Fundamentals of the NIH Grants Process

1
Fundamentals of the NIH Grants Process

• NIH Regional Seminar on Program Funding
• and Grants Administration
• March 25-26, 2008
• San Antonio, Texas

2
Presenters

• Harold Perl, PhD
• Center for the Clinical Trials Network
• National Institute on Drug Abuse
• David Curren
• Division of Grants Policy
• Office of Policy for Extramural Research
  Administration

3
Todays Topics

• Introduction to the NIH
• History
• Mission Organization
• Funding Facts
• Fundamentals of the Grants Process
• Types of Grants
• Roles Responsibilities
• Scientific Review Process
• NIH Program and Grants Management Staff Roles
• The Notice of Award (and after)
• Web Resources

4
Birthplace of the NIH 1887
Marine Hospital -- Staten Island, NY
5
(No Transcript)
6
October 31, 1940 FDR Dedicates NIH Bethesda
Campus
7
NIH Campus -- 1947
8
NIH Campus Today
9
NIH in 2008
One agency of 11 within U.S. Department of Health
and Human Services (HHS) Comprises 27 Institutes
and Centers (IC)
10
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)
11
NIH Mission

• NIH is the steward of medical and behavioral
  research for the Nation
• Our mission to acquire new knowledge to help
  prevent, detect, diagnose, and treat disease and
  disability
• from the rarest genetic disorder to the common
  cold

12
Fulfilling Our Mission

• Support research by non-Federal scientists across
  U.S. and abroad
• Help train research investigators
• Conduct research in our own labs
• Foster communication of medical and health
  sciences information

13
NIH Organizational Structure
Office of the Director
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute on Aging
National Institute of Child Health and
Human Development
National Institute of Allergy and Infectious
Diseases
National Institute of Dental and Craniofacial Rese
arch
National Institute of Diabetes and Digestive
and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health
Sciences
National Institute on Deafness and
Other Communication Disorders
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders
and Stroke
National Institute of General Medical Sciences
National Institute of Nursing Research
National Institute of Biomedical Imaging and
Bioengineering
National Center on Minority Health and Health
Disparities
National Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources
No funding authority

NIH Clinical Center
Center for Information Technology
Center for Scientific Review
14
Amazing Facts _at_ NIH
15
Did You Know?

• NIH is the Nations leading medical research
  agency
• NIH Bethesda campus is worlds largest research
  organization
• 6,000 scientists (18,000 employees)
• 5 Nobel Prize winners
• Over 50 members of the National Academy of
  Sciences
• 11 of 27 IC Directors are members of Institute of
  Medicine
• 3 Office of NIH Director staff
• NIH Extramural Research Program
• 105 Nobel Prize winners trained or funded by NIH
• More than half of all American Nobel Prize
  winners

16
NIH Budget Congressional Appropriations
NIH FY 2008 Increase of 0.4 billion
Doubling

17
NIH Gets 1 of U.S. Budget
18
FY 2008 ENACTED TOTAL NIH BUDGET AUTHORITY
29.457 BILLION
19
What Stays at NIH? What Goes Elsewhere?
Total FY 2008 Budget 29.46 Billion
84 Outside NIH gt 325,000 Scientists gt 3,000
Organizations Worldwide
16 Inside NIH 2.9 B Intramural Research
(10) 1.2 B Staff Buildings (4) 0.6 B
Other (2)
Attend Current Issues at NIH at 1000 today or
800 tomorrow
20
NIH Funding Across the U.S.
Alaska
Data Assoc of University Technology Managers
(AUTM) Survey 2004
21
NIH Grant Statistics

• Fiscal Year 2007
• Approx. 80,000 grant applications received (all
  mechanisms)
• 47,243 research grants awarded (20.35 billion)
• 79 of NIH extramural awards go to institutions
  of higher education

22
Success Rates ofCompeting RPG Applications

• FY 2007
• Reviewed Awarded Success
  
• All Competing
• RPG Appls 47,455 10,100
  21.3 3.72 B
• New Appls 40,256 7,320
  18.2 2.51 B
• Continuing Appls 7,018 2,719 38.7
  1.20 B
• Reviewed Awarded Success
  
• Original Appls 32,854 3,935
  12.0 1.58B
• A1 Appls 10,333 3,727 36.1
  1.30B
• A2 Appls 4,241 2,428
  57.3 .83B

23
Fundamentals of the Grants Process

• Grant Mechanisms

24
Whats the Difference Between Grants and
Contracts?

• GRANT
• Assistance
• Government is Patron or Partner
• Purpose
• to support and stimulate research
• Benefit a public purpose
• Investigator initiated

• CONTRACT
• Acquisition
• Government is Purchaser
• Purpose
• to acquire goods or services
• The direct benefit and use of the government
• Government initiated

Attend Research Contracts at 1215 tomorrow
25
Award MechanismsResearch Project Grants

• Traditional R01
• Exploratory/Development Grants R03/R21/R33/R34
• Program Project P01
• Research Center Grants P50
• Small Business R41, R42, R43, R44

Attend the NIH 2fer NIH Activity Code Primer at
1230 today
26
Research Training and Career Awards

• Training Grants T
• Institutional
• Predoctoral and Postdoctoral
• Fellowships F
• Individual
• Predoctoral F31
• Postdoctoral F32
• Career Development Awards K

Attend Research Training Awards at 400 today

and Career Development Opportunities at 1215
tomorrow
27
Cooperative Agreements (U)

• Specialized Grant mechanism
• Substantial NIH staff involvement in program and
  science
• Typically initiated by NIH
• Cooperative Agreement Kiosk
• http//odoerdb2-2.od.nih.gov/oer/programs/coop/

28
Fundamentals of the Grants Process

• Team Players

29
Grantee Institution Team

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

• Grants are awarded to institutions as represented
  by AOOs.
• PD/PIs manage and perform the science
• Research Administrators support business aspects
  of the grant

30
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

31
Responsibilities of the Authorized Organization
Representative (AOR)

• aka Authorized Organizational Official
  (AO)aka Signing Official (SO)
• Designated Representative of the grantee
  institution.
• 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.

32
Responsibilities of the Principal
Investigator(s) (PIs)

• Designated by the grantee institution
• 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 Principal Investigators

Attend Multiple PI Overview and FAQs at 1215
tomorrow
33
Responsibilities of the Research Administrator

• Acts as an agent of the Principal Investigator
  and the Authorized Institutional Official
• 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 Official or the PI

34
The NIH Extramural Team
Review Staff
Program Staff
Grants Management
35
Who Ya Gonna Call?

• If someone needs help with their application
  before the review?

36
Review StaffScientific Review Officer (SRO)

• Responsible to NIH 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 to
  aid funding recommendations made by National
  Advisory Councils and Institute Directors
• Review applications for completeness and
  conformance with application requirements
• Point of contact for applicants during the review
  process

37
Who Ya Gonna Call?

• If someone needs help with scientific and
  technical aspects of their application?

38
Program Staff Program Administrator

• (aka Program Officer, Program Director or
  Program Official)
• Responsible for the
  programmatic, scientific, and/or
  technical aspects of a grant

Attend How the NIH Program Official Works with
Investigators at 215 today
39
Who Ya Gonna Call?

• If someone needs help with business aspects of
  their application?

40
Grants Staff Chief Grants Management Officer
(CGMO)

• Responsible for ensuring that all required
  business management actions are performed by the
  grantee and the federal government in a timely
  and appropriate manner both prior to and after
  award.

41
Grants StaffGrants Management Specialists

• Assist GMOs/CGMOs in managing and awarding grants
• Answer questions about completing application
  forms
• Provide guidance on the administrative and fiscal
  aspects of an award
• Help navigate NIH grants management information
  on the Web

42
Fundamentals of the NIH Grants Process

• Scientific Review

43
Center for Scientific Review (CSR)

• Central receipt point for most PHS applications
• Electronic via Grants.gov
• Paper via delivery service
• Assigns application to NIH Institute/Center
• Assigns application to peer review group
• CSR Integrated Review Group/Study Section
• IC Scientific Review Group
• CSR conducts initial scientific merit review of
  most NIH research applications

Attend A Peer into the NIH Review Process at
1000 today
44
2 Level System for Application Review
1st Level

• Scientific Review Group (SRG)
• Independent outside reviewers
• Evaluate scientific merit significance
• Recommend length and level of funding

2nd Level

• National Advisory Council
• Assesses Quality of SRG Review
• Makes Recommendation to
• Institute Staff on Funding
• Evaluates Program Priorities and Relevance
• Advises on Policy

45
Receipt and Referral of Applications
CSR assigns application to NIH Institute
Electronic SF424 RR submitted through grants.gov
Paper PHS 398 delivered to CSR
CSR assigns application number
CSR Referral Office
CSR assigns application to Integrated Review Group
Notice of assignment available in eRA Commons in
4 weeks.
Application assessed for completeness
eligibility
1st Month
2nd Month
46
Review of Applications

• 23 CSR Integrated Review Groups
• 220 standing Study Sections
• 300 Special Emphasis Panels
• Review groups at each IC
• Dozens of standing Study Sections
• Several hundred SEP meetings

3rd Month
4th Month
47
Who Reviews Grant Applications?

• Scientist peers with appropriate expertise --
  recruited by the SRO
• Assigned to specific applications based on
  content
• 4 year term typical
• Temporary reviewers sought as needed

48
1st Level Review

• Standing study section typically has 12-24
  members
• 3 face-to-face meetings each year
• Review 60 - 100 applications at each meeting

View the Mock Study Section video today and
tomorrow
49
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 How Well Do You Know the eRA Commons?" at
400 today and Interacting with NIH
Electronically at 1000 or 215 today
50
2nd Level Review

• National Advisory Council or Board assesses
  quality of 1st level review
• Concurs with or modifies IRG action
• Reads summary statements only
• Can also designate application as High or Low
  program priority

8th Month
51
Who Makes Actual Funding Decisions?

• The Institute Director!
• Factors Considered
• Scientific Merit
• Contribution to Institute Mission
• Program Balance
• Availability of Funds

52
Timeline New Applications
1.7
2.5
2.2
Council Review October January May
Award Date December April July

• Receipt
• Date
• February 5
• June 5
• October 5

Scientific Review July October March
53
http//grants.nih.gov/grants/funding/submissionsch
edule.htm
54
SF424 (RR) Application and Electronic Submission
http//era.nih.gov/ElectronicReceipt
Attend A Walk Through the SF424 at 800 tomorrow
55
Program Staff

• Pre-Award and Post-Award

56
Program Officials Role in Application
Development

• Scientific Initiatives at ICs
• Develop concepts
• Communicate goals
• Advise applicants on funding mechanisms
• Provide application writing advice and technical
  assistance
• Advise on application procedures, requirements
  and general grant policy

Attend Grant Writing for Success at 1230 today
57
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

Attend How the NIH Program Official Works with
Investigators at 215 today
58
Program Officials Role At After Review
Meetings

• Attend and Observe
• Note Reviewer Enthusiasms and Concerns
• Discuss Summary Statements and Review Issues
  Raised with Applicants
• Advise on Resubmission Process

59
Program Officials Role at Advisory Council
Meetings

• Report and address any unresolved review concerns
• Human Subjects concerns
• Animal Welfare
• Address requirements for foreign applications

60
Program Officials Role in Funding Decisions

• Prepare Recommendations for Institute Director
• Priority Score/Percentile
• Areas of Emphasis
• Portfolio Balance

61
Human Subjects Protection

• 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
at 945 tomorrow
62
Humane Animal Research

• NIH Office of Laboratory Animal Welfare (OLAW)
  oversees policies to ensure humane care and use
  of animals
• Refer to website for information and resources

grants.nih.gov/grants/olaw
Attend NIH Mini on OLAW at 1230 or 215 today
63
Post-Award Grant Stewardship by Program
Officials

• Review annual non-competing renewal applications
• Evaluate scientific portions of renewal documents
• Assist grantees during award period

64
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?
• Invention that must be reported?
• Other issues that must be resolved?

65
Grants Management Staff

• Pre-Award and Post-Award

66
Award Negotiation Issuance

• There are still many steps after a funding
  decision is made before a grant is awarded.
• 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
67
Grants Management Issues

• Assurances in Place
• Office of Human Research Protections (humans)
• Office of Laboratory Animal Welfare (animals)
• Financial Status Report (FSR)
• (SF 269-long form)
• if applicable
• Human Subjects Education
• Performance Site(s)/Consortium(s) information
• Checklist completeness
• Just-In-Time Information

Attend Advanced Administrative Topics at 215
today or 1215 tomorrow
68
Just-In-Time Information

• Information not required to review the
  application but which is necessary to implement
  the grant.
• 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 Key
  Personnel

69
Grants Management Special Issues

• For Example
• Is there a foreign component to the grant?
• Includes grants to foreign organizations and
  grants with activities or consortium partners in
  foreign countries.
• Require State Department Clearance prior to
  award.
• Are there bars to the award?
• Human subjects and animal subjects concerns
• Are there research integrity issues?

Attend Research Integrity at 800 tomorrow
70
Budget Review

• Correctly applying modular and categorical
  budgets
• Modular budgets reduce burden by eliminating the
  need for specific budget numbers
• Available for grants at or below 250,000 per
  year
• Grantees awarded grants in modules of 25,000
• Budget Justification
• Adjustments applied to individual grant awards
  based on IC financial policies
• Caps on certain types of costs specific to that
  funding opportunity
• Limits on overall grant funding due to NIH budget
  constraints.

Attend Budget Basics for Investigators at 800
or 200 tomorrow and All About Costs at 1230
today or 200 tomorrow
71
The Notice of Award (and after)

• Content and Overview of Terms and Conditions

72
Notice of Award (NoA) Overview
LEGALLY BINDING DOCUMENT

• Award Data Fiscal Information
• Grant Payment Information
• OIG Hotline Information
• Terms and Conditions

Office of the Inspector General
73
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.

74
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
1000 today / 1115 tomorrow
75
Web-Based Resources
76
For Further Information

• Attend the Navigating NIH Resources session
  later today at 1230.
• Read about all aspects of the grant process on
  the Office of Extramural Research Home Page
  http//grants.nih.gov/grants/oer.htm
• Find Grant Opportunities through the NIH Guide
  http//grants.nih.gov/grants/guide/index.html
• Contact grants management, scientific review, and
  program office staff http//grants.nih.gov/grants
  /welcome.htmnew