Tl1 f award-nrsa-application-workshop-updated_8_march2018-2

The First (F) award?
No, F does not mean first
but Fellowship
TL1 Subcommittee on Funding Opportunities
PJ Simpson-Haidaris, PhD
Association for Clinical & Translational Science
Workshop presented April 20, 2017
SlideShare presentation updated 3-8-2018
1
Session: Preparing an F-Award at the Pre-Doctoral Level
(same information works for the F32 postdoc NRSA too)
Extended Version for SlideShare distribution and update
Updated to include new FOAs released Feb 2018
using Adobe Forms Series E

Disclosures
PJ Simpson-Haidaris, PhD
Translational Biomedical Science
PhD Program
Clinical and Translational Science Institute
University of Rochester, NY
pj_simpsonhaidaris@urmc.rochester.edu
PJ has no actual or potential conflict of interest
in relation to this program or presentation.
2

Table of Contents (1)
Topic Slide number
Speaker’s Credentials and Disclosures 1,2, 9, 10
Table of Contents 3 - 7
What is a Grant? And How do you get one? 8
Outline describing how presentation organized 11
Four Critical Take Home Messages About F-awards 12, 113
Four Critical Take Home Messages About Peer Review 13, 127
Ruth L. Kirschstein NRSA F-award program 14
NIH structure and NIH Path to a Successful F-award 15-17
Getting Started: F Kiosk is your Friend, Types of F-awards 18-20
How to read a Funding Opportunity Announcement 21-27
Fellowship Instructions for NIH and Other PHS Agencies-Link Series E 28
SF 424 (R&R) page 1 form information 29
SF 424 (R&R) page 2 form information 30
Research & Related Other Project Information SF 424 form 31
Clinical Trials Not Allowed for PA-18-666 F31 diversity 32, 33
PHS Fellowship Supplemental Form for required attachments 34-36
3

Topic Slide number
PJ’s recommended F-award Checklist per SF424 attachments 37, 38
Craft a Robust Title 39, 40
Training Specific Sections of F-award 41
Other grant sections to include depending on Research Conducted 42
Sections needed for Research Grant 43
Key Personnel: PI is the Trainee; Need eRA Commons ID as Trainee and PI 44
Rules: Font size, line spacing and type density 45
First Critical Take Home Message: Prepare Proper NIH Fellowship Biosketch 46-63
Interim Reports, what they are and how to cite them in grant and Biosketch 64-67
NIH example of Fellowship Biosketch 68-71
University Representative Submits Grant on Your Behalf 72
Cover Letter Requirements and Suggested Format (Example Provided) 73
Second Critical F-award Take Home Message: Build an Exceptional Research
and Career Development Mentoring TEAM
74-86
Back to the SF424 instructions and attachments 87
PD/PI and Key Personnel information required 88-89
4

Topic Slide number
Sponsors and Co-Sponsors Information ($$, former trainees, Mentoring Plan) 90-92
Consultant & Collaborators Letters of Support (LOS) 93
Third Critical F-award Take Home Message: Recruit outside Referee for Letters 94-96
Fourth Critical F-award Take Home Message: Individual Development Plan (IDP) 97, 98
Applicant’s Background and Goals for Fellowship Training (3 parts) 99-104
Respective Contributions (Example) 105, (106)
Selection of Sponsor and Institution 107
Responsible Conduct of Research (Example) 108, (109)
Training in Data Rigor and Reproducibility 110, 111
Select Agent Research 112
Resource Sharing Plan (Example) 113
Authentication of Key Biological and/or Chemical Resources 114
Research Grant and Other Important Sections on SF424 115, 116
Project Summary/Abstract 117
Project Narrative/Public Health Relevance 118
Bibliography & References Cited 119
5

Topic Slide number
Facilities & Other Resources (include intellectual resources) and example 120, 121
Equipment 122
Institutional Environment and Commitment to Training 123-126
Certification of Eligibility for Diversity Award (F31 Diversity only FOA) 127
Four Critical Take Home Messages About Peer Review 128
SF424 attachments Specific Aims Research Strategy 129
Peer Review Message 5. They are not called “Vague Aims but “Specific Aims
Specific Aims Page, Importance, Format and Language
130-134
Research Strategy: Significance 135
Purpose of Significance Section (Scientific Premise) 136
Research Strategy: Approach 137, 138
Peer Review Message 6. Reviewers have limited time to review YOUR grant 139
Peer Review Message 7. Enthusiasm and Passion for Research and Visually
Splendid Figures
140
Figures and Tables “Dos and Don’ts” 141
Diagrams and Drawings 142
Grant Schematics Dos and Don’ts 143-146
6

Topic Slide number
Some Sections Depend on Type of Research Conducted 147
Peer Review Message 8. 15 Minutes of Fame (aka Peer Review) 148
The NIH Grant Process: What Reviewers Are Looking For 149
Criteria for Reviewing F-awards 150-155
What will immediately cause an application to go un-reviewed
(because you did NOT READ the FOA)
156
Where FOA specific instructions Found? 157
What does it take to write an F-award application? (refusal to take “No” for an answer) 157, 159
Timeline for how long it takes to write a grant 160
Acknowledgements 161
Source Material 162, 163
Helpful NIH Websites and Videos (links) 164
Disclaimer 165
7

What is a grant?
noun
1. a sum of money given by an organization,
especially a government, for a particular
purpose.
= gr + ant?
How do you get one?
8

Seek formal instruction in Grant
Writing to increase success rate
Funding success
rates of
individual
predoctoral grant
recipients at the
University of
Rochester who
attended a
semester-long
grant writing
class (Dr. PJ’s)
9

• Mentored >80 MS, PhD & MD-PhD
students as primary, co-mentor or
thesis committee member.
• Served on 90+ peer-review grant
panels for NIH, DoD, AHA, Komen
Foundation, US Army, Air Force &
Combat Casualty Care & others.
• Awarded many grants (over 20
million dollars direct costs) as PI, Co-
Investigator or Institutional Training
Program Director!
• Written many grants not awarded;
some triaged.
• Knows what NOT to do to get grants.
• What to do RIGHT is the hardest part
of successful grant getting!
Dr. PJ’s mentoring and grant
reviewing & getting experience
10

Outline
• The presentation is organized around “Critical Take
Home Messages” about F-awards and Peer Review.
• Brief introduction to NIH and reading the Funding
Opportunity Announcement
• Detailed tips and examples of F-award grant sections
you need to get to next career stage
– Career Development and Skills acquisition — the training
sections
– Research Strategy—the science
• NIH Peer Review—what reviewers are looking for in an
F-award application.
• Resource Materials and Useful Links
11

Critical take home messages
about F awards
1. Prepare a proper NIH Fellowship Biosketch.
2. Build an exceptional Research and Career
Development Mentoring TEAM.
3. Recruit outside Referees who can write the
STRONGEST possible letters attesting to your
potential to launch an independent career.
4. Prepare a Research and Career Individual
Development Plan (IDP) to define gaps in training,
and design activities and metrics to meet career
goals.
12

about Peer Review
5. They are not called “Vague Aims”… they are
called “Specific Aims”
6. Reviewers are assigned 8-10 grants so they
have limited time to review YOUR grant.
7. Demonstrate your enthusiasm and passion
for research and attaining career goals with
Clear, Concise and Compelling writing and
Visually Splendid Figures.
8. You get 15 minutes of Fame at Peer Review
– (if you are lucky to have your grant discussed).
13

Ruth L. Kirschstein, MD NRSA
Individual Fellowship Funding
Opportunity Announcements (FOA)
• Role in development of safe
and effective polio vaccine
• First woman director of major
institute at the NIH (NIGMS)
• Champion of basic biomedical
research and training
programs for all talented
students, and particularly
underrepresented minorities.
http://www.nih.gov/about/kirschstein/
14

By now, you know what
NIH is, but maybe you
don’t know how it works
15
• The good news is, there are lots of resources to help you understand
how NIH works.
• The bad news is, there are so many its hard to know where to start.

NIH Path to a Successful
F-Award, in a Nutshell
• When choosing the
institute for your grant
oversight, consider
whether your research
project fits the
Funding Mission of
the Institute.
– Seek advice from
mentors and contact
NIH officials listed on
FOA
• Choose the Study
Section that best fits
your research topic.
– http://www.crs.nih.gov
16
8 Ways to Successfully Navigate NIH Peer Review and
Get a Fellowship Grant
URL in Source Materials slide

27 Institutes and Centers (IC)
at NIH
17
http://www/nih.gov/icd

Getting Started with FOA:
“F Kiosk” is your Friend
18
Always check for most recent
Funding Opportunity
Announcement
Although no longer called
the “F Kiosk, if you Google
“F Kiosk”, the web page of
NIH Individual Fellowship
(Fs) or (Google “K Kiosk”)
Career Development (Ks)
Funding Opportunity
Announcements are the top
links

19
Types of F-awards
• Predoc Parent FOAs
• F30 dual degree
• F31 (not diversity)
• F31 diversity
• Postdoc
• F32
• Predoc to Postdoc
• F99/K00 transition, tho few
IC participate
• Sr. Fellow
• F33

F-award FOAs requiring use of
Adobe Forms Series E released Feb 2018
20
https://researchtraining.nih.gov/programs/fellowships

Funding Opportunity
Announcement (FOA)
PA-18-666
21
The grant sections (grant
body parts) described in
this workshop essentially
the same for F30 and F31
funding mechanisms.
PA-18-666 is used as
model FOA.
Make sure the most recent
version of FOA.
Verify expiration date is in
the future.

Hard Part is Over
• Almost.
• Your know what kind of grant you will write
(F-award).
– Saves time navigating the landscape of all possible
funding agencies and different rules and types of
grants to write, i.e., finding the correct Funding
Opportunity Announcement
• You know what NIH Institute or Center (IC) will
most likely want to fund your research
– Because your advisor is already an expert in the field
and had been a successful “grant getter” with funding
from that institute
22

Must Check Which Institutes and
Centers (IC) Participate
23
Understand
how to read
the FOA
Must determine
IC specific rules
and
opportunities
for each
F-award
mechanism

PA-18-666 Diversity F31
IC-specific info and contacts
24
https://grants.nih.gov/grants/guide/contacts/parent_F31_diversity.html
Scroll
down
web page
to see
info
specific
to your IC

Before submitting grant, discuss Specific
Aims and Impact of Research with PO to
make sure fits IC funding mission
• Program Official (PO)
– Programmatic, scientific and technical
aspects of grant
– Pre- and post-award contact for
guidance
• Scientific Review Officer (SRO)
– Contact during Peer Review
– Assigns grants to reviewers
– Oversight for fair and unbiased review
of grants
– Provides evaluation summary of review
technical and scientific merit
• Grants Management Officer
– Negotiates awards
– Evaluates administrative content and
compliance with policy
– Post-award mostly
25
https://www.youtube.com/watch?v=rNwsg_PR90w

How do you obtain the
electronic application?
26
Look for the
“Apply Online Using
ASSIST”
button in program
announcement and
click on it
OR click on
Grants.gov in
FOA and
download the
Adobe FORMS-E
pdfs

SF424 Mandatory Forms
for PA-18-666
27

Make sure to download the
Fellowship Instruction Guide
28
• Look for new and
updated instructions
in section F.120 –
Significant Changes
https://grants.nih.gov/grants/how-to-apply-
application-guide/forms-e/fellowship-
forms-e.pdf

29
• Follow FELLOWSHIP
INSTRUCTIONS FOR NIH
AND OTHER PHS
AGENCIES
https://grants.nih.gov/grants/how-
to-apply-application-guide/forms-
e/fellowship-forms-e.pdf
• If you are lucky, your
departmental grants
administrator will fill this in,
or at least provide the
correct information!
• Line 11: Refer to upcoming
section on “Crafting a
Robust Title”
Note: all fields highlighted
in yellow are required
BUT
Not all fields required are
highlighted!

30
• Follow FELLOWSHIP
INSTRUCTIONS FOR NIH
AND OTHER PHS
AGENCIES
https://grants.nih.gov/grants/how-
to-apply-application-guide/forms-
e/fellowship-forms-e.pdf
• Hopefully, your departmental
grants administrator will fill
this in and connect you to
your Institution’s Signing
Official/ Authorized
Representative!
• Line 21: Refer to upcoming
section on mandatory “Cover
Letter”

Research & Related Other
Project Information SF 424
31
• Human Subjects Involved?
• PA-18-666 Funding Opportunity
Announcement (FOA) is designed
specifically for applicants
proposing research that does
NOT involve leading an
independent clinical trial, a clinical
trial feasibility study, or an
ancillary study to a clinical trial.
• PA-18-666 does allow
applicants to propose research
experience in a clinical trial led
by a sponsor or co-sponsor
(i.e., study already approved by
IRB for Sponsor’s funded
clinical trial).
Several Attachments here (lines 7-12); see
F-award Checklist and upcoming sections.

• Fellowship applicants who are proposing to gain clinical
trial research experience under a sponsor’s supervision
(not leading an independent clinical trial):
• Follow instructions to complete the PHS Human Subjects
and Clinical Trials Information form. See Section F.500 in
PHS R&R SF 424 FELLOWSHIP INSTRUCTIONS FOR NIH
AND OTHER PHS AGENCIES:
• In “Sponsor’s and Co-Sponsor’s Statement” attachment,
sponsors are required to include a statement to
document leadership of the clinical trial as specified in
section F.500 of the above instruction guide.
Clinical Trials Not Allowed (1)
32
application-guide/forms-e/fellowship-forms-e.pdf

• Consult the Director of your institution’s Office of Human
Subjects Protection 0or equivalent) and Departmental
Grants Administrator to comply with up-to-date-
requirements for research involving human subjects and
clinical trial research experience on F-awards.
• DISCLAIMER: Instructions in this presentation are
only a guide for the new requirements for the “New
Human Subjects and Clinical Trial Information Form”
in effect for applications submitted on or after Jan 25,
2018.
Clinical Trials Not Allowed (2)
33
application-guide/forms-e/fellowship-forms-e.pdf
https://grants.nih.gov/policy/clinical-trials/new-human-subject-
clinical-trial-info-form.htm

Upcoming sections
discuss what to include
in each of the SF 424 and
PHS Fellowship
Supplemental Form
attachments.
PJ created a word
document as a
checklist for
attachments, which
is downloadable
from SlideShare
(Google “Simpson-
Haidaris SlideShare”)
34

35
• Fill in sections appropriately.
• If you have received NRSA
support on an institutional
TL1 or T32, consult
departmental grants
administrator for accurate
information.
• By the time of award, the
individual must be a citizen
or a non-citizen national of
the United States or have
been lawfully admitted for
permanent residence (i.e.,
valid Permanent Resident
Card USCIS Form I-551).

Budget information usually filled out by
PI’s departmental grants administrator
36
• Include full graduate tuition
for PI’s institution.
• NIH funds awards based on
their rules but PI needs to
ask for full institutional
tuition amount.
• Contact PI’s Office of
Research and Grants
Administration or Graduate
Dean’s office to get most
up-to-date full-year
graduate tuition.
• Some students and grant
administrators have failed to
do this correctly resulting in
lost funding for tuition!

of
PJ’s
F-award
Checklist
per SF 424
instructions
37

of
PJ’s
F-award
Checklist
per SF 424
instructions
38

Craft a Robust Title—
Title Wins Over Grant
Reviewers
• Create a title that stands out from others and virtually
compels reviewers to read your application.
• Create a unique, relevant and intriguing description of
your research — all packed into about 80 to 200
characters (including spaces and punctuation).
• Use plain language that is Simple, Direct, and Impactful
but also use Word Economy.
• Use results-driven words instead of those that describe
your process.
• Title should address Institute-specific research mission.
39

• Limit in title length for
NIH is 200 characters
and spaces
1
• Can use Greek and
special symbol
characters
2
• Reviewers will ding
you for a lousy title3
NIH Grant Titles—Key Points
http://www.wtamu.edu/webres/File/Academics/Graduate%20School
/Sponsored%20Research%20Services/Craft_A_Winning_Title.pdf
40
TIP
Be sure the title
you create when
starting your
project remains
accurate to
reflect all
revisions and
changes in
Specific Aims of
submitted
project!
Recommended link

Knee joint connected to the leg
bone…Training-Specific Sections
41
Institutional
Environment
and
Commitment
to Training
(2-page limit)
Applicant's Background and Goals
for Fellowship Training (6-page limit)
Respective
Contributions
(1-page limit)
Selection of
Sponsor &
Institution
(1-page limit)
Sponsors Training
Plan, Mentoring
History and
Resources ($$)
(6-page limit)
Responsible
Conduct of
Research
(1-page limit)
Diversity
Eligibility Letter
If this section is missing from
F31 diversity application, it will
NOT get reviewed.

Some Sections Depend on Type
of Research Conducted
Human
Subjects?
• Independent clinical
trial, a clinical trial
feasibility study, or
an ancillary study to
a clinical trial is
NOT allowed.
• PA-18-666 allows
applicants to
propose research
experience in a
clinical trial led by a
sponsor or co-
sponsor.
Vertebrate
Animal
Research?
Vertebrate Animal
Attachment
• Description of
Procedures
• Justify Species Used
• Minimization of Pain
and Distress
• Note: Euthanasia now
addressed on SF 424
PHS Fellowship
Supplemental Form,
Line 12.
Select Agents?
Resource and
Data Sharing
Plan
Stem Cell
Research/Bio-
hazards?
Facilities & Other
Resources;
Equipment
(required, but include only facilities
related to YOUR research plan)
42

Don’t Forget the
Research Grant!
Summary/
Abstract
(30 lines max)
Narrative/
Public Health
Significance
(2-3 sentences)
Introduction, if
resubmission
(1-page limit)
Specific Aims
(1-page limit)
Research
Strategy
(6- page limit)
Bibliography/
References
Cited
(no page limit)
Cover Letter
(required)
PHS assignment
request form (optional)
Biosketches
• PD/PI (You!)
• Sponsor
• Co-sponsor
• Advisory
Committee
Members
• Consultants
3 Outside (Referees)
Letters of
Recommendation
Letters of Support
Consultants/Collaborators
(6-page limit)
43

Key Personnel: PD/PI is
automatically populated
PD/PI must include
eRA Commons ID
44
You must be listed in your
eRA Commons account as
a trainee AND as a PI

Pesky Grant Writing Rules
1. Prepare a
proper NIH
Fellowship
Biosketch.
45
Arial 11 pt most
frequently used font
Smaller font sizes
can be used in
figure legends
and tables, but no
smaller then 8 pt

First critical take home
message about F awards
46
1. Prepare a proper NIH Fellowship
Biosketch.
and Sponsors, Advisory Committee
Members, Consultants and
Collaborators need to update their
Biosketches to address their specific
role on the F31 grant!

47
NIH Biosketch Format
5-page limit
https://grants.nih.gov/grants/forms/biosketch.htm
R-award PIs and F- and
K-award Sponsors,
Mentors Collaborators
& Consultants as well
as K-award applicants
use this template.
F-award applicants
(F30, F31 and F32) use
the Fellowship
template.
Tip on NIH terminology:
Your primary advisor is called a
Sponsor for F-award applicants and a
Mentor for K-award applicants.
Investigate SciENcv and My Bibliography through
My NCBI to prepare electronic Biosketch:
https://www.ncbi.nlm.nih.gov/account/signin/

Sections of NIH Biosketch for a
Fellowship (F), Mentored Career
Development (K) or Researcher-
initiated (R) Grant
• Education and Training in Table Format
A. Personal Statement (can include 4 citations)
B. Positions and Honors (Fs-list grant support in
honors)
C. Contributions to Science (5 contributions with up to
4 citations for each contribution).
D. Scholastic Performance (F-grants) or Research
Support (K- and R-grants)
48

NIH Biosketch eRA Commons User
Name (Credential; Agency Login)
Tip: Be sure to get your Commons ID
and be listed in Commons as PD/PI as
well as trainee stage.
Education/Training Format same for all NIH
Biosketches for R, K and F awards 49

A. Personal Statement SF424
Instructions - Overview
• Describe collaborators or scientific environment; past
performance in this or related fields
Ø May identify up to 4 peer-reviewed publications or research
products including interim reports that specifically highlight your
experience and qualifications for this proposal’s project.
Ø The citations may be different from or also listed in Section C.
• May explain impediments to your past productivity by
describing factors such as family care responsibilities,
illness, disability, and active duty military service.
• Describe why well-suited to receive the award
for which you are applying (relevant previous
training, experimental work and technical
expertise).
50

A. Personal Statement must be
specific for current application!
– Start Personal Statement with your Role on Project and
Proposal Goal.
– Predocs with few publications may describe research
experiences demonstrating expertise for this proposal.
– Sponsors/Mentors (R-Bios) include leadership,
mentoring history qualifications and mentoring awards.
– F- and K-Bios include Training Potential to take you to
next career stage, which includes brief mention of skills
to be gained from training components.
– Reminder: K applicants use the same Biosketch
template as Mentors (not the fellowship bio template!).
51

Tip: Well-written personal statements really help reviewers write their critiques for
review criteria of applicant, sponsors, and training potential.
In Personal Statement, describe Training
Potential (F-predoc) or Launch to
Independence (F-postdoc and Ks)
§ Describe how new training plan will provide you with the
skills to launch next career stage.
§ Outline (briefly!) career development activities, didactic
coursework, workshops, seminar series, etc. that will
enhance your abilities to become an independent
investigator (or prepare for postdoc after predoc training).
§ Explain how your primary mentor/sponsor and mentoring
team members (advisory committee) will foster your career
goals and why your institution is perfect place for training.
§ Spell out the names of mentors and collaborators so reviewers do not
have to go back to other sections to look up
52

NIH Fellowship Predoc Personal
Statement Example
Highlight
Diversity Status
Highlight
manuscripts
Briefly Describe WHY sponsor
(mentor) and project is best
choice for YOU 53

NIH Example of Personal
Statement for R-award, or
Sponsor on F-award
Be careful that you do not dig a hole to
fall into because reviewers want to see
innovative research with high impact to
address NIH mission—remember F-awards do not have
innovation sections because the science falls thematically under
Mentor’s established and productive research program
Best to tell what that expertise is.
Statements with no specifics do
not help reviewers assess your
ability to carry out research
Your Sponsors, Co-sponsors and
Collaborators Biosketches must
include their history of mentoring
trainees and their specific role on
YOUR grant
54

Personal Issues
in Personal Statement
• NIH recognizes that personal factors affect
career advancement and productivity.
– Taking care of a terminally ill relative
– A complicated pregnancy requiring bed-rest
– A natural disaster that wiped out a valuable resource
– Death of a mentor (PJ has reviewed grants when
this has happened after submission of the grant)
• Optional, but best to explain if big gaps in training,
job history or publications occur!
Source—Modification of the Biographical Sketch in NIH Grant
Application Forms. Notice Number: NOT-OD-11-050
55

B. Positions and Honors
(Fellowship Bio example)
Remember to
List Oldest First
56
For fellowship Bios,
put grant support
received in Honors:
e.g., TL1, T32, pilot
funding, foundation
award, travel award

C. Contributions to Science
Instructions (1)
§ Considering your level of experience, briefly describe up to 5
of your most significant contributions to science.
§ Graduate students and post-docs encouraged to consider
high-lighting 2 or 3 research experiences considered most
significant.
§ For each contribution, indicate historical background that
frames the scientific problem; the central finding(s);
relevance of the finding(s) to science, technology, or public
health; and your specific role in the described work.
§ For each contribution, you may cite up to 4 peer-reviewed
publications, interim reports or other non-publication
research products—no more than 4 per Contribution—not
an average of 4 per Contribution! 57

Instructions (2)
§ Include audio or video products; patents; data and research
materials; databases; educational aids or curricula;
instruments or equipment; models; protocols; and software
or netware that are relevant to the described contribution.
§ Description of each contribution no more than ½ page
including citations (Figures, tables, graphs no longer allowed per
NOT-OD-16-004).
§ Optional: Provide a URL to full list of your published work
found in a publicly available digital database such as
SciENcv or My Bibliography, which are maintained by the
National Library of Medicine.
URL for My Bibliography—can only use Government
based URL (.gov) No Google Scholar; must type-out
URL, not embed as hyperlink.
58

Instructions (3)
• Sponsors/Collaborators/Consultants can include
abstracts but NOT manuscripts “in preparation”,
“submitted” or ”in review” as research products—can
discuss in narrative of scientific contribution.
• Exception: Fellowship Bios for F-awards, can
include “in preparation”, “submitted” or ”in review”
• Indicate if you previously used another name that is
reflected in any of the citations.
• Must include PMCID numbers on all publications listed
on Biosketch that fall under Public Access Policy.
59

What’s the difference
between PMID and PMCID?
61

Highlight experience
mentoring predoctoral
students who have gone on
to successful careers
62
C. Contributions to
Science (Example
Sponsor’s Bio)
Bold your own name so
Reviewers can determine your
Contribution to the pub the
old fashioned way
Names of
students trained
are underlined
Number each
Contribution (1-5)
and provide
descriptive title
PMCID denotes compliance with
NIH Public Access Policy

Pointers for Personal Statement
and Contributions to Science
• Your Personal Statement and Contributions to Science is
where your passion for what you do and what you have
accomplished needs to shine!
• Descriptive title of each contribution should be a bullet point
of your Achievements
Ø Write your own review: the reviewer can use these bullet points in
their critique to describe How You are Perfect for Your Role on
Current Grant (subtle yet effective!)
• Select Contributions that Showcase your Work but also
address the goals of the agency as defined in the
Funding Opportunity Announcement or Request for
Application
63

Interim Reports: what are they
and why should I care?
64

What are Interim
Research Products?
• Interim Research Products are complete, public research
products that are not final.
– Preprint, a complete and public draft of a scientific
document
• Preprints are typically not reviewed manuscripts written in the style
of a peer-reviewed journal article.
• Preprints issued to speed dissemination, establish priority, obtain
feedback, and offset publication bias.
• Preprints must be electronically archived to be cited
– Preregistered protocol
• Publicly declare key elements of your research protocol in advance.
• Helps enhance the rigor of your work.
65
NOT-OD-17-050 — Reporting Preprints and Other Interim Research
Products https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html

Interim Reports:
Why should I do it? Will it affect publication
in peer-reviewed journals later?
66
http://biorxiv.org
• bioRxiv (pronounced "bio-
archive") is a free online archive
and distribution service
for unpublished preprints in the
life sciences.
• Operated by Cold Spring Harbor
Laboratory, a not-for-profit
research and educational
institution.
• By posting preprints on bioRxiv,
authors are able to make their
findings immediately available to
the scientific community and
receive feedback on draft
manuscripts before they are
submitted to journals.
Concerns about “prior publication.”
List of academic journals by preprint policy:
https://en.wikipedia.org/wiki/List_of_academic_jo
urnals_by_preprint_policy

How to Cite Interim
Research Products
• To cite the product, must include the Digital Object
Identifier (doi) and the Object type (e.g. preprint,
protocol) in the citation.
• List any information about the document version (e.g.
most recent date modified), and if relevant, the date
the product was cited.
– Example: Bar DZ, Atkatsh K, Tavarez U, Erdos MR, Gruenbaum Y, Collins FS.
Biotinylation by antibody recognition- A novel method for proximity labeling.
BioRxiv 069187 [Preprint]. August 11, 2016 [cited 2017 Jan 12]. Available
from: https://doi.org/10.1101/069187.
• Proper citing of preprints helps reviewers understand that the
product is public, interim, and identifies the specific version that
is being referenced.
67

Can highlight in prep or
submitted manuscripts in
personal statement and
contribution narrative on K
or R Bio, but not list as
citation
Mention of High
School Research at
University Level
should be real
research, not washing
lab dishware
OK to list abstracts on all
Bios but in prep and in
review manuscripts on
Fellowship Bio only
NIH Fellowship
Biosketch
Example
Although no longer required, PJ recommends
including all authors names
68
Why does PJ recommend
including all authors names?
As a reviewer of 100s of
training/career development
grants, I want to see who you
have published with!

69
D. Scholastic
Achievement
for Fellowship
F-award
Biosketches
Indicate whether 4.0
grading scale or other
scale used and
describe University
specific grading
definitions

§ STICK to one format of your name for publication.
§ If you have a middle name use initial, especially if your
name is common and there are dozens of you in
PubMed!
§ Don’t do what I did—Published under 3 versions of name:
v PJ Simpson, PJ Haidaris, and PJ Simpson-Haidaris—eek
§ On my Biosketch, I used to include:
The following search string will retrieve the PI’s citations in PubMed:
v ("simpson-haidaris pj"[AU] OR "haidaris pj"[AU] OR “haidaris p” OR "simpson
pj"[AU] AND Rochester[AD]) OR ("simpson pj"[AU] AND "Gene"[Journal]) OR
("simpson-haidaris pj"[AU] AND "Thromb Res"[Journal]) OR ("simpson-haidaris
pj"[AU] AND "J Thromb Haemost"[Journal]) OR (“haidaris p”[AU] AND “Thromb
Haemost”[Journal])
§ Now I include:
v My NCBI | My Bibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/pj.simpson-
haidaris.1/bibliography/40100400/public/?sort=date&direction=ascending
NIH Biosketch Pointer
70

NIH Biosketch Review
• List positions/jobs, education, honors, experiences, and
memberships from oldest to newest (i.e., chronological order
unlike in CV where list newest first).
• Include Post-doc, Residency and Fellowship training in
Education table (include in Positions section as well).
• PJ recommends you include all authors names and
publication PMCID numbers indicating NIH Public Access
Policy compliance.
Ø https://publicaccess.nih.gov
Ø Can include PMID numbers if no PMCID assigned
• Use NIH legal fonts and type size
71

University Authorized
Representative submits
grant on your behalf
72

1. Application title
2. Title of FOA
3. Names of Outside Referees
(include name, department
affiliation, and institution
4. Statement on generating
large-scale genomic data, if
applicable
5. Statement that required
agency approval
documentation included, if
applicable
CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE
2000 CTSI Boulevard · PO Box 1 · Your Town, State Zip+four
555-555-5555· 555-555-5555 fax · www.urmc.UniversityofYours.edu/ctsi
March 5, 2018
Division of Receipt and Referral
To Whom It May Concern:
I am submitting my application, [insert title: “The most import research ever done”] for consideration
under the [insert FOA number and name] PA-18-666: Ruth L. Kirschstein National Research Service
Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31-
Diversity) funding announcement.
Please consider routing this application for review as indicated on the PHS Assignment Request Form.
Note, If you have spoken ahead of time with a Program Officer, include that person’s name and indicate
that the PO recommended the Institute and/or Study Section you selected.
Please consider dual assignment in the National Institute of [insert appropriate alternate institute
where research addresses Institute’s mission].
Research areas contained in this application include [insert four to five keywords that will help Division
of Receipt and Referral to route your application to the most appropriate study section] (Note: many ICs
have either special emphasis panels or standing study sections devoted to reviewing fellowship
awards—look these up and include here AND on optional NIH Institute and Study Section PHS
Assignment Request From.
If applicable, Include a statement in the cover letter if the proposed studies will generate large-scale
human or non-human genomic data as detailed in the NIH Genomic Data Sharing Policy (see
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3_application_information_and_process
es.htm#Policies and
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2_availability_of_research_results_publi
cations__intellectual_property_rights__and_sharing_research_resources.htm#Sharing
My Referees are [include name, departmental affiliation, and institution]:
1. Elmer Fudd, PhD, [insert position, departmental affiliation, and institution]
2. Bart Simpson, MD, PhD, [insert position, departmental affiliation, and institution]
3. Nobel Laureate, PhD, [insert position, departmental affiliation, and institution]
If appropriate, include a statement that you have attached any required agency approval documentation
and include the official communication from an NIH official as part of your cover letter attachment.
Sincerely,
e-signature
Stellar Student, MS
University of Yours
Example
Cover Letter
73
Communicate with Program
Officer before submitting grant to
make sure grant focus matches
expectations of Institute’s
Fellowship Training Mission.
You may use the optional PHS
(NIH Institute and Study Section)
Assignment Request Form—in
cover letter, you are still required
to list names of outside referees.

Second critical take home
2. Build an exceptional Research and Career
Development Mentoring TEAM (Key Personnel).
• Chose sponsors with complementary as role models to
develop research, career advancement and leadership skills.
• Add consultants and research content mentors for training in
highly unique skills.
• Form advisory committee from above individuals that are
essential to accomplish training goals to reach next career
stage—members of an F31 advisory committee do not have
to be the same as the thesis committee.
• Pick mentors (sponsors) with substantial research support
($$) and experience mentoring.
– If primary mentor/sponsor has expertise but “in between” NIH grants, recruit
a co-mentor with substantial funding who commits to support research.
74
TIP

Who are Key Personnel?
• Principal Investigator/Program Director
(PD/PI) (Trainee is PI of F-award)
• Multiple PIs (MPIs)-not allowed for Fs or Ks
• Mentors/Sponsor
• Co-Mentors/Co-Sponsors
• Co-Investigators
• Consultants/Collaborators
75

Mentor or Supervisor?
• A “mentor for life” or a “pair of hands” to advance
the mentor’s career?
• A great mentor vs great supervisor focuses on
helping build the trainee’s career
76
• A mentor for life
o is inspirational
o shares networking
o provides opportunities
o maximizes trainee’s abilities
and learning style
o is part of extended family
Lee et al, Nature 2007

An Inspirational Mentor is…
• Enthusiastic and Passionate
• Sensitive
• Appreciative of Individual Differences
• Respectful
• Unselfish
• Supportive of other trainees (not just his/her
own)
• A good communicator/teacher
• Available
77

Enthusiasm and Passion
• Years of research has not diminished mentor’s
drive to discover new ideas and to pass that
passion on to students
78
• Can find the “teaching
moment” in a bad result
• Unexpected
observations may
provide novel insight
• Provides a big picture
view

“One Size” Mentoring
Does Not Fit All
• Trainees are not like
Money where
– “One Size Fits All” and
– “Is the Perfect Color”
79
• Great mentor appreciates
individual differences
o Different learning styles
o Work ethics
o Cultural diversity
o Personalities
http://www.cyh.com/HealthTopics/library/diversity1.jpg

One Size Does Not Fit All
(mentoring style) (trainees)
80
http://live-language.com/wp-
content/uploads/2013/10/adult-learning-
styles.jpg
Mentor’s
management
style and
Trainee’s work
style need to be
compatible http://www.buzzle.com/img/article
Images/310162-38716-51.jpg

Respectful
81
• Inspires confidence in trainees
as collaborators
• Team Builder
• Treats colleagues and
trainees with same
high regard
• Gives positive and
constructive
assessment of
trainee’s progress http://monkeypantz.net/wp-content/uploads/2013/02/the-
cycle-of-Respect.gif

Unselfish
82
• Allows trainees to have experiences to build
career, network and be recognized for
contributions
• Shares own ideas—
lets trainees take
mentor’s ideas and
run with them
• Lacks defensive
manner http://www.isikplastik.com/wp-content/uploads/2013/10/career.jpg
• Delights in seeing younger scientists succeed

Picking a Mentor (1)
83
• Mentor needs to commit to the length of time
needed to accomplish your training
o Sufficient lab space, equipment and resources
o Financial resources from grants, start-up funds, industry
collaborations
o Does the professor plan to stay at the university?
• Mentor’s research is broadly aligned with your
research interests
o Is a recognized expert in the field
o Able to provide networking opportunities
o Publishes in a timely and regular manner
o Commits to trainee’s career development, hopefully lifelong
adapted from: http://www.cc.gatech.edu/faculty/ashwin/wisdom/how-to-choosean-advisor.html

Picking a Mentor (2)
84adapted from: http://www.cc.gatech.edu/faculty/ashwin/wisdom/how-to-choosean-advisor.html
• Are more advanced trainees happy with the
mentoring interaction?
o Check with 3rd or 4th year graduate students currently in the lab
o Are postdocs doing most of the mentoring?
o Is the lab environment congenial?
• Is the mentor’s lab in a department
associated with your training program?
• Are research projects identified such that a
“no” answer is still publishable?
o How are research projects assigned? (individually or several
people working on very similar projects?)—project “ownership”

Picking Mentoring Team
85
• Identify needed expertise to carry out research
project.
• Choose a co-mentor who complements the
primary mentor’s expertise.
o e.g., basic science researcher, clinician-scientist, or
population/public health researcher
• Advisory or thesis committee mentors who are
content mentors.
o Provide short-term training or expertise in special skills not
available in primary mentor’s lab
o Grant advisory committee members agree to meet 2-4
times/yr; Thesis committees usually meet 1-2 times/yr

Consultants & Collaborators
86
• Usually provide a very specialized reagent, method
or data analysis skill lacking on your mentoring
team
• Are often located at outside Universities
• Can be Advisory Committee Members and also
collaborators
• Must define their working relationship with you (PI)
o Provide reagents only
o Provide intellectual input, career guidance and authorship of
publications
o Consultants and collaborators provide letters of support agreeing to
their contributions
o Sometimes Consultants/Collaborators are also Key personnel, which
means must include their NIH Biosketch

Back to the SF 424 form
• Now that you know who belongs on your
mentoring team and in what capacity,
• Solicit NIH Biosketches (for all listed as
Key Personnel) and
• Request Letters of Support from
consultants and collaborators
– altogether these letters cannot exceed 6
pages
87

PD/PI field populated from
front page information
Asterisks denote
required
information,
including eRA
Commons ID
88
Make sure you are listed in eCommons
as both Trainee and PI; Consult the
person who has authority to submit NIH
grants on behalf of your University

After PD/PI, enter Sponsor and
Co-sponsor, then rest of
mentors alphabetically
Attach Biosketches as pdf files
89
Other Support only for some K-awards

Sponsor’s and Co-sponsor’s
Research Support available to
trainee (PD/PI) (6-page limit)
90
Include in
Sponsors & Co-
sponsors
Statements:
a) Resource
Support available
to Trainee (active
and pending
grants and $
amounts)

91
b) Sponsor’s and
Co-sponsor’s
Track Records of
Mentored Training
• Reviewers want to see that
your mentors are experienced
and passionate about training
predocs and postdocs.
• If Primary Mentor has little
experience, enlist co-mentor
with successful mentoring
history.

Sections c, d & e of Sponsor’s Statement
Activities Planned
Goals; Facilities
IDP
Dissertation
Research and
Prior Research
Experience
Respective
Contributions
Research
Approach
92
Section E is equivalent to the Sponsors Letter of Recommendation
Sponsor’s training plan must mesh with PI’s goals, activities,
research and milestones planned to accomplish goals to
reach next career stage as described in grant sections.
New in Series E for sponsors of fellowship applicants who are proposing to gain
clinical trial research experience under a sponsor's supervision (i.e., but will not be
leading an independent clinical trial—include required statement (p F-66).

Consultants and Collaborators
Letters of Support
(6-page limit in one pdf attachment)
• Consultant and Collaborator letters of support (LOS)
are NOT the same as the Reference letters provided
from 3 Outside Referees.
• Form an advisory committee of key collaborators,
consultants, or advisors who make substantive
contributions to the applicants planned project and
skills development.
• Contents of letter include their anticipated role and
contributions to the research training and/or career
development of the applicant.
93

Third critical take home
3. Recruit outside Referees who can write the
STRONGEST possible letters attesting to your
potential to launch to the next career stage (e.g.,
postdoc for F31 or independent research career
F32 and K-awards).
Three Letters of
Recommendation
Submitted
Separately from
ApplicationLink to format for outside referees to
follow when submitting letters:
https://public.era.nih.gov/commons/public/refere
nce/submitReferenceLetter.do?mode=new
94
• Outside Referees are individuals not
directly involved in the application.
• May need to consider whether a
collaborator is really better suited to be
an outside Referee.

Information PI provides to
outside referees
• PI (Fellowship applicant)
Commons user name
• PI first and last name as they
appear on the PI’s Commons
account
• Funding Opportunity
Announcement (FOA) under
which the applicant is applying
(in our example, PA-18-666)
95

Outside Referees should
comment on PI’s:
• Research ability and potential to become an independent
researcher
• Adequacy of scientific and technical background
• Written and verbal communication skills including ability to
organize scientific data
• Quality of research experiences and/or publications
• Perseverance in pursuing goals
• Evidence of originality
• Need for further research experience and training
• Familiarity with research literature
96
Link to video on Submitting Reference Letters through eRA Commons:
https://www.youtube.com/watch?v=gJwQSI9q5FM&feature=youtu.be

Fourth critical take home
4. Prepare a Research and Career Individual
Development Plan (IDP) to define gaps in training,
and design activities and metrics to meet career
goals and launch to next career stage.
97
Selection of
Sponsor &
Institution
A. Doctoral Dissertation
and Research Experience
C. Activities
Planned (from IDP)
B. Goals
(from IDP)
Respective
Contributions
Advisory (thesis)
committee members
Responsible
Conduct of
Research
Applicant’s Background and Goals
for Fellowship Training described
in 3 sections
An IDP is designed to be a blueprint for your success.

Research and Career
Individual Development Plan
• PI works with Sponsor to develop a research and career
individual development plan (IDP).
• All training grant mechanisms for NIH require that IDPs be
used and described in annual reporting to agency.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-113.html
• IDP is a “living document” where you define goals,
describe activities to meet goals, define benchmarks and
timelines to complete goals, define mentoring team
meetings to monitor progress in achieving goals and plans
to remedy situation if goals change.
– Goals, Respective Contributions, Selection of Sponsors, and
Activities Planned Under this Award are derived from IDP!
98

Applicant’s Background and
Goals for Fellowship Training
• This section was “new” in F-award FOAs released June
2016 and remains in the F-award FOAs released Feb
2018.
• Increased to 6-page limit (from 4 pages)
• Combines three sections (as defined in past FOAs) into
one attachment (and presented in this order):
A. Doctoral Dissertation and Research Experiences
B. Training Goals and Objectives
C. Activities Planned Under Award
99

A. Doctoral Dissertation
and Research Experience
• Summarize research experiences, including
undergrad experiences and lab rotations in
chronological order (oldest to newest).
• Describe your contribution to the research and how
it addressed the “big picture” of research question —
did your contribution help move the field forward?
• Include narrative of doctoral dissertation (may be
preliminary); Do not list academic courses.
• Postdoctoral applicants should specify which areas
of research were part of thesis and which, if any,
were part of a previous postdoctoral project.
PJ Recommends limit to 2 of 6 pages in section. 100

B. Goals and Objectives
• Describe your overall training goals for the
duration of the fellowship and how the proposed
fellowship will enable the attainment of these
goals.
• Identify the skills, theories, conceptual
approaches, etc. to be learned or enhanced
during the award.
• Discuss how proposed research and career
development training plans facilitate transition to
next career stage and future career goals.
PJ Recommends limit to 2 of 6 page in section. 101

C. Activities Planned Under
This Award
• Perform Gap
Analysis of what
skills you have and
what are missing to
achieve goals (This
comes from your
IDP).
• Define activities,
Timetable and
Milestone to verify
how to fill gaps.
• Mention training
activities to enhance
research skills in the
Research Strategy.
102
Example table taken from F31 Activities Planned
section in which the review criteria of “Training Plan”
scored 1 (Exceptional).

C. Activities Planned Under
This Award
• PJ recommends three areas of Activities Planned:
1. Didactic Coursework and Seminars
2. Mentored Research Activities
3. Career Development Activities
• Describe, by year, the activities (research, coursework,
professional development, clinical activities, etc.) you
will be involved in during the proposed award.
• Estimate the %-time devoted to each activity; should = 100% each year
• Describe the planned, non-research activities (e.g.
those related to professional development and clinical
activities) that you plan to engage in during the award
period.
103
Develop table with %-effort devoted to each training activity,
timeline of completion, and benchmarks to measure success!

C. Example of Activities
Planned Under This Award
3 first-authored papers high impact journals
Career skills workshop How to Negotiate
Present at National Meetings
Teach Class or Two in Research Discipline
Research techniques to be learned; how learn and
mentors involved
Short Course on Specialized Techniques
Biostatistics/Advanced Programing
Grant Writing
Seminar Series in Discipline of Science
Student Seminars
Discipline-specific courses to fill gaps
Travel to Collaborators Lab for Specialized Techniques
Lab Meetings, Research in Progress
Write and Defend PhD Thesis
Submit Grant Application
Secure Postdoc Position and others…specific to YOU
Suggest start section with three
paragraphs corresponding to 3 major
areas of Research and Career
Development:
1. Didactic Coursework and Seminars.
2. Mentored Research Activities.
3. Career Development Activities.
Briefly explain where you are to date in
training activities in each category and
describe new activities to meet your goals.
Include specifics on didactic course work
(# credit hours, course ID and Name and
how this will accomplish you training
objective).
Indicate time needed to accomplish and
percent of time on each major area. 104

Respective Contributions
This item is limited to one page.
• Describe the collaborative process between you and
your sponsor/co-sponsor in the development, review,
and editing of this research training plan.
• Discuss the respective roles in accomplishing the
proposed research.
• Include respective roles of Advisory Committee
members and consultants/collaborators.
105

Example
Template for
Respective
Contributions
Section for F31
106
TIP:
Include Milestones
and Benchmarks to
document
accomplishments—
Reviewers like this!

Selection of Sponsor and
Institution
Predoctoral and postdoctoral fellows:
• Describe the rationale/justification for the selection of the sponsor and
institution to accomplish research training goals.
Postdoctoral fellows only:
• Training is expected to broaden a fellow's perspective, thus postdoc
applicants requesting training at either their doctorate institution or at
the institution where they have been training for more than a year
must explain why further training at that institution would be valuable.
107

Responsible Conduct
of Research (RCR)
–Cover the five REQUIRED items:
1. Format with substantial face-to-face contact (all
online training not acceptable)
2. Content/Subject Matter
3. Participating Faculty (name specific faculty
involved)
4. Duration of training (contact hours)
5. Frequency—at least once per career stage or every
four years, whichever is shorter time period
108

Example
Template of
Responsible
Conduct of
Research
(RCR)
covering
format, content,
faculty, duration
and frequency
109
Recommend including
Training in Data
Reproducibility and
Rigor in Science

Training in Data Rigor and Reproducibility
Institutional Training Grants = new attachment “Plan for the Instruction in
Methods for Enhancing Reproducibility.”
Based on the new online training modules in Rigor and
Reproducibility, as developed and released by the National Institute
for General Medical Sciences (NIGMS), the PI in discussions with
Co-sponsors will examine each step of the scientific method from
the standpoint of enhancing scientific rigor and reproducibility –
starting with experimental design, and progressing to methodology
and laboratory practices, statistical data analysis, reporting of
results, data interpretation, the confirmation of bias in hypothesis
testing, and the current system of scientific rewards and
advancement - using specific examples and cases. Furthermore,
Authentication of Key Biological and/or Chemical Resources will be
carried out per NIH recommendations as well.
110
Sample Language (by PJ not NIH) for satisfying the need to
address scientific rigor and reproducibility. Can include in RCR,
Research Strategy Approach and/or Sponsor’s statement.

Videocasts and Training Modules
to Enhance Data Reproducibility
• Reproducibility of Data Collection and Analysis – Modern Technologies in Cell
Biology: Potentials and Pitfalls (11-24-2014)
https://videocast.nih.gov/summary.asp?Live=15277&bhcp=1
• Reproducibility of Data Collection and Analysis – Modern Technologies in Structural
Bi- ology: Potentials and Pitfalls (03-13-2015)
• Reproducibility of Data Collection and Analysis – Modern Technologies in Genome
Technology: Potentials and Pitfalls (06-04-2015)
• NIH Workshop on Reproducibility in Cell Culture Studies
09-28-2015 Day 1: https://videocast.nih.gov/summary.asp?Live=16876&bhcp=1 09-
29-2015 Day 2: https://videocast.nih.gov/Summary.asp?file=19196&bhcp=1
• Improving Openness and Reproducibility of Scientific Research (10-26-2015)
https://videocast.nih.gov/summary.asp?live=17454&bhcp=1
• Clearinghouse for Training Modules to Enhance Data Reproducibility
https://www.nigms.nih.gov/training/pages/clearinghouse-for-training-modules-to-
enhance-data-reproducibility.aspx
111

Select Agent Research
• A select agent is a biological agent or toxin that has the
potential to pose a severe threat to public health and safety,
animal or plant health, or animal or plant product
• Include a “Select Agent Research” attachment if your proposed
activities involve the use of select agents at any time, either at
the applicant organization or at any performance site.
• Your Primary Advisor/Sponsor will know if your research
involves select Agents!
• HOWEVER, if you use biohazardous agents, include in
Research Strategy how you handle them (e.g., BL2 organisms,
human primary cells, human tissue samples, lentiviral and other
viral constructs, etc.)
112

Resource Sharing Plan:
indicate how will distribute
113
• Sharing Model Organisms
– include a description of a specific plan for sharing and distributing
unique model organisms or state why such sharing is restricted or
not possible.
• Genomic Data Sharing (GDS)
– Examples of large-scale genomic data include genome-wide
association studies (GWAS), single nucleotide polymorphisms
(SNP) arrays, and genome sequence, transcriptomic, epigenomic,
and gene expression data.
• Other Unique Resources
– If generate other resources such as new monoclonal antibodies,
cell lines or other unique reagents not easily made or available,
must also include resource sharing plan.

Authentication of Key Biological
and/or Chemical Resources
• Do not submit an “Authentication of Key Biological
and/or Chemical Resources” attachment unless it is
specifically requested in the FOA.
– However, if you are using unique resources not widely
available, best to include information in Research Strategy
on how the reagent was validated for intended use.
• Check frequently for release of updated FOAs and
notices (NOTs) from NIH to verify whether sections
required or not!
114

Don’t Forget the
Research Grant!
Biosketches
PD/PI
Sponsor
Co-sponsor
Advisory
Committee
Members
Consultants
+ their letters
Summary/
Abstract
Narrative/
Public Health
Significance
Introduction,
if resubmission
Specific Aims
Research
Strategy
Bibliography/
References
Cited
Cover Letter
115

Other important sections of
F-award applications
Bibliography
Facilities & Other
Resources
Equipment
Summary/
Abstract
Narrative/
Public Health
Significance
Other
Attachments
1) Diversity eligibility
Diversity_Eligibility_Ltr.pdf
Only for F31 Diversity
PA-18-666
116

Project Summary/Abstract
(Max 30 lines of text)
• State the application’s broad, long-term objectives and specific
aims, making reference to the health relatedness of the project
(i.e., relevance to the mission of the funding agency).
• Describe concisely the research training program design and
methods for achieving stated goals.
• Avoid describing past accomplishments and the use of the first
person.
• Do not include proprietary, confidential information or trade
secrets.
117

Project Narrative
Public Health Relevance
• Describe the relevance of this research to public
health.
• Be succinct and use plain language that can be
understood by a general, lay audience.
• Use no more than two or three sentences.
118

Bibliography &
References Cited
• Should include names of all authors, the title, Journal name,
volume number, inclusive pages, and year of publication.
– Although no longer required to list all authors names, PJ recommends
to include all names so Reviewers can determine the senior authors
• Include only bibliographic citations.
• Interim reports are allowed.
• Provide PMCID number for PI’s and Sponsor’s articles that
fall under NIH Public Access Policy.
– https://publicaccess.nih.gov
119

Facilities & Other Resources
(no page limit)
• Identify only facilities used for this project and PI’s training activities
(Laboratory, Animal, Computer, Office, Clinical and Other such as Core
Facilities—some of this info is in Sponsors statement—make use of
sections to maximize information for reviewers).
• Describe how scientific & intellectual environment contributes to
probability of success (e.g., institutional support, physical resources,
and intellectual rapport/environment)
– Any Nobel Laureates, National Academy or Institute of Medicine members, etc., with
whom you interact or are invited to your institution to give seminars, lectures or
workshops? Be sure to mention—but only if real interactions!
• Discuss ways proposed studies will benefit from unique features of
scientific environment, subject populations or collaborative,
multidisciplinary arrangements.
• Include resources from Clinical and Translational Science Institutes
and support for Graduate Students at your University.
120

Describe the
physical layout of
research labs and
PhD training
program home
base and how
these resources
aid in training the
PI (F-award
applicant!)
121
Facilities and
Other
Resources
Section
example:

Equipment
(no page limit)
• List major items of equipment already available for this
project and, if appropriate identify location and pertinent
capabilities.
• List major equipment that will be used by PI in co-
sponsors’ and collaborators’ labs as well.
• Note, core facilities to be used by this project are usually
described in Facilities & Other Resources section.
122
Identify special equipment used in Sponsors’ and
collaborator’s labs. But, no need to identify every vortex, stir
plate, pipet-aid in the lab…

Institutional Environment and
Commitment to Training
• Document a strong, well-established research program related to
the candidate's area of interest.
• Describe opportunities for intellectual interactions with other
investigators, including didactic courses offered, journal clubs,
seminars, and presentations.
• Indicate the facilities and other resources that will be made
available for both career enhancement and the research
proposed in this application.
• Refer to other sections: Equipment, Facilities, and Other
Resources, Sponsor and Co-sponsor Statement, and
Applicant’s Background and Goals for Fellowship Training.
123
• These parts provided with input from Sponsors and PI (you)

Institutional Environment and
Commitment to Training
2-page limit
• Describe the dual-degree (F30) or graduate (F31) program in
which the applicant is enrolled.
• structure of the program, required milestones and their usual timing
• number of courses, teaching commitments and qualifying exams
• average time to degree over the past 10 years
• the progress/status of the applicant in relation to the program’s
timeline, and the frequency and method by which the program
formally monitors and evaluates a student’s progress.
• clinical tutorials during the graduate research years and any activities
to ease transition from the graduate to the clinical years of the dual-
degree program.
• research-associated activities during the clinical years of the dual-
degree program.
124
• This information is provided by the PhD and/or MD-PhD Program Directors.
• Include names of individuals providing this information at the end of section.

• Example information
included in
“Institutional
Environment and
Commitment to
Training” section.
• Received Criterion
Score of “1” from all
six reviewers on two
F31 applications
funded in 2017.
125

• Make sure information in this
section agrees with information
provided in other sections of
grant.
• Important for applicant to
provide PhD program director
and Sponsors with drafts of ALL
training sections of the grant
AND all Biosketches, including
Applicant, Sponsors and
Advisory Committee Members.
• Why is this important? Shows
the Reviewers that the applicant
TALKS to all faculty needed to
prepare the:
• BEST APPLICATION
POSSIBLE. 126

Certification of Eligibility for
Diversity Award Provided by Dean
of Graduate Studies Office
(e.g., Registrar or Dean)
127
Only needed for
Diversity F31
PA-18-666

about Peer Review
5. They are not called “Vague Aims”… they are
called “Specific Aims”
6. Reviewers are assigned 8-10 grants so they
7. Demonstrate your enthusiasm and passion
for research and attaining career goals with
Clear, Concise and Compelling writing and
Visually Splendid Figures.
8. You get 15 minutes of Fame at Peer Review
– if you are lucky to have your grant discussed.
128

Specific Aims and
Research Strategy
Specific Aims
1-page limit
• Your entire grant
condensed to 1-page!
Research Strategy
6-page limit
• Significance
• Approach
129

• Only 3 of 20 or so reviewers
on study section panel read
entire grant.
• Rest of panel members
have equal vote.
• Specific Aims page may be
only part of grant they read.
• Needs to clearly convey
entire grant to 17 other
reviewers.
130
NIH Peer Review Process Revealed:
https://www.youtube.com/watch?v=fBDxI6l4dOA&feature=youtu.be
5. They are not called
“Vague Aims”… they
are called “Specific
Aims” for a reason!

Specific Aims Language
There is no innovation
section in F-awards,
although they can still be
“innovative” but not risky!
131

Save space on specific aims page
to briefly describe training plan
and how it will launch you to next
career stage
(this information should also be in the abstract)
This last sentence is more appropriate for K award than F
award, but describe specific details of your training plan.
132

A good format for a Specific
Aims Section is a Sandwich
133
Specific Aims: objectives (working hypotheses) and
description of approach
the
Meat
Last paragraph: impact and outcomes and how
results will move the field forward
the
Bread
First section: topic, goals, objectives, overarching
hypothesis, and rationale to define gap in field
the
Bread
• Consider use of visual models (schematics) to communicate
a complex subject and how aims relate to central hypothesis
Additional Resource: http://www.biosciencewriters.com/NIH-Grant-
Applications-The-Anatomy-of-a-Specific-Aims-Page.aspx

TIP: Your aims must be written in such a way that, no matter
how the hypothesis tests – yes/no, up/down, left/right – you
will accomplish the aim’s objective.
Russell SW, Morrison DC. The Grant Application Writer’s Workbook
for NIH. 2015. http://www.grantcentral.com/ 134
We emphasize again that the importance of your specific aims cannot be exaggerated.
Therefore, before proceeding, we recommend that you review what you have just writ-
ten one more time with the following important questions in mind:
i. Are any of your aims descriptive, i.e., do any propose ‘look-to-see’ research, i.e.,
an unfocused fishing expedition?
ii. Are your aims directly linked to parts of your central hypothesis?
iii. Are any of your aims superfluous to testing a part of your central hypothesis?
iv. Is each aim driven by a working hypothesis that serves to focus the research that
is proposed under that aim?
v. Does your ability to pursue later aims depend in any critical way upon an expected
outcome of an earlier one?
If your answer is ‘Yes’ to question i, iii or v, or ‘No’ to either question ii or iv, you need
to reformulate your specific aims before proceeding.

Research Strategy
Limited to 6 pages
1. Significance
• Explain the importance of the problem or critical barrier to progress
that project addresses.
• Explain how project will improve scientific knowledge, technical
capability, and/or clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field will be
changed if the proposed aims are achieved.
• If proposing to gain experience in a clinical trial, describe the
relationship of the proposed research project to the clinical trial.
• Fellowship applicants should not include an Innovation section
except in the unusual circumstance where it is specified in the
FOA.
135
Innovation section is currently NOT included in F31
http://grants.nih.gov/grants/forms_page_limits.htm

Purpose of Significance Section
1) Justify the need for research you propose to do.
2) Establish the scientific premise (rationale) for your
application.
Ø Discuss the strengths and weaknesses of the published
literature cited in support of your research project that leads to
defining the gap in the field and hypothesis to be tested
Ø Discuss the strengths and weaknesses of your preliminary data
presented in grant demonstrating feasibility of your project
Ø Your data should provide support of your hypothesis and
demonstrate “doable” methods of approach
3) Inform reviewers as to why your research contribution
is expected to be significant.
136

Research Strategy
Limited to 6 pages
2. Approach
• Describe overall strategy, methodology, and analyses to accomplish
specific aims; how data will be collected, analyzed (statistics),
interpreted and how data or resources created are shared (include
Resource Sharing Plan as appropriate).
• Discuss potential problems, alternative strategies, and
benchmarks for success anticipated to achieve the aims.
• Provide preliminary data or strategy to establish feasibility, and
address the management of any high risk aspects of the proposed
work.
• Point out any procedures, situations, or materials that may be
hazardous/biohazardous to personnel and the precautions to be
taken.
137
http://grants.nih.gov/grants/forms_page_limits.htm

Research Strategy Tips
• Remember to include discussion of potential problems,
alternative strategies, and benchmarks for success
anticipated to achieve the aims.
• Discuss robustness of methods, soundness of published
literature and your preliminary results used to establish project
rationale (scientific premise) and define “Gap in Field” your
research is intended to answer.
• Provide a Gantt chart timeline for Research project.
138

Mail room 1
6. Reviewers are assigned 8-10 grants so
Mail room at NIH Office of Receipt and Referral.
The old days when we had to send between 5-25
printed copies of the grant!
139

Tell a good story and make is
easy to read
7. a. Demonstrate your enthusiasm and
passion for research and attaining career
goals with Clear, Concise and Compelling
writing.
– Sorry, you have to get your help with writing
from other sources such as:
– ”The Nuts and Bolts of Scientific Writing”
http://www.academicpeds.org/espauthoring/page_21.htm
b. Prepare Visually Splendid Figures.
140

Figures and Tables
“Dos and Don’ts”
• Figures and tables should stand on their own—
the legend should be informative and legible.
• Decide whether to present data in table, graph,
figure or in the text.
• Use the fewest figures and tables needed to tell
a story.
• Design figures, tables and graphs to have strong
visual impact.
141
Tip: place preliminary data near the text (narrative) that FIRST
describes the results. Don’t make the reviewer have to flip back
and forth from one page to another and back again.

Diagrams and Drawings
• Schematic (cartoon) representation of basic principles,
signaling pathways or summary of results may be
appropriate.
• This is a way to control amount of detail needed to
understand concepts or conclusions.
• Often schematics are overly complicated—more is not
always better.
…or, how not to get a grant…
142
Tip: Include ONLY data to support your proposed
research. If this means making a new figure to
simplify what you present—MAKE the New Figure!

Grant Schematic Don’t:
Fibrin(ogen)-mediated Mechanisms of
Wound Repair
143
How not to get a grant.
PJ’s figure from 2001
NIH grant not funded.

Larson, G. The Complete Far Side. 2003.
144
The KISS
principle to
making
figures.
Keep IT
Simple, Stupid.

Loss of Function Schematic—
from funded grant!
145
Grant
Schematic
“Do”
Figure from
PJ’s funded
DoD grant.

Gain of Function Schematic—
from funded grant!
146
Grant
Schematic
“Do”
Figure from
PJ’s funded
DoD grant.

Some Sections Depend on Type
of Research Conducted
147
Risks
Benefits
Human
Subjects?
Enrollment
Women
Children
Minorities
DSMP/DSMB
Vertebrate
Animal
Research?
Vertebrate Animal
Section
• Description of
Procedures
• Justify Species Used
• Minimization of Pain
and Distress
• Euthanasia
Select Agents?
Resource
Sharing Plan
Stem Cell
Research/Bio-
hazards?
Facilities & Other
Resources;
Equipment
(required, but include only facilities
related to YOUR research)
Data Sharing
Plan

8. 15 Minutes of Fame
aka Peer Review
• Three reviewers are assigned to your grant
– Primary and Secondary Reviewers read; tertiary reviewer usually
reads very quickly.
– Primary Reviewer BREIFLY describes proposal goals and
training plan; describes strengths and weaknesses of proposal
per review criteria.
– Secondary and tertiary reviewers concur or add strengths and
weakness that are different based on their perspective.
• In 15 minutes, the rest of reviewers on the study section panel
will receive all the information they will get to score your grant.
• How can 20+ people decide how to score your grant in 15
minutes?
148
Video on NIH Mock Study Section:
https://www.youtube.com/watch?v=lzBhKeR6VIE
Watch this video to understand
your 15 min (or less) of fame!

The NIH Grant Process:
The Big Picture
149
https://www.youtube.com/watch?v=rNwsg_PR90w
8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant
https://nexus.od.nih.gov/all/2017/02/03/new-peer-review-videos-for-applicants-and-
reviewers/?utm_source=nexus&utm_medium=email&utm_content=nihupdate&utm_camp
aign=jan17

Criteria for review of F-series NRSA
Individual Fellowship Awards (1)
- Overall Impact Score and Statement
Overall impact score reflects reviewer’s assessment of likelihood that
the fellowship will enhance the PI’s potential for, and commitment to, a
productive independent scientific research career in health-related field.
150
- Application Review Information
Verbatim from PA-18-666: A fellowship application has a research
project that is integrated with the training plan. The review will
emphasize the applicant's potential for a productive career, the
applicant's need for the proposed training, and the degree to which
the research project and training plan, the sponsor(s), and the
environment will satisfy those needs.

1. Fellowship Applicant
– Sections of grant that provide this information
• PI Biosketch
• Sponsor’s Statement
• Outside Letters of Support
• Applicant’s Background and Goals for Fellowship Training
• Enthusiasm and Passion must resonate throughout the
entire application
151

2. Sponsors, Collaborators and Consultants
– Sections of grant that provide this information
• Sponsors, Consultants and Collaborators Biosketches
• Sponsors Statement
• Consultants and Collaborators Letters of Support
• May be found in Outside Letters of Support if referees know
your sponsors really well
152

3. Research Training Plan
Sections of grant that provide this information
– Specific Aims page
– Research Strategy
– PI Biosketch
– Vertebrate Animals and Human Subjects/Clinical trial experiences
– Institutional Environment and Commitment to Training
– Applicant’s Background and Goals for Fellowship Training
• Gantt Charts/Tables included in Research Strategy and Activities Planned
153

4. Training Potential
– Sponsors, Consultants and Collaborators Biosketches
– Sponsors’ Statement
– Specific Aims page
– Research Strategy (Gantt Chart/Table included in Research Strategy)
– Applicant’s Background and Goals for Fellowship Training
• Gantt Chart/Table included in Activities Planned (section C)
– Institutional Environment & Commitment to Training 154

5. Institutional Environment & Commitment to
Training
– Institutional Environment & Commitment to Training
– Facilities and Other Resources
– Equipment
– Sponsors Statement (including intellectual environment)
– Consultant and Collaborators Letters and Biosketches
– Sponsors Biosketches (demonstrating grant support history)
155

What will immediately cause an
application to go un-reviewed
(because you did NOT READ the FOA)
• Not following Appendix Requirements
• Missing information required for F awards
– Diversity_Eligibility_Ltr.pdf, which certifies eligibility for the F31
Diversity Award
• Not following instructions found in NRSA parent FOAs
• PA-18-671 – F31, Predoc (Parent)
• PA-18-666 – F31, Diversity Predoc (Parent)
• PA-18-668 – F30, MD-PhD Predoc (Parent) for institutions with NIH funded
dual degree programs (e.g., MSTP)
• PA-18-673 – F30, MD-PhD Predoc (Parent) for institutions without NIH
funded dual degree programs
• PA-18-670 – F32, Postdoctoral (Parent)
156

FOA-specific Instructions are
Found in Section IV of FOA!
Required Application Instructions
It is critical that applicants follow the Fellowship (F) instructions in the
SF424 (R&R) Application Guide [URL below] EXCEPT where instructed
to do otherwise (this FOA or a Notice [NOT] from the NIH Guide for
Grants and Contracts). Conformance to all requirements (both in the
Application Guide and the FOA) is required and strictly enforced.
Applicants must read and follow all application instructions in the
Application Guide as well as any program-specific instructions noted in
Section IV [of F-award parent FOA]. When the program-specific
instructions [i.e., NRSA F-fellowship program] deviate from those in the
Application Guide, follow the program-specific [in FOA] instructions.
Applications that do not comply with these instructions may be
delayed or NOT accepted for review.
Verbatim instructions from PA-18-666
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/fellowship-forms-e.pdf
157

What does it take to write an
F-award application?
(refusal to take “No” for an answer) [1]
• Allow plenty of time to complete all sections.
– make sure when editing sections, such as goals you
also edit activities planned to accommodate changes in
goals.
– same goes for specific aims and research strategy—if
you add or delete an aim, make sure the experimental
design matches!
• Recommend you have at least 1 first-author
publication for F31/F30 (at least submitted) and
two-three for F32.
158

What does it take to write an
F-award application?
(refusal to take “No” for an answer) [2]
• Enlist mentors and outside referees early and
discuss project and goals so they can commit to
participate and write supportive letters because
they KNOW you.
• Work with sponsor and university representative
to complete all aspects of project.
• Read ALL instructions and Pay Attention to
detail; let others read, & edit, edit, edit.
• Oh, and edit some more after putting it aside for
awhile. 159

How long it really takes to
write a fundable grant
160Inouye & Fiellin Ann Intern Med. 2005;142:274-282.
and vertebrate animals

Acknowledgements
• Heartfelt thanks to PJ’s students in the Translational Biomedical Science
PhD program at the University of Rochester who have graciously agreed
to share their experiences in writing successful F30s and F31s.
• Supported by the University of Rochester CTSA awards UL1 TR000042,
TL1 TR000096 and TL1 TR002000 from the National Center for
Advancing Translational Sciences, and the Rochester Bridges to the
Doctorate for Deaf and Hard-of-Hearing Students award R25 GM107739
and Rochester Postdoc Partnership to Advance Research and Academic
Careers of Deaf Scholars award K12 GM106997 from the National
Institute of General Medical Sciences of the National Institutes of Health.
• The suggestions are solely the responsibility of the author and does not
necessarily represent the official views of the National Institutes of
Health.
161

Source Material
• PA-18-666: Ruth L. Kirschstein National Research Service
Award Individual Predoctoral Fellowship to Promote
Diversity in Health-Related Research (Parent F31 –
Diversity)
• FELLOWSHIP INSTRUCTIONS FOR NIH AND OTHER
PHS AGENCIES SF424 (R&R) APPLICATION
PACKAGES (Updated Dec 29, 2017).
• Fellowship Applicant Biosketch samples from NIH
• NIH websites as screen shots
• Section Templates constructed by PJ and students
162

Source Material
• “Nuts and Bolts of Scientific Writing”
– http://www.academicpeds.org/espauthoring/page_21.
htm
• “Clear, Concise and Compelling”
– https://incrediblemessages.com/strategies-clear-
concise-and-compelling-writing/ (retrieved 3-7-2018).
163

Helpful NIH Websites and Videos
• NIH Peer Review Mock Study Section
– https://www.youtube.com/watch?v=lzBhKeR6VIE
• 8 Ways to Successfully Navigate NIH Peer
Review and Get a Fellowship Grant
– https://www.youtube.com/watch?v=_Gr-D68NawQ&t=
• NIH Grants Process: The Big Picture (video)
– https://www.youtube.com/watch?v=rNwsg_PR90w
• Getting Started: Learn the Basics
– https://grants.nih.gov/grants/grant_basics.htm
• Grants Process Overview
– https://grants.nih.gov/grants/grants_process.htm
164

Disclaimer
• This presentation includes recommendations from successful F-award
applications of trainees, details of instructions extracted from the
Fellowship Instructions for NIH and Other PHS Agencies (Updated
Dec 29, 2017), PA-18-666 and NIH websites. Appropriate Links are
provided in specific sections of this presentation.
• Because NIH grant instructions change periodically, we recommend
that all information be verified as the most recent by frequently checking
for updated NIH instructions, notices (NOTs), URL links, and funding
opportunity announcements (FOAs).
• Finally, specific content to include in trainee and research sections is
the direct responsibility of the PI and his/her mentoring team
members—information provided here is for guidance only and should
not be used verbatim.
165

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