National Institutes of Health
http://www.nih.gov/icd/
Office of the Director
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of Nursing Research
National Center on
Minority Health
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Research
Resources
and Health
Disparities
National Library
of Medicine
National Institute
of Biomedical
Imaging
and
Bioengineering
Largest SBIR/STTR
set-asides
Senate Panel Proposes - a Tiny Increase for NIH
By STEPHEN BURD
The Chronicle of Higher Education
July 28, 2006
For the National Institutes of Health, the Senate subcommittee's bill would provide
$28.5-billion, which is about $150-million more than Congress gave the agency in the
2006 fiscal year, and about $250-million more than President Bush and the House
Appropriations Committee have proposed.
The full Senate Appropriations Committee was scheduled to consider the bill late
NIH Budget Facing a
“Perfect Storm” in 2006
Federal & Trade Deficits
Defense and Homeland
Security needs
Katrina
last week. If Congress approves the increase, it would be the fourth straight year
Pandemic flu
in which the agency's budget failed to keep pace with inflation
Post- Doubling effects
Physical Sciences focus
Biomedical research
inflation- 3 to 5%
1
NIH GRANT MECHANISMS
TYPE
CODE
YEARS
Regular research grant
R01
3-5
MERIT award
R37
8-10
Program project grant
P01
3-5
Conference grant
R13
1-5
Small grant
R03
2
Exploratory/developmental grant
R21
2
R21/33
2/2-3
SBIR grant
R/U43/44
0.5/2
STTR grant
R/U41/42
1/2
Phased Innovation award
Requests for Applications
(RFA)
• Announcement describing an institute initiative
in a well-defined scientific area
• Invitation to the field to submit research grant
applications for a one-time competition
• Set-aside of funds for a certain number of
awards
• Applications generally reviewed within the
issuing institute
Program Announcement
(PA)
• Invites grant applications in a given research
area
• May describe new or expanded interest in a
particular extramural program
• May be a reminder of a continuing interest in a
particular extramural program
• Generally has no funds set aside
• Applications reviewed in CSR along with
unsolicited grant applications
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----
2
Role of Scientific Review
Administrator
• Performs administrative and technical
review of applications
• Selects reviewers
• Manages study sections
• Prepares summary statements
• Determines acceptance of supplemental
materials for review
Role of Program Director
• Advise Applicants:
Application Process
New or Revised Grant Applications
• Make Funding Recommendations
Competing and Non-Competing Grants
• Attend Study Section Meetings
• Initiate or Encourage Interest in a
Scientific Area of High Priority to the NCI
through: Program Announcements, Request for
Who Do You Contact & When?
Program
Pre-Application
+
Review
Post-Review
+
Award
+
Renewal
+
Review
+
+
+
Applications, Grant Exceptions, Workshops
3
PROACTIVE APPROACH
• Discuss Ideas Before Writing
• Get Feedback As You Write the
Application
• Suggest Study Section(s)
• Suggest Institute Assignment
• Submission of supplemental material
to the Scientific Review
Administrator
eSubmission Is Becoming a Reality for NIH
SBIR/STTR (Dec. 1, 2005)
R13/U13 (Dec. 15, 2005)
ceived
0 apps re
Over 5,00
to date
lly
ca
ni
electro
R18/U18, R25, C06/UC6
(Oct. 1, 2006)
R36 (Feb. 17, 2006)
R15 (Feb. 25, 2006)
S10 (Mar. 22, 2006)
X02 (April 18, 2006)
X01
(May 18, 2006)
01
2006
02
03
04
05
06
07
08
09
Fellowship (F) (Aug. 5,
2007)
Potential R01
Multi-PI Pilot
(Oct. 1, 2006)
Training (T&D), U45,
D71/U2R (Sep. 10,
2007)
DP1
(Jan. 22, 2007)
Project/Center (P),
G12, M01, S06,
R10/U10, U01, U19,
U54, U56, R24/U24
(Oct. 1, 2007)
R01
(Feb. 1, 2007)
R03, R21/R33,
R34
(June 1, 2006)
12
Resource (G7, G8, G11, G13, G20),
Career Development (K), S11, S21,
S22 (Jun. 1, 2007)
10
11
12
01
02
03
04
05
06
07
08
09
10
2007
Current as of February 2, 2006. Visit the Web site for the latest version: http://era.nih.gov/ElectronicReceipt/
Mechanism Abbreviation Key:
C06/UC6
Research Facilities Construction Grants
DP1
NIH Director’s Pioneer Award Program
D71/U2R
International Training Cooperative Agreement/
Phase 2 of FIC mechanism D71
R01
Research Project Grant Program
R03
Small Grant Programs
R10/U10
Cooperative Clinical Research Grants
R13/U13
Support for Conferences & Scientific Meetings
R15
Academic Research Enhancement Awards (AREA)
R18/U18
Research Demonstration and Dissemination Projects
R21/R33
R24/U24
R25
R34
R36
SBIR
STTR
S06,S10,S11
S21,22
U
X02
Exploratory/Development Research
Resource Related Research Projects
Education Projects
Clinical Trial Planning Grant Program
Research Dissertation Grant Program
Small Business Innovation Research
Small Business Technology Transfer
Biomedical Research
Health Disparities Endowment Grants
Cooperative Agreement Awards
Preapplication
4
5
http://www.aecom.yu.edu/ogs/NIHInfo/paylines.htm
HUMAN SUBJECTS ??
EXEMPTION ???
Basic and Applied Research
60.0%
obtaining identifiable private information or identifiable specimens for
research purposes constitutes human subjects research.
53.9%
55.2%
56.4%
55.2%
55.2%
56.6%
55.8%
52.1%
56.1%
53.0%
50.0%
43.5%
40.5%
40.0%
Exemption 4: Research involving the collection or study of existing data,
documents, records, pathological specimens, or diagnostic specimens, if
these sources are publicly available or if the information is recorded by
the investigator in such a manner that subjects cannot be identified,
directly or through identifiers linked to the subjects
39.8%
39.2%
38.4%
38.5%
5.2%
4.8%
40.8%
3.7%
3.1%
3.1%
20.0%
5.7%
Deyej@mail.nih.gov
41.0%
30.0%
10.0%
CONTACT YOUR Program Director !!!
41.0%
40.8%
5.5%
5.0%
7.0%
3.6%
0.0%
FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
Basic Research
Applied Research
Other
6
What Is Really Happening?
3 Fundamental Drivers
Large capacity building throughout
U.S. research institutions and
increase in number of tenure-track
faculty
Large increase in applicants
and applications occurring
after 2003
Budgets:
– Appropriations below inflation
after 2003 ( +3 % in ‘04, 2.2%
in ‘05 and 0% in 06 ) while
BRDPI in 2004 was ~ 5%
– Budget cycling phenomenon
The Bottom Line:
Demand for Grants “Took
Off” Just as NIH Budget
Was “Landing!”
NIH managed well in 2004 and 2005 by shifting “one
time” funds from 2003 to 2004, and obtaining small
increases in 2004 (2.9%) and 2005 (2%)
Katrina requirements led to a flat 2006 NIH while rest
of HHS underwent a 2.5% cut
Budget cycling effect will improve demand vs supply of
grants in 2007 but we need to educate public about
need for sustainability in research
7
Review Process for a Research Grant
National Institutes of Health
Research
Grant
Application
Initiates
Research
Idea
School or Other
Research Center
Center for Scientific Review
Assigns to IRG/Study Section & IC
Study Section
Submits Application
Types of Scientific Review Groups
Where are Applications Reviewed?
GROUPS
CSR IRGs
Study Sections
Special Emphasis Panels
Evaluates for Scientific Merit
Institute
Evaluates for Program Relevance
INSTITUTES
Scientific Review Groups
Advisory Councils and Boards
Conducts
Research
Allocates Funds
Recommends Action
Institute Director
Takes final action for NIH Director
Contract Review Committees
APPLICATIONS REVIEWED
Research Projects
Academic Research
Enhancement Awards
Postdoctoral Fellowships
Small Business Innovation
Research
Shared Instrumentation
Program Projects
Centers
Institutional Training Grants
Conference Grants
Career Awards
Small Grants
RFAs
Contracts
8
Pre-application Advice
• Be Familiar with the Peer Review
System
• Be Proactive and Well-Prepared
Before Submission = Better
Application & As Good a Score as
Possible the First Time
–Talking to SRA & Program Director
–Talking to mentors/colleagues
Proactive Approach - Why?
Are there Advantages?
• Less # of Revisions = less downtime
• AER = Accelerated Executive Review
Only Unamended R01 Applications
Eligibility differs between basic and
POR applications
• Exception funding to the payline
• Private Foundations
• New Investigators
• Minority Investigators
9
NIH Opportunities for
Young Investigators
• National Research Service Individual Fellowship
(F32)
• Howard Temin Bridging Award (K01)
• Clinical Oncology Research Career Development
Award (K12)
• Transition Career Development Award (K22)
• Mentored Patient-Oriented Research Career
Development Award (K23)
• Small Grant (R03)
• Academic Research Enhancement Award (R15)
• Exploratory/Developmental Grant (R21)
10
Website has a new look and feel. Get yourself
oriented so you can help applicants find
answers quickly!
http://era.nih.gov/ElectronicReceipt/
11
12
Small Business Programs
• SBIR: Set-aside Program for Small Business
Concerns to engage in Federal R&D-with potential for commercialization.
• STTR: Set-aside Program to facilitate
cooperative R&D between Small
Business Concerns and U.S. Research
Institutions-- with potential for
commercialization.
an important amendment to the SBA’s Reauthorization bill that was
passed by the Senate Small Business and Entrepreneurship
Committee today (7/27/2006). Note….Before the language becomes law
it must be passed by the full Senate, reconciled with the House of
Representatives bill and signed by the President.
In short:
1) Bond’s amendment helps “level the playing field by allowing venture
backed small businesses to compete for up to 25 percent of an
agency's SBIR funds.”
2) In addition, there was some mention of an increase in the SBIR setaside (over 5 years) but specifics were not revealed
3) The vote also included an amendment for a pilot grant program that
would give SBIRs a bonus of $10K for college students in Science,
Technology, Engineering & Mathematics (STEM) to work with an
SBIR firm.
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