Working with the NIH

1. Working with the NIH

2. Introduction to the NIH History Mission & Organization Funding Facts Fundamentals of NIH Grants Types of Grants Roles & Responsibilities (handout) Decoding the NIH Funding sources Applications & Scientific Review Current Issues Budgets Program & Grants Staff Actions The Notice of Award (and after) Today’s Topics

3. Introduction to NIH

4. U. S. Dept. of Health and Human Services Secretary of Health and Human Services Administration for Children and Families (ACF) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Administration on Aging (AoA) 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)

5. NIH Founded in 1887 One agency of 11 within U.S. Department of Health and Human Services (HHS) Comprises 27 Institutes and Centers (IC)

6. NIH Mission NIH is the steward of medical and behavioral research for the Nation Our mission: to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability … … from the rarest genetic disorder to the common cold

7. NIH Organizational Structure 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 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 Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering No funding authority NIH Clinical Center Center for Information Technology Center for Scientific Review

8. Fulfilling the Mission • Support research by non-Federal scientists across U.S. and abroad • Help train research investigators • Conduct research in our own labs • Foster communication of medical and health sciences information

9. What Stays at NIH? What Goes Elsewhere? Total FY 2008 Budget: $29.46 Billion 84% Outside NIH > 325,000 Scientists > 3,000 Organizations Worldwide 16% Inside NIH $2.9 B Intramural Research (10%) $1.2 B Staff & Buildings (4%) $0.6 B Other (2%)

10. Success Rates

11. Fundamentals of NIH Grants

12. Grants are awarded to institutions as represented by AORs. PD/PIs manage and perform the science Research Administrators support business aspects of the grant Successful grants require close coordination between all members of the grantee team. Grantee Institution Team Authorized Organizational Reps Research Administrator Principal Investigator

13. The Grantee Institution • Actual recipient of award • Legally responsible for proper conduct and execution of grant • Provides fiscal management • Provides oversight on allocation decisions • Assures compliance with Federal, NIH, and organization-wide requirements

14. Georgia Tech Source of Awards

15. Decoding the NIH

16. Sample Application Number Suffixes Activity Code Serial Number 1 R01GM01234510A1/S1 Application Type Institute/Center Year of Support http://grants.nih.gov/grants/funding/ac_search_results.htm

17. Research Grants Traditional – R01 Exploratory/Development Grants – R03/R21/R33/R34 Program Project – P01 Research Center Grants – P50 Small Business – R41, R42, R43, R44 Cooperative Agreements (U) Specialized Grant mechanism Substantial NIH staff involvement in program and science Typically initiated by NIH Research Training and Career Awards Training Grants – T Institutional Pre-doctoral and Postdoctoral Fellowships – F Individual Pre-doctoral – F31 Postdoctoral – F32 Career Development Award – K Award Mechanisms

18. Mandatory Use of Cayuse424

19. Cayuse424

20. NIH Scientific Review

21. NIH Organizational Structure 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 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 Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering No funding authority NIH Clinical Center Center for Information Technology Center for Scientific Review

22. The Division of Receipt and Referral (DRR) within the CSR

23. Peer Review

24. Initial Level of Review • Standing study section typically has 12-24 members • 3 face-to-face meetings each year • Review 60 - 100 applications at each meeting

25. Impact Score • The NIH grant application scoring system uses a 9-point scale • This scale is used by all eligible (without conflict of interest)

26. Peer Review • Priority Scores recorded • Summary Statements prepared • Overall Resume and Summary of Review Discussion • Essentially Unedited Critiques • Priority Score and Percentile Ranking • Budget Recommendations • Administrative Notes • Viewable 4-6 weeks after review meeting • Only available to the PI through the eRA Commons

27. Summary Statement • Understanding the Percentile • A percentile is the approximate percentage of applications that received a better overall impact/priority score from the study section during the past year. • Only a subset of all applications receive percentiles. The types of applications that are percentiled vary across different NIH Institutes and Centers.

28. Video

29. Second Level of Review - Advisory Council or Board • NIH program staff members examine applications, their overall impact scores, percentile rankings (if applicable) and their summary statements and consider these against the IC's needs. • Program staff provide a grant-funding plan to the Advisory Board/Council. • The Advisory Board/Council also considers the IC’s goals and needs and advises the IC director. • The IC director makes final funding decisions based on staff and Advisory Council/Board advice. 8th Month

30. Second Level of Review - Advisory Council or Board • Beginning in September 2012, Council members will receive a list of competing applications that will be considered for funding from PD/PIs that meet the threshold for Special Council Review. These are investigators who currently receive $1 million or more in direct costs of NIH funding to support Research Project Grants. Council members will be asked to recommend consideration of funding for applications that afford a unique opportunity to advance research which is both highly promising and distinct from the other funded projects from the PD/PI. This does not represent a cap to NIH funding. 8th Month

31. Timeline: New Applications Receipt Date February 5 June 5 October 5 Council Review October January May Review & Award Cycle I Cycle II Cycle III Scientific Review July October March Award Date December April July

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

33. Award Negotiation & Issuance

34. Award Negotiation & Issuance • There are still many steps after a funding decision is made before a grant is awarded. • Grants management staff work closely with grantee and NIH program staff to complete this final process.

35. Just-In-Time Information Information not required to review the application but which is necessary to implement the grant. • Certification of Education on Human Subjects • Institutional Review Board (IRB) approval • Required within 1 year and before any human subjects research begins. • Institutional Animal Care and Use Committee (IACUC) Approval • Required within 3 years and before animal research begins. • Information on “Other Support” received by Key Personnel

36. Grants Management: Special Issues For Example: • Is there a “foreign component” to the grant? • Includes grants to foreign organizations and grants with activities or consortium partners in foreign countries. • Require State Department Clearance prior to award. • Are there bars to the award? • Human subjects and animal subjects concerns • Are there research integrity issues?

37. Award Process • Notice of Award (NoA) • The NoA is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual • Accepting the Award • The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees.

38. After the Award… • Administrative and Fiscal Monitoring Requirements • Annual Progress Report (SNAP) • Annual Financial Status Reports (FSR) • Invention Reporting • Yearly Audits (as applicable) • Final Closeout Reports

39. Budget

40. Budgetary Issues • Correctly apply modular and categorical budgets • Modular budgets reduce burden by eliminating the need for specific budget numbers • Available for grants at or below $250,000 per year • Grantees awarded grants in “modules” of $25,000 • Budget Justification • Adjustments may be applied to individual grant awards based on IC financial policies • Caps on certain types of costs specific to that funding opportunity • Limits on overall grant funding due to NIH budget constraints.

41. Modular Budget

42. Modular Budget Sections A&B:Personnel • Determine the amount of time (effort) that you will spend on this project. • Calendar, Academic, or Summer Months • Determine the number, qualifications and amount of time needed for other personnel • Technicians • Postdoctoral Fellows • Graduate Students • Undergraduate Students

43. Modular Budget Sections A&B:Personnel • There are no magic numbers regarding the qualifications and/or number of individuals needed for each aim. • Be realistic about what each individual can accomplish, and the time necessary to complete the work. • Remember the current NIH Salary cap is $191,300

44. Modular Budget Section C: Do you need new equipment? • If you need additional equipment, this is the time to consider it. • Equipment should be project specific – be sure to include a written justification. • Most equipment is requested during the first year of the grant. • If you use a modular budget format, you may ask for extra module(s) to cover equipment.

45. Modular Budget Section D: Travel funds • This amount is usually small: • $1,000 - 2,000 per meeting per individual per year • Generally supports one meeting per year for 2-3 individuals

46. Modular Budget Section E: Participant/Trainee Support Costs • Unless stated in the FOA, this section should be left blank for NIH applications • Include tuition remission under Section F: Other Direct Costs

47. Modular Budget Section F: Other Direct Costs Estimate the materials and supplies needed for the personnel involved It may be reasonable to estimate a supply budget of ~$12,000–15,000/year for each FTE • This number will vary depending on the nature of the research proposed. • Animal intensive studies and studies involving human subjects tend to be more costly. • In silico studies tend to be less costly for supplies. • Consider stage of career of personnel involved

48. Modular Budget Section F: Other Direct Costs • This category also includes funds needed for things such as: • Publication costs • Equipment maintenance • Consortium/subcontracts • Tuition remission. • Estimate these expenses realistically.

49. Example Modular Budget Cal Req. Fringe Funds Mon Salary Benefits Req. A. Senior/Key Person PI 2 15,333 4,293 19,626 B. Other Personnel Postdoc Assoc 12 38,976 10,913 49,889 Grad Student 12 20,772 5,454 26,226 Grad Student 12 20,772 5,454 26,226 C. Equipment – Microscope 19,000 D. Travel - (2 meetings) 4,000 E. Participant/Trainee usually left blank F. Other Direct Costs Materials/Supplies 25,533 Publication Costs 1,500 Subaward/Consortium/Contractual costs none Tuition Remission 7,000 G. Total Direct Costs 179,000

50. Example Modular Budget • Calculate the direct costs for the first year. • (for example, Year 1 budget = $179,000) • Calculate the direct costs for subsequent years taking into account salary increases and changes in funds requested for equipment. • Year 2 = $164,800 • Year 3 = $169,744 • Year 4 = $174,836 • Year 5 = $180,081