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

Data Source: NIH Office of Budget This Morning’s Topics NIH & Funding Facts Fundamentals of the Grants Process –Roles & Responsibilities: Yours & Ours –Applications & Scientific Review –Program & Grants Management –Web Resources

Data Source: NIH Office of Budget FDR Dedicates NIH Campus October 31, 1940

Data Source: NIH Office of Budget NIH Campus

Data Source: NIH Office of Budget NIH Campus Today NIH INTRAMURAL Campus Today

Data Source: NIH Office of Budget NIH EXTRAMURAL Campus Rockledge 1 & 2 Neuroscience Center Executive Plaza South and North Democracy 1 & 2 NIEHS Campus Research Triangle Park, NC

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

Data Source: NIH Office of Budget Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion $16.4 B

Data Source: NIH Office of Budget What’s the Difference Between Grants and Contracts? 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

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Roles and Responsibilities: Yours and Ours (Team Players)

Data Source: NIH Office of Budget 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:

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

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget Program Staff Review Staff Grants Management The NIH Extramural Team

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget 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 Point of contact for applicants during the review process – Review applications for completeness and conformance with application requirements – Provides accurate summaries of the evaluation for National Advisory Councils and Institute Directors Applicants – Ensures fair and unbiased evaluation of the scientific and technical merit

Data Source: NIH Office of Budget Ensures performance of business management actions by the grantee and the federal government. Grants Management Officer (GMO) with the business aspects of your application. 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 When you need help…

Data Source: NIH Office of Budget Fundamentals of the Grants Process Grant Application and Scientific Review (Game Plan) NIH OFFICE OF EXTRAMURAL PROGRAMS

Data Source: NIH Office of Budget The Grants Process Overview

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget Receipt and Referral of Applications to Integrated Review Group (IRG) and then a study section (SRG) CSR Referral Office assigns the application… to an NIH Institute (IC) a unique identifier (application number) CA st Month2 nd Month Application assessed for completeness & eligibility Electronic SF424 R&R submitted through grants.gov Notice of assignment available in eRA Commons in 4 weeks.

Data Source: NIH Office of Budget 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 Output: Impact/Priority Score and Summary Statement Output: Funding Recommendations Institute Director Makes final decision based on Council input, programmatic priorities Must also Pass Administrative Review Output: Awards or Resubmission months months 1st level 2nd level

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget 1 st Level Review Standing study section typically has members 3 face-to-face meetings each year Review applications at each meeting

Data Source: NIH Office of Budget 2 nd Level Review National Advisory Council or Board assesses quality of 1 st 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

Data Source: NIH Office of Budget Who Makes Actual Funding Decisions? The Institute Director! Factors Considered: –Scientific Merit –Contribution to Institute/Center Mission –Program Balance –Availability of Funds

Data Source: NIH Office of Budget Fundamentals of the Grants Process Program Staff (Special Teams) NIH OFFICE OF EXTRAMURAL PROGRAMS

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

Data Source: NIH Office of Budget Fundamentals of the Grants Process Grants Management (Coaching Staff) NIH OFFICE OF EXTRAMURAL PROGRAMS

Data Source: NIH Office of Budget 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 Issued Final review & Negotiations Congressional Liaison Notified Award Received by Grantee Investigator Begins Work

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget 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

Data Source: NIH Office of Budget Notice of Award … and after NIH OFFICE OF EXTRAMURAL PROGRAMS

Data Source: NIH Office of Budget 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.

Data Source: NIH Office of Budget After the Award… Administrative and Fiscal Monitoring Requirements – Final Closeout Reports – Yearly Audits (as applicable) – Invention Reporting - iEdison – Annual Financial Status Reports (FSR) submitted electronically – Annual Progress Report (PHS 2590)

Data Source: NIH Office of Budget Take Home Messages Monitor Institute/Center Web sites and the NIH Guide for Grants and Contracts ( 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

Data Source: NIH Office of Budget Step #1: Do your homework; learn a bit about the grant process and the options. Step #2: Contact us because… We’re from the Government, we’re here to help you! Path to Success at NIH Office of Extramural Research: Basics - Overview - IC priorities: NIH Guide Provides Weekly Updates on Funding Opportunities:

Data Source: NIH Office of Budget Questions ?