NIH Grants Process: The Big Picture

NIH OFFICE OF EXTRAMURAL RESEARCH

NIH Grants Process:

The Big Picture

University of Texas, El Paso February 19, 2010

Cynthia Dwyer

f C O O

Division of Communications and Outreach, OER

Pam Gilden

Office of Policy for Extramural Research Administration OER Office of Policy for Extramural Research Administration, OER

This Morning’s Topics

NIH & F

di

F

t

• NIH & Funding Facts

• Fundamentals of the Grants

Process

– Roles & Responsibilities:

Yours & Ours

– Applications & Scientific Review

Program & Grants Management

– Program & Grants Management – Web Resources

FDR Dedicates NIH Campus

NIH Campus -- 1947

NIH Campus Today

NIH

EXTRAMURAL

E ti Pl Rockledge 1 & 2

Executive Plaza South and North

Neuroscience Center Neuroscience Center

NIEHS Campus

Democracy 1 & 2

NIEHS Campus

NIH FY2010 Budget

NIH FY2010 Budget

NIH divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers)

NCCAM NIEHS NIAMS NIAAA NHGRI NIDCD NIDCRNLM NIBIBNCMHD NINR

Total = $31.2 B

Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion

9.6% 53.2% 5.8% 2.6% 11.0% $16.4 B 10.5% 4.7% 2.6%

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%) 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 Acq isition Assistance Government is Acquisition Government is Patron or Partner Purpose: Purchaser Purpose: to support and stimulate research to acquire goods or services

Benefit a public purpose The direct benefit and use of the government

Research Training and

Research Career Development Awards

• Training Grants – T

I tit ti l – Institutional

– Predoctoral and Postdoctoral T i t b U S iti

– Trainees must be U.S. citizens

• Fellowships (U.S. Domestic only) – F

Individual – Individual

• Predoctoral – F31 • Postdoctoral F32 • Postdoctoral – F32

– Fellows must be U.S. citizens • Career Development Awards

K

–

K

Research Training and

Research Career Development Awards

• Training Grants – T

I tit ti l – Institutional

– Predoctoral and Postdoctoral T i t b U S iti

– Trainees must be U.S. citizens

• Fellowships (U.S. Domestic only) – F

Individual – Individual

• Predoctoral – F31 • Postdoctoral F32 • Postdoctoral – F32

– Fellows must be U.S. citizens • Career Development Awards

K

–

K

NIH OFFICE OF EXTRAMURAL PROGRAMS

Fundamentals of the

Grants Process

Grants Process

Roles and Responsibilities:

Yours and Ours

The Grantee Institution

• Actual recipient of award

• Legally responsible for proper • Legally responsible for proper

conduct and execution of grant

P id fi l t

• Provides fiscal management

• Provides oversight on allocation decisions

• Assures compliance with Federal, p , NIH, and organization-wide

requirements

Grantee Institution Team

Successful grants require close coordination between all members of the grantee team.

Authorized

• Grants are awarded to

between all members of the grantee team.

Organizational Reps institutions as represented by AORs. Principal Investigator Research Administrator

• PD/PIs manage and perform the science

p

• Research Administrators

support business aspects 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 Research

– Immediate Office of the Director – Policy Development & Support:

• Office of Policy for Extramural Research (OPERA)

Offi f E t l P (OEP)

• 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

– Scientific Review Groups

• Institutes/Centers

– Senior Leadership – Grants Management:g

– Program Officers – Review Officers

The NIH Extramural Team

When you need help…

with scientific and technical aspects of your application.

Program Administrator

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 • 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)

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 scientific and technical merit

f f

– 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…

Grants Management Officer (GMO)

Grants Management Officer (GMO)

with the business aspects of your application.

• Ensures performance of business management actions by the grantee and the federal

Grants Management Officer (GMO)

Grants Management Officer (GMO)

government.

Grants Management Specialists (GMS)

Grants Management Specialists (GMS)

Grants Management Specialists (GMS)

Grants Management Specialists (GMS)

• Assists GMOs/CGMOs in managing grants • Answers questions about completing s e s quest o s about co p et g

application forms

• Provides guidance on the administrative and

fi l t f d

NIH OFFICE OF EXTRAMURAL PROGRAMS

Fundamentals of the

Grants Process

Grants Process

Grant Application and

Grant Application and

Scientific Review

(Game Plan)

The Grants Process Overview

Getting to the Top:

•

Components of successful applications

– Strong Idea

– Strong Idea

– Strong Science

– Strong Teamg

– Strong Presentation

•

Match idea/science to the NIH Institute

Match idea/science to the NIH Institute

– Every IC has specific mission

•

Hone high-quality grant writing skills

Hone high quality grant writing skills

– Communicate scientific content compellingly

Writing a Grant Application

• Research plan answers 4 essential

ti

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:

pp

yp

y

– Well-focused and explicitly written – Not overly ambitiousNot overly ambitious

Do I Contact NIH Before Applying?

Mandatory:

• Application with budget >$500 000 direct costs

• Application with budget >$500,000 direct costs for any single year

• R13 Conference Grants

• R13 Conference Grants

Optional:

Wh

RFA

L

f I

•

When RFA requests a Letter of Intent

Recommended:

• When you think about applying for any

grant

Receipt and Referral of Applications

submitted through t

to an NIH Institute (IC) grants.gov

CSR Referral

Office assigns the application…

a unique identifier (application number) CA54321-01

to Integrated Review Group (IRG) and then a pp _{CA54321 01}

f p ( )

study section (SRG)

Application assessed for completeness & eligibility

Notice of assignment available in eRA

Commons in 4 weeks.

Peer Review System for Grants

Scientific Review Group (SRG)

• Independent outside review

• Evaluate scientific merit significance

1st level

Evaluate scientific merit, significance • Recommend length and level of

funding Output: Impact/Priority

Score and Summary Statement

Advisory Council

• Assess quality of SRG process

• Offers recommendation to Institute Staff

Statement

3 - 7 months _{2nd level}

• Evaluates program priorities and relevance

• Advises on policy

Output: Funding Recommendations

1 - 3 months

Institute Director

• Makes final decision based on Council input, programmatic priorities

• Must also Pass Administrative Review

Output: Awards

1 - 3 months

• Must also Pass Administrative Review

Output: Awards or Resubmission

Who Reviews Grant Applications?

• Scientist peers with appropriate

ti

it d b th S i

tifi

expertise -- recruited by the Scientific

Review Officer

• Assigned to specific applications based

on content

• 4 year term typical

1

_{Level Review}

• Standing study

section typically has 12 24 members

12-24 members • 3 face-to-face

meetings each year • Review 60 - 100

applications at each meeting

2

Level Review

• National Advisory Council or Board

lit

f 1

l

l

i

assesses quality of 1

level review

– Concurs with or modifies action of Scientific R i G

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:

•

Factors Considered:

– Scientific Merit

C t ib ti t I tit t /C t Mi i

– Contribution to Institute/Center Mission – Program Balance

NIH OFFICE OF EXTRAMURAL PROGRAMS

Fundamentals of the

Grants Process

Grants Process

Program Staff

Program Staff

(Special Teams)

Program Officials’ Role in Funding Decisions At & After Review Meeting

• Note reviewer enthusiasms and concerns

Discuss Summary Statements with applicants

At Advisory Council

• Discuss Summary Statements with applicants

• Advise on resubmission process

• Report and address any unresolved review concerns

– Human Subjects

y

– Animal Welfare

For the IC Director

• Address requirements for foreign applications

For the IC Director

• Impact/Priority Score; Percentile

• Areas of Emphasis

NIH OFFICE OF EXTRAMURAL PROGRAMS

Fundamentals of the

Grants Process

Grants Process

Grants Management

(Coaching Staff)

(

g

)

Award Negotiation & Issuance

• Many steps between a funding decision and aMany steps between a funding decision and a grant award

• Grants management staff work closely with • Grants management staff work closely with

grantee and NIH program staff to complete this final processp

Funding

approval Final review _Award & Congressional Liaison Award Received Investigator Begins from Program Issued & Negotiations Liaison Notified by _Grantee Begins Work

Human Subjects Protection

• Safeguarding the rights and welfare of individuals research subjects based on DHHS regulations and research subjects based on DHHS regulations and established, recognized ethical principles

• DHHS Office of Human Subjects Research Protections • DHHS Office of Human Subjects Research Protections

(OHRP) oversees all issues for Federally-funded research involving people

OHRP

Office of Human Research Protections

Humane Animal Research

•

Grantees are responsible for the

•

Grantees are responsible for the

humane care and treatment of animals

NIH Offi

f L b

t

A i

l

•

NIH Office of Laboratory Animal

Welfare (OLAW) oversees policies for

humane animal care and use

humane animal care and use.

grants nih gov/grants/olaw

grants.nih.gov/grants/olaw

NIH OFFICE OF EXTRAMURAL PROGRAMS

Notice of Award …

and after

Notice of Award (NoA)

LEGALLY BINDING DOCUMENT

ƒ Award Data & Fiscal Information ƒ Award Data & Fiscal Information

ƒ Grant Payment Information

ƒ OIG* Hotline Information

ƒ Terms and Conditions

* Office of the Inspector General

The grantee indicates acceptance of the terms and conditions of the award by drawing down

f d i t th t f th P t

funds against the grant from the Payment Management System.

After the Award…

Administrative and Fiscal Monitoring

Requirements

Requirements

– Annual Progress Report (PHS 2590)

– Annual Financial Status Reports (FSR) submitted electronically

(PHS 2590)

– Invention Reporting - iEdison (FSR) submitted electronically

Final Closeout Reports

– Yearly Audits (as applicable)

Take Home Messages

• Monitor Institute/Center Web sites and the

Lots of directions and opportunities at the NIH 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

• 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 i iti htt // ih /i d/i d ht l

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 Step #2: Contact us

because… We’re from the Government, we’re here to

h l !