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
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Research
Resources
Largest SBIR/STTR
set-asides
National Library
of Medicine
National Institute
of Biomedical
Imaging
and
Bioengineering
NIH GUIDE
for Grants
and Contracts
U.S. Department of Health and Human Services
• Announces NIH Scientific Initiatives
• Provides NIH Policy and Administrative
Information
• Available on the NIH Web Site :
http://www.nih.gov
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
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)
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----
Applications Submitted to NIH
• Approximately 80,000
grant applications are
submitted to NIH each
year, of which 25-30%
are funded
• Competing grant
applications are
received for three
review cycles per year
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
Evaluates for Scientific Merit
Institute
Evaluates for Program Relevance
Advisory Councils and Boards
Conducts
Research
Allocates Funds
Recommends Action
Institute Director
Takes final action for NIH Director
Types of Scientific Review Groups
Where are Applications Reviewed?
GROUPS
CSR IRGs
Study Sections
Special Emphasis Panels
INSTITUTES
Scientific Review Groups
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
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 Applications,
Grant Exceptions, Workshops
Who Do You Contact & When?
Program Review
Pre-Application
+
+
Review
+
Post-Review
+
Award
+
Renewal
+
+
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
• 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
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
Useful booklet
• Everything you wanted to know
about the NCI Grants Process ….
but were afraid to ask. (NIH
Publication No. 02-1222, Revised
April 2002)
http://www3.cancer.gov/admin/gab
/index.htm
Problem Areas in Clinical
Research Grant Applications
•
•
•
•
•
Lacks a testable hypothesis
Unfocused specific aims
Poor prioritization of specific aims
Lack of milestones and time tables
Lack of critical assessment including
alternative plans
• Lack of sufficient preliminary data
• Poor selection and documentation of study
population
Problem Areas in Clinical
Research Grant Applications
• Unclear relationship between laboratory and
clinical studies
• Statistical power deficiencies
– Clinical trial itself
– Laboratory correlative studies
• Poor presentation style and proof reading
• Failure to follow PHS 398 instructions
APPLICATIONS RECEIVED BY
FISCAL YEAR
90,000
80,000
70,000
60,000
50,000
# Appl.
40,000
30,000
20,000
10,000
0
1998
1999
2000
2001
2002
2003
2004*
* projected
NCI BUDGET PICTURE for 2004
FY 2003 Budget
$4,592,000,000
Omnibus Bill Budget ’04’
$4,771,000,000
Difference = 3.9% increase
$ 178,000,000
Less 2 set-asides, new money=
$ 150,000,000
Less non-competing commitments $
(i.e. ~ 1.5% increase in RPG funds)
37,000,000
Set- aside Initiatives
NIH Roadmap - ~ $1000 M over 5 yrs
caBIG - ~ $100 M over 3 yrs
CTWG - $113 M over 5 yrs
Proteomics - $ 104 M over 5 yrs
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
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
Exploratory/Developmental
Grants (R21)
• UTILIZED FOR PILOT OR FEASIBILITY
STUDIES TO SUPPORT NOVEL, HIGH
RISK/HIGH PAYOFF RESEARCH
• MINIMAL PRELIMINARY DATA
REQUIRED
• SHORT TERM RESEARCH PROJECTS (UP
TO TWO YEARS)
• LIMITED FUNDS (100,000 – 250,000 DIRECT
COSTS)
• NON-RENEWABLE BUT INITIATIVE MAY
INCLUDE OPTION OF SUPPORT
THROUGH R33 MECHANISM
Program Announcements for
Exploratory Grants (R21)
• PAR 00-047 QUICK TRIALS for Novel Cancer
Therapies
• PA 03-003 Exploratory Studies in Cancer
Detection, Diagnosis and Prognosis
• PA 03-064 Correlative Studies Using Specimens
from Multi-institutional Prevention and Treatment
Trials
• PA 04-045 In Vivo Cancer Imaging
• PAR 03-124 Development of Novel Technologies
for In Vivo Imaging (R21/33)
QUICK-TRIALS for Novel
Cancer Therapies
PAR-03-005
• Provides support for clinical trials and
associated patient monitoring and laboratory
studies using R21 exploratory/developmental
grant mechanism
• Maximum of $250,000 direct costs per year for
two years
• Three receipt dates per year with rapid review
and funding (six months)
• Clinical protocol included as part of the grant
application
Small Grants Program (R03)
• SUPPORTS PRELIMINARY SHORT TERM
STUDIES TO TEST NEW IDEAS
• FUNDS LIMITED TO $50,000 DIRECT COSTS
• SHORT TERM RESEARCH PROJECTS (UP TO
TWO YEARS)
• TIME INTERVAL FROM APPLICATION TO
FUNDING IS SHORTENED
• INSTITUTE REVIEW COMMITTEE
• NON-RENEWABLE GRANTS
Numerous established and new NCI initiatives and
programs support interdisciplinary teams.
¾ Academic Public-Private Partnership Programs,
¾ cancer Biomedical Informatics Grid and consortium (caBIG)
¾ new Centers for Cancer Nanotechnology Excellence,
¾ new Clinical Proteomics and Biomarker Discovery Program,
¾ Clinical Trials Cooperative Group Program,
¾ Early Detection Research Network,
¾ In Vivo Cellular and Molecular Imaging Centers,
¾ Integrative Cancer Biology Programs,
¾ Network for Translational Research Optical Imaging,
¾ Interdisciplinary Research Teams for Molecular Target Assessment,
RRP / Medical Physics
Technology Development
• Workshops
–
–
–
–
Monte Carlo ( with DOE )
Optimization (with NSF)
Image guided RT (with CIP)
New Investigator WS ( with NIBIB)
• Cooperative efforts
– Web-based tools (NSF)
– Meetings with vendors (Varian, Siemens --)
• Research programs
–
FDA reform plans
Why Imaging?
validated image data could lead to:
• Smaller clinical trials with fewer patients
• Earlier ‘go - no go’ decisions on
compounds
• Faster regulatory approval
• Shorter time to market
http://www.aecom.yu.edu/ogs/NIHInfo/paylines.htm
HUMAN SUBJECTS ??
obtaining identifiable private information or identifiable specimens for
research purposes constitutes human subjects research.
EXEMPTION ???
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
CALL YOUR Program Director !!!
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.
SBIR / STTR Participating Agencies
υ
υ
υ
υ
υ
υ
υ
υ
υ
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TOTAL ~ $2.0 + B
FY 2004
υ
υ
DOD
HHS
NASA
DOE
NSF
DHS
USDA
DOC
ED
EPA
DOT
HUD
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR
SBIR
SBIR
SBIR
SBIR
SBIR
New
New
SBIR/STTR: 3-Phase Program
PHASE I
⇐ Feasibility Study
⇐ $100K and 6-month (SBIR)
or 12-month (STTR) Award
PHASE II
⇐ Full Research/R&D
⇐ $750K and 2-year Award
(SBIR/STTR)
PHASE III
⇐ Commercialization Stage
⇐ Use of non-SBIR/STTR Funds
SBIR PROGRAM
ELIGIBILITY CHECKPOINTS
9 Organized for- profit U.S. business
9 At least 51% U.S.- owned by
individuals and independently operated
9 Small Business located in the U.S.
9 500 or fewer employees
9 P.I.’s primary employment with small
business during project
STTR PROGRAM
ELIGIBILITY CHECKPOINTS
9 Applicant is Small Business Concern
9 Formal Cooperative R&D Effort
⇐ Minimum 40% by small business
⇐ Minimum 30% by U.S. research institution
9
U.S. Research Institution
⇐ College or University; other non-profit research
organization; Federal R&D center
9
Intellectual Property Agreement
⇐Allocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES
υ
Research Partner
SBIR: Permits research institution partners
[Outsource ~ 33% Phase I and 50% Phase II R&D]
STTR: Requires research institution partners
(e.g., universities)
[40% small business concerns (for-profit) and
30% U.S. research institution (non-profit)]
AWARD ALWAYS MADE TO SMALL BUSINESS
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES
υ
Principal Investigator
SBIR: Primary (>50%) employment must
be with small business concern
STTR: Primary employment not stipulated
[PI can be from research institution and/or
from small business concern*]
*DISCUSS WITH AGENCIES
NIH SBIR/STTR FUNDING RATES
Success Rate (%)
FISCAL YEAR 2003
327
45
40
18
44%
43%
35
30
25
20
15
$563 M
SBIR/STTR
(set aside $556
95
981
61
27%
24%
22%
10
5
0
S BI R
STTR
5
28%
Ph ase I
Ph ase I I
F ast-T r ack