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NIH OFFICE OF EXTRAMURAL RESEARCH

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NIH OFFICE OF EXTRAMURAL RESEARCH Making Connections: NIH Grants Process NIH Regional Seminar April 15, 2009 Philadelphia, PA Cheryl Anne Boyce, Ph.D. – PowerPoint PPT presentation

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Title: NIH OFFICE OF EXTRAMURAL RESEARCH


1
NIH OFFICE OF EXTRAMURAL RESEARCH
Making Connections NIH Grants Process
NIH Regional Seminar April 15, 2009
Philadelphia, PA
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
Linde Policy Analyst, Division of Grants Policy
Office of Policy for Extramural Research
Administration (OPERA) OER/OD/NIH/DHHS
2
Todays 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

3
FDR Dedicates NIH Campus October 31, 1940
4
NIH INTRAMURAL Campus Today
NIH Campus Today
5
NIH EXTRAMURAL Sites
Executive Plaza South and North
Rockledge 1 2
Neuroscience Center
NIEHS Campus Research Triangle Park, NC
Democracy 1 2
6
U. S. Dept. of Health and Human Services
Secretary of Health and Human Services
Administration for Children and Families (ACF)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA
)
Administration on Aging (AoA)
Center for Medicare Medicaid Services (CMS)
Indian Health Services (IHS)
National Institutes of Health (NIH)
Agency for Healthcare Research and
Quality (AHRQ)
Centers for Disease Control and Prevention (CDC)
Substance Abuse and Mental Health
Services Administration (SAMHSA)
Agency for Toxic Substances and Disease
Registry (ATSDR)
7
NIH is organized into
  • 27 Separate Institutes Centers (IC) each with
    different
  • missions priorities
  • budgets
  • ways of deciding which grants to
    fund

8
NIH FY2010 Budget
NIH divides most of its investment according to
the interests of the component parts (i.e.
Institutes or Centers)
Total 31.2 B
NCI
NIDA
NIAID
NIA
NCRR
NHLBI
NIGMS
NIDDK
NICHD
NIMH
NINDS
About 85 distributed via Extramural grants,
contracts, cooperative agreements
9
Breakdown of FY 2011 Presidents Budget Request
for NIH 32.2 Billion
16.4 B
10
Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
  • Grant Mechanisms

11
Whats the Difference Between Grants and
Contracts?
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

Attend R D Contracts at 800am tomorrow or
Budget Basics for investigators at 800am
tomorrow.
12
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

13
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
1245pm tomorrow or Takin Care of Business
SBIR/STTRs 130pm today.
14
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
  • Fellows must be U.S. citizens
  • Predoctoral F31
  • Postdoctoral F32
  • Career Development Awards K

Attend Research Training Awards at 1245pm
tomorrow.
15
Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
Roles and Responsibilities
16
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

17
Grantee Institution
Authorized Organizational Reps
Research Administrator
Program Director/ Principal Investigator
18
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.

19
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

20
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

21
The NIH Extramural Team
Review Staff
Program Staff
Grants Management
22
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

23
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 ICs Mission
  • Post-Award Administration

24
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

25
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

26
Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
  • Grant Application and
  • Scientific Review

27
The Grants Process Overview http//grants.nih.gov/
grants/grants_process.htm
28
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 130pm
today.
29
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

30
Receipt and Referral of Applications
Electronic SF424 RR submitted through grants.gov
to an NIH Institute (IC)
CSR Referral Office assigns the application
a unique identifier (application number)
to Integrated Review Group (IRG) and then a study
section (SRG)
Application assessed for completeness
eligibility
Notice of assignment available in eRA Commons in
4 weeks.
1st Month
2nd Month
31
Decoding Your NIH Grant Number
Application Type
Activity Code
Institute Code
Serial Number
Support Year
Extension
1 R01 EB 12345 01 A1
1 new 2 renewal 3 supplement 5 non-
competing continuation
R Research project P Program project
or Center T Training (institutional) F
Fellowship (individual) K Career
Development U Cooperative agreement
Unique, up to six digits
Years of Continuous Funding
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
A1 first resubmission A2 second
resubmission
HG NHGRI HL NHLBI LM NLM MD NCMHD MH
NIMH NR NINR NS NINDS RR NCRR TW FIC
32
Review System for Grants
  • Scientific Review Group (SRG)
  • Independent outside review
  • Evaluate scientific merit, significance
  • Recommend length and level of funding

1st level
Output Priority Score and Summary Statement
  • Advisory Council
  • assess quality of SRG process
  • offers recommendation to Institute Staff
  • evaluates program priorities and relevance
  • advises on policy

3 - 7 months
2nd level
Output Funding Recommendations
  • Institute Director
  • makes final decision based on Council input,
    programmatic priorities
  • Must also Pass Administrative Review

1 - 3 months
Output Awards or Resubmission
Attend A Peer into the NIH Review Process at
1030am today.
33
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

34
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 315pm today.
35
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 315pm today.
36
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
37
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

38
Timeline New Applications
1 9
Council Review October January May
Award Date December April July
Scientific Review July October March
Receipt Date February 5 June 5 October 5
http//grants.nih.gov/grants/funding/submissionsch
edule.htm
39
Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
  • Program Staff
  • Pre- and Post-Award

40
Do I Contact NIH Before Applying?
  • Mandatory
  • Application with budget gt500,000 direct costs
    for any single year
  • R13 Conference Grants
  • Optional
  • When RFAs request a Letter of Intent
  • Recommended
  • When you think about applying for any grant

Working with NIH Program Officials
PreAward PostAward at 945am
tomorrow.
41
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

42
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

43
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?

44
Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
  • Grants Management
  • Pre- and Post-Award

45
Grants Managements 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

46
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

47
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 Received by Grantee
Final review Negotiations
Investigator Begins Work
Award Issued
Congressional Liaison Notified
9th Month
10th Month
48
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/ohrp
Attend Research Involving Human Subjects Primer
for Investigators at 945am tomorrow.
49
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 315pm today or
230pm tomorrow.
50
Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
  • Notice of Award
  • (and after)

51
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 315pm today or 1245
tomorrow.
52
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.

53
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

Attend After the Award is MadeThen What at
315pm today or 230pm tomorrow.
54
Take Home Messages
Lots of directions and opportunities at the NIH
  • 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)

55
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_p
rocess.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 uswere here to help you.
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