THE NIH GRANTS PROCESS from the Macro to the Micro Level and INFORMATION TECHNOLOGY: New Directions

1
THE NIH GRANTS PROCESSfrom theMacro to the
Micro LevelandINFORMATION TECHNOLOGYNew
Directions at the NIH

• Thorsten A. Fjellstedt, Ph.D.
• Center for Information Technology
• National Institutes Of Health
• Bethesda [phone]
• North Carolina [phone]
• fjellst_at_mail.nih.gov

2
OVERALL OUTLINE

• The Federal Role of the NIH
• The NIH Mission
• How the NIH does its Job
• How the Institutes are organized and Why
• The Tools the NIH has to do its job
• Facts and statistics about the NIH
• The scale of the NIH enterprise
• The NIH application receipt, referral and review
  process (How extramural programs operate)
• The role of information technology in extramural
  programs
• Future directions

3
What is the Federal Role of the NIH?
Improved Public Health
Congressional Appropriation
NIH
4
What is the Scientific role of the NIH ?
Medical Advances/Improved Public Health
Human Biology Biological, Social and Behavioral
Processes
NIH At the intersection of Biology and Public
Health
5
Why Are There So Many NIH Institutes?
Public Health Need Congressional
Interest Public Interest
6
Who are the Stakeholders?
Interest groups Congress/geography focused The
general public and disease focused groups
(survivors, etc.) Granters NIHInstitutes/Centers
Non-profit foundations Grantee GranteeInstitution
s/Deans GranteeInvestigators Commercial Biotechno
logy companies Pharmaceutical companies Other
support offers
7
NIH Extramural Funding Components
How Is The NIH Organized?

• CANational Cancer Institute (NCI)
• HLNational Heart, Lung, and Blood Institute
  (NHLBI)
• DKNational Institute of Diabetes and Digestive
  and Kidney Diseases (NIDDK)
• LMNational Library of Medicine (NLM)
• HDNational Institute of Child Health and Human
  Development (NICHD)
• DCNational Institute of Deafness and Other
  Communication Disorders (NIDCD)
• ESNational Institute of Environmental Health
  Sciences (NIEHS)
• NSNational Institute of Neurological Disorders
  and Stroke (NINDS)
• AGNational Institute on Aging (NIA)
• AINational Institute of Allergy and Infectious
  Diseases (NIAID)
• ARNational Institute of Arthritis and
  Musculoskeletal and Skin Diseases (NIAMS)
• DENational Institute of Dental and Craniofacial
  Research (NIDCR)
• EYNational Eye Institute (NEI)
• GMNational Institute of General Medical Sciences
  (NIGMS)
• MHNational Institute of Mental Health (NIMH)
• NRNational Institute for Nursing Research (NINR)
• AANational Institute on Alcohol Abuse and
  Alcoholism (NIAAA)
• DANational Institute on Drug Abuse (NIDA)
• ATNational Center for Complementary and
  Alternative Medicine (NCCAM)

Does not make Extramural Awards
8
How Are The NIH Institutes Organized?
Director
Intramural Director
Extramural Director
Intramural Program
Extramural Program
Research Laboratories on NIH Campus and Elsewhere
Divisions/Centers/ Branches (Managing External
Funding)
9
How Do The Institutes/Centers Support Research?
Director
Intramural Program
Extramural Program
Fund Research at Universities and Research
Institute
Supports Research Laboratories on NIH Campus and
Elsewhere
10
What Tools Does The NIH Have To Support
Extramural Research?
Assistance to recipient Institution Same as
above but with close coordination with NIH
staff Procurement mechanism
Grants Cooperative Agreements Contracts
11
The scale of the NIH enterprise Facts and
Statistics About the NIH
12
Statistics about the NIH

• NIH accounts for approximately 30 of the total
  national support for Health RD.
• NIH obligations account for approximately 79 of
  the Federal share of obligations for Health RD
  .
• Approximately 80 of the NIH Budget is devoted to
  extramural awards.
• Over 90 of NIHs extramural awards are grants.

13
(No Transcript)
14
Fiscal Year 2002 Total Extramural Expenditures
15
Approximate Distribution of NIH Expenditures
16
Approximate Distribution of NIH Appropriation
17
Whats Involved

• NIH budget of approximately 27 billion
• Over 65,000 new or competing applications
• Almost 10,000 new and competing grant awards
• Over 38,000 grant awards
• Operate 3,166 study section meetings
• Support the 80 council meetings
• Approximately 200 million pieces of paper
• Maintain historical records (1973-Present)
• Multiple reports and analysis

18
How does the NIH carry out its responsibility to
Congress and to the Public?
Two Key Responsibilities
NIH must manage the budget NIH must manage and
guide the biomedical research it supports
19
THE NIH PROCESS OVERVIEW
Grantee Institution
Non-competing application
New Grant application
NIH Guide Announcement
Issue notice of grant award (NGA)
Negotiate with other ICs
Evaluate non-competing applications
NIH
Award Grants to successful applicants
Develop research initiatives
Monitor funded grants
20
Grant Application Cycle The Individuals
Principal Investigator and Grants Official
NIH
Scientific Review Administrator and Grants
Technical Assistant
Program Administrator and Grants Management Staff
21
Roles of the Scientific Program Manager
Assess Portfolio Balance
Identify Gaps in Scientific Programs
Develop New Initiatives
Work with Grantees/ Applicants
Scientific Program Manager
Coordinate with other ICs/Divisions/Groups
Think about science
Monitor Progress of Projects
Browse Science
Communicate with review staff on program matters
Produce Reports
22
Scientific ReviewAdministrator
Roles of the Scientific Review Administrator

• Nominate SRG members

Manage SRG meetings
Produce Reports
Assign review responsibilities
Select ad hoc reviewers and site visitors
Communicate to Advisory Councils regarding SRG
recommendations
Think about science
Communicate with program staff on review matters
Provide orientation for SRG members
Browse Science
Prepare summary statements
23
Roles of the Grants Management Specialist
Provide business guidance to applicants and
reviewers
Assist in developing program policy
Interpret and apply grant policy
Maintain official grant files
Provide fiscal management of grants
Grants Management Specialist
Coordinate with other ICs/Divisions/Groups
Attend SRG meetings as resource
Participate with program staff in budget
negotiations prior to and following award
Manage Overall budget
Produce Reports
Award Grants
24
Budget Balancing Issuesat the NIH
Balancing a VERY BIG Checkbook
25
How Does the NIH Manage the Budget?
What are the major issues?
The NIH gets an appropriation each FY. All
appropriated funds must be obligated in that
FY. The appropriation doesnt always happen at
the beginning of the FY. New grants are funded
each year. Almost ALL grants request funds for
multiple yearsnominally 3 to 5 years.
26
How Does the NIH Manage the Budget?
What are the major issues? (Continued)
It takes almost a year to launch a scientific
initiative and get the projects submitted,
reviewed and funded. The NIH commitment to a
grant is based on the assumption that funds will
be available for future years.
27
Budgetary Issues to Consider
NIH projects have future-year commitments (most
projects have 4-5 future years of
commitments) The NIH often does not have a
budget at the beginning of the fiscal year (NIH
is frequently on a continuing resolution at the
beginning of the fiscal year) Sometimes funds
are withheld at various levels Scientific
initiatives take time to initiate and fund (It is
frequently 9 to 12 months to go from a concept to
a funded project) Congress often directs
scientific initiatives The cost of supporting
science inflates rapidly
28
Initiating new Science at the NIH
Time Line
0 Months
3-4 Months
Conceptualize Initiative
Outside Input
Develop Written Initiative (RFA/PA)
Time Line (Continued)
3-4 Months
6-7 Months
9-10 Months
12 Months
Publish Announcement
Receive/Review Applications
Develop Funding Plan
Council Meeting
Fund Applications
29
Funding GrantsIt isnt as easy as it appears
Current Yr
1st Future Yr
2nd Future Yr
3rd Future Yr
4th Future Yr
Type 1 Type 2
Awarded this Year
Type 5
Awarded last Year
Type 5
Awarded 2 Yrs Ago
Type 5
This simple diagram depicts two assumptions that
are not true 1)Future year commitments remain
the same 2)The NIH funds the same dollar
value of grants each year
Awarded 3 Yrs Ago
Type 5
Awarded 4Yrs Ago
30
Funding GrantsIt isnt as easy as it
appearsGrant Cost Escalation
Current Yr
1st Future Yr
2nd Future Yr
3rd Future Yr
4th Future Yr
Type 1 Type 2
Awarded this Year
Type 5
Awarded last Year
Type 5
Awarded 2 Yrs Ago
Type 5
Awarded 3 Yrs Ago
Thus, the commitment of funds in the each future
year is significantly greater than the current
year for the same group of grants. (Example1st
Future yr)
Type 5
Awarded 4Yrs Ago
31
NIH Budget AllocationsGrant Related
Research Project Grants Research
Centers Institutional Training Individual
Training Other Research Related SBIR-STTR
32
The NIH Application Receipt, Referral and Review
Process
From the Macro to the Micro
33
THE NIH PROCESS OVERVIEW
Grantee Institution
Non-competing application
New Grant application
NIH Guide Announcement
Issue notice of grant award (NGA)
Negotiate with other ICs
Evaluate non-competing applications
NIH
Award Grants to successful applicants
Develop research initiatives
Monitor funded grants
34
THE NIH PROCESS OVERVIEW
Drilling Down in Detail
RECEIPT
REFERRAL
REVIEW
COUNCIL
AWARD
35
Overall TimeframeSubmission to Award

• There are three overlapping cycles per year

JAN FEB MAR APR MAY JUN
JUL AUG SEP OCT NOV DEC
JAN FEB MAR APR MAY JUN
JUL
Cycle 1
Review
Council
Receipt
Award
Referral
36
Receipt Dates
Depends on the Type of Application

• Institutional Training Applications
• Academic Research Enhancement Award Applications
• New Research Applications
• Revised Applications
• Competing Continuation Applications
• Supplemental Applications
• Small Business Technology Transfer Research
  Applications
• Small Business Innovation Research Applications
• Individual NRSA Applications
• AIDS Applications

Jan 10 May 10 Sept 10
Jan 25 May 25 Sept 25
Feb 1 June 1 Oct 1
Mar 1 July 1 Nov 1
April 1 Aug 1 Dec 1
April 5 Aug 5 Dec 5
May 1 Sept 1 Jan 1
37
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Center For Scientific Review (CSR)
1 Month
Assigned To Institutes
Assigned To Initial Review Group (IRG)
NIH
CSR Referral
Office
Institutes
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
Study Section
SRA uploads scores into IMPAC
Institute staff review summary statements
using the Electronic Council Book
Meeting
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Summary statement uploaded into IMPAC system
Advisory
7 Months
Committee
Meeting
Funding Decision by IC
Award Grant to
Notify Unsuccessful
9 - 22 Months
Successful
Applicants
Applicants
38
Applications Receipt Room
39
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center for Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH
Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
Study Section
SRA uploads scores into IMPAC
Institute staff review summary statements
using the Electronic Council Book
Meeting
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Summary statement uploaded into IMPAC system
Advisory
7 Months
Committee
Meeting
Funding Decision by IC
Award Grant to
Notify Unsuccessful
9 - 22 Months
Successful
Applicants
Applicants
40
Flow of a Competing Grant Application
Through the CSR Referral Section
Project Control Unit Receipt Record
Group (Process, Enter Skeletal Data into
Computer, Print Status)
Mailroom (Receive, Date Stamp, Preliminary Sort,
Add Bar Code)
Application (Original 5 Copies)
Assignment Unit (Assign to Scientific Review
Group and Awarding Organization)
(Advance Copy) Scientific Review Group
Project Control Unit Review Control Group (Add
Labels, Send Data to IMPAC, Print Mailers,
Distribute)
(2 Copies) Scientific Review Group
(Original) Print Shop
(1 copy) OPERA EIS,DMC
(1 copy) Project Control Files
(35 copies) SRG
(20 copies) Original Awarding Organization
(1 copy) Project Control
(1 copy) Research Documents (IC only)
41
Flow of a Competing Grant Application
Through the CSR Referral Section
Project Control Unit Receipt Record
Group (Process, Enter Skeletal Data into
Computer, Print Status)
Mailroom (Receive, Date Stamp, Preliminary Sort,
Add Bar Code)
Application (Original 5 Copies)
Assignment Unit (Assign to Scientific Review
Group and Awarding Organization)
(Advance Copy) Scientific Review Group
Project Control Unit Review Control Group (Add
Labels, Send Data to IMPAC, Print Mailers,
Distribute)
(2 Copies) Scientific Review Group
(Original) Print Shop
(1 copy) OPERA EIS,DMC
(1 copy) Project Control Files
(35 copies) SRG
(20 copies) Original Awarding Organization
(1 copy) Project Control
(1 copy) Research Documents (IC only)
42
Flow of a Competing Grant Application
Through the CSR Referral Section
Project Control Unit Receipt Record
Group (Process, Enter Skeletal Data into
Computer, Print Status)
Mailroom (Receive, Date Stamp, Preliminary Sort,
Add Bar Code)
Application (Original 5 Copies)
Assignment Unit (Assign to Scientific Review
Group and Awarding Organization)
(Advance Copy) Scientific Review Group
Project Control Unit Review Control Group (Add
Labels, Send Data to IMPAC, Print Mailers,
Distribute)
(2 Copies) Scientific Review Group
(Original) Print Shop
(1 copy) OPERA EIS,DMC
(1 copy) Project Control Files
(35 copies) SRG
(20 copies) Original Awarding Organization
(1 copy) Project Control
(1 copy) Research Documents (IC only)
43
Flow of a Competing Grant Application
Through the CSR Referral Section
Project Control Unit Receipt Record
Group (Process, Enter Skeletal Data into
Computer, Print Status)
Mailroom (Receive, Date Stamp, Preliminary Sort,
Add Bar Code)
Application (Original 5 Copies)
Assignment Unit (Assign to Scientific Review
Group and Awarding Organization)
(Advance Copy) Scientific Review Group
Project Control Unit Review Control Group (Add
Labels, Send Data to IMPAC, Print Mailers,
Distribute)
(2 Copies) Scientific Review Group
(Original) Print Shop
(1 copy) OPERA EIS,DMC
(1 copy) Project Control Files
(35 copies) SRG
(20 copies) Original Awarding Organization
(1 copy) Project Control
(1 copy) Research Documents (IC only)
44
HOW ARE ASSIGNMENTS MADE?

• TO STUDY SECTIONS BASED ON
• Specific Review Guidelines of Each Study
  Section
• TO INSTITUTES BASED ON
• Overall Mission of The Institute
• Specific Programmatic Mandates and Interests of
  the Institute

45
NIH Extramural Funding Components
How Is The NIH Organized?

• CANational Cancer Institute (NCI)
• HLNational Heart, Lung, and Blood Institute
  (NHLBI)
• DKNational Institute of Diabetes and Digestive
  and Kidney Diseases (NIDDK)
• LMNational Library of Medicine (NLM)
• HDNational Institute of Child Health and Human
  Development (NICHD)
• DCNational Institute of Deafness and Other
  Communication Disorders (NIDCD)
• ESNational Institute of Environmental Health
  Sciences (NIEHS)
• NSNational Institute of Neurological Disorders
  and Stroke (NINDS)
• AGNational Institute on Aging (NIA)
• AINational Institute of Allergy and Infectious
  Diseases (NIAID)
• ARNational Institute of Arthritis and
  Musculoskeletal and Skin Diseases (NIAMS)
• DENational Institute of Dental and Craniofacial
  Research (NIDCR)
• EYNational Eye Institute (NEI)
• GMNational Institute of General Medical Sciences
  (NIGMS)
• MHNational Institute of Mental Health (NIMH)
• NRNational Institute for Nursing Research (NINR)
• AANational Institute on Alcohol Abuse and
  Alcoholism (NIAAA)
• DANational Institute on Drug Abuse (NIDA)
• ATNational Center for Complementary and
  Alternative Medicine (NCCAM)

Does not make Extramural Awards
46
Flow of a Competing Grant Application
Through the CSR Referral Section
Project Control Unit Receipt Record
Group (Process, Enter Skeletal Data into
Computer, Print Status)
Mailroom (Receive, Date Stamp, Preliminary Sort,
Add Bar Code)
Application (Original 5 Copies)
Assignment Unit (Assign to Scientific Review
Group and Awarding Organization)
(Advance Copy) Scientific Review Group
Project Control Unit Review Control Group (Add
Labels, Send Data to IMPAC, Print Mailers,
Distribute)
(2 Copies) Scientific Review Group
(Original) Print Shop
(1 copy) OPERA EIS,DMC
(1 copy) Project Control Files
(35 copies) SRG
(20 copies) Original Awarding Organization
(1 copy) Project Control
(1 copy) Research Documents (IC only)
47
Flow of a Competing Grant Application
Through the CSR Referral Section
Project Control Unit Receipt Record
Group (Process, Enter Skeletal Data into
Computer, Print Status)
Mailroom (Receive, Date Stamp, Preliminary Sort,
Add Bar Code)
Application (Original 5 Copies)
Assignment Unit (Assign to Scientific Review
Group and Awarding Organization)
(Advance Copy) Scientific Review Group
Project Control Unit Review Control Group (Add
Labels, Send Data to IMPAC, Print Mailers,
Distribute)
(2 Copies) Scientific Review Group
(Original) Print Shop
(1 copy) OPERA EIS,DMC
(1 copy) Project Control Files
(35 copies) SRG
(20 copies) Original Awarding Organization
(1 copy) Project Control
(1 copy) Research Documents (IC only)
48
Flow of a Competing Grant Application
Through the CSR Referral Section
Project Control Unit Receipt Record
Group (Process, Enter Skeletal Data into
Computer, Print Status)
Mailroom (Receive, Date Stamp, Preliminary Sort,
Add Bar Code)
Application (Original 5 Copies)
Assignment Unit (Assign to Scientific Review
Group and Awarding Organization)
(Advance Copy) Scientific Review Group
Project Control Unit Review Control Group (Add
Labels, Send Data to IMPAC, Print Mailers,
Distribute)
(2 Copies) Scientific Review Group
(Original) Print Shop
(1 copy) OPERA EIS,DMC
(1 copy) Project Control Files
(35 copies) SRG
(20 copies) Original Awarding Organization
(1 copy) Project Control
(1 copy) Research Documents (IC only)
49
Sample Application Number
Application Type
Activity Code
Institute Code
Serial Number
Support Year
Extension
1 R01 CA 123456 01 A1 01
New Application
Individual Research Grant
National Cancer Institute
Now Six Digits
First Year
First Amended Application
Sub-project
50
Types of Scientific Review GroupsWhere are
Applications Reviewed?
GROUPS
APPLICATIONS REVIEWED
Research Projects
CSR IRGs
Academic Research

Study Sections
Enhancement Awards
Postdoctoral Fellowships
Special Emphasis Panels
Small Business Innovation
Research
Shared Instrumentation
INSTITUTES
Program Projects
Scientific Review Groups
Centers
Institutional Training Grants
Conference Grants
Career Awards
Small Grants
RFAs
Contract Review Committees
Contracts
51
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
52
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
53
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
54
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
55
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
56
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
57
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
58
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
59
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
60
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
61
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
62
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
63
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
64
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
65
THE GRANTS PROCESS
Time Line
Grant Application
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center For Scientific Review (CSR)
Assigned To Institutes
1 Month
CSR Referral Office
NIH Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
Initial Review Group
3-5 Months
Scientific Review Administrator (SRA) Assigns
application to reviewers
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Council members access the Electronic Council Book
Advisory Committee Meeting
Summary statement uploaded into IMPAC system
7 Months
Funding Decision by IC
Award Grants to successful applicants
9 - 22 Months
Notify unsuccessful applicants
66
Electronic Tools for Extramural Staff and
Applicants
CommonsAdministrative Module CGAPCompetitive
Grant Application Process RRReceipt and Referral
Module CMCommittee Management Module REVReview
Module ECB/CAMElectronic Council Book/Council
Administration Module Early Concurrence
Module GMGrants Management Module ICOInstitute
and Center Operation Module E-SNAPStreamlined
Non-Competing Award Process i-EdisonInvention
Reporting Module QVRQuery/View/Reporting
System IC-STOReIC Search, Track, Order and
Report (Shared Module) ICDIC Specific Data
System StatusApplicant status system
RED Applicant Tools YELLOW Staff Tools GREEN
Staff and Council
67
THE GRANTS PROCESS and IMPAC APPLICATIONS
CGAP
iEdison
NIH Commons
Time Line
Grant Application
eSNAP
Status
Application submitted to Center for Scientific
Review -- NIH
Receipt Deadline
Center for
Scientific Review
Receipt and Referral
(CSR)
1 Month
Assigned To Institutes
NIH
CSR Referral
Office
Institutes
Assigned To Initial Review Group (IRG)
Assignment to Program official within each
Institute
3-5 Months
Initial Review Group
Scientific Review Administrator (SRA) Assigns
application to reviewers
ECB/CAM Early Concurrence
Reviewers prepare written critique
Applications Reviewed by IRG members
SRA uploads scores into IMPAC
Study Section Meeting
Institute staff review summary statements
using the Electronic Council Book
6 Months
SRA prepares Summary Statement
Committee Management
Council members access the Electronic Council Book
Summary statement uploaded into IMPAC system
Advisory Committee Meeting
7 Months
Review
Funding Decision by IC
Notify Unsuccessful Applicants
Award Grants to Successful Applicants
9 - 22 Months
Grants Management
QVR System
68
THE GRANTS PROCESS and IMPAC APPLICATIONS
Non-competing application
Issue notice of grant award (NGA)
NIH Guide Announcement
New Grant application
Grantee Institution
Evaluate non-competing applications
Award Grants to successful applicants
Negotiate with other ICs
NIH
Develop research initiatives
Grants Management Responsibilities
Program Responsibilities
Monitor funded grants
69
THE GRANTS PROCESS and IMPAC APPLICATIONS
Non-competing application
Notice of grant award (NGA)
NIH Guide Announcement
New Grant application
Grantee Institution
Evaluate non-competing applications
Award Grants to successful applicants
Negotiate with other ICs
Query/View/Reporting System (QVR) IC-STORe
NIH
Develop research initiatives
Grants Management Module
IC Operations Module
Grants Management Responsibilities
Program Responsibilities
Monitor funded grants
eSNAP
70
Some Added Complexities That Need IT Solutions
901 Change of Assignment ARA Awaiting
Receipt of Assignment RFAs Request for
Applications PA Program Announcement Just in
Time Joint Funding Secondary Assignments Sub-proje
cts
71
Challenges and Hurtles
Inertia of Rest We have been doing business like
this for years--Why change now? Training of Busy
Extramural Staff Training of Busy IRG and Council
Members
Connections to Our Grantee Customers The NIH
Commons
72
The Electronic Council BookOne Example of the
future of the NIH

• Presentation to the NIEHS
• Advisory Council
• September 11, 2001

73
Advisory Council--Then and Now
Before the ECB
Using the ECB

• Council books contained ALL summary statements
  generally sorted in alphabetical order
• Difficult for the council members to analyze by
  topic
• Council members must request analysis from IC
  staff (time delay)

• Council members can analyze information in a
  variety of ways
• Instantly by
• - Scientific topic
• - Priority/percentile score
• - Funding mechanism
• - Special areas such as clinical trials, AIDS

74
Advisory Council--Then and Now One Institutes
Experience
Before the ECB
Using the ECB

• Collect and print summary statements as they
  become available
• Prepare mailings to each council member (18 to 20
  members)
• Generally, three mailings per council member per
  council round (160 FEDEX packages per year for
  the NIEHS)
• Late material delivered to hotel the night before
  council

• Notify Council members that the information is
  available on the ECB website
• All summary statements available INSTANTLY
• Website has ALL information pertaining to the
  council meeting including the agenda
  material--even the Metro map
• Allows for archiving previous council rounds

75
Advisory CouncilSavings and EfficienciesOne
Institutes Experience
EACH COUNCIL ROUND Copy approximately 450 summary
statements sixty copies of each set 60 foot high
stack of paper
ELIMINATION OF STAFF TIME and COSTS

• Duplication of materials
• Collating of materials
• Preparation of mailings
• FedEx expenses
• Filing of Institute copies

76
Advisory CouncilsSavings and EfficienciesThe
NIH Experience
THREE COUNCIL ROUNDS PER YEAR
40,000 summary statements copied in
approximately 60 sets
Estimate 34 MILLION impressions ONE mile high
stack of paper Approximately 1400 express
packages to council members
77
Improved Effectiveness of Council Members

• The system is simple to use--short learning
  time.
• Council members can easily query the system.
• Council members can focus their attention on
• applications of particular interest to them.
• Staff can assign particular applications to
• council members for review--council members
• can easily retrieve that information.
• Users can access the system from any location.

78
Goals for Extramural Programs

• Applications in Electronic Format (Currently have
  Scanned Applicationselectronic submission of
  applications under development)
• Electronic Review of Applications (Web-based
  review use by several ICs
• Virtual Initial Review Group Meeting (Currently
  used where appropriate)
• Early Council Concurrence (In production)
• Virtual Council Meeting (Feasible now)

79
Overall TimeframeSubmission to Award

• Where can we improve the efficiency of the
  process?

JAN FEB MAR
APR MAY JUN JUL
AUG SEP OCT
NOV DEC
Review
Council
Receipt
Award
Referral
NIH Commons Electronic Applications
Electronic Review and Virtual Review Meetings
Business Intelligence in Referral Process
Early Council Concurrence Electronic Council Book
Internal And External Electronic Award Processing
80
Future Considerations
Videos in Applications Elimination of Receipt
Dates Federal Grant Application Security Freedom
of Information Requests
81
The NIH Since September 11, 2001
EIGHTEEN ADVISORY COUNCILS MET ON OR WERE
SCHEDULED TO MEET AFTER THAT INFAMOUS DATE
The Electronic Council Book And IMPAC system
allowed NIH to conduct its important business
82
THANK YOU
83
The NIH Extramural Team
ScientificReview
Scientific Programs
Grants Management
84
PROGRAM ADMINISTRATOR

• Develop program initiatives
• Provide guidance and assistance to applicants
• Interpret program policy and guidelines for
  reviewers
• Attend Scientific review group (SRG) meetings as
  program resource person(s)
• Present SRG recommendations to council
• Communicate results of review to applicants
• Make funding recommendations
• Participate in identifying prospective SRG and
  Council nominees
• Evaluate programs
• Communicate with review staff on program matters
• Monitor progress during the award period

85
GRANTS MANAGEMENT SPECIALIST

• Provide business guidance to applicants and
  reviewers as necessary
• Participate with program staff in budget
  negotiations prior to and following award
• Attend SRG meetings as resource person(s)
• Maintain official grant files
• Assist in developing program policy
• Provide fiscal management of grants
• Interpret and apply grant policy

86
SCIENTIFIC REVIEW ADMINISTRATOR

• Nominate SRG members
• Select ad hoc reviewers and site visitors
• Provide orientation for SRG members
• Explain and interpret NIH review policy and
  procedures
• Assign review responsibilities
• Manage project site visits
• Manage SRG meetings
• Prepare summary statements
• Attend council meetings to provide requested
  information in support of committee
  recommendations
• Communicate with program staff on review matters

87
Typical Timeline for a New Individual Research
Project Grant Application (R01)

• There are three overlapping cycles per year

• Submit in February (June, October)
• Review in June (October, February)
• Council in September (January, May)
• Earliest award in December (April, July)

• Cycle 1----
• Cycle 2----
• Cycle 3----

88
NIH Grant Receipt, Review, and Award Schedule

• Jan-May
• May-Sept Receipt Dates
• Sept-Jan
• June-July
• Oct-Nov Review Dates
• Feb-Mar
• Sept-Oct
• Jan-Feb National Advisory Council Board Dates
• May-June
• Dec 1
• Apr 1 Earliest Possible Beginning Date
• July 1