NIH Fundamentals and Need to Know Resources

1. NIH Fundamentals and Need to Know Resources Megan Columbus NIH Office of Extramural Research (OER) November 2019

2. Goal: To give you the basics all the other sessions will build upon

3. Answers to Top 10 Questions #1: Where’s the funding? #2: Next steps after finding an FOA #3: Should I contact NIH before applying? #4: How long does it take to get funded? #5: What’s the right type of grant for my idea (and me)? #6: Got Funded! Now What? #7: Not Funded! Now What? #8: How do I track my application? #9: Where is my “go-to” place for info? #10: Final Pieces of Advice?

4. #1 Where is the Funding?

5. Understanding NIH Our mission: to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

6. A Look at the Numbers

7. 27 Institutes and Centers (IC) Each with a different: • mission & priorities • budget • funding strategy

8. Funding Opportunity Announcements (FOAs) Used to advertise grant opportunities Contain information for successful application • Due dates, • Individual and organizational eligibility • Submission requirements • Scientific area(s) • Review criteria • Award administration • Agency points-of-contact Dig deeper: - Finding and Understanding FOAs

9. Finding an Opportunity of Interest NIH Guide to Grants & Contracts Grants.gov • FOAs • NIH, AHRQ, CDC (subset), FDA (subset) • Notices • Notices of special interest • Policy updates • Changes to FOAs • RFIs • Webinars and training events • And more • FOAs • All federal grant making agencies Search both: NIH Guide – full text & notices. Grants.gov – synopsis & all agencies.

10. Types of Funding Opportunity Announcements (FOA) Also Look at Notices of Special Interest

11. Notices of Special Interest (NOSIs) • Increasingly used instead of program announcements • Highlight areas of scientific interest • Designate existing FOAs to use for application submission

12. Tips for Choosing the Right FOA • Check participating NIH Institutes • Should align with your research • Also check related notices • Determine if NIH considers your study to be a clinical trial • Our decision tool can help https://grants.nih.gov/ct-decision/ • Pick an FOA accordingly • Review eligibility requirements in FOA

13. #2: I’ve found the right FOA, what’s the next step?

14. Register and Learn the Application Process • Complete/renew required registrations (Start now!) • Institutions - required to register in multiple systems • Investigators - must register in the eRA Commons • Learn about the electronic application submission process well before the application due date • grants.nih.gov/grants/how-to-apply-application-guide • Dig deeper: • Ready, Set, Submit! Application Preparation and Submission • Preparing & Submitting Multi-project Grant Applications Using ASSIST

15. Develop Your Application • Access application forms from funding opportunity announcement • Carefully read the funding opportunity and application instructions • Carefully read the funding opportunity and application instructions • Carefully read the funding opportunity and application instructions • Carefully read the funding opportunity and application instructions • Carefully read the funding opportunity and application instructions Dig deeper: - Finding and Understanding FOAs

16. Follow all Instructions Carefully

17. Where to start • Develop your research idea • Should be important (have high impact) • Needs to align with an IC mission and research priorities • Identify a funding opportunity announcement (FOA) • No FOA specific to your area? Use a “parent” announcement • Talk with NIH staff about your idea and where it fits • Write a strong proposal that addresses review criteria Dig deeper: - Grant Writing for Success

18. Understand Roles and Responsibilities at Your Institution • What is your role? • What roles do other people play? • Authorized Organizational Representative • Principal Investigator • Administrator • Coordination and respect for each other’s roles is key • Understand your institutional processes and timelines for grant related activities

19. Understand the NIH Extramural Team

20. Program Official • Responsible for the programmatic, scientific, and/or technical aspects of a grant • Provides scientific guidance to investigators pre- and post-award • Develops grant initiatives • Provides post-award oversight Digging deeper: - Navigating NIH Programs to Advance Your Career - After Your First Award: Next Steps in Your Journey with NIH

21. Scientific Review Officer • Responsible for scientific and technical review • Ensures fair and unbiased evaluation of scientific and technical merit • Provides a summary of the evaluation • Reviews applications for completeness and conformance with application requirements • Point of contact for applicants during the review process Digging Deeper: - NIH Peer Review Process Overview - NIH Peer Review Live Mock Study Section

22. Grants Management Officer Responsible for completion of business management requirements • Evaluates applications for administrative content and compliance with policy • Negotiates Awards • Interprets grants administration policies • Digging deeper: • - Budget Basics for Administrators • - All About Costs Primer • Advanced Administrative Topics • Compliance Pitfalls and Strategies for Success • Policy and Compliance Working Together • - From the Inbox: Pre- and Post-award Issues

23. #3: Should I Contact NIH Before Applying?

24. Do I Contact NIH Before Applying? Mandatory • Application with budget >$500,000 direct costs for any single year • R13 Conference Grants Optional • When RFAs request a Letter of Intent Always Recommended • When you think about applying for any grant Yes!

25. #4: How Long Does It Take to Get Funded?

26. How does a grant get funded? National Institutes of Health Center for Scientific Review Great Research Idea! Assigns to IC & IRG / Study Section Institution Study Section Submits Application Reviews for Scientific Merit Institute Allocates Funds Evaluates for Relevance Investigator Advisory Councils & Board Performs the Research Recommends Action Institute Director Digging deeper: - Peer Review Process - Ready, Set, Submit! Application Preparation and Submission - Post-Review to Award Makes Funding Decision

27. Ready for Award…When? • All pre-award issues are resolved • Budget Negotiation • Certification on Education on Human Subjects • Animals & Human Subject Protection Issues • Other Support Documentation • Application to award takes ~9-10 months Digging deeper: - Budget Building Blocks for Investigators - All About Costs

28. #5: What’s the Right Type of Grant for My Idea (and Me)? Small Business Research Projects Training & Career Development Research Centers • Digging deeper: • Navigating NIH Programs to Advance Your Career • After your First Award: Next Steps in Your Journey with NIH

29. Career Stages of Funding Programs

30. #6: Got Funded…Now What?

31. You’ll Receive a Notice of Award (NoA) • Legally binding document • Award data and fiscal information • Grant payment info • Terms and conditions of award • Grantee accepts terms and conditions of award as soon as funds are drawn down

32. https://grants.nih.gov/policy/nihgps/index.htm NIH Grants Policy Statement • Is a term and condition of all grant awards • Explicitly defines roles, responsibilities • Updated each fall

33. Post-Award Management Annual progress reporting Annual federal financial reporting Invention reporting Yearly audits (as applicable) Closeout reporting • Digging deeper: • All About Costs • Advanced Administrative Topics • Compliance Pitfalls and Strategies for Success • Policy and Compliance Working Together • - From the Inbox: Pre- and Post-award Issues

34. #7: Not Funded! Now What? RESUBMISSION AVENUE NEWPROPOSAL LANE

35. Regroup • Take a deep breath • Read summary statement • Read it again • Talk with your NIH program official • Evaluate your options • Revise & submit again? (discuss with your program officer) • Choose a new research direction? Digging deeper: - Grant Writing for Success

36. #8: How do I track my application? Digging deeper: - Interacting electronically with NIH Visit the eRA booth to get your questions answered!

37. Commons.era.nih.gov In eRA Commons you can find: Application image Application status Assignments (institute, review group) NIH staff contacts (SRO, program, grants management) Scores (PI only) Summary statement (PI only) Notice of Award Links to tools for reporting, no cost extensions, etc. Digging deeper: - How Well Do You Know eRA Systems?

38. eRA Commons Investigators, work with your office of sponsored research to be sure you are registered and your account is affiliated with your institution BEFORE you apply. 2 weeks lead time – PI registration in Commons 6-8 weeks – All institutional registrations and renewals Digging deeper: - Ready, Set, Submit: Application Preparation and Submission Commons.era.nih.gov

39. #9: Where is my “go-to” place when I get home? eRA Web- sites NoA NIH Guide Application RePORT Grants Policy Statement

40. Bookmark Grants.nih.gov Your home base for grant opportunities, policies, processes

41. Trying to make heads or tails of the grants process?

42. Grants Process Overview a Good Place to Startgrants.nih.gov

43. Grants Process Overview - Top

44. Grants Process Overview Bottom

45. Get Startedgrants.nih.gov • Under Get Started find the basics: • understanding NIH • eligibility • types of grant programs • types of applications

46. Types of Grant Programs What is an R03, F31, X02, etc? Find programs for your career stage! grants.nih.gov/grants/funding/funding_program.htm

47. Looking for the latest grants policy changes or funding announcements?

48. Looking for the latest grants policy changes or funding announcements? NIH Guide to Grants and Contracts https://grants.nih.gov/funding/searchguide

49. Search NIH Opportunities (grants.nih.gov) Learn about grant, contract and loan repayment opportunities through the Funding tab Or use Find Funding for quick access to grant opportunities (NIH Guide)

50. Export Share Save Search NIH Guide to Grants and Contracts Search the Guide at: Grants.nih.gov/Funding/SearchGuide