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. 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 2

3. FDR Dedicates NIH Campus
October 31, 1940

4. NIH INTRAMURAL Campus Today
NIH Campus Today 4

5. Research Triangle Park, NC
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)
Administration on
Aging
(AoA)
Food and Drug
Administration
(FDA)
Health Resources
and Services
Administration
(HRSA)
Center for Medicare & Medicaid Services
(CMS)
Agency for
Healthcare Research and Quality
(AHRQ)
Indian Health
Services
(IHS)
National Institutes
of Health
(NIH)
Centers for
Disease Control
and Prevention
(CDC)
Agency for Toxic
Substances and
Disease Registry
(ATSDR)
Substance Abuse and
Mental Health Services
Administration
(SAMHSA) 6

7. NIH is organized into:
27 Separate Institutes & Centers (IC) each with different:
missions & priorities
budgets
ways of deciding which grants to fund
NIGMS
International Center
Clinical Center 7

8. NIH FY2010 Budget Total = $31.2 B NCI NIAID NHLBI NIDDK NIGMS
NIH divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers)
NEI
NCCAM OD
NIEHS
NIAMS
NIAAA
NHGRI
NIDCD
NIDCR
NLM
NIBIB
NCMHD
NINR
FIC
Total = $31.2 B
NCI
NIDA
NIA
NIAID
NCRR
NHLBI
NIDDK
NIGMS
NICHD
NIMH
NINDS
About 85% distributed via Extramural grants, contracts, cooperative agreements

9. Breakdown of FY 2011 President’s Budget Request for NIH – $32
Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion
$16.4 B 9

10. Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
Fundamentals of the Grants Process
Grant Mechanisms 10

11. What’s the Difference Between Grants and Contracts?$
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 8:00am tomorrow or
“Budget Basics for investigators at 8:00am tomorrow. 11

12. How Does NIH Solicit Applications?
Federal Opportunity Announcements (FOA) published through
the NIH 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 12:45pm tomorrow
or “Takin’ Care of Business: SBIR/STTRs” 1:30pm today. 13

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 12:45pm tomorrow. 14

15. Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
Fundamentals of the Grants Process
Roles and Responsibilities 15

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 16

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

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. 18

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 19

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 20

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

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 22

23. [aka Program Officer or Program Director]
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 23

24. Grants Management Officer
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 24

25. Grants Management Specialist
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 25

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

27. The Grants Process Overview http://grants. nih

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 1:30pm today. 28

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 R&R 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 30

31. Decoding Your NIH Grant Number Years of Continuous Funding
Application Type
Activity Code
Institute Code
Serial Number
Support Year
Extension
1 R EB 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
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
months
Output: Awards or Resubmission
Attend “A Peer into the NIH Review Process” at 10:30am today. 32

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 33

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 3:15pm today. 34

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 3:15pm today. 35

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 36

37. The Institute Director has the final funding decision.
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 37

38. Timeline: New Applications
1 – 9
1.3
1.9
1.6
Receipt
Date
February 5
June 5
October 5
Scientific
Review
July
October
March
Council
Review
October
January
May
Award
Date
December
April
July 38

39. Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
Fundamentals of the Grants Process
Program Staff
Pre- and Post-Award 39

40. 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. 40

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 41

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 42

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? 43

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

45. 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 45

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 46

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
Congressional Liaison Notified
Award Issued
9th Month
10th Month 47

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
OHRP
Office of Human Research Protections
Attend ““Research Involving Human Subjects Primer for Investigators” at 9:45am tomorrow. 48

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 3:15pm today or 2:30pm tomorrow. 49

50. Fundamentals of the Grants Process
NIH OFFICE OF EXTRAMURAL PROGRAMS
Fundamentals of the Grants Process
Notice of Award
(and after) 50

51. LEGALLY BINDING DOCUMENT
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. 51

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. 52

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 Made…Then What”
at 3:15pm today or 2:30pm tomorrow. 53

54. Take Home Messages Lots of directions and opportunities at the NIH
Monitor IC websites and the NIH 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 -
Overview -
IC priorities:
NIH Guide Provides Weekly Updates on Funding Opportunities:
Step #2: Contact us…we’re here to help you.