Grants 101: An Introduction
to NIH Grants
Lynn Clemow, Ph.D.
Overview
 Outline
the organization of the National
Institutes of Health
 Program Announcements and RFAs
 Describe commonly-used grant
mechanisms
 Application and Review Process
Structure of the NIH
 Intramural
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Research
Research done onsite by NIH scientists
9% of the NIH budget
 Extramural
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Research – 82% of budget
Research grants
Training
R& D contracts
 Research
Management & Support
NIH Budget
Intramural
Grants &
Contracts
Offices of: Women’s Health
AIDS Research
-
Disease Prevention
Behavioral & Social Science Research (OBSSR)
Institutes and Annual Budgets 2007
 National
Cancer Institute – (NCI) $4.8
billion
 National Institute of Allergy & Infectious
Disease (NIAID) - $4.5 billion
 National Heart, Lung & Blood Institute
(NHLBI) $2.9 billion
 National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) $1.85 billion
Institutes and Budgets - 2007
 National
Institute of Neurological Diseases
and Stroke (NINDS) - $1.5 billion
 National Institute of Mental Health (NIMH)$1.4 billion
 National Institute on Aging (NIA)- $1.04
billion
 National Institute of Drug Abuse (NIDA) $1.0 billion
Centers and Budgets
 NCCAM
- Complementary and Alternative
Medicine - $121 million
 NCMHD – Minority Health & Health
Disparities - $190 million
 NINR – Nursing Research - $135 million
Other Federal Entities
 Agency
for Healthcare Research & Quality
(AHRQ)
 Centers for Disease Control & Prevention
(CDC)
 Health Resources and Services
Administration (HRSA)
Grant Application Overview
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regular grant submission cycles every year
February 1 (+/- 2 weeks)
June 1 (+/- 2 weeks)
October 1 (+/- 2 weeks)
If a resubmission, due 1 month later (Mar, July,
Nov).
 Also
special one-shot grant opportunities
come up (Requests for Applications or RFAs)
with very little notice.
Grant Submission Rules
 Prior
to January, 2009, many grant
mechanisms could be re-submitted twice
(i.e., total of 3 submissions), and that rule still
applies to grants submitted prior to 1/09
 As of January, 2009, new grants can only be
re-submitted once (for a total of 2
submissions)
Grant Budgets
Budgets include:
 DIRECT COSTS: (GO TO THE PROJECT)
Personnel costs (salary + ~36% fringe benefits rate) –
specifying % effort for each person
 Equipment
 Supplies
 Subject payments/ incentives
 Travel (local mileage and conference travel)
Each person and item needs to be justified in budget
justification section of grant
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Grant Budgets
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INDIRECT COSTS: (GO TO INSTITUTION)
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Money goes to the institution to provide facilities and
administrative support to researchers
Rate calculated by periodic negotiations between each
institution and the Federal Government – at UMDNJ
currently 56% .
For every dollar of direct costs (excluding large equipment
purchases) UMDNJ gets an additional $.56.
Usually indirect costs are given OVER AND ABOVE
budget limits…. Usually ceilings apply only to direct costs.
How that money gets divided up within the institution varies
a great deal from place to place. For many medical
schools, the dean/central admin. gets half, the department
gets half (in large depts., shared with the division and
investigator in some way for resources).
NIH Grant Mechanisms

T - Institutional Research Training Grants
(granted to institutions – grad students and postdocs appointed by institution) (e.g., NRSA)
 F – Fellowships – Individual post-doc
fellowships for research training in biomedical or
behavioral science
 K – Research Career Development Awards – to
develop research scientists with clear potential
(can be early or later career, mentored or to
support mentoring)
Grant Mechanisms
R – Research grants – Awarded to fund a specific
objective or study in the area of the principal
investigator’s interest & competence
 P - Program Grants – awarded to more senior
investigators only, funds a broad-based long-term
program of research, interacting projects with groups
of investigators, often 3 or 4 projects and shared
cores for stats, admin, training, instrumentation, etc.
Tend to focus on mechanisms of disease.
 P- Center Grants – Senior investigators, research
likely to have a more clinical focus, in response to I/C
priorities. (MUPS center grant)
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Grant Mechanisms
– Grants made to small business
concerns that have expertise to contribute
to scientific mission of NIH
 Small Business Technology Transfer
(STTR) – to facilitate research between
small businesses and research
institutions.
 Conference Grants
 SBIR
Career Development Grants
Many K-award mechanisms:
 Great career step, at whatever level.
 Must devote >75% effort to research in most
 Covers 75% base salary for up to 5 years
 For mentored mechanisms often want people to be with 5 years of end
of training, though some career transition awards exist
For early-career researchers, this kind of award is the “Holy Grail”.
 Protects the time and space to develop research skills, ideas
 The project is usually of fairly limited scope
 Can’t take any other NIH money for duration of award
 Develops a track record with NIH funding.
 The mentors and institutional resources are often key elements for
success
Career Development Award
Some K grants are more basic-science focused
 K01 – Mentored research scientist award
 K02 – Independent scientist award
 K05 – Senior scientist award
 K07 – Academic career award - curriculum development focus
Some with more clinical scientist focus:
 K08 – Mentored clinical scientist award
 K23 – Mentored patient-oriented research career development
award
 K24 - Mid-career investigator award in patient-oriented
research (must spend 25-50 % effort on pt-oriented research
There are many others…Important to note that each I/C uses
these mechanisms differently – important to check
R-Series Grants
SMALLER/ DEVELOPMENTAL GRANTS: Used
in different ways by different I/Cs
 R03 – Small grant program:
May request up to 2 years of funding
@$50,000 / year. Great for pilot data for larger
study.
 R21 – Exploratory/developmental grant:
May request up to 2 years for project, with
TOTAL of $275,000. Often used to develop and
pilot test an intervention.
R-Series Grants
SMALLER / DEVELOPMENTAL GRANTS
 R34 – Clinical Trial Planning grantproject to prepare for a larger clinical trial,
(often R-18 or large R01) which generally
is used to translate established scientific
findings into clinical practice.
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Total of $100,000 / year, 1 or 2 years
R-Series Grants
R01 – Research Project Grant Program
To support a discrete, specific project
Need to have pilot & feasibility data and a team
with necessary expertise (preferably some of
whom have worked together before)
 Budget: <$500,000 direct costs per year, up to
5 years
 Supplements and amendments are allowed.
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P-Series
Large program-projects or center grants
Led by senior investigators (supported by
collaborative interdisciplinary group)
Usually made up of 3-4 interacting projects
and several shared core functions
(biostatistics/ data management,
administration, training, instrumentation,
laboratories, etc.)
Budgets usually $1.5 million/year for 5 years,
goes up for competitive renewal every 5
years
Minority Supplements
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Trainees and junior investigators who are members of
under-represented minorities are eligible for special
minority supplements grants.
 Generally propose a relatively simple additional measure
or research question to be added to the parent grant…
covers time at designated stipend levels.
 Benefit to applicant: Great opportunity to get research
experience and funding for that time
 Benefit to project: an extra pair of hands that are free to
the project, sponsoring minority trainees viewed
positively by NIH
 No specific deadlines for applications (usually ~ 5 pages
and admin. paperwork) – quick turnaround – 2 months.
Issues in working with institutional HR, etc.
Stimulus Plan (ARRA) Funding
Whole bunch of RFAs, used differently by I/Cs.
 Challenge Grants (RC-1) – Each I/C defines
specific research aims. 12-page application
format, $500,000 per year x 2 years.
 Administrative Supplements – Again, each I/C
defines use of these supplements, many
institutes gave these primarily to new
investigators
 Announcements still emerging
 Very high level of special reporting and tracking
of funds
GRANT DEVELOPMENT
PROCESS
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Get an idea, discuss with colleagues, mentors
Think about appropriate grant mechanisms
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Adequate pilot data?
Scope of project?
NIH grant deadline to shoot for?
Develop sample size estimates & project timeline –
and budget flows from those
 Develop budget and budget justification, consult with
administrator regarding budget details, has to be in
early.
 Develop grant application
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New NIH Grant Scoring
Domains
 OVERALL
IMPACT (Summary score)
 SCORED REVIEW CRITERIA:
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Significance
Investigators
Innovation
Approach
Environment
Grant Outline / Formatting
R01 – 12 pages of science for the
project.
 For R21 and some other mechanisms –
shorter format (6 pages)
 For
Grant Outline
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Introduction (for resubmission only, 1 page)
Page limits apply
Specific Aims (1 page)
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Research Strategy
to these sections
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Significance
Innovation
Approach
• Preliminary Studies for New Applications
• Progress Report for Renewal and Revision Applications
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References
Human Subjects issues, Environment, etc
Grant Outline
Also need to include:
 Budget/ budget justification
 Any subcontract paperwork, if including
co-investigators from other institution
 Biosketches (4-page limit) for investigators
and main staff people
 Letters of support
 Administrative pages with info on PI,
investigators, and institution
Grant Submission
Have to get internal sign-offs
Financial disclosure from each investigator
Grants office, financial review of budgets.
Admin. sign-off from departments, facilities
Submissions done electronically in almost all
cases at this time… to grants.gov via
grants office
Grant Review Process
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Sent to Center for Scientific Review, directed to
an I/C
Assigned to a Study Section (can request
specific assignment)
Can submit 3 pages of supplemental data/ info
prior to review.
Reviewed ~ 4 months later when Study Section
meets
After study section meets (usually a few days)
get score, summary statement follows within 30
days.
Scoring
 Approximately
half of grants don’t get
scored and are not discussed at the study
section meeting. So you get reviews, but
no discussion and no overall priority
score.
 New scoring system gives reviewers’
ratings of each scoring criteria
 Scored grants (and grant elements) are
rated from 1 - 9:
1 = perfect score; 9 = worst possible score
NEW SCORING CRITERIA
Score
 1
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 5
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 9
Descriptor
Exceptional
Outstanding
Excellent
Very Good
Good
Satisfactory
Fair
Marginal
Poor
Additional Guidance on Strengths/Weaknesses
Exceptionally strong with essentially no weaknesses
Extremely strong with negligible weaknesses
Very strong with only some minor weaknesses
Strong but with numerous minor weaknesses
Strong but with at least one moderate weakness
Some strengths but also some moderate weaknesses
Some strengths but with at least one major weakness
A few strengths and a few major weaknesses
Very few strengths and numerous major weaknesses
Minor Weakness: An easily addressable weakness that does not substantially lessen impact
Moderate Weakness: A weakness that lessens impact
Major Weakness: A weakness that severely limits impact
The final overall impact/priority score: Average of OVERALL IMPACT/PRIORITY SCORES
OF REVIEW PANEL MEMBERS to one decimal point and multiplying by ten. Thus, the
new scores range from 10-90 in whole numbers.
PERCENTILES
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Also get a percentile rank
Percentile lets you compare your grant’s score
to the likely payline (cutoff percentile score).
The lower the percentile and the score, the
better. Fundable % scores generally published
every year by the I/C
 Example: Score : 21, 11%
Payline: 15% - grant is nearly sure to
be funded
Can’t be absolutely sure until the Council meets (3
times/year) and confirms payline.
Later: Notice of Grant Award is issued (that’s the
actual money)
Paylines Differ
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Year by year, given level of NIH budget
 Institute by Institute – depends on budget level
and their long-term commitments
 Depending on the Investigator – Advantage
given to new investigators (sometimes get extra
5% points). People who have had K awards or
small R grants are still considered “new”
 At some I/Cs, if you get close to the payline, can
submit a 5-page response to the reviewers and
undergoes administrative review
Resubmission
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Need to carefully digest the reviews and decide
how best to respond.
May need to strengthen background, study
rationale, details of methods, statistical analysis
plan, adjust budget, or collect additional pilot data
May just need to highlight things you originally
wrote, but didn’t emphasize
Always best to be clear that you are being
responsive to feedback
Great to get advice from Program Officer assigned
to your grant once you get score – they were
generally in the room when it was discussed
Resubmission
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You have up to 2 years to resubmit…. Most
often done sooner.
Deadline usually a month later than regular
intervals, but check about special mechanisms
Sooner rather than later is the general rule, but
totally worth it to wait a cycle and collect pilot
data if feasibility is questioned.
You have 1 additional page up front to respond
directly to the reviewers’ comments, and mark
other revisions in body of grant
Generally goes back to the same study section
Especially important to get the response right
when only 1 resubmission is allowed