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NIH OFFICE OF EXTRAMURAL RESEARCH

NIH OFFICE OF EXTRAMURAL RESEARCH. NIH Grants Process: The Big Picture. University of Texas, El Paso February 19, 2010. Cynthia Dwyer Division of Communications and Outreach, OER Pam Gilden Office of Policy for Extramural Research Administration, OER. This Morning’s Topics.

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NIH OFFICE OF EXTRAMURAL RESEARCH

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  1. NIH OFFICE OF EXTRAMURAL RESEARCH NIH Grants Process: The Big Picture University of Texas, El Paso February 19, 2010 Cynthia Dwyer Division of Communications and Outreach, OER Pam Gilden Office of Policy for Extramural Research Administration, OER

  2. This Morning’s Topics NIH & Funding Facts Fundamentals of the Grants Process Roles & Responsibilities: Yours & Ours Applications & Scientific Review Program & Grants Management Web Resources

  3. FDR Dedicates NIH Campus October 31, 1940

  4. NIH Campus -- 1947

  5. NIHINTRAMURALCampus Today NIH Campus Today

  6. NIHEXTRAMURALCampus Executive Plaza South and North Rockledge 1 & 2 Neuroscience Center NIEHS Campus Research Triangle Park, NC Democracy 1 & 2

  7. NLM NIBIB NIDCR NCMHD NHGRI NIDCD NINR NIAMS NIAAA NCCAM NIEHS FIC NEI OD NIH FY2010 Budget NIH divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers) Total = $31.2 B NCI NIDA NIA NIAID NCRR NHLBI NIDDK NIGMS NICHD NIMH NINDS About 90% distributed via Extramural grants, contracts, cooperative agreements

  8. Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion $16.4 B

  9. GRANT Assistance Government is Patron or Partner Purpose: to support and stimulate research Benefit a public purpose Investigator initiated CONTRACT Acquisition Government is Purchaser Purpose: to acquire goods or services The direct benefit and use of the government Government initiated What’s the Difference Between Grants and Contracts?

  10. Award Activity Codes:Research Project Grants • Traditional – R01 • Small Research – R03 • Exploratory/Development Grants – R21/R33 • Program Project – P01 • Research Center Grants – P50 • Small Business – R41, R42, R43, R44 • Cooperative Agreements– U01 -Substantial NIH staff involvement in program and science -Typically initiated by NIH

  11. Research Training and Research Career Development Awards • Training Grants – T • Institutional • Predoctoral and Postdoctoral • Trainees must be U.S. citizens • Fellowships (U.S. Domestic only) – F • Individual • Predoctoral – F31 • Postdoctoral – F32 • Fellows must be U.S. citizens • Career Development Awards – K

  12. Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Roles and Responsibilities: Yours and Ours (Team Players)

  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 Delegates responsibilities to:

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

  15. Extramural Research Policy & Process: Key NIH Roles • Office of Extramural Research (OER) • Dr. Sally Rockey – NIH Acting Deputy Director for Extramural Research • Immediate Office of the Director • Policy Development & Support: • Office of Policy for Extramural Research (OPERA) • Office of Extramural Programs (OEP) • Office of Laboratory Animal Welfare (OLAW) • Electronic Research Administration (eRA) • The Commons • Electronic System Development & Support • Center for Scientific Review • Scientific Review Officers • Scientific Review Groups • Institutes/Centers • Senior Leadership • Grants Management: • Program Officers • Review Officers

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

  17. with scientific and technical aspects of your application. When you need help… Program Administrator (aka Program Officer, Program Director or Program Official) • Discusses relevance to NIH and fit to IC’s mission • Identifies appropriate grant mechanisms for a project • Helps interpret reviewer’s comments

  18. with your application before the review. When you need help… Scientific Review Officer (SRO) • Responsible to NIH for the scientific and technical review of applications • Ensures fair and unbiased evaluation of the scientific and technical merit • Review applications for completeness and conformance with application requirements • Provides accurate summaries of the evaluation for • National Advisory Councils and Institute Directors • Applicants • Point of contact for applicants during • the review process

  19. Ensures performance of business management actions by the grantee and the federal government. When you need help… with the business aspects of your application. Grants Management Officer (GMO) Grants Management Specialists (GMS) • Assists GMOs/CGMOs in managing grants • Answers questions about completing application forms • Provides guidance on the administrative and fiscal aspects of an award

  20. Fundamentals of the Grants Process Grant Application and Scientific Review (Game Plan) NIH OFFICE OF EXTRAMURAL PROGRAMS

  21. The Grants Process Overviewhttp://grants.nih.gov/grants/grants_process.htm

  22. Getting to the Top:Writing Great Grants Components of successful applications Strong Idea Strong Science Strong Team Strong Presentation Match idea/science to the NIH Institute Every IC has specific mission Hone high-quality grant writing skills Communicate scientific content compellingly Follow all the instructions

  23. Writing a Grant Application • Research plan answers 4 essential questions • What do you intend to do? • Why is the work important? • What has already been done? • How are you going to do the work? • Successful applications typically are: • Well-focused and explicitly written • Not overly ambitious • Understandable by a naïve reader

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

  25. Receipt and Referral of Applications Electronic SF424 R&R submitted through grants.gov to an NIH Institute (IC) CSR Referral Office assigns the application… a unique identifier (application number) CA54321-01 to Integrated Review Group (IRG) and then a study section (SRG) Application assessed for completeness & eligibility Notice of assignment available in eRA Commons in 4 weeks. 1st Month 2nd Month

  26. Peer Review System for Grants Advisory Council Assess quality of SRG process Offers recommendation to Institute Staff Evaluates program priorities and relevance Advises on policy • Scientific Review Group (SRG) • Independent outside review • Evaluate scientific merit, significance • Recommend length and level of funding 1st level Output: Impact/Priority Score and Summary Statement 3 - 7 months 2nd level Output: Funding Recommendations • Institute Director • Makes final decision based on Council input, programmatic priorities • Must also Pass Administrative Review 1 - 3 months Output: Awards or Resubmission

  27. Who Reviews Grant Applications? • Scientist peers with appropriate expertise -- recruited by the Scientific Review Officer • Assigned to specific applications based on content • 4 year term typical • Temporary reviewers sought as needed

  28. 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

  29. 2nd Level Review • National Advisory Council or Board assesses quality of 1st level review • Concurs with or modifies action of Scientific Review Groups • Reads summary statements only • Can also designate application as “High” or “Low” program priority

  30. Who Makes Actual Funding Decisions? The Institute Director! Factors Considered: Scientific Merit Contribution to Institute/Center Mission Program Balance Availability of Funds

  31. Fundamentals of the Grants Process Program Staff (Special Teams) NIH OFFICE OF EXTRAMURAL PROGRAMS

  32. Report and address any unresolved review concerns Human Subjects Animal Welfare Program Officials’ Role in Funding Decisions At & After Review Meeting • Note reviewer enthusiasms and concerns • Discuss Summary Statements with applicants • Advise on resubmission process At Advisory Council • Address requirements for foreign applications • Impact/Priority Score; Percentile • Areas of Emphasis • Portfolio Balance For the IC Director

  33. Fundamentals of the Grants Process Grants Management (Coaching Staff) NIH OFFICE OF EXTRAMURAL PROGRAMS

  34. Award Negotiation & Issuance Many steps between a funding decision and a grant award 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 Congressional Liaison Notified Investigator Begins Work Award Issued

  35. Human Subjects Protection Safeguarding the rights and welfare of individuals research subjects based on DHHS regulations and established, recognized ethical principles DHHS Office of Human Subjects Research Protections (OHRP) oversees all issues for Federally-funded research involving people OHRP Office of Human Research Protections www.hhs.gov/ohrp

  36. Humane Animal Research Grantees are responsible for the humane care and treatment of animals NIH Office of Laboratory Animal Welfare (OLAW) oversees policies for humane animal care and use. grants.nih.gov/grants/olaw

  37. Notice of Award … and after NIH OFFICE OF EXTRAMURAL PROGRAMS

  38. Notice of Award (NoA) LEGALLY BINDING DOCUMENT • Award Data & Fiscal Information • Grant Payment Information • OIG* Hotline Information • Terms and Conditions * Office of the Inspector General The grantee indicates acceptance of the terms and conditions of the award bydrawing down funds against the grantfrom the Payment Management System.

  39. After the Award… Administrative and Fiscal Monitoring Requirements • Annual Progress Report (PHS 2590) • Annual Financial Status Reports (FSR) submitted electronically • Invention Reporting - iEdison • Yearly Audits (as applicable) • Final Closeout Reports

  40. Take Home Messages • Monitor Institute/Center Web sites and the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/) • Get to know the Program Director for your scientific area • Contact them about your research ideas • Fit with IC mission and priorities • Best grant activity code or program • Best study section for review • Participate in workshops and symposia • Participate in review of grant applications (study sections) Lots of directions and opportunities at the NIH

  41. Path to Success at NIH Step #1: Do your homework; learn a bit about the grant process and the options. Office of Extramural Research: Basics -http://grants.nih.gov/grants/grant_basics.htm Overview -http://grants.nih.gov/grants/grants_process.htm IC priorities:http://www.nih.gov/icd/index.html NIH Guide Provides Weekly Updates on Funding Opportunities: http://grants.nih.gov/grants/guide/ Step #2: Contact us because… We’re from the Government, we’re here to help you!

  42. Questions ?

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