Working with NIH Program Officials PreAward & PostAward

1. Working with NIH Program OfficialsPreAward & PostAward Peter C. Preusch, Ph.D National Institute of General Medical Sciences NIH Regional Meeting 2012, Omni Shoreham, Washington, DC National Institutes of Health Department of Health and Human Services

2. NIH Extramural Grants Process

3. The NIH Extramural Team Review Staff Grants Management Program Staff

4. What is a Program Official? Scientist andAdministrator Responsible for programmatic, scientific, and technical aspects of a grant • Also known as: • Program Director Project Officer

5. Responsibilities of theProgram Official • Manages scientific research portfolio of grants, contracts, and cooperative agreements • Identifies opportunities and needs of science specific to an Institute’s mission • Stimulates interest in scientific areas of emphasis for each Institute • Communicates program priorities • Program Announcements (PA) • Request for Applications (RFA)

6. Responsibilities of theProgram Official • Provides technical assistance to applicants • Observes scientific review meetings • Discusses review issues with applicant • Ascertains programmatic and mission relevance of applications • Prepares funding recommendations • Reviews annual research progress of grantees • Reports on scientific progress and program accomplishments

7. Responsibilities of the Program Official Principal liaison between extramural investigators and the NIH Your most important contact Call us early … Contact us often!

8. NIH Research Programs 27 Institutes and Centers • Divisions • Branches • Programs How Do I Know Where to Go?

9. Getting Started:Contact a Program Official Why? We can Direct You to: • The appropriate Institute • 24 institutes have granting authority • The appropriate Division/Office • Basic, clinical, behavioral, translational • The appropriate Program Official • Extramural research portfolio

10. Getting Started:Contact a Program Official • Where Can I Find a Program Official? • At Your Favorite Scientific or Professional Meeting • Institute-sponsored Workshops • Mingling through the Crowds • Institute Exhibit Booths • Ask a Colleague or Mentor • Someone you know knows a Program Contact • Search NIH Institute Websites, Employee Directoryor RePORTER

11. Finding Your Way at NIH Office of the Director 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 of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences 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 Center on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine No funding authority NIH Clinical Center Center for Information Technology Center for Scientific Review

12. RePORTER • Research Portfolio Online Reporting Tools Expendituresand Results • Searchable database of federally supported biomedical research • Identify the ICs that support areas of research you want to do • Identify Program Officials that manage research similar to what you want to do

13. RePORTER projectreporter.nih.gov/reporter.cfm

14. Must I Contact NIH Before Applying? Yes… under certain circumstances it is MANDATORY • Applications with budgets >$500,000 (direct cost) for any single year • IC must agree to accept the application • Request must be six weeks before receipt date • NIH Guide NOT-OD-02-004 (10/16/2001) • R13 Conference Grant Applications • IC must agree to accept the application

15. Must I Contact NIH Before Applying? Usually, it’s just a smart idea • When RFA’s request Letter of Intent • If you have questions about grant mechanisms or budget limitations or eligibility or ... • When you are considering applying for any grant • whether you are a new or experienced investigator • contact with program is always highly recommended Prior contact with a program official will always save you time!

16. Program Contact Before Submission has Benefits Two more important reasons: • Develop a relationship with a potential program official • Assure that your application has a home (appropriate Institute)

17. Your Program Official Can Help ... • During Application Development and Preparation • During Scientific Review • After Peer Review • After Award

18. Develop Your Application Your Research Needs and Interests • My research interests focus on the link between widgets and type II diabetes • My need is for additional research training or career development

19. Develop Your Application A Program Official can discuss • Your ideas • Match your scientific interests with the mission and focus of NIH Institutes • NIH ideas • Research initiatives and priorities already established by ICs

20. Create a Concept Paper Organizes your thoughts for a productive discussion with NIH Program Official • Purpose: What exactly do you want to do? • Problem/Background: Why does this topic need study? • Significance: Why is this important to the field? • Question: What research questions or hypotheses will you test? What model guides them? • Design/Analysis: What study design will you use? What is the analytic approach? • Team: Who will be the key participants on the project (co-investigators and organizations)?

21. Program Officials ... can help During Application Preparation • Budget issues • NIH requirements • Technical Assistance

22. Develop Your Application What is “Technical Assistance”? • Advice on Grant Writing and Preparation • Clarification of Policies and Regulations • Confirm Applicant Eligibility • Determine Responsiveness to Program Initiative • Development of • Scientific concepts • Scientific aims & objectives

23. Develop Your Application Guide you to Appropriate Grant Mechanism • Training Grant • Career Development Award • Research Project Grant Explain the different Funding Opportunity Announcements (FOA)

24. Recap of Resources • Search RePORTER to learn what research is supported http://projectreporter.nih.gov/reporter.cfm • Search Institute Web Sites www.nih.gov/icd/ • Contact Institute Staff http://ned.nih.gov/ • Identify Relevant RFA or PA in NIH Guide http://grants.nih.gov/grants/guide/index.html

25. NIH Award Mechanisms R21 R01 K08 F33 R03 T32 K23 R43

26. Grant Award Mechanisms • Individual Fellowships (NRSA) • Institutional Research Training Grants • Career Development Awards • Research Grants • Program Project & Centers Grants • Small Business Awards (SBIR/STTR)

27. Different Types of AwardsDifferent Interactions • Grant • Financial assistance to carry out approved activities (e.g., research, training) • Contract • Acquisition of goods or services • Cooperative Agreement • Grant support that includes substantial Federal involvement

28. Which Applications Become Grants? • Scientific merit • Peer Review Group • Program Considerations Institute Director • advised by Program Staff and Advisory Council • Availability of funds

29. Program Officials ... Give advice and encouragement! Larry! Go for the cape!

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

31. Program Officials ... can help During Scientific Review • Answer your questions about the grant review process • Be a liaison to the SRO • Observe review group meeting

32. Scientific Review – Process We can answer your questions about review of applications. SRO is in charge of review process. BUT the Program Official can discuss and explain grant assignment to an Institute and Study Section. We help you navigate peer review process.

33. Scientific Review – Liaison We can be a Liaison to the SRO. SRO is in charge of review process. BUT the Program Official can convey to the SRO: • Requests to submit additional data • Missing elements of your application • Notifying of accepted papers

34. Scientific Review – Observe We can observe study section review. SRO is in charge of review process. BUT the Program Official can: • Listen to panel discussion of your grant • Listen to panel discussion of other grants • Helpful when an application is unscored • Provide clarification of Program Initiatives (RFA, PA) if requested by SRO

35. Program Officials ... can help After Peer Review • Priority Scores and Percentiles • Study Section Review • National Advisory Council Review • Prepare Funding Recommendations

36. After Review – Priority Score and Percentile Do Priority Score and Percentile Indicate … … I Will Get Funding? Important: Nothing is Official Until You Receive the Notice of Award

37. After Review – Critiques Your Job • Read summary statement • Reread summary statement • Talk with your Program Official • Wait for the AWARD, or • Revise and Resubmit the Application • Listen to advice from Program Official

38. After Review - Critiques Discuss Study Section Review • What is written in the Summary Statement • What was said during the review • Do you really want to appeal the review? • Factual errors • Evidence of bias • Conflict of interest • Lack of expertise

39. After Review – Council Attend National Advisory Council Review • Clarify Scientific Objectives of Applications to Council • Present Appeal Letters • Present High Program Priority Applications • Get Program Priorities from Council

40. After Review – Funding Decisions Prepare Funding Recommendations to Institute Director • Priority Score and Percentile • Areas of Scientific Emphasis • Council/Institute Program Priority • Portfolio Balance

41. Remember … … the INSTITUTE DIRECTOR makes the final Funding Decisions

42. Program Officials ... can help After Peer Review Consult with applicant on possible next steps: • Respond to reviewer concerns (revise and resubmit) • Submit a new application • Change study section or mechanism? If funding seems unlikely:

43. After Review - Resubmissions Responding to Reviewer Concerns • What is written in the Summary Statement • What was discussed during Peer Review Please be responsive to reviewer concerns!

44. Q:If you know that you are “right” and the reviewers are “wrong”, is it appropriate to argue your position in your resubmission? A:NO! Remember Never be argumentative ! Never be abrasive ! Do not do long term damage to yourself! After Review - Resubmissions

45. After Review - Resubmissions • Remember that properly revised applications can receive fundable scores and subsequent $$$$$ • Score can inform degree of revision necessary • Maintain communications with Scientific Review Officer and Program Official

46. Prepare an INTRODUCTION Address all criticisms thoroughly Respond constructively Acknowledge and accept the help of reviewer comments Don’t be argumentative! Don’t be abrasive or sarcastic! After Review - Resubmissions

47. As necessary adjust: Hypothesis Specific Aims & Objectives Experimental Approach & Design Update Preliminary Results Update Letters After Review - Resubmissions

48. After Review - Resubmissions Prepare a RESUBMISSION COVER LETTER Indicate review history Request same OR different Study Section/IC Provide justification for your request

49. After Review – New Application • Is your application a terminal A1? • OR • Are the revisions taking your application in a new direction? • “Significant and substantial change in content and scope”

50. After Review – Other Changes • Should you request change in Reviewers or Study Section? • Should you change mechanism?