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29 April 2017 the file was updated.
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The document provides guidance on writing successful research proposals. It discusses dealing with writing blocks, getting ready to write, elements of a proposal such as the title, abstract, introduction, objectives, literature review, proposed work description, budget, resumes and final checks. Tips are provided for each element, including developing an outline, following funding guidelines, establishing a timetable, and reviewing proposals repeatedly. The document emphasizes establishing objectives, justifying budgets, showing qualifications in resumes, and ensuring proposals address the problem and methodology clearly.
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Based on National Qualifications Framework for Higher Education of Thailand, this Doctor of Philosophy in eLearning Methodology (PhDeLM) is a Plan 1.1 research degree program requiring students to take no coursework but register for 48 credits for research work to complete their dissertation. This Stylebook comprise of two main chapters.This chapter includes the details about three phases of study. Chapter-2 covers the Stylebook which provided details of formats of documents, reports and
dissertation in order to help all students to have uniformity in writing the manuscripts.
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TL1 NRSA F award application workshop and How to Prepare Complete ApplicationPJ Simpson-Haidaris
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29 April 2017 the file was updated.
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Final f award-nrsa-fellowship-application-series-f-forms-workshop-updated_may 26, 2021
1. The First (F) award?
No, F does not mean First but Fellowship
PJ Simpson-Haidaris, PhD
Association for Clinical & Translational Science
Workshop presented April 20, 2017
TL1 Subcommittee on Funding Opportunities
SlideShare presentation updates:
3-8-2018 and 5-26-2021
1
Session: Preparing an F-Award at the Pre-Doctoral Level
(same information works for the F32 postdoc NRSA too)
This is an Extended Version with updates for SlideShare distribution
Updated May 26, 2021 to include new F-award FOAs using Adobe Forms Series F
2. Disclosures
PJ Simpson-Haidaris, PhD
Associate Professor of Medicine
Translational Biomedical Science
PhD Program Director, 2011-2017
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
3. Table of Contents (1)
Topic Slide number
Speaker’s Credentials and Disclosures 1,2, 10, 11
Table of Contents 3 - 8
What is a Grant? And How do you get one? 9
Outline describing how presentation organized 12
Critical Take Home Messages 1-4 About F-awards 13
Four Critical Take Home Messages 5-8 About Peer Review 14, 136
Ruth L. Kirschstein NRSA F-award program 15
NIH structure and NIH Path to a Successful F-award 16-18
Getting Started: “F Kiosk” is your Friend, Types of F-awards 19-21
How to read a Funding Opportunity Announcement 22-29
Fellowship Instruction Guide for NIH and Other PHS Agencies-Forms Version F 30
SF424 (R&R) page 1 form required information 31
SF424 (R&R) page 2 form required information 32
Research & Related Other Project Information SF424 form 33
3
4. Table of Contents (2)
Topic Slide number
Clinical Trials Not Allowed for PA-21-052 F31 diversity 34, 35
PHS Fellowship Supplemental Form and required attachments 36-38
PJ’s recommended F-award Checklist per SF424 attachments 39, 40
Craft a Robust Title 41, 42
Training Specific Sections of F-award 43
Other grant sections to include depending on Research Conducted 44
Sections needed for Research Grant 45
Key Personnel: PI is the Trainee; Need eRA Commons ID as Trainee and PI 46
Rules: Font size, line spacing and type density 47
First Critical Take Home Message: Prepare Proper NIH Fellowship Biosketch 48-70
Example NIH Fellowship Biosketch 59, 61, 65, 67
NIH Public Access Policy 71, 72
Interim Reports, what they are and how to cite them in grant and Biosketch 73-76
University Representative Submits Grant on Your Behalf 77
Cover Letter Requirements and Suggested Format (Example Provided) 78
4
5. Table of Contents (3)
Topic Slide number
PHS Assignment Request Form to suggest NIH Institute of Center (IC) and study
section for review
79
Second Critical F-award Take Home Message: Build an Exceptional Research and
Career Development Mentoring TEAM
80-92
Back to the SF424 instructions and attachments 93
PD/PI and Key Personnel information required on SF424 form 94, 95
Sponsors and Co-Sponsors Information ($$, former trainees, Mentoring Plan) 96-98
Consultant & Collaborators Letters of Support (LOS) 99
Third Critical F-award Take Home Message: Recruiting Outside Referee for Letters 100-102
Fourth Critical F-award Take Home Message: Individual Development Plan (IDP) 103-105
Applicant’s Background and Goals for Fellowship Training (3 parts) 106-111
Respective Contributions (Example) 112, (113)
Selection of Sponsor and Institution 114
Responsible Conduct of Research (Example) 115, (116)
Training in Data Rigor and Reproducibility 117-119
Select Agent Research 120
Resource Sharing Plan (Example) 121
5
6. Table of Contents (4)
Topic Slide number
Authentication of Key Biological and/or Chemical Resources 122
Research Grant and Other Important Sections on SF424 123, 124
Project Summary/Abstract 125
Project Narrative/Public Health Relevance 126
Bibliography & References Cited 127
Facilities & Other Resources (include intellectual resources) and example 128, 129
Equipment 130
Institutional Environment and Commitment to Training 131-134
Certification of Eligibility for Diversity Award (F31 Diversity only FOA) 135
Critical Take Home Messages 5-8 About Peer Review 136
SF424 attachments Specific Aims & Research Strategy 137
Peer Review Message 5. They are not called “Vague Aims but “Specific Aims
Specific Aims Page, Importance, Format and Language
138
NIH Instructions for Content of Specific Aims page 139
Structure of Specific Aims page in more detail 140-144
Typical Specific Aims Language 145
6
7. Table of Contents (5)
Topic Slide number
F-trainees and K-scholars need to describe “Training Potential” or how the
research and career development training will launch PI to next career stage
146
Sample Structure for Specific Aims Page Format 147, 148
Tip: Yes or No questions your Specific Aims must adhere to 149
Are your Specific Aims Hypothesis-Driven of Exploratory/Discovery/Descriptive
Science?
150-155
Research Strategy: Significance 156
NIH definition of “Significance” vs “Overall Impact” of research proposal 157
Research Strategy: Approach 158, 159
Peer Review Message 6. Reviewers have limited time to review YOUR grant 160
Peer Review Message 7. Enthusiasm and Passion for Research and Visually
Splendid Figures
161
Figures and Tables “Dos and Don’ts” 162
Diagrams and Drawings 163
Grant Schematics Dos and Don’ts 164-167
The Temptation of Image Manipulation—Just Don’t Do It 168-170
7
8. Table of Contents (6)
Topic Slide number
Some Sections Depend on Type of Research Conducted 171
Peer Review Message 8. 15 Minutes of Fame (aka Peer Review) 172
The NIH Grant Process: What Reviewers Are Looking For 173
Criteria for Reviewing F-awards 174-179
What will immediately cause an application to go unreviewed
(because you did NOT READ the FOA)
180
Where FOA specific instructions found? 181
What does it take to write an F-award application? (refusal to take “No” for an answer) 182, 183
Timeline for how long it takes to write a grant 184
Acknowledgements 185
Source Material 186
Helpful NIH Websites and Videos (links) 187
Disclaimer 188
8
9. What is a grant?
9
noun
1. a sum of money given by an organization,
especially a government, for a particular
purpose.
= gr + ant?
How do you get one?
10. 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)
10
11. Dr. PJ’s mentoring and grant reviewing &
getting experience
• 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!
11
12. Outline
• The presentation is organized around “Critical Take Home Messages” about F-awards
and National Institutes of Health (NIH) 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 using F31 Diversity Predoc as example.
– SF424 form—the pesky administrative details and electronic forms
– Training Plan and Activities for Career Development and Skills acquisition
• Applicants Background, Career Goals, and Activities Planned to get you to next career stage
• Selection of Sponsors and Mentors (detailed information to help make the best choices for you)
• Sponsors (Mentors) Statement—How sponsors oversee applicant’s career development and research training
• Other required Grant Body Parts (Biosketches, Facilities & Other Resources, and many more)
– Research Training Plan
• Specific Aims—the whole grant in one page—details of crafting a compelling specific aims page
• Is your research Hypothesis-Driven or Exploratory (Descriptive, Discovery) in nature?
• Research Strategy—the science
• Grant figures, graphs, and schematics dos and don’ts—ethical issues of research and scientific communications
• NIH Peer Review—what reviewers are looking for in an F-award application.
• Resource Materials and Useful Links.
12
13. 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.
13
14. Critical take home messages about
Peer Review
5. They are not called “Vague Aims”… they are called
“Specific Aims” for a reason!
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).
14
15. Ruth L. Kirschstein, MD
NRSA Individual Fellowship Funding Opportunity
Announcements (FOA)
• Played a 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.
15
http://www.nih.gov/about/kirschstein/
16. You likely know what NIH is, but maybe
you don’t know how it works
16
• 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.
17. NIH Path to a Successful
F-Award, in a Nutshell
• When choosing the Institute or
Center (IC) 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 and institute program
officers
–Choose the Study Section
that best fits your research
topic.
– https://public.csr.nih.gov/StudySe
ctions
17
8 Ways to Successfully Navigate NIH Peer Review and
Get a Fellowship Grant
https://www.youtube.com/watch?v=_Gr-D68NawQ&t=
19. Find your FOA: “F Kiosk” is your Friend
19
Always check for most recent
Funding Opportunity Announcement
• NIH has a habit of updating FOAs two
months (or less) before a due date.
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 (FOAs) are top links
https://researchtraining.nih.gov/programs
/fellowships
21. F-award FOAs requiring use of Adobe Forms Series F
21
https://researchtraining.nih.gov/programs/fellowships
Active as of May 4, 2021
Diversity FOAs in Blue Font
22. Funding Opportunity Announcement (FOA)
PA-21-052
22
The grant sections (grant body
parts) described in this workshop
are essentially the same for F30,
F31 and F32 funding mechanisms.
PA-21-052 is used as model FOA.
Make sure you use the most
recent version of FOA.
Verify that expiration date is in the
future.
23. Hard Part is Over
• Almost.
• You 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.
23
24. Check Which Institutes and Centers (IC) Participate
24
Understand
how to read
the FOA
Must determine IC specific rules
and opportunities for each
F-award mechanism
25. PA-21-052 Diversity F31 IC-specific info and contacts
25
https://grants.nih.gov/grants
/guide/pa-files/PA-21-
052.html
Scroll down
web page to
see info
specific to
your IC
27. 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
– Involvement post-award mostly
27
https://www.youtube.com/watch?v=rNwsg_PR90w
Video is several years old, but information is still applicable
Tip: Get to know your University Authorized
Representative who approves and submits your
final electronic application to NIH.
28. How do you obtain the electronic application?
28
Look for the
“Apply Online Using ASSIST”
button in program
announcement and click on it.
(If you cannot find it, that is a clue
that the FOA has expired!)
Click on Grants.gov in FOA
for Workspace authorized user
to start application process.
Tip: Usually you will have a department grants administrator
who is authorized to fill out the forms and upload documents
for you, but you need to know how it works using ASSIST!
30. Download most recent NIH
SF424 Fellowship
Instruction Guide
30
• Look for new and updated
instructions in section F.120
– Significant Changes
https://grants.nih.gov/grants/how-to-apply-
application-guide/forms-f/fellowship-forms-f.pdf
31. 31
• Follow FELLOWSHIP
INSTRUCTIONS FOR NIH AND
OTHER PHS AGENCIES
https://grants.nih.gov/grants/how-to-
apply-application-guide/forms-
f/fellowship-forms-f.pdf
• Your authorized 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!
32. 32
• Follow FELLOWSHIP
INSTRUCTIONS FOR NIH AND
OTHER PHS AGENCIES
https://grants.nih.gov/grants/how-to-apply-
application-guide/forms-f/fellowship-
forms-f.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”
33. Research & Related Other Project
Information SF424
33
• Human Subjects Involved?
• PA-21-052 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-21-052 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.
34. • 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 SF424
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)
34
https://grants.nih.gov/grants/how-to-apply-
application-guide/forms-f/fellowship-forms-f.pdf
35. • Consult the Director of your institution’s Office of Human Subjects
Protection (or 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 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)
35
https://grants.nih.gov/grants/how-to-apply-
application-guide/forms-f/fellowship-forms-f.pdf
https://grants.nih.gov/policy/clinical-trials/new-human-subject-
clinical-trial-info-form.htm
36. Upcoming sections discuss what to include in
each of the SF424 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”)
36
PHS Fellowship
Supplemental Form,
lines 1-14
37. PHS Fellowship
Supplemental Form,
lines 14-24
(should be numbered 15-25)
37
• Fill in sections appropriately.
• If you have received NRSA support on an
institutional TL1 or T32, consult departmental
grants administrator for accurate information.
• Limit of 5 years combined NRSA support for
PhD training and 6 years for dual MD-PhD
training.
• Limit of 3 years NRSA support for Postdoctoral
training.
• 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).
38. Budget information should be filled out by
PI’s departmental grants administrator
38
• Include full graduate tuition for PI’s
institution (health fees not included here).
• NIH funds a portion of tuition 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!
PHS Fellowship
Supplemental Form,
lines 26-29
39. Page 1 of Dr. PJ’s
F-award Checklist
per SF424
instructions using
Adobe Forms
Series F
39
40. 40
Page 2 of Dr. PJ’s
F-award Checklist
per SF424
instructions using
Adobe Forms
Series F
Note: line 14 was duplicated on example
PHS Fellowship Supplemental Form in the
Oct 16, 2020 update of SF424 Fellowship
Instructions Guide for Series F forms.
41. 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 no more than 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.
41
42. • Limit in title length for NIH
is 200 characters including
spaces
1
• Can use Greek and special
symbol characters
2
• Reviewers will ding you for
a lousy title
3
NIH Grant Titles—Key Points
42
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!
Strongly recommended that you review the information at this link
43. Knee joint connected to the leg bone…
Training-Specific Sections
43
Institutional
Environment
and
Commitment
to Training
(2-page limit)
Applicant's Background, Goals and Activities
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.
Tip on NIH
terminology:
Your primary
advisor is
called a
Sponsor for F-
applications
and a Mentor
for K-
applications.
44. Some Grant Sections Depend on
Type of Research Conducted
44
Human
Subjects?
• Independent clinical
trial, a clinical trial
feasibility study, or
an ancillary study to
a clinical trial is
NOT allowed.
• PA-21-052 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 SF424
PHS Fellowship
Supplemental Form,
Line 13.
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)
45. Don’t Forget the Research Grant!
45
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 for all letters)
46. Key Personnel: PD/PI is
automatically populated
46
PD/PI must include
eRA Commons ID
You must be listed in your
eRA Commons account as
a trainee AND as a PI
47. Pesky Grant Writing Rules
NIH requirements for
formatting pdf
attachments:
https://grants.nih.gov/grants/h
ow-to-apply-application-
guide/format-and-write/format-
attachments.htm
47
Arial 11 pt most
frequently used font
Smaller font sizes
can be used in
figure legends
and tables, but no
smaller then 8 pt
48. First critical take home message
about F awards
48
1. Prepare a proper NIH Fellowship
Biosketch.
Make sure Sponsors, Advisory Committee
Members, Consultants and Collaborators update
their Personal Statements and Contributions to
Science sections of their Biosketches to address
their specific role and expertise on YOUR F31 grant
(not their own R01 grants)!
49. Changes to NIH Biosketch Format
49
• Use of the updated format pages will be
required for applications and Research
Performance Progress Reports (RPPRs)
submitted for due dates on or after May
25, 2021. See NOT-OD-21-073.
• During the transition to the new Biosketch
format, NIH will not withdraw applications
that include the previous Biosketch format.
• Beginning with applications submitted on
or after January 25, 2022, failure to follow
the appropriate Biosketch format may
cause NIH to withdraw your application
from consideration.
Section C. Contributions to Science remains the
same. Scientific contributions are typically listed
in chronological order.
Fellowship Biosketch
Section D list only
Scholastic
Performance
Section B renamed;
now list these in
REVERSE
chronological order
50. 50
Form Name
Biographical Sketch Format Page (fellowship) - Due Dates
on/after January 25, 2022
Description
Prepare biographical sketches for applications and progress
reports for fellowship applications and awards.
How to
Access
Fellowship Biosketch (blank format page, Word)
Instructions
Instructions for Biographical Sketch
These instructions will be incorporated into the NIH Application
Form Instructions with the next update by FY 2022.
Additional
Information
•Predoctoral Fellowship biosketch sample (Word)
•Postdoctoral Fellowship biosketch sample (Word)
•FAQs
Try SciENcv to help you develop your biosketch and
automatically format it according to NIH requirements.
Updated
Date
March 2021
Links to
Biosketch
templates and
Instructions for
Fellowship
(F30, F31, F32)
applications.
51. Links to
Biosketch
template and
Instructions for
Sponsors of F
Candidates,
Mentors of K
Scholars, and
PIs of
investigator
initiated (R01,
R21, R03, etc)
grants.
51
Form Name
Biographical Sketch Format Page (non-fellowship) - Due
Dates on/after January 25, 2022
Description Prepare biographical sketches for applications and progress
reports for all applications and awards, except fellowships.
How to
Access
Non-fellowship Biosketch (blank format page, Word)
Instructions
Instructions for Biographical Sketch
These instructions will be incorporated into the NIH Application
Form Instructions with the next update by FY 2022.
Additional
Information
• SAMPLE: Non-fellowship biosketch
• FAQs
Try SciENcv to help you develop your biosketch and
automatically format it according to NIH requirements.
Updated
Date
March 2021
52. Electronic Help to Prepare NIH Biosketch
52
Forms and Instructions from NIH: https://grants.nih.gov/grants/forms/biosketch.htm
Investigate SciENcv and My Bibliography through My NCBI to prepare electronic Biosketch:
https://www.ncbi.nlm.nih.gov/sciencv/
As of June 1, 2021, logging into my NCBI requires updated credentials:
https://ncbiinsights.ncbi.nlm.nih.gov/2021/01/05/important-changes-ncbi-accounts-2021/
All NIH applicants must obtain an ORCID ID. See this video for helpful instructions on how to obtain and
populate data in your ORCID record. This information can be imported into SciENcv for generation of NIH
Biosketches (and info on NSF Biosketches). https://www.youtube.com/watch?v=R6J2C-qfgk4
Note: the NIH Biosketch format used in this video is the old 5-page format. The information to link
ORCID account to My NCBI and SciENcv is valid.
53. Sections of NIH Biosketch for a Fellowship (F),
Mentored Career Development (K), or Researcher-
initiated (R) Grant (changes in format effective 5-25-2021)
• Education and Training in Table Format (must include Commons
ID for all Senior/Key Personnel listed on grant).
A. Personal Statement (can include 4 citations/research products AND
relevant current and past 3 years of Research Support).
B. Positions, Scientific Appointments, and Honors (previously Positions
and Honors—now required to list in Reverse chronological order).
C. Contributions to Science (5 contributions with up to 4 citations for each
contribution—this is the same).
D. Scholastic Performance (F-grants) (Research Support deleted from
Section D for all NIH Biosketches, F-, R-, and K-awards). 53
54. Education and Training Table
(Name, eRA Commons ID, Current Position, Education)
54
Tip: Be sure to get your Commons ID and be listed in Commons as PD/PI as well as trainee stage.
Your University Authorized Representative can do this for you.
Education/Training Format same for all NIH Biosketches for R, K and F awards
55. A. Personal Statement – What to include
55
• Describe collaborators (mentoring team) and key features of your scientific
environment that will enhance your training above expectations of PhD
program.
• May explain impediments to your past productivity by describing factors such as
family care responsibilities, illness, disability, military service, or natural disaster.
• Describe why well-suited for the fellowship award for which you are applying
Ø Relevant previous training, experimental work, and technical expertise
Ø Past performance in this or related fields
Ø Future career goals and brief description of why you need additional training
Ø May identify up to 4 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.
Ø May include relevant Current and past 3 years of Research Support
56. A. Personal Statement—it’s about you!
– Start Personal Statement with your Role on Project, Research Proposal Goal (the
science!) and how this research aligns with your career goals.
– Predocs with few publications may describe research experiences demonstrating
expertise for this proposal.
– 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!).
– Make sure Sponsors include their specific role on YOUR proposal. Their Personal
Statement should include descriptions of their leadership skills, expertise in the
scientific field, productivity, mentoring history qualifications, and mentoring awards .
56
Tip: Personal statement for F predoc and postdoc applicants is a perfect place to
summarize your 6-page “Applicant's Background and Goals for Fellowship Training”
section (see next slide). This will help reviewers write their critiques!
57. Remember: A well-written personal statements help reviewers write their
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 training plan tailored to you will provide you with new 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. Include why this training will better prepare you for
your next career stage than just following the required curriculum of your PhD
program (but don’t bash your PhD program’s curriculum!).
§ Spell out names of mentors and collaborators so reviewers do not have to go back to
other sections to look up
57
58. Predoc Fellowship Personal Statement: NIH’s Example
58
Highlight
Diversity Status
Highlight
manuscripts
Briefly Describe WHY sponsor
(mentor) and project is best
choice for YOU
Training Potential:
the value of the
proposed
fellowship
experience as it
relates to the
candidate's needs
to prepare for the
next career stage
in a chosen
scientific
discipline.
Note: This example of a
predoc personal statement
as prepared by NIH could
be significantly improved!
Dr. PJ’s opinion!
59. NIH Example of Personal Statement for
R-award, or Sponsor on F-award
59
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
60. Personal Issues
in Biosketch 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 and is addressed by
PI in supplemental material submitted before review)
• Optional, but best to explain if big gaps in training, job
history or publications occur!
60
Source—Modification of the Biographical Sketch in NIH Grant
Application Forms. Notice Number: NOT-OD-11-050
61. B. Positions, Scientific Appointments, and Honors
(Predoc Fellowship Bio example by NIH)
61
New rule per NIH—list
in REVERSE
chronological order!
For fellowship Bios,
put grant support
received in Honors:
e.g., TL1, T32, pilot
funding, foundation
award, travel award
62. 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!
62
63. C. Contributions to Science 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).
§ Can include links to DOI, PMID or PMCID for publications but not URLs for
websites, online videos, or other research products.
§ 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.
63
URL for My Bibliography—can only use Government
based URL (.gov) No Google Scholar; must type-out
URL, not embed as hyperlink.
64. C. Contributions to Science Instructions (3)
• Can include abstracts but NOT manuscripts “in preparation”, “submitted”
or ”in review” as research products.
• While in the narrative you may mention manuscripts that have not been
accepted for publication as part of your contribution, you may cite only
published papers that are archived, which includes preprint/interim
reports, to support each contribution.
• 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. (See slides that follow for examples of
“Contributions to Science” for Public Access Policy and PMCID definition).
64
65. Can highlight in prep or
submitted manuscripts in
personal statement and
contribution narrative, 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 NOT “in prep”
“submitted” or “in
review” manuscripts
NIH Predoctoral Fellowship
Biosketch Example
Although no longer required, Dr. PJ
recommends including all authors names
65
Why does Dr. 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!
66. Highlight experience mentoring
predoctoral students who have
gone on to successful careers
C. Contributions to Science
(Example Sponsor’s Bio)
66
Bold your own name so
Reviewers can determine your
Contribution to the publication
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
67. 67
D. Scholastic Performance
Only for Fellowship F-
award Biosketches
Indicate whether 4.0 grading
scale or other scale used and
describe University specific
grading definitions.
Ø List by institution and year
all undergraduate and graduate
courses, with grades.
68. 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 and Expertise
but also address the goals of the agency as defined in the
Funding Opportunity Announcement or Request for Application.
68
69. One more NIH Biosketch Pointer
§ 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:
vMy NCBI | My Bibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/pj.simpson-
haidaris.1/bibliography/40100400/public/?sort=date&direction=ascending
69
70. NIH Biosketch Review
• List positions, scientific appointments, and honors from newest to oldest
(i.e., reverse chronological order like in CV where list newest first).
• Include Post-doc, Residency and Fellowship training in Education table
(in chronological order) AND in Positions & Scientific Appointments (in
reverse chronological order).
• PJ recommends you include all authors names in publications cited
• Include 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
70
74. 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.
74
NOT-OD-17-050 — Reporting Preprints and Other Interim Research
Products https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html
75. Interim Reports:
Why should I do it?
Will it affect publication in peer-reviewed journals later?
75
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 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 publishers by preprint policy:
https://en.wikipedia.org/wiki/List_of_academic_journals_by_preprint_policy
76. 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.
76
78. 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
Example Cover Letter
78
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.
6. See “Fellowship Instructions for NIH
and Other PHS Agencies - Forms
Version F Series” for additional details
required for special circumstances that
must be included in cover letter.
79. Optional Form
to request
assignment of
your grant to
specific
Institutes or
Centers of NIH
(awarding
components)
and suggested
study sections
for review
79
https://grants.nih.gov/grants/phs_assignment_information.htm
80. Second critical take home message
about F awards
2. Build an exceptional Research and Career Development
Mentoring TEAM (Key Personnel).
• Chose sponsors with complementary attributes 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 ($$) and experience
mentoring.
80
If primary mentor/sponsor has expertise but is “in between” NIH grants/other research funding,
recruit a co-mentor with substantial funding who commits to supporting your research.
TIP
81. Who are Key Personnel?
• Principal Investigator/Program Director (PD/PI)
(Trainee is PI of F-award)
• Multiple PIs (MPIs)-not allowed for Fs or Ks
• Mentors/Sponsor
• Co-Mentors/Co-Sponsors/Content Mentors
• Co-Investigators
• Consultants/Collaborators
• Other Significant Contributors
81
82. Mentor or Supervisor?
• A “mentor for life” or a “pair of hands” to advance
the mentor’s career?
• A great mentor vs great supervisor focuses on
helping build the trainee’s career
82
• A mentor for life
o is inspirational
o shares networking
o provides opportunities
o maximizes trainee’s abilities
and learning style
o is part of extended family
Lee et al, Nature 2007
83. An Inspirational Mentor is…
• Enthusiastic and Passionate
• Sensitive
• Appreciative of Individual Differences
• Respectful
• Unselfish
• Supportive of other trainees (not just his/her own)
• A good communicator/teacher
• Available
83
Lee et al, Nature 2007
84. Enthusiasm and Passion
• Years of research has not diminished mentor’s
drive to discover new ideas and to pass that
passion on to students
84
Lee et al, Nature 2007
• Can find the “teaching
moment” in a bad result
• Unexpected observations
may provide novel insight
• Provides a big picture view
85. “One Size” Mentoring Does Not Fit All
• Trainees are not like Money
– “One Size ($$) Fits All” and
– “Is the Perfect Color”
85
Lee et al, Nature 2007
• Great mentors appreciate
individual differences
o Different learning styles
o Work ethics
o Cultural diversity
o Personalities http://www.cyh.com/HealthTopics/library/diversity1.jpg
86. One Size Does Not Fit All
(mentoring style) (trainees)
86
Lee et al, Nature 2007
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/articleImages
/310162-38716-51.jpg
88. Unselfish
88
Lee et al, Nature 2007
• 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
• Delights in seeing younger
scientists succeed http://www.isikplastik.com/wp-content/uploads/2013/10/career.jpg
89. Picking a Mentor (1)
89
• 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?
• Although things happen, PIs leave so trainees need to know whether they can go with PI to new institution or need
to find a new mentor at home institution
• If need to find a new mentor and project, try to get current PI to facilitate transition to colleague as mentor; also,
work with PhD Program Director and Dean of Graduate Education
• 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: https://www.cc.gatech.edu/faculty/ashwin/wisdom/how-to-choose-an-advisor.html
90. Picking a Mentor (2)
90
adapted from: https://www.cc.gatech.edu/faculty/ashwin/wisdom/how-to-choose-an-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”
91. Picking Mentoring Team
91
• 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 Advisory committee members on your grant agree to meet 2-4 times/yr;
Thesis committees usually meet 1-2 times/yr
92. Consultants & Collaborators
92
• 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
93. Back to the SF424 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 (not the same as your outside referees letters of recommendation)
– altogether these letters cannot exceed 6 pages
93
94. PD/PI field populated from
front page information
94
Asterisks denote
required
information,
including eRA
Commons ID
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
95. After PD/PI, enter Sponsor and Co-sponsor, then
rest of mentors/key personnel alphabetically
95
Attach Biosketches as pdf files
Other Support only for some K-awards
96. Sponsor’s and Co-sponsor’s Statement
Section A. Research Support available to trainee (PD/PI)
(6-page limit for sponsor statement)
96
Include in Sponsors &
Co-sponsors
Statements:
a) Resource Support
available to Trainee
(active and pending
grants and $ amounts)
97. 97
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.
98. Sections c, d & e of Sponsor’s Statement
98
Activities Planned
Goals; Facilities
IDP
Dissertation
Research and
Prior Research
Experience
Respective
Contributions
Research
Approach
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.
Sponsors of fellowship applicants who are proposing to gain clinical trial research experience under a sponsor's
supervision— i.e., will not be leading an independent clinical trial—include required statement (p F-71).
99. 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.
99
100. Third critical take home message
about F awards
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).
100
Three Letters of
Recommendation
Submitted
Separately from
Application
Link to instructions for outside referees to
follow when submitting letters:
https://public.era.nih.gov/commons/public/reference/
submitReferenceLetter.do?mode=new
• Outside Referees are individuals not
directly involved in the application.
• May need to consider whether a
collaborator is better suited to be an
outside Referee.
101. Information PI provides to outside referees
to download word doc of instructions to provide referees, see:
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjhltia3tTwAhW1FVkFHT
UqAq4QFjAAegQIBBAD&url=https%3A%2F%2Fgrants.nih.gov%2Fsites%2Fdefault%2Ffiles%2Finstructions-
for-fellowship-referees.docx&usg=AOvVaw3iAlhhKqgpMny1OvJT-elR
101
• PI (Fellowship applicant) Commons
user ID
• PI (trainee) 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-21-052)
102. 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
102
Link to video on Submitting Reference Letters through eRA Commons:
https://www.youtube.com/watch?v=gJwQSI9q5FM&feature=youtu.be
103. Fourth critical take home message
about F awards
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.
103
Selection of
Sponsor &
Institution
A. Doctoral Dissertation
and Research Experience
C. Activities
Planned (from IDP)
B. Training Goals
and Objectives
(from IDP)
Respective
Contributions
Sponsor(s), Advisory
(thesis) committee
members, consultants 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.
104. 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!
104
105. The “Training Potential” of the fellowship
application must meet the following criteria:
• Are the proposed research project and training plan likely to provide the
candidate with the requisite individualized and mentored experiences
in to obtain appropriate skills for a research career?
• Does the training plan take advantage of the candidate’s strengths
and address gaps in needed skills?
• Does the training plan document a clear need for, and value of, the
proposed training?
• Does the proposed training have the potential to serve as a sound
foundation that will clearly enhance the candidate’s ability to develop
into a productive researcher?
105
106. 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 in 2021.
• 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
106
107. A. Doctoral Dissertation and Research Experience
• Summarize research experiences, results and conclusions including
undergrad experiences and lab rotations
• Describe your contribution to the research and how it addressed the “big
picture” of research question—did your contribution help move the field
forward?
• Describe how the experiences relate to long-term career goals leading to the
career development and research proposed in this fellowship application.
• Include narrative of doctoral dissertation (may be preliminary if you have not
passed qualifying exams); Do not list academic courses.
• Postdoctoral applicants should specify which areas of research were part of
PhD thesis and which, if any, were part of a previous postdoctoral project.
107
PJ Recommends limit section A to 2 of 6 pages.
108. B. Training 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 award, including, as
applicable, expertise in rigorous research design, experimental
methods, quantitative approaches, and data analysis and
interpretation.
• Discuss how proposed research and career development
training plans facilitate transition to next career stage and future
career goals.
108
PJ Recommends limit section B to 1-2 pages of 6 pages allowed.
109. C. Activities Planned Under This Award
• Perform Gap Analysis of what
skills you have and what skills and
critical thinking knowledge are
missing to achieve goals (This
comes from your IDP).
• Define Activities, Timetable, and
Milestones to verify how to fill gaps.
• Also, mention planned training
activities to enhance research skills
in the Research Strategy section
where the specific training will be
applied.
• Be sure to name the appropriate
mentor(s) who will oversee specific
aspects of your training.
109
Example table (although labeled generically to be modified for YOUR
specific training needs) taken from F31 Activities Planned section in
which the review criteria of “Training Plan” scored 1 (Exceptional).
110. C. Activities Planned Under This Award
• After performing the “Skills Gap Analysis” to define what your specific
training needs are, PJ recommends three areas of Activities Planned:
1. Didactic Coursework and Seminars
2. Mentored Research Activities (include a table describing all members of your
mentoring team and their responsibilities to oversee your training; include frequency of
meetings and how feedback from mentors received).
3. Career Development Activities
• Describe, by year, the activities (research, coursework, professional
development, clinical activities, etc.) you will be involved in during the award.
• Describe the research skills and techniques that you intend to learn.
• Estimate the %-time devoted to each activity; should = 100% each year.
• Activities planned should be individually tailored and well-integrated with your
research project.
110
TIP: Develop table with %-effort devoted to each training activity, timeline of completion,
and benchmarks to measure success!
111. C. Example of Activities Planned Under This Award
111
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 your training objective).
Indicate time needed to accomplish and
percent of time on each major area.
Biostatistics/Advanced Programing
Grant Writing
Seminar Series in Discipline of Science
Student Seminars
Discipline-specific courses to fill gaps
Describe research techniques to be learned; how
learned and mentors involved
Short Course on Specialized Techniques
Travel to Collaborators Lab for Specialized Techniques
Lab Meetings, Research in Progress
3 first-authored papers high impact journals
Write and Defend PhD Thesis
Secure Postdoc Position and others…specific to YOU
Take didactic course work for grade
Career skills workshop How to Negotiate
Present at National Meetings
Teach Class or Two in Research Discipline
Submit Grant Application
Enhance Mentoring Skills
Improve Scientific Communication Skills
112. Respective Contributions
112
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 your respective roles in accomplishing the
proposed research.
• Include respective roles of Advisory Committee members
and consultants/collaborators.
114. Selection of Sponsor and Institution
114
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.
This item is limited to one page.
115. Responsible Conduct of Research (RCR)
115
This item is limited to one page.
–Cover the five REQUIRED items:
1. Format: Describe the required format of instruction (i.e., face-to-face lectures, coursework,
and/or real-time discussion groups). A plan with only on-line instruction is not acceptable.
2. Subject Matter: Describe the breadth of subject matter (e.g., conflict of interest,
authorship, data management, human subjects and animal use, laboratory safety, research
misconduct, and research ethics).
3. Faculty Participation: Describe the role of the sponsor/mentor(s) and other faculty
involvement in the instruction.
4. Duration of Instruction: Describe the total number of contact hours of instruction, taking
into consideration the duration of the program.
5. Frequency of Instruction: Instruction must occur during each career stage and at least
once every four years. Document any prior instruction during the applicant’s current career
stage, including the inclusive dates instruction was last completed.
116. Example Template of
Responsible Conduct of
Research (RCR)
116
For rigor and reproducibility training,
the PI will complete the Rigor and
Reproducibility Training modules
put forward by NIGMS to enhance
trainees and early-stage investigators’
understanding of rigor and
reproducibility of scientific research,
and authentication of biologicals and
unique experimental resources. The
PI will complete the 4 NIGMS
modules and discuss what is learned
with their sponsor and lab members.
Ø Be sure to cover:
1. format
2. content
3. faculty
4. duration
5. frequency
Ø Tailor training to your research needs
• Vertebrate animal research
• Human Subjects research
Ø Also include training in Rigor and
Reproducibility in Science—resources
described in next 3 slides.
117. Training in Data Rigor and Reproducibility
Institutional Training Grants require attachment “Plan for the Instruction in
Methods for Enhancing Reproducibility.”
No attachment required for individual F-award applications.
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.
117
Sample Language for satisfying the need to address scientific
rigor and reproducibility. Should include in RCR, Research
Strategy Approach and/or Sponsor’s statement.
119. 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 Biology:
Potentials and Pitfalls (03-13-2015)
https://videocast.nih.gov/summary.asp?Live=15910&bhcp=1
• Reproducibility of Data Collection and Analysis – Modern Technologies in Genome Technology:
Potentials and Pitfalls (06-04-2015)
https://videocast.nih.gov/summary.asp?Live=16381&bhcp=1
• NIH Workshop on Reproducibility in Cell Culture Studies
09-28-2015 Day 1: https://videocast.nih.gov/watch=16876
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/watch=17454
• Clearinghouse for Training Modules to Enhance Data Reproducibility
https://www.nigms.nih.gov/training/pages/clearinghouse-for-training-modules-to-enhance-data-
reproducibility.aspx
119
Links up-to-date as of 5-20-2021
120. 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.)
120
121. Resource Sharing Plan:
indicate how will distribute
• 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.
121
Additional Information:
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.3_sharing_research_resources.htm
122. 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!
122
123. Don’t Forget the Research Grant!
123
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
124. Other important sections of F-award applications
124
Bibliography &
References
Cited
Facilities & Other
Resources
Equipment
Summary/
Abstract
Narrative/
Public Health
Significance
Other
Attachments
1) Diversity eligibility
Diversity_Eligibility_Ltr.pdf
Only for F31 Diversity
PA-21-052
125. Project Summary/Abstract
(Max 30 lines of text)
125
• State the application’s broad, long-term objectives and specific aims,
refer 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.
126. Project Narrative
Public Health Relevance
126
• 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.
127. Bibliography & References Cited
127
• Recommend you include names of all authors, the title, Journal name, volume
number, inclusive pages, year of publication, and PMCID.
– Although no longer required to list all authors names, Dr. PJ recommends to include all names so
Reviewers can determine the senior authors
– Helps reviewers determine that you are citing literature important to your field and research
questions
• Include only bibliographic citations.
• Interim reports are allowed.
• Required: provide PMCID for PI’s and Sponsor’s articles that fall under NIH Public
Access Policy. (https://publicaccess.nih.gov)
128. 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 Sponsor’s
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, including career development activities, at your University.
• Include resources on Diversity and Inclusion Education and Training at your University (e.g.,
Healthcare, Research, Community Participation, Disabilities, Harassment and Discrimination) as
appropriate (especially for F31 Diversity applications).
128
129. • Describe the physical layout of research labs and
PhD training program home base and how these
resources aid in training the PI (F-applicant!).
• Describe facilities, career development opportunities
and intellectual environment that UNIQUELY apply to
YOUR training.
• Describe any special facilities used for working with
biohazards and any other potentially dangerous
substances.
• Information in Facilities and Other Resources should
agree with information provided in Sponsor’s
Statement and Activities Planned Under this Award.
• For diversity application, it is important to include
Institution’s resources for training in diversity and
inclusion AND University’s commitment to
providing access services and disability
accommodations as appropriate.
129
Facilities and Other
Resources Section example:
130. Equipment
(no page limit)
130
• 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.
Identify special equipment used in Sponsors’ and
collaborator’s labs. No need to identify every vortex, stir
plate, pipet-aid in the lab…
131. Institutional Environment and Commitment to Training (1)
• 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.
131
This document is prepared by your PhD program director
(and, if F30, your MSTP director adds a section) and/or
graduate education office with information provided by
Sponsors and PI (you).
132. Institutional Environment and Commitment to Training (2)
2-page limit
132
• 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.
• 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.
133. • 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.
133
“Institutional Environment
and Commitment to
Training” example
134. • 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.
134
“Institutional Environment
and Commitment to
Training” example
Although this information is also in other sections of the application, providing a
succinct summary will help Reviewers write their critiques for the Review
Criterion “Sponsors, Collaborators and Consultants, Training Potential and (of
course), Institutional Commitment to Training, the name of this section!
135. Certification of Eligibility for Diversity Award
Provided by Dean of Graduate Studies Office
(e.g., Registrar or Dean)
135
Only needed for
Diversity F31
PA-21-052
136. Critical take home messages 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.
136
137. Specific Aims and Research Strategy
137
Specific Aims
1-page limit
• Your entire grant
condensed to 1-page!
Research Strategy
6-page limit
• Significance
• Approach
138. • 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 all read.
• Needs to clearly convey entire grant
to 17 other reviewers.
138
NIH Peer Review Webinars & Videos:
https://public.csr.nih.gov/NewsAndPolicy/PeerReviewVideos
They are NOT called “Vague
Aims”… they ARE called
“Specific Aims” for a reason!
5. Critical take home message
about Peer Review
139. NIH instructions for content of Specific Aims page
per SF424 instruction guide
• “State concisely the goals of the proposed research and summarize the
expected outcome(s), including the impact that the results of the proposed
research will have on the research field(s) involved(limit 1-page).”
• “List succinctly the specific objectives of the research proposed (e.g., to test
a stated hypothesis, create a novel design, solve a specific problem,
challenge an existing paradigm or clinical practice, address a critical barrier
to progress in the filed, or develop new technology).”
• HOWEVER, to prepare an exceptional and compelling Specific Aims
page, you need to know much more about how to craft the information.
139
141. Structure of a Specific Aims Page
1st paragraph
• Introductory paragraph:
– Briefly explain what the proposal is about and why it is critical this
research be conducted-this is the “Hook.”
– Concisely describe what is known in the field
– Define the gap in knowledge or critical barrier that prevents further
understanding of the problem
– Define the critical need that you propose to solve by hypothesis-driven or
exploratory research—Why this research is Significant and needs to be
funded (describing the significance will imply the need to be funded!).
141
https://www.biosciencewriters.com/NIH-Grant-Applications-The-Anatomy-of-a-Specific-Aims-Page.aspx
Accessed 5-21-2021
142. Structure of a Specific Aims Page
2nd paragraph
• Introduce the solution that fills the gap in knowledge
– Describe your long-term goal (focus of your research program or future career for F-trainees—the
F-award training will prepare you for this career!).
– Describe your testable central/overarching hypothesis and objectives (aims) and how your
solutions will address the gap in knowledge. Of course, the research is top priority for the
funding agency!
– Describe the rationale based on past studies, published literature and your preliminary data that
led to your hypothesis—include discussion of the rigor of the supporting science.
– Describe the “pay-off”—how successful completion of research will lead to new
therapies/mechanistic understanding—move the field forward and tied to the funding agency’s
mission—this information may be placed in final paragraph.
– Explain why the experimental design and your research team are the best to accomplish the
research goals (prelim data, personnel expertise, unique facilities…)
142
https://www.biosciencewriters.com/NIH-Grant-Applications-The-Anatomy-of-a-Specific-Aims-Page.aspx
Accessed 5-21-2021
143. Structure of a Specific Aims Page
3rd paragraph
• Specific Aims must address the Central/Overarching Hypothesis
– Develop specific aims (2-3) that address a testable component of the
overarching hypothesis
– Aims should be related, but not dependent, upon each other (taken from source below)
– Give your aim an active title that clearly states the objective in relationship to the
hypothesis.
– Include a brief summary of the experimental approach/strategy/design and
anticipated outcomes for each aim.
– You may wish to include a sub-hypothesis (a portion of the overall hypothesis) and a
short description of the pay-off of each aim. Including these is helpful to create the
impression that each aim is valuable, testable, and independent of the others.
– To make it easier for the reviewers to clearly read and understand each aim, it is
often helpful to use headings and/or bullets to delineate each specific aim.
143
https://www.biosciencewriters.com/NIH-Grant-Applications-The-Anatomy-of-a-Specific-Aims-Page.aspx
Accessed 5-21-2021
144. Structure of a Specific Aims Page
4th paragraph
• Summary Paragraph should include two parts for F & K applicants
– Fellowship (F) and Career Development (K) applicants must include a brief
description of the “Training Potential” of their proposal—how the research
and training plans will launch the F-trainee to next career stage in research
(e.g., postdoc, Jr faculty position, or other research position) or launch a K-
Scholar to independence as a clinician research scientist (most K
mechanisms) or a research scientist for diversity K-mechanisms.
– Specific Aims pages for all types of grants should end with the “Big Picture”
view of how the successful completion of proposed aims will innovatively (K &
R grants) and significantly impact the field (public health and funding agency
relevance) and, hopefully, will have broader impact on other related scientific
disciplines as well.
144
https://www.biosciencewriters.com/NIH-Grant-Applications-The-Anatomy-of-a-Specific-Aims-Page.aspx
Accessed 5-21-2021
146. “Training Potential”
Briefly describe on specific aims page how your
training plan will launch you to next career stage
(this information should also be in the abstract)
146
This last sentence is more appropriate for K award than F
award but describe specific details of your training plan.
147. One format for a Specific Aims—a “Sandwich”
147
Specific Aims: objectives (working hypotheses), broad
strokes description of approach, anticipated outcomes
the
“Meat”
Last section: impact of outcomes and how results will move
knowledge in your field forward (and Training Potential for
F- and K-applicants); indicate the broader public health
relevance and impact on related disciplines
the
Bread
First section: topic, goals, objectives, overarching
hypothesis, rationale to define gap in field, briefly state
solution to address gap
the
Bread
• Consider use of visual models (schematics) to communicate a complex
subject and how aims relate to central/overarching hypothesis
Resource: http://www.biosciencewriters.com/NIH-Grant-Applications-The-Anatomy-of-a-Specific-Aims-Page.aspx
148. Another Specific Aims Format: Hourglass Funnel
Succinctly state the critical barrier (gap in
knowledge) that is preventing the field
from moving forward and why your
research group is the the best to do this
(why should be funded)
Describe what is known about the
problem (rationale) that culminates
in defining the critical barrier the
proposed research will address
State the global problem (the what)
and why it needs to be addressed
State the overarching hypothesis that, when
tested as proposed, will lead to solving the
critical barrier/problem in the field
State Specific Aims, experimental
approaches, anticipated outcomes—
be specific NOT vague or general
Training Potential—Describe how
the career development and
research training plans will launch
PI to next career stage
Big Picture
Background and
Significance of
Problem
Proposal
Details
Big Picture Impact
and Broader
Public Health
Relevance
Describe the impact your findings will
exert a sustained, powerful influence on
the research field(s) and broader public
health relevance
https://www.biosciencewriters.com/NIH-Grant-
Applications-The-Anatomy-of-a-Specific-Aims-
Page.aspx Accessed 5-21-2021 148
149. 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. Updated workbooks available:
http://www.grantcentral.com/ 149
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.
150. Are Your Specific Aims Hypothesis-Driven
or Exploratory/Discovery Science?
Hypothesis-driven research
• Based on scientific theories
• Takes the next step in scientific theory, having
already stood the rigors of examination—
reviewers perceive as less risky
• Researchers propose what the study hopes to
accomplish, how it will be done, and possible
outcomes
• Preliminary data usually presented with
supporting rationale drawn from published
literature to build a strong case for future
success
• Science community (grant reviewers!) has long
accepted hypothesis testing as the “gold
standard” for evaluating research proposals
Exploratory (hypothesis generating research)
• Based on a search for discovery backed by few
theories or none
• Driven more by hope and chance of discovery
• Exploratory inquiry is generally aimed only at
generating new lines of inquiry
• Does not usually lead to a big “payoff”, i.e., a new
therapeutic treatment, biological marker of
disease…
• Examines unknown areas with no or little-known
theories to back them—perceived as a riskier bet
• Reviewers have a difficult time judging a project’s
importance and likelihood of having a “sustained
and powerful influence on progress in the field”
150
Case Western Reserve University. "Philosopher examines the hypothesis vs.
exploratory funding divide." ScienceDaily. ScienceDaily, 27 September 2013.
www.sciencedaily.com/releases/2013/09/130927105138.htm
Haufe, C. (2013). Why do funding agencies favor hypothesis testing? Studies
in History and Philosophy of Science Part A, 44(3), 363-374.
doi:https://doi.org/10.1016/j.shpsa.2013.05.002
&
151. Discovery Science
“the goal is to discover things we neither knew
nor expected, and to see relationships and
connections among the elements, whether
previously suspected or not.”
151
Brown, P. O., & Botstein, D. (1999). Exploring the new world of the
genome with DNA microarrays. Nat Genet, 21(1 Suppl), 33-37.
doi:https://doi.org/10.1038/4462
152. Types of Omics Experiments:
Data-Driven Science
1. Discovery-focused (Exploratory)
– Designed to discover things neither known nor expected.
– Applies new or existing methodologies to biological systems under conditions or at time points that
are most likely to reveal key aspects of the biology.
2. Mechanism-focused (functional; generally, hypothesis-driven)
– Based on clear hypotheses and are designed to test underlying molecular mechanisms on a global
scale using perturbation-effect approaches.
– Reveals the generality of a molecular mechanism, or variations in a mechanism, across the ome
(genome, proteome, transcriptome. Metabolome, etc.) in question.
3. Descriptive (can be confirmatory)
– Surveys the biological system, without leading to significant discovery, and may appear to address
a mechanism without actually doing so.
– Produces catalogs (lists of genes, transcripts, proteins, or metabolites) whose levels change from
condition A to condition B, without revealing how or why.
152
Taken from: Kraus, W. L. (2015). Editorial: Would You Like A Hypothesis With Those Data? Omics and the Age of Discovery
Science. Molecular Endocrinology, 29(11), 1531-1534. doi:https://doi.org/10.1210/me.2015-1253
153. Data-Driven
Research
• Data science is an inherently
interdisciplinary approach to
science.
• New experimental techniques
have revolutionized biology.
• Data science is not a single
technique, but a framework for
solving a whole range of
problems.
• Data science has the potential to
answer questions in a range of
different disciplines.
153
Ezer, D., & Whitaker, K. (2019). Data
science for the scientific life cycle. Elife, 8.
doi:https://doi.org/10.7554/eLife.43979
154. Resources for Hypothesis-Driven and Exploratory
(Discovery/Data-Driven/Omics) Research
1. Brown, P. O., & Botstein, D. (1999). Exploring the new world of the genome with DNA microarrays. Nat Genet,
21(1 Suppl), 33-37. doi:https://doi.org/10.1038/4462
2. Case Western Reserve University. (2013). Philosopher examines the hypothesis vs. exploratory funding divide.
ScienceDaily. Retrieved from https://www.sciencedaily.com/releases/2013/09/130927105138.htm
3. Ezer, D., & Whitaker, K. (2019). Data science for the scientific life cycle. Elife, 8.
doi:https://doi.org/10.7554/eLife.43979
4. Fox, J. (2017). Ask Us Anything: descriptive research vs. hypothesis-driven research. Dynamic Ecology. Retrieved
from https://dynamicecology.wordpress.com/2017/11/01/ask-us-anything-descriptive-research-vs-hypothesis-
driven-research/
5. Haufe, C. (2013). Why do funding agencies favor hypothesis testing? Studies in History and Philosophy of
Science Part A, 44(3), 363-374. doi:https://doi.org/10.1016/j.shpsa.2013.05.002
6. JEI Editorial Staff. Submission Guidelines for Hypothesis-Driven Research. Journal of Emerging Investigators.
Retrieved from https://www.emerginginvestigators.org/submissions/hypothesis-driven-research
7. Kraus, W. L. (2015). Editorial: Would You Like A Hypothesis With Those Data? Omics and the Age of Discovery
Science. Molecular Endocrinology, 29(11), 1531-1534. doi:https://doi.org/10.1210/me.2015-1253
8. Smalheiser, N. R. (2002). Informatics and hypothesis-driven research. EMBO Rep, 3(8), 702.
doi:https://doi.org/10.1093/embo-reports/kvf164
9. van Helden, P. (2013). Data-driven hypotheses. EMBO Rep, 14(2), 104.
doi:https://doi.org/10.1038/embor.2012.207 154
155. A good Hypothesis or Exploratory question is
only as good as the importance of the problem
being studied and the critical need for a
solution to be found
“What makes good science is a really good question that comes from a
really good knowledge of the system, a lot of reading of the literature, and
a creative mind. Those three tools can combine to do good hypothesis-
driven or descriptive research. And many good questions are inherently
descriptive.”
Brian McGill
155
Ask Us Anything: descriptive research vs. hypothesis-driven research. Posted on November 1, 2017,
by Jeremy Fox. Accessed 4-28-2021.
https://dynamicecology.wordpress.com/2017/11/01/ask-us-anything-descriptive-research-vs-
hypothesis-driven-research/
156. Research Strategy
Limited to 6 pages
1. Significance
• Explain the importance of the problem or critical barrier to progress that the proposed
project addresses.
• Describe the strengths and weaknesses in the rigor of the prior research (both
published and unpublished—this includes your preliminary data) that serves as the key
support (rationale) for the proposed project.
• Describe how the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field will be changed if the proposed aims are achieved.
• Explain how successful completion of aims will improve scientific knowledge, technical
capability, and/or clinical practice in additional more broad fields.
• If proposing to gain experience in a clinical trial, describe the relationship of the proposed
research project to the clinical trial.
156
http://grants.nih.gov/grants/forms_page_limits.htm
157. What is the distinction between “Significance”
and “Overall Impact” Review Criteria for
evaluation of NIH research applications?
DEFINITIONS FROM NOT-OD-09-025 and NOT-OD-16-011
• Significance: Does the project address an important problem or critical barrier to
progress in the field? Is there a strong scientific premise (rationale/supporting data)
for the project? If the aims of the project are achieved, how will scientific knowledge,
technical capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?
• Overall Impact: Reviewers will provide an overall impact score to reflect their
assessment of the likelihood for the project to exert a sustained, powerful
influence on the research field(s) involved, in consideration of the core review
criteria, and additional review criteria (as applicable for the project proposed).
157
158. 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; 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.
158
http://grants.nih.gov/grants/forms_page_limits.htm
159. 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 (the reasons
leading to identification of the research problem) and define the “Gap in
Knowledge” in the field your research is intended to answer.
• Provide a Gantt chart timeline for Research project.
159
160. Mail room 1
160
6. Critical Take Home Message About Peer Review
• Reviewers are assigned 8-10 grants so have
limited time to review YOUR grant.
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!
161. 7. Critical Take Home Message About Peer Review
Tell a good story and make is easy to read
a. Demonstrate your enthusiasm and passion for
research and attaining career goals with Clear,
Concise and Compelling Writing.
ØSorry, you have to get help with writing from other sources
b. Prepare Visually Splendid Figures.
161
162. Figures and Tables
“Dos and Don’ts”
• Figures and tables should stand on their own—the legend and figure
labels 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.
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Tip: place preliminary data near the text (narrative) that FIRST
describes the results. Don’t make the reviewer have to flip/scroll
back and forth from one page to another and back again.
(Yes, some reviewers still print hard copies of grants to review)
163. 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…
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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!