OUTLINE

1. Working with NIH Program Officials: Pre-Award & Post-AwardShawn Gaillard, NIGMSandFrancisco Sy, NIMHD2013 NIH Regional Seminar, Baltimore, MD

2. OUTLINE NIH Overview Pre-award: Communication w/ Program Staff Post-award: Communication w/ Program Staff

3. NIH Overview

4. “To win the future, America needs to out-educate, out-innovate, and out-build the rest of the world.” President Barack Obama, Weekly Address February 5, 2011

5. Secretary of Health and Human Services Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Center for Medicare & Medicaid Services (CMS) Agency for Healthcare Research and Quality (AHRQ) Indian Health Services (IHS) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA) U.S. Dept. of Health & Human Services

6. NIGMS National Institutes of Health • The mission of the NIH is to uncover new knowledge that will lead to better health for everyone by: • Conducting research in our own laboratories (Intramural) • Providing support for research outside of our labs (Extramural) • Training future research investigators • Communicating medical information to public All Other Training 3% 3% Mgmt & Support 5% Research Project Grants (RPG) Other Research 6% 10% 53% Research Centers Annual Budget 11% ~$31 Billion 11% Fiscal Year 2013 R&D Contracts Intramural Research

7. National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of General Medical Sciences National Center for Complementary and Alternative Medicine National Center on Minority Health and Health Disparities Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering Clinical Center Center for Information Technology Center for Scientific Review NIGMS 27 Institutes and Centers (IC) Office of the Director no funding authority

8. Dual Nature of NIH 8 NIH Intramural Research ~ 6K scientists & researchers ~ 10% of NIH budget NIH Extramural Research ~ 90K applications/year ~ 45K ongoing awards/year ~ 3K institutions > 300K scientists & researchers ~ 83% of the NIH budget

9. Pre-award: Communication w/Program Staff

10. Application to NIH Application to NIH via CSR NIH Application Process Overview CSR assigns to IC, SRG Summary Statement (SS) to Applicant SRG 1st level of Review 2nd level of Review = Council Fundable Not Fundable Applicant Notified and Given Feedback IC Makes Award Applicant Evaluates SS Progress Reports Revised Application (x1) Prepared Award Ends, Renewal Application Prepared Time to Talk w/ NIH Program Officer

11. Communication: Means to Funding • Communicate with: • NIH staff – esp., PROGRAM OFFICIALS • Your Fellow Investigators • Your Institutional Administrators

12. Grants Management Administrator TEAMS Applicant Institution NIH Principal Investigator Authorized Institutional Official Review Officer Program Officer Sponsored Research Administrator

13. Program Official aka Program Director orProgram Officer Both a Scientist and Administrator Responsible for the programmatic, scientific, and technical aspects of a grant

14. Program Official Responsibilities • Provide technical assistance to applicants • Observe scientific review meetings • Discuss review issues with applicants • Prepare funding recommendations • Manage scientific research/training portfolios • Review annual research/training progress of grantees • Report scientific progress and program accomplishments • Identify opportunities and needs of science specific to an Institute’s mission • Communicate program priorities - Funding Opportunity Announcements (FOA) - Request for Applications (RFA)

15. Program Official (PO) Principal liaison between investigators & NIH Yourmost important contact Contact us early … Contact us often!

16. How to Meet a Program Officer? • Meet PO at Your Favorite Scientific or Professional Meeting • Institute Booths • Mingling thru the Crowds • Institute sponsored Workshops • Ask your Colleagues • Search NIH Institute Websites or Directory • View names/contact info on FOAs and RFAs

17. Why Contact a Program Officer? • To Direct You to: • The appropriate Institute • 24 Institutes have granting authority • The appropriate Division/Office • Basic, clinical, behavioral, translational, training • The appropriate Program Official • Extramural research portfolio

18. Must I Contact the NIH Before Applying? --- YES! • Mandatory: • Application with >$500K budget DC/year • R13 Conference Grants • Optional: • When RFAs request a Letter of Intent • Recommended: • When you think about applying for ANY grant

19. Benefits of Making Contact To develop a relationship with a potential program official To assure that your application has a home (appropriate Institute)

20. Developing Your Application • Search NIH RePORT • http://projectreporter.nih.gov/reporter.cfm • NIH Guide – FOAs and RFAs • http://grants.nih.gov/grants/guide/index.html • Search Institute Web Sites • www.nih.gov/icd/ • Contact Institute Staff • http://ned.nih.gov/

21. Before You Submit – Talk to PO Organize your thoughts for productive conversation • Grant Purpose: Want a grant from which IC to do what? • Problem/Background: Explain why you to think this topic needs study. Demonstrate you know Institute priorities. • Significance: Explain why this is important in the field. • Question: What hypotheses will you test and what model will guide your hypotheses? • Design/Analysis: What is the study design that will enable testing your hypotheses? What statistical approach? • Team: Who will be the key participants (co-investigators and organizations) on the project? • Miscellaneous: Other issues that may be relevant

22. Program Officials… … are not done after you submit your application

23. PO Attends Review Meeting Observes the review group meeting Is a liaison to Scientific Review Officer (SRO) (e.g., provide clarification of FOA to the panel, if requested by the SRO) Is able to answer your questions about the review (especially useful if your application is unscored)

24. Review Meeting • Review Meeting (or called Study Sections) are managed by NIH personnel called Scientific Review Official who is a PhD-level professional with scientific background close to the expertise of the study section • Each standing study section has 12 - 24 members who are primarily from academia • As many as 60 - 100 applications are reviewed at each study section meeting

25. After Peer Review • Applicants receive a Summary Statement (SS) • Written Account of Essentially Unedited Critiques • Overall Resume and Summary of Review • Priority Score & Percentile Ranking • Budget Recommendations • Contact PO to inquire about likelihood of funding • If you disagree with facts on SS; contact your Program Official (PO). PO may submit an appeal to Council (2nd level of review) • PO- prepares funding recommendations

26. What Determines Funding? • Scientific Merit (Review Group) • Program Considerations (Program Official, Advisory Council, IC Director) • Availability of funds

27. NIGMS Impact Scores & Meanings * URM as indicated in FOA. *^ Honors as defined by applicant institution, typically GPA

28. Not Funded? • Consult with program officer on possible next steps • Respond to reviewer concerns • Revise application and resubmit

29. Revise and Resubmit • Write a clear Introduction section • Address all criticisms thoroughly • Respond constructively: don’t be argumentative, abrasive or sarcastic! • Acknowledge and accept the help of reviewer comments

30. Post-award: Communication w/Program Staff

31. Funded, Now What? • 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 when draw down funds

32. PO: Grant Oversight • Serve as resource and liaison • Answer technical questions • Monitor progress of study

33. PO: Grant Oversight – Progress Reports You Submit Annual Non-competing Renewals • Monitor scientific progress • Confirm policy adherence • Evaluate changes in key personnel or levels of effort • Communicate your exciting results

34. Annual Progress Reports • Summary of your accomplishments • Specific aims (as funded) • Results (during reporting period) • Significance • Plans for next budget period • List of publications generated by project • Explain any changes in Human Subjects or Vertebrate Animal Research • Report on gender and minority inclusion

35. Annual Progress Reports Due • 60 days prior to budget period start date • eSNAP - due date is the 15th day of the month preceding the month in which the current budget period ends Submit Preferred via NIH eRA Commons https://commons.era.nih.gov/commons/index.jsp or to Centralized NIH Receipt Point http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-063.html

36. Progress Report Checklist for PO   Program Looks to See : • Is progress satisfactory? (If no, explain.) Add Comment • Is there a change in the scope, goals, or objectives of the project? • If yes, does this change benefit the project and is it approved? (If not, explain.) • Is there a change in key personnel or their level of effort? (If yes, describe.) • If there are changes/concerns in the Multiple PI leadership plan, is the new plan acceptable? • Is there evidence of scientific overlap? (If yes, explain.) ….. • If a progress report for a supplement is required, is progress reported and acceptable? • Are there other issues that should be resolved prior to issuing an award? (If yes, provide details.) • If any issues have not been resolved, should a restricted award be made?

37. PO: Grant Oversight – Actions Requiring Prior Approval • Change in Scope • Significant change in aims, methodology, approach, or other aspects of project objectives • Reflects significant change from the project as reviewed and approved • Examples: • Change in specific aims • Change to a different animal model • Any change from the approved use of animals or human subjects • Shift of research emphasis to a different disease area

38. PO: Grant Oversight – Actions Requiring Prior Approval • Desired Change of Grantee Institution • Program Official assesses: • If Grant mechanism permits • Progress to date • Adequacy of new resources and environment • Availability of expertise (key personnel) • Potential problems (e.g., equipment) • Contact NIH Program Officer early!

39. PO: Grant Oversight – Actions Requiring Prior Approval • Desired Change in Status of PI • Change of PI • >25% change in PI effort • PI absence of 90 days or more Note: A project cannot be converted from a single PI to a Multiple PI project during a non-competing phase

40. NIH Resource Web Links: • Overview of Electronic Submission http://era.nih.gov/ElectronicReceipt/ • Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm • Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.ht • Office of Extramural Research Grants Home Page: http://grants.nih.gov/grants/oer.htm • PHS2590 Progress Report (form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm

41. Questions?