1. Submitting to the NIH ERA Empowerment Series MAY 2014

2. Housekeeping

3. Learning Objectives By the end of this course, you will be able to: Describe the NIH structure and determine the appropriate point of contact, and evaluate the impact of NIH funding on Stanford Successfully differentiate the NIH funding mechanisms and programs Review the NIH announcement Prepare NIH budgets with special attention to the NIH salary cap and student compensation limitation Identify the differences between modular and non- modular applications Review the application for completeness

4. National Institutes of Health (NIH) NIH’s primary mission is to improve the health of the nation. The mission is accomplished by supporting and conducting research. NIH supports extramural research by issuing grants and contracts. Apply for grants through Grants.gov or through paper applications. 4

5. 27 S EPARATE I NSTITUTES & C ENTERS (IC) EACH WITH DIFFERENT : M ISSIONS & P RIORITIES B UDGETS F UNDING S TRATEGIES NIH is organized into… NIGMS Clinical Center International Center 5

6. NIH Staff 6 RoleResponsibility Program Official a. Responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants b. Involved in the development of research and research training programs to meet the Institute or Center’s mission c. Post-award administration duties (review of progress reports, site visits, etc.) Grants Management Officer (GMO) a. Involved with business management and non-programmatic aspects of award b. The only NIH official authorized to: i.) obligate NIH to the expenditure of funds and ii.) change funding, duration, or other terms/conditions of award Grants Management Specialist a.An agent of GMO b.Responsible for day-to-day management of grant c.Receives and acts upon requests, including prior approval requests and changes to award terms and conditions

7. NIH Funding Mechanisms 7 ContractGrantCooperative Agreement Procurement/purchasing action (bid process) Awards of financial assistance Sponsor defined work scopePI defined work scopeSubstantial programmatic involvement by the Sponsor Period of performance Cost-reimbursement or fixed price agreement Cost-reimbursement agreement Specific deliverables, reports and/or milestones Technical and financial reports Revocable in whole or in part Specific rights reserved by sponsor in award terms Financial and performance terms

8. NIH Programs Examples of programs within the funding mechanisms: Research (R) Program Project / Center Grants (P) Career Development Awards (K) Training (T) Fellowships (F) Cooperative Agreements (U) Minority Supplements Administrative Supplements Facilities/Equipment Travel/Conference 8

9. Research Grants - “R” Series Awarded to an eligible institution Awarded on behalf of a PI Supports project related to the investigator’s area of research Research grants provide funds for  Reasonable costs of research activity  Salaries, equipment, supplies, travel and other related expenses 9

10. Examples of “R” Awards R 01 Research Project R 03 Small Research Grants R 15 Academic Research Enhancement Awards (AREA) R 21 Exploratory/Developmental Grants R 35 Outstanding Investigator Grants R 37 Method to Extend Research in Time (MERIT) Award 10

11. Program Projects & Centers - “P” Series Award supports several projects within the larger grant One Principal Investigator Program Administrator or Director for each project Examples:  P 01 Research Program Projects  P 30 Center Core Grants  P 50 Specialized Center  P 60 Comprehensive Center Exception to the rule: M01 Clinical and Translational Science Awards (CTSA) 11

12. Research Career Awards - “K” Series Provides support for a supervised career development. Experience leading to independent research. Have a research or health professional doctorate and postdoctoral research experience at the time of the application. Demonstrate the need for a 3-5 year period of supervised research as well as the capacity/potential for highly productive independent research. Provide a plan for achieving independent research support by the end of the award period. 12

13. Examples of “K” Awards K 01 Research Career Award K 02 The Independent Scientist Award K 07 Academic Career Award K 22 Career Transition Award K 25 Mentored Quantitative Research Career Development Award K99/R00 Pathway to Independence Award 13

14. Training Programs - “T” Series Federal funding for all or part of expenses incurred for training or other educational services  The type of work covered by training grants include summer institutes and training programs for selected participants Development and introduction of new or expanded courses Examples:  T 32 Institutional NRSA  T 14 Conferences  T 35 NRSA Short-term Research Training Note: Some training programs may also fall under the “D” or “A” series 14

15. Fellowship Program – “F” Series An amount paid to or for the benefit of an investigator to assist him/her in the pursuit of their research career Stipend-based Examples:  F 05 - International Research Fellowships  F 31 - Predoctoral Individual NRSA*  F 32 - Postdoctoral Individual NRSA*  F 37 - Medical Informatics Fellowship *These grants are awarded to institution 15

16. Travel / Conference Grants Support the PI’s conferences, symposia, or workshops 16

17. Reviewing the NIH Announcement Confirm Activity Code and Application Due Date Confirm Funding Limitation Modular or Non-Modular Application? Check for Special Restrictions

18. Preparing NIH Budgets NIH Salary Cap is $181,500 per year. Graduate student funding is limited to NRSA Postdoctoral Stipend level for zero years of experience. This is currently $42,000 per year. Graduate student salary, benefits, and tuition cannot exceed $42,000 per year.

19. Will the application be modular or non-modular?

20. Modular Applications Funding is requested in “modules” of $25,000 direct costs up to $250,000 direct costs per year. The PHS 398 Modular Budget form is preferred, but not required. Detailed budgets are permitted regardless of the budgeted amount. http://grants.nih.gov/grants/detailed-modular_flowchart.jpg http://grants.nih.gov/grants/detailed-modular_flowchart.jpg

21. Modular Applications (continued) Budget justifications are required for: Personnel Consortium Additional Narrative Justification (if number of modules varies from year to year)

22. Non-Modular Applications For funding in excess of $250,000 direct cost in a given year. NIH Research and Related Budget form must be used. Budget justification must be attached to the budget form.

23. How do I review the application for completeness?

24. How do I submit to the NIH?

25. Demo!

26. Questions?

27. Next Steps… In the next day or two, you will receive an email message containing: a.) a feedback form link and b.) a quiz! To receive credit for this class, you’ll need to complete both the quiz and feedback form within 7 days.

28. Thanks for attending!