making connections: the nih grants process

Data Source: NIH Office of Budget

NIH OFFICE OF EXTRAMURAL RESEARCH

Making Connections: NIHGrants Process

Cheryl Anne Boyce, Ph.D.Chief, Behavioral and Brain Development Branch (BBDB) and Associate Director for Child and Adolescent Research, Division of Clinical Neuroscience and Behavioral Research (DCNBR)NIDA/NIH/DHHS

Emily LindePolicy Analyst, Division of Grants Policy Office of Policy for Extramural Research Administration (OPERA)OER/OD/NIH/DHHS

NIH Regional Seminar

April 15, 2009 – Philadelphia, PA


Today’s Topics

• NIH & Funding Facts• Fundamentals of the Grants

Process– Types of Support– Roles & Responsibilities:

Yours & Ours– Applications & Scientific Review– Program & Grants Staff Actions– The Notice of Award (and after)– Web Resources


FDR Dedicates NIH CampusOctober 31, 1940


NIH Campus Today NIH INTRAMURAL Campus Today


NIH EXTRAMURAL Sites

Rockledge 1 & 2

Neuroscience Center

Executive PlazaSouth and North

Democracy 1 & 2

NIEHS CampusResearch Triangle Park, NC


U. S. Dept. of Health and Human Services

Administration forChildren and Families

(ACF)

Administration forChildren and Families

(ACF)

Food and DrugAdministration

(FDA)

Food and DrugAdministration

(FDA)

Health Resourcesand Services

Administration(HRSA)

Health Resourcesand Services

Administration(HRSA)

Secretary of Health and

Human Services

Secretary of Health and

Human Services

Administration onAging(AoA)

Administration onAging(AoA)

Center for Medicare &

Medicaid Services

(CMS)

Center for Medicare &

Medicaid Services

(CMS)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Centers for Disease Controland Prevention

(CDC)

Centers for Disease Controland Prevention

(CDC)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for Healthcare

Research and Quality(AHRQ)

Agency for Healthcare

Research and Quality(AHRQ)


27 Separate Institutes & Centers (IC) each with different:

missions & priorities

budgets

ways of deciding which grants to fund

NIH is organized into:NIH is organized into:

NIGMS

Clinical CenterInternational Center


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 85% 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


Fundamentals of the Grants Process

Grant Mechanisms

NIH OFFICE OF EXTRAMURAL PROGRAMS


What’s the Difference Between Grants and Contracts?

Attend “R& D Contracts” at 8:00am tomorrow or “Budget Basics for investigators at 8:00am tomorrow.

$$$$$$$$$$$$$

GRANT CONTRACT

• Assistance • Acquisition

• Government is Patron or Partner

• Government is Purchaser

• Purpose: support and stimulate research

• Purpose: acquire goods or services

• Benefit a public purpose

• Benefit and use of the government

• Investigator initiated • Government initiated


How Does NIH Solicit Applications?

Federal Opportunity Announcements (FOA) published through

the NIH Guide (http://grants.nih.gov/grants/guide/) at grants.gov

Parent Announcements cover basic mechanisms

investigator-initiated applications

Special Opportunities to fill gaps Requests for Applications (RFA), a one-time call with set

aside funds

Program Announcement (PA) highlights areas of focus

Program Announcement with Special Review (PAR) for special consideration and “protected” review

Program Announcement with Set Aside (PAS) essentially, an RFA with multiple receipt dates


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 – Us

•Substantial NIH staff involvement in program and science•Typically initiated by NIH

Attend “Prime Time with NIH Program” RPGs” at 12:45pm tomorrowor “Takin’ Care of Business: SBIR/STTRs” 1:30pm today.


Research Training and Research Career Development Awards

Attend “Research Training Awards” at 12:45pm tomorrow.

•Training Grants – T•Institutional•Predoctoral and Postdoctoral•Trainees must be U.S. citizens

•Fellowships (U.S. Domestic only) – F•Individual•Fellows must be U.S. citizens •Predoctoral – F31•Postdoctoral – F32

•Career Development Awards – K




Roles and Responsibilities


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


Grantee Institution

ResearchAdministrator

Authorized Organizational

Reps

Program Director/Principal

Investigator


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.


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-to-

day basis• Assures scientific compliance by

maintaining contact with the NIH Program Officer

• Coordinates with other PDs/PIs on projects with multiple PDs/PIs


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


ProgramStaff

ReviewStaff

GrantsManagement

The NIH Extramural Team


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


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


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


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



Grant Application and

Scientific Review



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

Attend “Grant Writing for Success” at 1:30pm today.


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


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)

1st Month

2nd Month

Application assessed for completeness & eligibility

Notice of assignment available in eRA Commons in 4 weeks.

Electronic SF424 R&R submitted through

grants.gov


Decoding Your NIH Grant Number

11 R01 EB 12345 01 A1 R01 EB 12345 01 A1

Application Type

Activity Code

Institute Code

Serial Number

Support Year Extension

1 = new1 = new2 = renewal2 = renewal3 = supplement3 = supplement5 = non- 5 = non- competingcompeting continuationcontinuation

R = Research projectR = Research projectP = Program project P = Program project or Centeror CenterT = Training T = Training (institutional)(institutional)F = FellowshipF = Fellowship (individual)(individual)K = Career K = Career DevelopmentDevelopment U = CooperativeU = Cooperative agreementagreement

AA = NIAAAAA = NIAAAAG = NIAAG = NIAAI = NIAIDAI = NIAIDAR = NIAMSAR = NIAMSAT = NCCAMAT = NCCAMCA = NCICA = NCIDA = NIDADA = NIDADC = NIDCDDC = NIDCDDE = NIDCRDE = NIDCRDK = NIDDKDK = NIDDKEB = NIBIBEB = NIBIBES = NIEHSES = NIEHSEY = NEIEY = NEIGM = NIGMSGM = NIGMSHD = NICHDHD = NICHD

HG = NHGRIHG = NHGRIHL = NHLBIHL = NHLBILM = NLMLM = NLMMD = NCMHDMD = NCMHDMH = NIMHMH = NIMHNR = NINRNR = NINRNS = NINDSNS = NINDSRR = NCRRRR = NCRRTW = FICTW = FIC

Unique, Unique, up to six up to six

digitsdigits

Years of Years of Continuous Continuous

FundingFundingA1 = firstA1 = first resubmissionresubmissionA2 = secondA2 = second resubmissionresubmission


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: 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

Attend “A Peer into the NIH Review Process” at 10:30am today.


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


• 12-24 members: scientist peers

• 3 face-to-face meetings per year, and a 4 year term of service.

Standing study sections typically have

1st Level Review

3rd Month 4th Month

• 60 – 100 applications to review at each meeting

Attend “For Your Review: NIH Mock Study Section” at 3:15pm today.


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.


2nd Level Review

• National Advisory Council or Board assesses quality of 1st level review– Concurs with or modifies IRG

reocmmended action – Reads summary statements only

• Can also designate application as “High” or “Low” program priority

8th Month


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


Timeline: New Applications

ScientificReview

July

October

March

CouncilReview

October

January

May

AwardDate

December

April

July

ReceiptDate

February 5

June 5

October 5http://grants.nih.gov/grants/funding/submissionschedule.htm

1.3 1.9 1.61 – 9



Program Staff

Pre- and Post-Award



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

“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


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


Non-Competing Continuation Progress Reports (Form 2590)

Program Official evaluates progress report– 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?



Grants Management

Pre- and Post-Award



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


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


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

9th Month 10th Month

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 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

www.hhs.gov/ohrpAttend ““Research Involving Human Subjects Primer for

Investigators” at 9:45am tomorrow.

OHRPOffice of Human Research Protections


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.



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

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.


After the Award…

Administrative and Fiscal Monitoring Requirements

Attend “After the Award is Made…Then What” at 3:15pm today or 2:30pm tomorrow.

– Final Closeout Reports

– Yearly Audits (as applicable)

– Invention Reporting

– Annual Financial Status Reports (FSR)

– Annual Progress Report (PHS 2590)


Take Home Messages

• Monitor IC websites and the NIH Guide (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 mechanism 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.

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/

Step #2: Contact us…we’re here to help you.

making connections: the nih grants process

Documents

authorized

program officials

15pm today

human services

scientific

prior approval

human subjects

15pm today