NIH OFFICE OF EXTRAMURAL RESEARCH
Making Connections: NIH
Grants Process
NIH Regional Seminar
June 23, 2010 – Portland, OR
Cecelia McNamara Spitznas, Ph.D.
Program Official
Behavioral and Integrative Treatment Branch (BITB)
Division of Clinical Neuroscience and Behavioral Research (DCNBR)
NIDA/NIH/DHHS
Emily Linde
Policy Analyst, Division of Grants Policy
Office of Policy for Extramural Research Administration (OPERA)
OER/OD/NIH/DHHS
Data Source: NIH Office of Budget
NIH OFFICE OF EXTRAMURAL PROGRAMS
• What is NIH’s primary mission?
– To improve the health of the Nation
• How is that mission accomplished?
– By supporting and conducting research
• How do we support extramural Research?
– By issuing grants and contracts
• How do you apply for grants?
– Grants.gov or paper applications*
• Who is involved in the application process
and what are their roles?
– Applicant and NIH staff
Data Source: NIH Office of Budget
NIH is organized into:
27 Separate Institutes &
Centers (IC) each with
different:
NIGMS
 missions & priorities
 budgets
 funding strategies
Data Source: NIH Office of Budget
International Center
Clinical Center
What’s the Difference Between
Grants and Contracts?
GRANT
•
•
•
•
•
$
$
Assistance
$
Government is Patron $
$
or Partner
$
Purpose: support and $
stimulate research
$
$
Benefit a public
$
purpose
$
$
Investigator initiated
$
Data Source: NIH Office of Budget
CONTRACT
• Acquisition
• Government is
Purchaser
• Purpose: acquire
goods or services
• Benefit and use of
the government
• Government initiated
Attend “R& D Contracts” at 8:00am tomorrow or
“Budget Basics for investigators at 8:00am tomorrow .
How Does NIH Solicit Applications?
 Funding Opportunity Announcements
(FOA) published through
- NIH Guide (http://grants.nih.gov/grants/guide/)
- Grants.gov
Type of FOA
General
Description
Parent
Announcements
Program
Announcements
Requests for
Applications (RFA)
Investigator initiated for
basic mechanisms
Data Source: NIH Office of Budget
highlights areas of focus
a one-time call with set-aside
NIH OFFICE OF EXTRAMURAL PROGRAMS
Roles and Responsibilities
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
Data Source: NIH Office of Budget
Grantee Institution
Authorized
Organizational
Reps
Program
Research
Director/
Administrator
Principal
Investigator
Data Source: NIH Office of Budget
The Grantee
Authorized Organizational
Representative
[a.k.a Signing Official in eRA]
• Designated representative of the
grantee organization for award and
administration of NIH grants
• Accountable for appropriately
utilizing Federal funds and for the
performance of a project
• Signs all official correspondence to
NIH, including grant applications,
financial reports, assurances, and
certifications.
Data Source: NIH Office of Budget
The Grantee
Program Director/Principal
Investigator (PD/PI)
• Individual designated by grantee
• Responsible for the scientific and
technical aspects of project
• Directly manages the project on a day-today basis
• Assures scientific compliance by
maintaining contact with the NIH
Program Officer
• Coordinates with other PDs/PIs on
projects with multiple PDs/PIs
Data Source: NIH Office of Budget
The Grantee
Research Administrator
• Acts as an agent of the PD/PI and the
Authorized Organizational
Representative
• Gathers information needed to ensure
compliance with Federal regulations, as
well as organization-wide requirements
• Provides essential grant-related support
• Cannot assume responsibilities assigned
to the Authorized Organizational
Representative or the PD/PI
Data Source: NIH Office of Budget
The NIH Extramural Team
Review
Staff
Grants
Management
Data Source: NIH Office of Budget
Program
Staff
The NIH
Scientific Review Officer
• Responsible for the scientific and technical
review of applications
– Ensure fair and unbiased evaluation of the scientific
and technical merit of the proposed research
– Provide accurate summaries of the evaluation for
• National Advisory Councils and Institute Directors
• Applicants
– Review applications for completeness and
conformance with application requirements
• Point of contact for applicants during the
review process
Data Source: NIH Office of Budget
The NIH
Program Official
[aka Program Officer or Program
Director]
• Responsible for the programmatic,
scientific, and/or technical aspects of a
grant
• Development of Research and Research
Training Programs for IC’s Mission
• Post-Award Administration
Data Source: NIH Office of Budget
The NIH
Grants Management Officer
• Ensures performance of business
management actions by the grantee and
the federal government.
– Evaluates grant applications for
administrative content and compliance with
statutes, regulations, and guidelines.
– Interprets grants administration
policies
– Negotiates Awards
Data Source: NIH Office of Budget
The NIH
Grants Management Specialist
•
•
•
•
Acts as an agent of the GMO
Assist GMOs/CGMOs in managing grants
Day-to-day management of portfolio of grants
Answer applicant questions about completing
application forms
• Provide guidance on the administrative
and fiscal aspects of an award
Data Source: NIH Office of Budget
NIH OFFICE OF EXTRAMURAL PROGRAMS
Grant Application and
Scientific Review
Data Source: NIH Office of Budget
The Grants Process Overview
http://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
Attend “Grant Writing for Success” at 1:30pm today.
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
Receipt and Referral of Applications
Electronic SF424 R&R
submitted through
grants.gov
to an NIH Institute (IC)
CSR Referral
Office assigns the
application…
Application assessed
for completeness &
eligibility
1st Month
Data Source: NIH Office of Budget
Notice of assignment
available in eRA
Commons in 4 weeks.
a unique identifier
(application number)
to Integrated Review
Group (IRG) and then a
study section (SRG)
2nd Month
Decoding Your NIH Grant Number
Application
Type
Activity
Code
Institute
Code
1
R01
EB
1 = new
2 = renewal
3 = supplement
5 = noncompeting
continuation
R = Research project
P = Program project
or Center
T = Training
(institutional)
F = Fellowship
(individual)
K = Career
Development
U = Cooperative
agreement
Data Source: NIH Office of Budget
AA = NIAAA
AG = NIA
AI = NIAID
AR = NIAMS
AT = NCCAM
CA = NCI
DA = NIDA
DC = NIDCD
DE = NIDCR
DK = NIDDK
EB = NIBIB
ES = NIEHS
EY = NEI
GM = NIGMS
HD = NICHD
Serial
Support
Number
Year
12345 01
Unique,
up to six
digits
Years of
Continuous
Funding
HG = NHGRI
HL = NHLBI
LM = NLM
MD = NCMHD
MH = NIMH
NR = NINR
NS = NINDS
RR = NCRR
TW = FIC
Extension
A1
A1 = first
resubmission
A2 = second
resubmission
Review System for Grants
1st level
Scientific Review Group (SRG)
• Independent outside review
• Evaluate scientific merit, significance
• Recommend length and level of
Output: Priority Score and
funding
Summary Statement
3 - 7 months
Output: Funding
Recommendations
2nd level
Advisory Council
•
•
•
•
assess quality of SRG process
offers recommendation to Institute Staff
evaluates program priorities and relevance
advises on policy
1 - 3 months
Institute Director
Output: Awards
or Resubmission
• makes final decision based on Council
input, programmatic priorities
• Must also Pass Administrative Review
Attend “A Peer into the NIH Review Process” at 10:30am today.
Data Source: NIH Office of Budget
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
Data Source: NIH Office of Budget
1st Level Review
Standing study sections typically have
• 12-24 members: scientist
peers
• 3 face-to-face meetings per
year, and a 4 year term of
service.
• 60 – 100 applications to
review at each meeting
3rd Month
4th Month
Attend “For Your Review: NIH Mock Study Section” at 3:15pm today.
Data Source: NIH Office of Budget
After 1st Level Review
• Priority Scores recorded
• Summary Statements prepared
–
–
–
–
–
Overall Resume and Summary of Review Discussion
Essentially Unedited Critiques
Priority Score and Percentile Ranking
Budget Recommendations
Administrative Notes
• Viewable 4-6 weeks after review meeting
– Only available through the eRA Commons
5th Month
6th Month
7th Month
Attend “For Your Review: NIH Mock Study Section” at 3:15pm today.
Data Source: NIH Office of Budget
2nd Level Review
• National Advisory Council or Board
assesses quality of 1st level review
– Concurs with or modifies IRG
recommended action
– Reads summary statements only
• Can also designate application as
“High” or “Low” program priority
8th Month
Data Source: NIH Office of Budget
Funding Decisions
• The Institute Director has the final
funding decision.
• Factors Considered in Funding
Selections:
– Scientific Merit
– Contribution to Institute Mission
– Program Balance
– Availability of Funds
Data Source: NIH Office of Budget
Timeline: New Applications
– 91.6
1.311.9
Receipt
Date
Scientific
Review
Council
Review
Award
Date
February 5
July
October
December
June 5
October
January
April
October 5
March
May
July
http://grants.nih.gov/grants/funding/submissionschedule.htm
Data Source: NIH Office of Budget
NIH OFFICE OF EXTRAMURAL PROGRAMS
Program Staff Role
Pre- and Post-Award
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’s request a Letter of Intent
Recommended:
• When you think about applying for any
grant
Data Source: NIH Office of Budget
“Working with NIH Program Officials:
PreAward & PostAward at 9:45am tomorrow.
Program Officials’ Role
• At Review Meeting
– Note reviewer enthusiasms and concerns
• After Review Meeting
– 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
Data Source: NIH Office of Budget
Program Officials’ Role
• After Advisory Council
– Make funding recommendations to IC
Director based on:
• Impact/Priority Score and Percentile
• Areas of Emphasis
• Portfolio Balance
– Resolve overlap issues with GMS
• After Award
– Evaluate Progress Report
– Make recommendations on prior approval
requests
Data Source: NIH Office of Budget
Non-Competing Continuation
Progress Reports (Form 2590)
Program Official evaluates progress report
–
–
–
–
–
–
–
–
–
–
–
Data Source: NIH Office of Budget
Satisfactory progress?
Change in the scope, goals, or objectives?
Change in key personnel or level of effort?
Evidence of scientific overlap?
Human subject issues or concerns?
Animal welfare issues or concerns?
Genome-Wide Association Study sharing?
Biohazard reporting?
Invention that must be reported?
Adherence to Public Access Policy?
Other issues that must be resolved?
NIH OFFICE OF EXTRAMURAL PROGRAMS
Grants Management Role
Pre- and Post-Award
Data Source: NIH Office of Budget
Grants Management’s Role
• Prior to Award
– Review
•
•
•
•
Applications
Budgets
Just-In-Time Information
FSR (if applicable)
– Assure compliance with Federal law and NIH and IC
policies and procedures
– Apply IC funding policies
– Prepare Notice of Award
• After Award
– Review Progress Report
– Provide official response to prior approval requests
Data Source: NIH Office of Budget
Just-In-Time Information
• Not required for review, but required to make
an award.
• JIT Information
– Certification of Education on Human Subjects
– Institutional Review Board (IRB) approval
• Required within 1 year and before any human subjects
research begins.
– Institutional Animal Care and Use Committee (IACUC)
Approval
• Required within 3 years and before animal research begins.
– Information on “Other Support” received by Senior/Key
Personnel
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
Final review
&
Negotiations
Congressional
Liaison Notified
9th Month
Data Source: NIH Office of Budget
Award
Issued
Award
Received
by
Grantee
Investigator
Begins Work
10th Month
Human Subjects Protection
• Safeguarding the rights and welfare of individuals who
participate as subjects in research based on DHHS
regulations and established, internationally recognized
ethical principles
• DHHS Office of Human Subjects Research Protections
(OHRP) oversees all issues for Federally-funded
research involving people
• Refer to website for information and
resources
OHRP
Office of Human Research Protections
www.hhs.gov/ohrp
Data Source: NIH Office of Budget
Attend ““Research Involving Human Subjects Primer for
Investigators” at 9:45am tomorrow.
Humane Animal Research
• Grantees are responsible for the
humane care and treatment of animals
under NIH-supported activities.
• NIH Office of Laboratory Animal
Welfare (OLAW) oversees policies for
humane animal care and use.
• Refer to website for information
and resources
grants.nih.gov/grants/olaw
“Attend Research Involving… “at 3:15pm today or 2:30pm tomorrow.
Data Source: NIH Office of Budget
NIH OFFICE OF EXTRAMURAL PROGRAMS
Notice of Award
(and after)
Data Source: NIH Office of Budget
Notice of Award (NoA)
LEGALLY BINDING DOCUMENT
 Award Data & Fiscal Information
 Grant Payment Information
 Terms and Conditions
 OIG* Hotline Information
* Office of the Inspector General
Data Source: NIH Office of Budget
Attend “Common Compliance Pitfalls
and Strategies for Success…” at 3:15pm today or 12:45 tomorrow.
Grantee Acceptance
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
– Annual Progress Report
(PHS 2590)
– Annual Financial Status Reports
(FSR)
– Invention Reporting
– Yearly Audits (as applicable)
– Final Closeout Reports
Data Source: NIH Office of Budget
Attend “After the Award is Made…Then What”
at 3:15pm today or 2:30pm tomorrow.
Take Home Messages
• Monitor IC websites and the NIH Guide
(http://grants.nih.gov/grants/guide/)
• Get to know Program Director for your scientific area
• Contact them about your research ideas
- Fit with IC mission and priorities
- Best grant mechanism or program
- Best study section for review
• Participate in workshops and symposia
• Participate in review of grant applications
(study sections)
Data Source: NIH Office of Budget
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: 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…we’re here to help you.
Data Source: NIH Office of Budget