Grant Writing, Grantsmanship,
& Grant Submission
Jared B Jobe, PhD, FABMR
Division of Cancer Control and Population Sciences
National Cancer Institute
National Institutes of Health
Department of Health and Human Services
Acknowledgements
Susan Czajkowski, PhD, NHLBI
 Ellen Werner, PhD, NHLBI
 William Elwood, PhD, CSR
 Mary Horlick, MD, NIDDK
 Tom Pearson, MD, MPH, PhD, Univ of Rochester
 Charlotte Pratt, PhD, NHLBI
 Julia Rowland, PhD, NCI
 Lorraine Silsbee, MS, NHLBI

Learning Objectives



Understand new NIH policies on New & Early
Stage PIs.
Understand the increased importance of the
Specific Aims page.
Consider steps needed in organizing and writing
an effective research grant application.
Initial Step: Become Familiar with
Relevant NIH Institutes

Identify the several most likely Institutes for funding
based on your specialty/scientific interests .
 See who funds your mentor’s research.
 See what Institutes are issuing FOAs in your area.
 See what Institute staff attend the same meetings you
do.
 Become familiar with the websites of those Institutes
who might fund you.
 Review funding agencies priorities and review FOAs.
Next Steps in Applying for an NIH
Grant

Sign up for the NIH Guide ListServe


The Guide is emailed once a week, and contains Table of
Contents with ‘links’ to PAs, Notices, and RFAs
http://grants1.nih.gov/grants/guide/listserv.htm
Review recently funded grants (RePORTER)
http://projectreporter.nih.gov/reporter.cfm
 http://nexus.od.nih.gov/all/DiscNIHReport/index.htm

Review model grants on the NIH website
 Discuss your ideas with colleagues.
 Consider a consultant.

Next Steps in Applying for an NIH
Grant (continued)

Contact program officers (POs) to obtain info on:
 Mechanisms
supported by that Institute;
 Institute-specific policies & procedures; and
 Other relevant program information.
Write a concept paper with your specific aims (1-2
pages).
 Send concept paper to a Scientific Review Officer
(SRO) at the Center for Scientific Review to discuss
possible study section assignment.

Determine the Institute’s Interest and
Receive Feedback on Your Idea

Share your concept paper/prospectus with an NIH
Institute program officer(s) & request feedback:
 Is
your Institute interested in funding research like
this?
 Are others currently funded doing similar work?
 Does this fall within a priority area of research for your
institute?
 What study section group would likely review the
application?
 How can I improve this concept?
Institute Specific Policies and
Procedures




Payline (the percentile at which an Institute will provide funds
for an application)
New Investigator payline at NHLBI
Paylines vary across institutes
Budgetary policies
 Grants> $500 K direct costs/year require prior Institute
approval
 Across the board funding cuts, decreases in duration of
funding
9
10
New NIH Policies:
New & Early Stage Investigators
NIH Definition of New Investigator (NI)



A principal investigator (PI) is considered a New Investigator (NI)
if he/she has not previously competed successfully as a PI for a
significant NIH independent research award
May have received funding as PI on small, early stage, training
and mentored career awards including:
 Small Grant (R03)
 Academic Research Enhancement Award (R15)
 Exploratory/Developmental grant (R21)
 Training & Research Career Awards (F awards, K awards)
If multiple PIs, to obtain “New Investigator” status, all PIs must
conform to New Investigator criteria
New NIH Policies: New & Early Stage
Investigators (cont’d)
NIH Definition of Early Stage Investigator (ESI)

A PI who qualifies as a New Investigator is considered an
Early Stage Investigator (ESI) if, at the time of submission,
he/she is:
 within 10 years of completing his/her terminal research
degree or
 within 10 years of completing medical residency (or the
equivalent)
NIH Approach to
New/Early Stage Investigators - 1
13



Applications will be more effectively evaluated
when judged against applications from individuals
at the same career stage.
Whenever possible, CSR will cluster applications
from New Investigators for discussion during
initial peer review.
Reviewers are asked to focus more on the
research proposed and less on the track record
and preliminary studies of the New Investigators.
NIH Approach to
New/Early Stage Investigators - 2
14


Priority processing and release of summary
statements have been established for New
Investigators.
Special Receipt dates have been established for New
Investigators who resubmit their applications in
consecutive rounds (see NOT-OD-07-083 at
http://grants.nih.gov/grants/guide/notice-files/NOTOD-07-083.html)
NIH Approach to
New/Early Stage Investigators - 3
15



Small Grant (R03) and the NIH Exploratory/
Developmental Research Grant (R21) applications
have increased over the last few years.
A smaller proportion of individuals with initial R21 or
R03 grant support subsequently apply for and obtain
R01-equivalent funding than those who first apply
for an R01.
The initial success rate for R21 applications often is
lower than for R01 applications.
NIH Approach to
New/Early Stage Investigators - 4
16




Because R03 and R21 grants are limited in scope and period of
support, they may not be the most effective way to launch an
independent research career.
NIH encourages New Investigators, particularly ESIs, to apply
for R01 grants when seeking first-time funding from the NIH
(excepting mentored career awards of course).
NIH’s partners--Institutions--must continue to look for ways to
reduce the duration of graduate and postdoctoral training and
to find new ways to enable new investigators to compete
successfully for extramural funding.
For more details, see:
http://grants.nih.gov/grants/new_investigators/
Allowable Grants for New PIs
17








Pathway to Independence Award-Research Phase
(R00)
Small Grant (R03)
Academic Research Enhancement Award (R15)
Exploratory/Developmental Grant (R21)
Research Education Grants (R25, R90, RL9, RL5)
Clinical Trial Planning Grant (R34)
Dissertation Award (R36)
Shannon Award (R55)
Allowable Grants for New PIs (Cont)
18







Small Business Technology Transfer Grant-Phase I
(R41)
Small Business Innovation Research Grant-Phase I
(R43)
NIH High Priority, Short-Term Project Award (R56)
Competitive Research Pilot Projects (SC2, SC3)
Resource Access Award (X01)
All Fellowships (F awards)
All mentored individual and institutional career
awards (K awards). Some K grants are not
mentored.
Allowable Grants for New PIs (Cont)
19






Loan repayment contracts (L30, L32, L40, L50, L60)
All training grants (T32, T34, T35, T90, D43)
Instrumentation, Construction, Education, Health
Disparity Endowment Grants, or Meeting Awards
G07, G08, G11, G13, G20
R13
S10, S15, S21, S22
What Not to Do if You are an ESI


Never, ever agree to become a transition PI on an
ESI-disqualifying grant.
Never agree to become a PI on a multiple-PI grant,
if all the PIs are not ESIs.
NHLBI Policy for ESIs
21





The special payline policy for non-ESIs was phased out in FY
2010 as planned.
The NHLBI payline for ESI only is 5 percentile points above the
regular R01 payline (i.e., 10%-tile) for FY 2012 (15th %-tile).
ESI applications on which all named principal investigators are
ESI investigators that are >5 but <=10 percentile points above
the regular R01 payline may undergo an expedited review to
resolve comments in the summary statement (16-20th %-tile).
All awards to ESI applicants under this policy will be funded
for all years recommended.
For NHLBI-specific policy:
http://www.nhlbi.nih.gov/funding/training/redbook/newinve
st.htm
Submitting a Multi-PI Application




For investigators seeking support for projects or
activities that require a team science approach
A contact PI is responsible for communication
between the NIH and the leadership team
Awards managed using subcontracts, if have PIs at
different institutions
NIH policies related to New Investigators will be
applied to multi-PI applications only when all PIs
involved are classified as New Investigators
Grantsmanship:
The Idea Marketplace
Is the idea important?
Your
Good
Idea
Can you do the work?
Is your plan feasible and
well thought out?
Research
Support
Traits of a Successful Grant Getter






Research skills
Salesmanship skills
Communication skills
Ingenuity and
flexibility
Administrative skills
Human relations




Persistence,
dedication, patience
Ability to work hard
Political awareness
and action
Integrity
The research-grant application
provides numerous opportunities to
demonstrate qualifications and
scholarly attributes, but it easily
reveals faulty thinking, hasty
preparation, superficiality, and
inexperience.
‘I THINK YOU SHOULD BE MORE EXPLICIT HERE
IN STEP TWO.”
Career Vision






It’s critical to have a research career vision!
Don’t focus too much on what’s hot.
Rather, focus on what you can do best.
Don’t think just about the current application or
plans.
Design a long-term program of research.
Communicate that vision in your application.
Larson, G. The Complete Far Side. 2003.
Goals of Restructured Applications
29



Align the structure and content of the forms with
review criteria.
To focus the applicants and reviewers on the same
elements.
To help ensure a more efficient and transparent
review process
Overview of the Application Changes
30

Application forms have been revised in three
sections (January, 2010):
 Research
Plan
 Biographical Sketch
 Resources and Facilities
Anatomy of a Research Grant:
New Research Plan Components
Introduction (for revised or supplemental applications)
Specific Aims
Research Strategy
-Background and Significance
-Preliminary Studies/Progress Report
-Research Design and Methods
Inclusion Enrollment Report
Bibliography and References Cited
Human Subjects Sections - protections, women/minorities,
enrollment, children
Other Research Plan Sections - animals, select agents, multi PD/PI,
consortium, support, resource sharing
Appendix
Application Alignment with Review
Criteria
32
Review Criteria

Significance
Application Sections

Research Strategy
 A.


Investigators
Innovation


Biosketch
Research Strategy
 B.

Approach

Environment

Innovation
Research Strategy
 C.

Significance
Approach
Resources
Page Limit Summary
Section of Application
Page Limits
Introduction to resubmission or
revision applications
1
Specific Aims
1
Research Strategy
12
Biographical Sketch
4
Specific Aims: One Page



List the broad, long term objectives and what the
proposed research is intended to accomplish
Often list 4-6 specific aims which are used to
organize the background and significance
preliminary studies, and design/methods sections
State hypotheses to be tested
Specific Aims Prototype

Text
 Overall
goal of the project
 Hypothesis to be tested

Bullet Points
 Population/animal

model to be studied
 Data to be collected or intervention used
 Endpoints to be measured
 Analysis of data
Accomplishments expected at the end of the project
Research Strategy: 12 pages

Background and Significance

Preliminary Studies

Research Design and Methods
Background and Significance





Why should this application be funded?
Critically evaluate existing knowledge
Specifically identify gaps that the project is
intended to fill
Relate the specific aims to long term relevance
Answer the “So what?” question
Background and Significance Prototype




What is known about the condition or disease in
the population being studied?
What is known about the independent variables
being studied?
How well is the endpoint usually measured?
What analyses have been performed by others to
date?
Preliminary Studies



Provide information that will help to establish the
experience and competence of the investigator to
pursue the proposed project.
Competing continuation grants should summarize
the previous application’s specific aims and the
progress made toward them
May list publications relevant to or supported by
prior grant and submit up to 10 manuscripts in
Appendix
Preliminary Studies Prototype




What is your experience with the proposed study
population or animal model?
Can you precisely and accurately measure the
endpoint variables?
Can you precisely and accurately measure the
dependent (outcome) variables?
Can you manage and analyze the data?
Purpose of a Pilot Study




Demonstrate ability to recruit/access/retain study
population.
Establish ability to perform assay reproducibility,
validity, precision, accuracy.
Estimate prevalence/incidence of endpoints.
Quantify variability and magnitude of change in
endpoint for purpose of sample size calculation.
Research Design and Methods






Overall Study Design
Participant Population
Data Collection
Endpoint Definition
Data Management
Data analysis



Sample Size Calculation
Study Strengths and Limitations
Timeline
Issues in Research Design and
Methods


Data management is often left out
Involve biostatistical colleagues early and often
and have them write the analysis section
 Analysis
of study design
 Sample size calculation


Provide a frank discussion of application’s
limitations, including alternatives considered
Include a timeline either here or in the budget
justification to demonstrate feasibility
Human Subjects Research





Deficiencies in human subjects research plan
appear to account for most of the reduction in
funding rates in clinical versus basic science
applications.
Provide complete answers to required questions.
Provide projections on recruitments of women,
underrepresented minorities, and children.
Describe recruitment procedures in detail in the
research plan.
Keep the community involved, so you have their
consent and approval throughout.
Components of a Research Career
Development Award






Specific Aims
Candidate
Mentor(s)
Institution
Research Project
Page limits:
http://grants.nih.gov/grants/forms_pa
ge_limits.htm#car
Candidate for an RCDA
(part of the page limit)




Background and Training: Potential for research career
Scientific Bibliography: Commitment to research career
Career Development Plan / Training Activities
 Formal coursework/degree program
 Seminars/journal clubs
 Summer institutes/outside courses
 Annual scientific meetings
 Interactions with mentor(s)
 Publications, grant applications
 Timeline for career development
Training in Responsible Conduct or Research
Mentors(s) for an RCDA
(not part of the page limit)

Primary mentor’s experience
Background and training
 Experience and funding in area of mentee interest
 Track record and current involvement in research training


Mentorial committee (3-4 co-mentors encourage
multidisciplinary research)
Describe role of each co-mentor
 May have co-mentors from outside institutions, as needed
 Describe function of the mentorial committee


Mentoring plan should be detailed
Institutional Sponsorship of an RCDA
(not part of the page limit)


Description of resources relevant to candidate’s career
 Education and training programs (e.g. K30)
 Research facilities
Institutional commitment signed by official
 Support of candidate for faculty career development
(e.g. tenure track)
 Promise to protect % effort as required by the RCDA
 Usually description of remainder of time not supported
by RCDA
Research Plan
(part of the page limit)



Similar to an R01, except shorter due to
candidate’s statement
Preliminary results need not be lengthy, may
include mentor’s laboratory results if relevant
Describe expected results and transition to R01
type funding
Practical Tips for RCDA’s





K08/K23 have relatively good funding rates
Submit K and then R01, not vice versa
Understand NIH Institute’s guidelines about
submitting R01’s during K Award. Transition of K
to R is a measure of K award’s success
Plan for prompt revision, if not immediately
funded
Talk with current K Awardees, review their
applications
Community Partnered Approaches





Understand the differences among the terms:
 CBPR, community research, community-based research.
CBPR requires community involvement in ALL phases of the
project.
Don’t claim in your application that you will conduct CBPR if
the community doesn’t partner in ALL of the areas.
Go with one of the other terms, and explain why.
OBSSR definition on CBPR:
 http://obssr.od.nih.gov/scientific_areas/methodology/com
munity_based_participatory_research/index.aspx
Suggestions for Community
Partnerships - I







Describe the scientific, logistic, and organizational
responsibilities of each partner.
Describe the history of partnership collaboration.
Submit evidence of strong scientific capabilities.
Submit evidence of community involvement and support.
Emphasize human subjects protections.
Include a Data and Safety Monitoring Plan.
Include a Community Advisory Board.
Suggestions for Community
Partnerships - II




Use community members as intervention staff and
measurement staff—and remember that they must be
different people.
Use a qualitative phase to work with the community to
develop the specifics of the intervention.
Negotiate an agreement regarding ownership or control of
research data and biological samples.
Negotiate an agreement regarding authorship, and the
review and approval of research protocols, abstracts, and
manuscripts.
Writing an Appealing Application - I
Read and follow all instructions in NIH Guide,
PHS398/SF424 R&R, and related updates.
 I said, “All instructions.” This means you!
 Conduct and demonstrate a thorough literature
review. Make reasonably detailed arguments!
 Provide a specific rationale for your proposed
investigation.
 Present a complete and organized research plan.

Writing an Appealing Application - II






Adherence to pitch, font, and margin rules and page
limits
Correct spelling or grammatical errors
Organize by headings
Use spacing and indentation strategically
Break-up text with well-designed and legible figures
and tables
There is, in fact, no rule against using commas
Writing an Appealing Application - III






Your reviewers assume nothing!
Propose realistic and detailed amounts of work.
Include preliminary and/or related data whenever
possible.
Obtain pre-submission feedback from your institutional
colleagues, other peers, or NIH program directors.
Consider multiple Federal, state, and private funding
sources.
Volunteer to review NIH, CDC, AHRQ, and other
applications!
Writing an Appealing Application - IV
It All Should Match






Specific aims
Hypotheses
Theory
Pilot data
Detail about methods
Analysis plan



Power calculations
Data and Safety Monitoring Plan
Minority, women, children recruitment
Before Submitting
Do your homework in researching review groups.
 Choose an appropriate Review Group (locate listing
of Review Groups and rosters via NIH Webpage).
 Use key words in title & abstract that will ensure an
appropriate assignment for your application.
 Be sure to observe any Institute-specific
requirements when preparing your application.
 You should contact the Scientific Review
Administrators, just as you should contact institute
program officers.

More New NIH Policies

Resubmission (Amended) Applications:
NIH is now only allowing applicants to submit an application
twice rather than three times (the original and a single
resubmission).
 If applicants do not receive funding after 2 submissions, they
must significantly re-design the project & submit as a new
application.


Shorter Applications:
Applicants now have shorter application page limits, as of
January, 2010
 Keep informed of all new submission & review changes at:
http://enhancing-peer-review.nih.gov/

Biographical Sketch

Personal Statement added:
 “Briefly
describe why your experience and
qualifications make you particularly well-suited for
your role in the project”

Publications revised:
 Limit
the list of publications or manuscripts to no
more than 15
 Applicant is encouraged to make selections based on
recency, importance to the field, and/or relevance to
the application
Resources and Facilities

Instructions added to Resources:
 Provide
a description of how the scientific
environment will contribute to the probability of
success of the project.
 For Early Stage Investigators (ESIs), describe the
institutional investment in the success of the
investigator.
What Has Not Changed

You need to have a good idea about how to answer
an important question

Reviewers need to be able to understand WHAT
you want to do, WHY it is important, and can YOU
do it?

You need to align YOUR goals with the funding
agency goals, not vice versa.
Larson, G. The Complete Far Side. 2003.
A Strong ARA Letter –
Awaiting Receipt of Application


Letter of intent – requests approval to submit
application:
Title of grant
 Scientific
impact
 Budget
 Cost


reduction measures
Draft budget
Abstract with specific aims
Submission Requirements
All applicant organizations must have a DUNS
number.
http://www.grants.gov/applicants/org_step1.jsp
 All applicants must register with the federal Central
Contractor Registry
http://www.grants.gov/applicants/org_step2.jsp
 Complete application instructions are at:
http://www.grants.gov/CompleteApplication

Submission Requirements (continued)
66



All applications must be submitted electronically at
grants.gov/apply
Use the FOA-specific application web site to apply.
Obtain all application forms and instructions
 Local
sign-off forms
 Grant-making agency
Typical Timeline for a New R01
Grant Application
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---
Grants.gov Assistance

Applicant Contact Center
 Support
available 24/7
 Email: [email protected]
 Toll-Free Phone Number: 1-800-518-4726
 Self-help iPortal: (http://grants.gov/iportal)

Additional Resources
 Animated
Tutorials
 Brochures (Overview/Registration) (for applicants
only)
 FAQs
 User Guides
For More Information:
NIH grants process:
http://grants.nih.gov/grants/grants_process.htm

NIH grant eligibility:
http://grants.nih.gov/grants/grant_basics.htm

New NIH Peer Review System
http://enhancing-peer-review.nih.gov

Grants.gov help:
http://grants.gov/agencies/grantors_help_resou.jsp

Thank You for Your Attention!
“You miss 100% of the shots you
never take.”
Wayne Gretzky
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