NIH OFFICE OF EXTRAMURAL RESEARCH NIH Grants Process: The Big Picture University of Texas, El Paso February 19, 2010 Cynthia Dwyer Division of fcommunications and Outreach, OER Pam Gilden Office of Policy for Extramural Research Administration, OER
NIH Deadlines
The Peer Review Process
Who to Call and Where to Look
This Morning s Topics NIH&F Funding Facts Fundamentals of the Grants Process Roles & Responsibilities: Yours & Ours Applications & Scientific Review Program & Grants Management Web Resources
FDR Dedicates NIH Campus October 31, 1940
NIH Campus -- 1947
NIH INTRAMURAL NIH Campus Campus Today Today
NIH EXTRAMURAL Campus Rockledge 1 & 2 Executive Plaza South and North Neuroscience Center NIEHS Campus Research Triangle Park, NC Democracy 1 & 2
NIH FY2010 Budget NIH divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers) NHGRI NIAMS NIEHS NEI OD NLM NIDCR NIDCD NIAAA NIBIBNCMHD NINR NCCAM FIC NCI Total = $31.2 B NIDA NIA NIAID NCRR NIDDK NIGMS NHLBI NICHD NIMH NINDS About 90% distributed via Extramural grants, contracts, cooperative agreements
Breakdown of FY 2011 President s Budget Request for NIH $32.2 Billion 53.2% 9.6% 5.8% 2.6% $16.4 B 11.0% 2.6% 4.7% 10.5% Research Project Grants (53.2%) Research Centers (9.6%) Other Research (5.8%) Research Training (2.6%) R&D Contracts (11.0%) Intramural Research (10.5%) Research Mgmt & Support (4.7%) All Other (2.6%)
What s the Difference Between Grants and Contracts? GRANT Assistance CONTRACT Acquisition Government is Patron or Partner Government is Purchaser Purpose: to support and stimulate research Purpose: to acquire goods or services Benefit a public purpose The direct benefit and use of the government Investigator initiated Government initiated
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
www.grants.nih.gov www.grants.nih.gov
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
NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Roles and Responsibilities: Yours and Ours (Team Players)
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:
Grantee Institution Team Successful grants require close coordination between all members of the grantee team. Grants are awarded to institutions as represented by AORs. PD/PIs manage and perform the science Authorized Organizational Reps Research Administrator Principal Investigator Research Administrators support business aspects
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
The NIH Extramural Team Review Staff Grants Management Program Staff
When you need help with scientific and technical aspects of your application. 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
When you need help with your application before the review. 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
When you need help with the business aspects of your application. Grants Management Officer (GMO) Ensures performance of business management actions by the grantee and the federal government. Grants Management Specialists (GMS) Assists GMOs/CGMOs in managing grants Answers s questions s about completing application forms Provides guidance on the administrative and fiscal aspects of an award
NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Grant Application and Scientific Review (Game Plan)
The Grants Process Overview http://grants.nih.gov/grants/grants_process.htm
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
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 y are: Well-focused and explicitly written Not overly ambitious Understandable by a naïve reader
Mandatory: Do I Contact NIH Before Applying? Application with budget >$500,000 000 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
Receipt and Referral of Applications Electronic SF424 R&R submitted through grants.gov to an NIH Institute (IC) CSR Referral a unique identifier Office assigns the (application number) application CA54321-01 Application assessed for completeness & eligibility Notice of assignment available in era Commons in 4 weeks. to Integrated Review Group p( (IRG) and then a study section (SRG) 1 st Month 2 nd Month
Peer Review System for Grants Scientific Review Group (SRG) Independent outside review 1st level Evaluate scientific merit, significance Recommend length and level of funding Output: Impact/Priority Score and Summary Statement 3-7 months 2nd level Output: Funding Recommendations Advisory Council Assess quality of SRG process Offers recommendation to Institute Staff Evaluates program priorities and relevance Advises on policy 1-3 months Output: Awards or Resubmission Institute Director Makes final decision based on Council input, programmatic priorities Must also Pass Administrative Review
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
1 st Level Review Standing study section typically has 12-2424 members 3 face-to-face meetings each year Review 60-100 applications at each meeting
2 nd Level Review National Advisory Council or Board assesses quality of 1 st level l review Concurs with or modifies action of Scientific Review Groups Reads summary statements only Can also designate application as High or Low program priority
Who Makes Actual Funding Decisions? The Institute Director! Factors Considered: Scientific Merit Contribution ti to Institute/Center t t Mission i Program Balance Availability of Funds
NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Program Staff (Special Teams)
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 Report and address any unresolved review concerns Human Subjects Animal Welfare Address requirements for foreign applications For the IC Director Impact/Priority Score; Percentile Areas of Emphasis Portfolio Balance
NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Grants Management (Coaching Staff)
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 Final review & Negotiations Congressional Liaison Notified Award Issued Award Received by Grantee Investigator Begins Work
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
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/olawnih gov/grants/olaw
NIH OFFICE OF EXTRAMURAL PROGRAMS Notice of Award and after
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 by drawing down funds against the grant from the Payment Management System.
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
Take Home Messages Lots of directions and opportunities at the NIH 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)
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: iti http://www.nih.gov/icd/index.html /i d 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!
Questions?