Dr. Carol Mangione_Plan for R Grant_Nov_2024.pptx

Dr. Carol Mangione: How to Anticipate and Plan for an R Grant Application

1. Carol M. Mangione, MD, MSPH Barbara A. Levy and Gerald S. Levey Distinguished Professor of Medicine and Public Health Director, UCLA CTSI Workforce Development Program David Geffen School of Medicine at UCLA, UCLA Fielding School of Public Health How to anticipate and plan for an R grant application

2. Outline Strategies for making the most of the research you conduct during the K award The importance of relationship building at the NIH Keep an eye out for the FOAs and RFAs that are the best fit for your work Next Generation Researchers Initiative Getting Organized: Your results Your team Your timeline

3. Making the most of the K research Early on, try to identify at least one research question and testable hypothesis that is important regardless of the direction or significance of your findings. If you can link the K research to the first R grant this will help you have strong preliminary studies and it will be easier to defend why the work proposed in the R is the most important and logical next step and why you are the best PI to do this work

4. Making the most of the K research Get out front with your research findings so that you start to develop a name and identity in your field Present your work at the most important meetings Take advantage of opportunities to participate in NIH conferences and other symposia in your field Get to know the most prominent scientists in your field so that you can get their input on your work Publish… try not to get scooped! Time is your most precious commodity , don’t waste it on low yield activities – If you are not sure which ones fall in this category, talk to your mentor

5. Be aware of who else is working in your area of research! Literature search - Pubmed : what has been published - Google scholar (may pick up abstracts presented at meetings) NIH reporter (grants that have been funded already) - http:// projectreporter.nih.gov / reporter.cfm

6. Making the most of the K research Look for opportunities to be independent of your mentor In some fields this is accomplished by working and publishing with more than one senior researcher Or, you may have the opportunity to “PI” a smaller foundation grant in your field that is related to or is an extension of your main work Early on, talk to your mentor about what you should do now or in the next couple of years so that when the first R goes in with you as PI there will not be questions about your independence.

7. Relationship Building at the NIH Establish relationships with the program officers at the institute(s) in your research area Know the institute’s priority areas in your field Each Institute handles grants in slightly different ways 2 parts: Program- Includes the Institutes that set the research priorities – get to know your institute’s priorities! Review - CSR or Center for Scientific Review Evaluates the scientific merits of the proposals http://www.csr.nih.gov

8. Sign up for the NIH GUIDE ListServe http://grants1.nih.gov/grants/guide/ listserv.htm once a week receive a Table of Contents with ‘ links ’ to PAs, Notices, FOAs and RFAs The best way to know your institute Follow your Institute’s Blogs!

9. Resources NIH Guide for Grants and Contracts Institute web pages/blogs Grants Net ( http://www.grantsnet.org ) Mentors and colleagues NIH staff

10. NIH Program staff Program Director/Administrator or ‘ Project Officer ’ Works for an Institute or Center Handles pre-application questions Manages grant portfolios Develops RFAs and PAs Observers at study section meetings Handles post-review issues Sends out summary statements Initiates funding plans Reviews yearly progress reports

11. Governmental Alphabet Soup NIH - National Institutes of Health AHRQ - Agency for Healthcare Research and Quality PCORI – Patient Centered Outcomes Research Institute CDC – Centers for Disease Control NSF – National Science Foundation

12. NOFO: Notice of Funding Opportunity "NOFO" (Notice of Funding Opportunity was adopted by the National Institutes of Health (NIH) to replace the familiar "FOA" (Funding Opportunity Announcement). The Need for Clarity and Consistency: Over time, the use of different acronyms, such as "FOA," "RFA," and "PA," has led to confusion and hindered effective communication across federal agencies. The transition from FOA to NOFO represents a shift towards a more standardized and intuitive terminology. The acronym "NOFO," or Notice of Funding Opportunity, provides a clear and concise description of the purpose and nature of the funding announcement.

13. Funding the transition from K to R Look for funding announcements, NOFOs that have specific dollars allocated to your area What if there aren’t any or what if the pay lines are unrealistically low? Consider foundations, professional organizations, industry, or institutional grants to tide you over Awards from these sources can keep you working, publishing, and staying active in the field and can strengthen your portfolio while you try to identify the best opportunity at NIH

14. K Award Salary Supplementation (NOT-OD-17-094) Effort directly committed to the K award - must be from non-Federal sources (including institutional sources) and not require extra duties that would interfere with the goals of the K award. Effort not directly committed to the K award, recipients may devote effort, with compensation, on Federal or non-Federal sources as PD/PI or in another role (e.g., co-I), as long the specific aims of the other supporting grant(s) differ from those of the K award. https://nexus.od.nih.gov/all/2017/10/11/clarifying-percent-effort-and-support-for-career-development-k-awardees /

15. https :// /nexus.od.nih.gov/all/2017/10/11/clarifying-percent-effort-and-support-for-career-development-k-awardees Figure 1: Salary supplementation and compensation during the entire period of K award (up to 5 years)

16. K to R % Effort (NOT-OD-08-065, NOT-OD-18-157) During the last two years of a mentored career development award (K01, K07, K08, K22, K23, K25, K12/KL2), NIH will permit you to receive concurrent salary support from any peer-reviewed grant from any FEDERAL agency and NON-FEDERAL SOURCES (NOT-OD-18-157), if you meet the following criteria: You are the PI on a competing research project grant, or director of a sub-project on a multi-component grant of at least $100,000 in direct costs. Your K award is active when the R, P or U grant is submitted. If awarding entity allows such an arrangement. Under those circumstances, you may reduce your K award's time and effort to 50%. NIH will adjust salary for reduced effort but will provide full research development support costs.

17. https :// /nexus.od.nih.gov/all/2017/10/11/clarifying-percent-effort-and-support-for-career-development-k-awardees Figure 2: Reduced effort during the final two years of a mentored K award.

18. Common R Grant Types R01 NIH Research Project Grant Program Parent FOAs: PA-18-484 (No Clinical Trial) and PA-18-345 (Clinical Trial) Used to support a discrete, specified, circumscribed research project NIH's most commonly used grant program No specific dollar limit unless specified in FOA Advance permission required for $500K or more (direct costs) in any year Generally awarded for 3 -5 years Utilized by all ICs  R03 NIH Small Grant Program (parent FOA: PA-18-488 ) Provides limited funding for a short period of time to support a variety of types of projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self-contained research projects, development of new research technology, etc. Limited to two years of funding Direct costs generally up to $50,000 per year for two years of funding Not renewable Utilized by more than half of the NIH ICs R21 NIH Exploratory/Developmental Research Grant Award Parent FOAs: PA-18-489 (No Clinical Trial) and PA-18-344 (Clinical Trial) Encourages new, exploratory and developmental research projects by providing support for the early stages of project development.  Sometimes used for pilot and feasibility studies. Limited to up to two years of funding Combined budget for direct costs for the two year project period usually may not exceed $275,000. No preliminary data is generally required Most ICs utilize Other R grants: http://grants.nih.gov/grants/funding/funding_program.htm#RSeries

19. New Investigators (NI) Definition : A PD/PI is identified as a New Investigator if he/she has  not  previously competed successfully for an NIH-supported research project  other than early stage or small research grants (R03, R21) or for training, infrastructure, and career awards (F, T, K).

20. Early Stage Investigators (ESI) ESIs are New Investigators who are: Within 10 years of completing terminal research degree. Within 10 years of completing residency (or equivalent. Extension: injury, parental leave (NOT-OD-09-034) Breaks for ESIs Separate payline 5-10 points higher Fund all years requested Expedited review for revision if within 5-10% of payline (NOT-OD-06-013) First competitive renewal: 5 points higher Applies to R01 applications only

21. NIH Next Generation Researchers Initiative Applications will receive special consideration if you are: an early-stage investigator (within 10 years of completing your terminal research degree or medical residency and have not previously received a substantial independent NIH research award) and receive a score in the top 25th percentile (or an impact score of 35 if the application is not percentiled ) a mid-career investigator (within 10 years of receiving your first NIH R01 equivalent award) who scores in the 25th percentile, and either: are at risk of losing all support, or, a re a particularly promising investigator currently supported by a single ongoing award ( i.e , NIH will prioritize funding an additional concurrent research project grant award) See this website for more information: https://grants.nih.gov/ngri.htm

22. Stephen I. Katz Early Stage Investigator Research Grant Program PAR-21-038 & PAR-21-039 The Katz R01 award program will build on the successful Next Generation Researchers Initiative. ESIs may apply for this new opportunity to support their innovative ideas if they are proposing research that is a change in direction from their past work and experience , and for which they have no preliminary data. ESIs who have preliminary data for research projects or those who want to continue on with their current research direction, NIH’s Parent R01 funding opportunities are still available. The first due date for applications was January 26, 2021. https://grants.nih.gov/funding/katz-esi-r01.htm

23. New Investigator R01 Resubmission Policy NOT-OD-19-053 Starting with R01 applications submitted for due dates on or after January 25, 2019: New Investigator (NI) R01 applications will be reviewed on the same timeline as other applications submitted to the same FOA. NI R01 applications will be clustered together for review within a meeting. Summary statements for all NI R01 applications will be prioritized: to the extent possible, they will be released before summary statements for other applications reviewed in the same meeting. In general, summary statements will be available no later than 30 days before council. A1 resubmission of NI R01 applications will be accepted on the resubmission due date of any Program Announcement (PA, PAR, or PAS), both standard and special due dates, that accepts resubmission applications. See the NIH Resubmission Policy for requirements and instructions. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-053.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html

24. First steps in R proposal preparation Take a hard look at what you have published and try to build the R around your most significant research findings – this may or may not be your K funded research Decide where the grant will go and/or who your audience is Check NIH Reporter to make sure that the study isn ’ t already underway Requires several months of reading, organizing, writing, and revising

25. Review and Award Cycles Cycle I Cycle II Cycle III Scientific Merit Review June – July October – November February - March Advisory Council Round August or October * January May Earliest Start Date September or December * April July * Advisory Council Round for Cycle I applications may be August or October, and their earliest project start date may be September or December respectively.

26. First steps in proposal preparation EARLY ON talk to the scientific administrator! Follow the written guidelines from the funder carefully Outline of the structure Page limits Font sizes Funding limits Elements that must be included Priority areas

27. Get Organized Work from an outline Establish a timeline for completing the proposal - make time to work on this Have the project team meet periodically Give assignments with deadlines Make deadlines for yourself Find a model proposal recently funded by the same agency look over the reviews if you can get a hold of them REVIEW, PRETEST, REVISE RETEATABLY

28. Are You On the Fence About Whether to Resubmit?

29. Summary Things won’t go as smoothly as this talk sounds Be flexible, take advantage of unexpected opportunities when they come your way Be very protective of your time Be strategic, keep doing the research you love and you will be in the strongest position to compete when the time is right to submit an R

30. NIH Award Success