont) • Loan repayment contracts (L30, L32, L40, L50, L60) • All training grants (T32, T34, T35, T90, D43) • Instrumentation, Construction, Education, Health Disparity Endowment Grants, or Meeting Awards • G07, G08, G11, G13, G20 • R13 • S10, S15, S21, S22

20. What Not to Do if You are an ESI • Never, ever agree to become a transition PI on an ESI-disqualifying grant. • Never agree to become a PI on a multiple-PI grant, if all the PIs are not ESIs.

21. NHLBI Policy for ESIs • The special payline policy for non-ESIs was phased out in FY 2010 as planned. • The NHLBI payline for ESI only is 5 percentile points above the regular R01 payline (i.e., 10%-tile) for FY 2012 (15th %-tile). • ESI applications on which all named principal investigators are ESI investigators that are >5 but <=10 percentile points above the regular R01 payline may undergo an expedited review to resolve comments in the summary statement (16-20th %-tile). • All awards to ESI applicants under this policy will be funded for all years recommended. • For NHLBI-specific policy: http://www.nhlbi.nih.gov/funding/training/redbook/newinvest.htm

22. Submitting a Multi-PI Application • For investigators seeking support for projects or activities that require a team science approach • A contact PI is responsible for communication between the NIH and the leadership team • Awards managed using subcontracts, if have PIs at different institutions • NIH policies related to New Investigators will be applied to multi-PI applications only when all PIs involved are classified as New Investigators

23. Grantsmanship: The Idea Marketplace Is the idea important? Your Good Can you do the work? Research Idea Support Is your plan feasible and well thought out?

24. Research skills Salesmanship skills Communication skills Ingenuity and flexibility Administrative skills Human relations Persistence, dedication, patience Ability to work hard Political awareness and action Integrity Traits of a Successful Grant Getter

25. The research-grant application provides numerous opportunities to demonstrate qualifications and scholarly attributes, but it easily reveals faulty thinking, hasty preparation, superficiality, and inexperience.

26. ‘I THINK YOU SHOULD BE MORE EXPLICIT HERE IN STEP TWO.”

27. Career Vision • It’s critical to have a research career vision! • Don’t focus too much on what’s hot. • Rather, focus on what you can do best. • Don’t think just about the current application or plans. • Design a long-term program of research. • Communicate that vision in your application.

28. Larson, G. The Complete Far Side. 2003.

29. Goals of Restructured Applications • Align the structure and content of the forms with review criteria. • To focus the applicants and reviewers on the same elements. • To help ensure a more efficient and transparent review process

30. Overview of the Application Changes • Application forms have been revised in three sections (January, 2010): • Research Plan • Biographical Sketch • Resources and Facilities

31. Anatomy of a Research Grant: New Research Plan Components Introduction (for revised or supplemental applications) Specific Aims Research Strategy -Background and Significance -Preliminary Studies/Progress Report -Research Design and Methods Inclusion Enrollment Report Bibliography and References Cited Human Subjects Sections - protections, women/minorities, enrollment, children Other Research Plan Sections - animals, select agents, multi PD/PI, consortium, support, resource sharing Appendix

32. Application Alignment with Review Criteria Review Criteria Application Sections • Significance • Investigators • Innovation • Approach • Environment • Research Strategy • A. Significance • Biosketch • Research Strategy • B. Innovation • Research Strategy • C. Approach • Resources

33. Page Limit Summary

34. Specific Aims: One Page • List the broad, long term objectives and what the proposed research is intended to accomplish • Often list 4-6 specific aims which are used to organize the background and significance preliminary studies, and design/methods sections • State hypotheses to be tested

35. Specific Aims Prototype • Text • Overall goal of the project • Hypothesis to be tested • Bullet Points • Population/animal model to be studied • Data to be collected or intervention used • Endpoints to be measured • Analysis of data • Accomplishments expected at the end of the project

36. Research Strategy: 12 pages • Background and Significance • Preliminary Studies • Research Design and Methods

37. Background and Significance • Why should this application be funded? • Critically evaluate existing knowledge • Specifically identify gaps that the project is intended to fill • Relate the specific aims to long term relevance • Answer the “So what?” question

38. Background and Significance Prototype • What is known about the condition or disease in the population being studied? • What is known about the independent variables being studied? • How well is the endpoint usually measured? • What analyses have been performed by others to date?

39. Preliminary Studies • Provide information that will help to establish the experience and competence of the investigator to pursue the proposed project. • Competing continuation grants should summarize the previous application’s specific aims and the progress made toward them • May list publications relevant to or supported by prior grant and submit up to 10 manuscripts in Appendix

40. Preliminary Studies Prototype • What is your experience with the proposed study population or animal model? • Can you precisely and accurately measure the endpoint variables? • Can you precisely and accurately measure the dependent (outcome) variables? • Can you manage and analyze the data?

41. Purpose of a Pilot Study • Demonstrate ability to recruit/access/retain study population. • Establish ability to perform assay reproducibility, validity, precision, accuracy. • Estimate prevalence/incidence of endpoints. • Quantify variability and magnitude of change in endpoint for purpose of sample size calculation.

42. Research Design and Methods • Overall Study Design • Participant Population • Data Collection • Endpoint Definition • Data Management • Data analysis • Sample Size Calculation • Study Strengths and Limitations • Timeline

43. Issues in Research Design and Methods • Data management is often left out • Involve biostatistical colleagues early and often and have them write the analysis section • Analysis of study design • Sample size calculation • Provide a frank discussion of application’s limitations, including alternatives considered • Include a timeline either here or in the budget justification to demonstrate feasibility

44. Human Subjects Research • Deficiencies in human subjects research plan appear to account for most of the reduction in funding rates in clinical versus basic science applications. • Provide complete answers to required questions. • Provide projections on recruitments of women, underrepresented minorities, and children. • Describe recruitment procedures in detail in the research plan. • Keep the community involved, so you have their consent and approval throughout.

45. Components of a Research Career Development Award • Specific Aims • Candidate • Mentor(s) • Institution • Research Project • Page limits: http://grants.nih.gov/grants/forms_page_limits.htm#car

46. Candidate for an RCDA (part of the page limit) • Background and Training: Potential for research career • Scientific Bibliography: Commitment to research career • Career Development Plan / Training Activities • Formal coursework/degree program • Seminars/journal clubs • Summer institutes/outside courses • Annual scientific meetings • Interactions with mentor(s) • Publications, grant applications • Timeline for career development • Training in Responsible Conduct or Research

47. Mentors(s) for an RCDA(not part of the page limit) • Primary mentor’s experience • Background and training • Experience and funding in area of mentee interest • Track record and current involvement in research training • Mentorial committee (3-4 co-mentors encourage multidisciplinary research) • Describe role of each co-mentor • May have co-mentors from outside institutions, as needed • Describe function of the mentorial committee • Mentoring plan should be detailed

48. Institutional Sponsorship of an RCDA (not part of the page limit) • Description of resources relevant to candidate’s career • Education and training programs (e.g. K30) • Research facilities • Institutional commitment signed by official • Support of candidate for faculty career development (e.g. tenure track) • Promise to protect % effort as required by the RCDA • Usually description of remainder of time not supported by RCDA

49. Research Plan(part of the page limit) • Similar to an R01, except shorter due to candidate’s statement • Preliminary results need not be lengthy, may include mentor’s laboratory results if relevant • Describe expected results and transition to R01 type funding

50. Practical Tips for RCDA’s • K08/K23 have relatively good funding rates • Submit K and then R01, not vice versa • Understand NIH Institute’s guidelines about submitting R01’s during K Award. Transition of K to R is a measure of K award’s success • Plan for prompt revision, if not immediately funded • Talk with current K Awardees, review their applications