data source: nih office of budget nih office of extramural research nih grants process: the big...
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Data Source: NIH Office of Budget
NIH OFFICE OF EXTRAMURAL RESEARCH
NIH Grants Process:The Big Picture
Cynthia DwyerDivision of Communications and Outreach, OER
Pam GildenOffice 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 CampusOctober 31, 1940
Data Source: NIH Office of Budget
NIH Campus -- 1947
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 PlazaSouth and North
Democracy 1 & 2
NIEHS CampusResearch Triangle Park, NC
Data Source: NIH Office of Budget
NIH FY2010 BudgetNIH FY2010 Budget
NIH divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers)
NCI
NIAID
NHLBINIGMSNIDDK
NINDSNIMH
NICHD
NCRR
NIA
NIDA
NEI
NCCAM
OD
NIEHSNIAMS NIAAANHGRI NIDCD
NIDCRNLM NIBIB
NCMHDNINR
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
53.2%
5.8%2.6%
11.0%
10.5%4.7%2.6%
9.6%
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%)
$16.4 B
Data Source: NIH Office of Budget
What’s the Difference Between Grants and Contracts?
GRANTAssistance
Government is Patron or Partner
Purpose:
to support and stimulate research
Benefit a public purpose
Investigator initiated
CONTRACTAcquisition
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
PrincipalInvestigator
Authorized Organizational
Reps
ResearchAdministrator
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
ProgramStaff
ReviewStaff
GrantsManagement
The NIH Extramural Team
Data Source: NIH Office of Budget
with scientific and technical aspects of your application.
When you need help…
Program AdministratorProgram 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)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)Grants Management Officer (GMO)
with the business aspects of your application.
Grants Management Specialists (GMS)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 Overviewhttp://grants.nih.gov/grants/grants_process.htm
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)
CA54321-01
1st Month
2nd 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 ReviewOutput: Awards
or Resubmission
3 - 7 months
1 - 3 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
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
Data Source: NIH Office of Budget
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
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
www.hhs.gov/ohrp
OHRPOffice 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 (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 NIHLots 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 - 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/
Data Source: NIH Office of Budget
Questions ?