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 Budgets Program & Grants Staff Actions The Notice of Award (and after) Web & GT Resources 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 ofCompeting Research Progress Grant (RPG) Applications FY 2007 Reviewed Awarded Success $$$ All Competing RPG Appls 47,455 10,100 21.3% 3.72 B New Appls 40,256 7,320 18.2% 2.51 B Continuing Appls 7,018 2,719 38.7% 1.20 B Reviewed Awarded Success $$$ Original Appls 32,854 3,935 12.0% 1.58B A1 Appls 10,333 3,727 36.1% 1.30B A2 Appls 4,241 2,428 57.3% .83B

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. NIH Activity Codes An activity code is a three-character code identifying a specific category of extramural activity. K08 T32 R43 R03 K23 F32 R01 R21

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. 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

19. Find Grant Opportunities in NIH Guide Find Grant Opportunities in NIH Guide Select the FOA number to open the announcement

20. Find Opportunity & Download FOA Read the FOA carefully for specific application instructions! Within the announcement – Click the Apply for Grant Electronically button This will take you directly to Grants.gov to download the package

21. NIH Scientific Review

22. 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

23. Receipt and Referral of Applications Electronic SF424 R&R submitted through grants.gov CSR assigns application to NIH Institute Paper PHS 398 delivered to CSR CSR assigns application number CSR Referral Office CSR assigns application to Integrated Review Group Notice of assignment available in eRA Commons in 4 weeks. Application assessed for completeness & eligibility 1st Month 2nd Month

24. 2 Level System for Application Review 1st Level National Advisory Council • Assesses Quality of SRG Review • Makes Recommendation to • Institute Staff on Funding • Evaluates Program Priorities and Relevance • Advises on Policy • Scientific Review Group (SRG) • Independent outside reviewers • Evaluate scientific merit & significance • Recommend length and level of funding 2nd Level

25. 1st Level Review • Standing study section typically has 12-24 members • 3 face-to-face meetings each year • Review 60 - 100 applications at each meeting

26. New Priority Score • The NIH grant application scoring system uses a 9-point scale • A score of 1 indicates an exceptionally strong application with essentially no weaknesses. A score of 9 indicates an application with serious and substantive weaknesses with very few strengths; 5 is considered an average score • Ratings are in whole numbers only (no decimal ratings) • This scale is used by all eligible (without conflict of interest)

27. Pay Line • Conservative funding cutoff point for grant applications set at the beginning of a fiscal year. Institutes determine pay lines by balancing projected grant numbers, grant budgets, and monies in the budget. • The lower numbers represent better scores.

28. Video

29. Review of Applications • 23 CSR Integrated Review Groups • 220 standing Study Sections • 300 + Special Emphasis Panels • Review groups at each IC • Dozens of standing Study Sections • Several hundred SEP meetings 3rd Month 4th Month

30. After 1st Level 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 through the eRA Commons 5th Month 6th Month 7th Month

31. 2nd Level Review • National Advisory Council or Board assesses quality of 1st level review • Concurs with or modifies SRG action • Reads summary statements only • Can also designate application as “High” or “Low” program priority 8th Month

32. Timeline: New Applications Receipt Date February 5 June 5 October 5 Scientific Review July October March Council Review October January May Award Date December April July

33. 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

34. Who Makes Actual Funding Decisions? The Institute Director Factors they considered: • Scientific Merit • Contribution to Institute Mission • Program Balance • Availability of Funds

35. 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. Funding approval from Program Award Received by Grantee Final review & Negotiations Investigator Begins Work Congressional Liaison Notified Award Issued 9th Month 10th Month

36. Grants Management Issues • Assurances in Place • Office of Human Research Protections (humans) • Office of Laboratory Animal Welfare (animals) • Financial Status Report (FSR) • (SF 269-long form) • if applicable • Human Subjects Education • Performance Site(s)/Consortium(s) information • Checklist completeness • Just-In-Time Information

37. 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

38. 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?

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