Data Source: NIH Office of Budget NIH OFFICE OF EXTRAMURAL RESEARCH NIH Grants Process: The Big...

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


This Morning’s Topics

• NIH & Funding Facts

• Fundamentals of the Grants Process– Roles & Responsibilities:

Yours & Ours– Applications & Scientific Review– Program & Grants Management– Web Resources


FDR Dedicates NIH CampusOctober 31, 1940


NIH Campus -- 1947


NIH Campus Today NIH INTRAMURAL Campus Today


NIH EXTRAMURAL Campus

Rockledge 1 & 2

Neuroscience Center

Executive PlazaSouth and North

Democracy 1 & 2

NIEHS CampusResearch Triangle Park, NC


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


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


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


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


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


Fundamentals of the Grants Process

NIH OFFICE OF EXTRAMURAL PROGRAMS

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:


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


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


ProgramStaff

ReviewStaff

GrantsManagement

The NIH Extramural Team


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


with your application before the review.


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


• 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




Grant Application and

Scientific Review

(Game Plan)



The Grants Process Overviewhttp://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 are:– Well-focused and explicitly written– Not overly ambitious– Understandable by a naïve reader


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


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.


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


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


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


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


Who Makes Actual Funding Decisions?

The Institute Director!

• Factors Considered: – Scientific Merit– Contribution to Institute/Center Mission– Program Balance– Availability of Funds



Program Staff (Special Teams)



• 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



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

Award Issued

Final review &

Negotiations

Congressional Liaison Notified

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

www.hhs.gov/ohrp

OHRPOffice of Human Research Protections


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


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

– Final Closeout Reports

– Yearly Audits (as applicable)

– Invention Reporting - iEdison

– Annual Financial Status Reports (FSR) submitted electronically

– Annual Progress Report (PHS 2590)


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


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/


Questions ?

Data Source: NIH Office of Budget NIH OFFICE OF EXTRAMURAL RESEARCH NIH Grants Process: The Big...

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