NIH - Proposal Development Checklist

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Syracuse University
Office of Sponsored Programs
http://osp.syr.edu
NIH 424 R&R Summary and Checklist
http://grants.nih.gov/grants/funding/424/index.htm
www.grants.gov
Numbered Items (1., 2., 3., etc) represent individual files to be uploaded at PDF documents
General Information & Guidance
OSP, the authorized organizational representative for
submitting applications to Grants.gov, is registered
in all systems – ignore registration instructions.
Read specific solicitation (FOA) for deviations on 424
(R&R) instructions and other specific guidance. This
summary does not replace that review.
Download fresh Grants.gov application file from FOA
The NIH Grants.gov application is a combination of
‘generic’ and specific requirements. The 424 R&R
and FOA instructions should be followed, even
when something seems ‘optional’ (e.g., Commons
User ID for PIs, etc)
Annotated sample and example proposals from NIAID.
http://www.niaid.nih.gov/researchfunding/grant/pages/samples.aspx
NIH – Grants.gov Components
Mandatory forms. Identified by orange boxes
Optional forms: Budget forms - dashed orange boxes;
one of the following must be included: PHS 398
Modular Budget or R&R budget . Other optional
forms in blue boxes
SF 424 (R&R)
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R01, R21, R03 Parent Applications on OSP website have Highlighted info pre-populated:
http://osp.syr.edu/forms%20and%20pages/forms.html
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Sample SU NIH awarded proposals:
https://sushare.syr.edu/display/vfc/Sample+Awarded+Proposals
Create a shared site: Drop Box or Google Drive so you,
OSP, dept support and others have access to files.
Applications materials should be final three business
days before application deadline.
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FORMATTING REQUIREMENTS
 Black Font: Arial, Helvetica, Palatino Linotype,
Georgia 11 pt. or larger
 Figures and tables can have smaller black font.
Legibility is guiding principle
 No more than 6 lines/vertical inch; no more than 15
characters/linear inch
 At least ½” margins – No headers or footers; no
page numbers
 Name file PDFs using standard characters and
underscore (_).
PAGE LIMITS
 Introduction for Resubmission or Revision – 1 pg.
 Specific Aims – 1 pg.
 Research Strategy (or follow FOA instructions):
o R03/R21 – 6 pg.
o R01 – 12 pg.
 Biosketch – 4 pg.
 Other page limits: See table 2.6-1 in 424 guidelines
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Box 4.a Federal Identifier – for resubmission,
renewal or revision applications. Enter C/I and 6
digit unique id: CA987654 for 1R01CA987654-01A1
Box 4.b Agency Routing Number – ordinarily n/a;
use only if mandated by FOA
Box 4.c Previous Grants.gov Tracking ID for
change/corrected app
Box 5. DUNS no.: 002257350
Legal Name: Syracuse University
Dept/Address: Office of Sponsored Programs, 113
Bowne Hall, Syracuse, NY, 13244-1200
Contact Person: Your OSP Research Administrator
Box 6. EIN: for NIH only this is 1150532081A1
Box 7. Applicant Type: O- Private Institution of
Higher Education
Box 8. Type of Application – select as appropriate:
New, Resubmission, Renewal, Continuation
(ordinarily not used) Revision (e.g., for Supplement)
Box 9. NIH – pre-populated
Box 10. CFDA - no action required
Box 11. Descriptive Title. 81 characters & spaces.
Ordinarily renewal app’s will have same title as
previous award unless aims have significantly
changed. Titles are important; they frame the
readers thinking / mind-set about your project.
Box 12. Project Start – end dates. Ordinarily per
FOA or review cycle:
http://grants.nih.gov/grants/funding/submissionschedule.htm#review
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Box 13. Congressional District: NY-024
Box 14. PI/PD name & Contact info
Box 15. Estimated Project Funding. A. Enter Total
Federal Funds requested. D. Program Income (if
applicable)
Box 16. Subject to EO 12372? Usually no. Check FOA
Box 17. Certification. Completed by OSP, which
relies on IRR
Box 18. SFLLL – Ordinarily no
Box 19. Authorized Representative: OSP Research
Administrator
Box 20. Pre-application – ordinarily n/a.
Box 21. Cover letter. To Division of Receipt and
Referral of Center for Scientific Review. Body
should present (concise / single lines) - example:
Please assign this application to the following:
Institutes/Centers
National Cancer Institute - NCI
National Institute for Dental and Craniofacial
Research – NIDCR
Scientific Review Groups
Molecular Oncogenesis Study Section – MONC
Cancer Etiology Study Section – CE
Please do not assign this application to the following:
Scientific Review Groups
Cancer Genetics Study Section – CG
The reasons for this request are [provide a narrative
explanation for the request(s)]
PHS 398 RESEARCH PLAN – pdf files only
1. Introduction to Application
Summarize changes from prior app and how
changes are indicated (e.g. bracketing;
indenting; change of typography)
2. Specific Aims
Summarize goals; objectives; outcomes; impact
3. Research Strategy, present in separate sections:
a. Significance
b. Innovation
c. Approach
4. Progress Report Publication List (renewal)
(myBibliography may be helpful.
http://www.ncbi.nlm.nih.gov/books/NBK53595/
Human Subjects Sections – Now in separate document:
http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf
5. Protection of Human Subjects
6. Inclusion of Women and Minorities
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If included, “Planned Enrollment Report” is
required (see Optional Forms)
7. Inclusion of Children
Other Research Plan Sections
8. Vertebrate Animals
9. Selection Agent Research (contact EHO / OSP)
10. Multiple PD/PI Leadership Plan. For multiple
PD/PIs applications only. Include a leadership plan.
Described why the multiple PD/PI approach is
appropriate, the governance and organizational
structure of the leadership team and the research
project. Include communication plans, and
procedures for making decisions on scientific
direction and for resolving conflicts. Define the roles
and administrative, technical, and scientific
responsibilities for the project or program for the
PD/PIs and other collaborators. If budget allocation
is planned, the distribution of resources to specific
parts of the project or the individual PD/PIs should
be delineated in the Leadership Plan.
11. Consortium/Contractual Arrangements Explain the
programmatic, fiscal, and administrative
arrangements to be made between the applicant
organization and the consortium organization(s). If
consortium/contractual activities represent a
significant portion of the overall project, explain
why the applicant organization, rather than the
ultimate performer of the activities, should be the
grantee.
12. Letters of Support. Include letters demonstrating
the support of consortium participants and
collaborators such as Senior/Key Personnel and
Other Significant Contributors included in the
application.
 Letters should stipulate expectations for coauthorship, and whether cell lines, samples or other
resources promised in the letter are freely available
to other investigators in the scientific community or
will be provided to the particular investigators only.
For consultants, letters should include rate/charge
for consulting services and level of effort/number of
hours per year anticipated. NOTE: Consultant
biographical sketches should be included in
senior/key personal form. Letters ensuring access to
core facilities and resources should stipulate
whether access will be provided as a fee-for-service.
13. Resource Sharing Plan – single document
 See Supplemental Instructions Part III, 1.5 Sharing
Research Resources.
Data Sharing Plan: Required for any requests of
direct costs of $500k or more in any year or in
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specific FOA. Provide a brief 1-paragraph
description of how final research data will be
shared, or explain why data-sharing is not possible.
See Data-Sharing Policy or
http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-03-032.html.
Sharing Model Organisms: All applications that will
develop model organisms must include a specific
plan for sharing and distributing unique model
organisms or state why such sharing is restricted or
not possible. See Sharing Model Organisms Policy,
and NIH Guide NOT-OD-04-042.
Genome Wide Association Studies (GWAS): Provide
a plan for submission of GWAS data to the NIHdesignated GWAS data repository, or an
appropriate explanation why submission to the
repository is not possible. See Policy for Sharing of
Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies, NIH Guide NOTOD-07-088, and http://gwas.nih.gov/.
14. Appendix (if applicable): Do not use to circumvent
research strategy page limits
o Up to three publications only IF
 Accepted for publication/not yet published
 Published but free/online link not available
 Patents directly relevant to project
o Surveys; questionnaires; data collection
instruments as necessary
o Up to 10 attachments total allowed; provide
descriptive file names, as order in assembled
application may change. A summary sheet
listing all items is encouraged and should be at
front of first appendix item.
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R&R SENIOR/KEY PERSON PROFILE (expanded)
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Box 1.Project Director / Principal Investigator
Box 2. Human Subjects
o Clinical Trial
o Agency-defined Phase III Clinical Trial
Box 3. Disclosure Permission Statement – allows
NIH to share contact info and title with other
foundations etc for possible collaboration or
investment
Box 4. Program Income- Check yes if you will
generate revenue directly from grant-activities (e.g.,
conference registration fees; fees from use of
equipment, and the like)
Box 5. Human Embryonic Stem Cells – Contact EHO
and OSP if yes.
Box 6. Inventions & Patents (for renewals only)
PI(s) must have eRA Commons User Name
o Postdocs and students should obtain eRA
Commons user names for progress
performance reporting
Credential: eRA Commons User Name must be
provided for anyone assigned PI/PD role
Multi-PI application: All individuals have the PD/PI
role, regardless of organizational affiliation.
Co-PI is not recognized by NIH. Use Co-Investigator
Postdocs should be included if they meet the
definition of Senior/Key Personnel (individuals who
contribute in a substantive, meaningful way to the
scientific development or execution of project,
whether or not salaries are requested)
Project Role on budget = Role on senior/key person
profile
Include senior/key personnel from subcontracts
Include senior / key personnel even if not receiving
compensation (e.g., mentors, letter of support
expected)
Current/Pending Support: Not Applicable
Biosketch: Use NIH format. Check out SciENcv:
http://www.ncbi.nlm.nih.gov/books/NBK154494/
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PHS 398 Cover Page Supplement
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Box 7. Change of Investigator / Change of
Institution. Ordinarily n/a for new applications
Education: chronological order
Personal Statement: briefly describe why your
experience and qualifications make you well
suited for your role in the project
Positions/Honors: chronological order
Publications: limit to no more than 15
Research Support: ongoing/completed in the
past 3 years (no effort; no dollars). If none,
state so
R&R Other Project Information
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Box 1. Are Human Subjects Involved?
o Exempt or non-exempt information
o SU Human Subject Assurance No. 00007077
Box 2. Are Vertebrate Animals Used
o SU Animal Welfare Assurance No. A3687-01
Box 3. Is proprietary / privileged information
included?
Box 4.Environmental impact?
Box 5.Research performance site historical
(ordinarily no)
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Box 6.Project involve activities outside the US or
partnerships with international collaborators?
o Also note on IRR. (report also Performance site)
7. Project Summary / Abstract
o No longer than 30 lines of text; succinct &
accurate description of project
8. Project Narrative
o 2-3 sentences in plain everyday language on the
project’s relevance to public health
9. Bibliography & References Cited (in Research Plan)
o References must include: all authors (as they
appear in the publication), the article and
journal title, book title, volume number, page
numbers, and year of publication.
o Limit to relevant and current literature.
o For articles that PI / team authored subject to
the Public Access Policy: include the NIH
Manuscript Submission reference number (e.g.,
NIHMS97531) or the PubMed Central (PMC)
reference number (e.g., PMCID234567). For
those journals that submit articles directly to
PMC on behalf of their authors, indicate “PMC
Journal – In Process.” A list of these journals is
posted at:
http://publicaccess.nih.gov/submit_process_journals.htm.
o Citations not covered by the Public Access
Policy, but are publicly available in a free, online
format may include URLs or PubMed ID (PMID)
numbers along with the full reference
10. Facilities and Other Resources – used to assess the
capability of environment to support project
success. Describe, institutional support, physical
resources (e.g., (Laboratory, Animal, Computer,
Office, Clinical and Other) in direct support of the
project. Indicate their capacities, pertinent
capabilities, relative proximity and extent of
availability to the project and intellectual rapport).
Describe ways in which the proposed studies will
benefit from unique features of the scientific
environment or subject populations or will employ
useful collaborative arrangements. For Early Stage
Investigators (ESIs), also describe institutional
investment in your success, e.g., resources for
classes, travel, training; collegial support such as
career enrichment programs, assistance and
guidance in the supervision of trainees involved
with the ESI’s project, and availability of organized
peer groups; logistical support such as
administrative management and oversight and best
practices training; and financial support such as
protected time for research with salary support.
See, http://grants.nih.gov/grants/new_investigators/.
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If there are multiple performance sites, describe
the resources available at each site.
o Describe any special facilities used for working
with biohazards or other potentially dangerous
substances. Note: Information about select
agents must be described in the Research Plan,
Section 11 (Select Agent Research).
11. Equipment – list equipment already available for
the project and, if appropriate identify location and
pertinent capabilities
12. Other attachments - if required by FOA.
PROJECT/PERFORMANCE SITE LOCATIONS
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Ordinarily, primary location is the applicant
organization (SU)
Any portion of the project performed at another
site (e.g. subcontract) must be identified, need:
o DUNS number and congressional district
PHS 398 Modular Budget
Used when annual direct costs are less than or equal to
$250,000 per year or if required by FOA
Cognizant Agency (Name, POC, and No.)
Department of Health and Human Services
Ryan McCarthy
212-264-2069
Indirect Cost Rate Agreement: 01/29/2014
 Use OSP budget template and modular sheet
 NOTE: Budget Justification must be attached in
order to navigate to next budget period
BUDGET JUSTIFICATION
For Modular Budget
 Personnel Justification: List all personnel who will be
compensated on the project; include person
months effort (cal or AY/Sumr); describe role,
responsibilities and provide sufficient information
justifying why effort committed is appropriate and
necessary for work.
 Consortium Justification: provide estimate of total
costs rounded to the nearest $1000; list org.
(foreign/domestic); personnel; effort; role. Detailed
subaward budgets not required for submission.
Detailed Budget Component
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When Direct Costs exceed $250K per year or when
required by FOA
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Separate subcontract detailed budgets are required
when submitting the Detailed Budget Component
OSP budget template organized for easy
comparison to NIH budget form
Sr. Personnel role/committed effort all described
Note 8.5 AY appt./3% salary escalation rate
Justify all other personnel: post-doc; graduate
students (AY 0.5 FTE; Sum. 0.5-1.0 FTE)
Essential administrative/clerical support explicitly
ordinarily justified to be allowable
Equipment adequately justified (why essential
(availability of other resources and why
inadequate), impact of not acquiring
Describe purpose of travel: where, who, how long
and cost breakdown
Consultant-describe work to be performed; daily
rate of pay; number of days(must also provide a
letter of collaboration with above described
elements)
Subcontracts Include Subaward R&R budget, budget
narrative. NOTE: OSP will also require a scope of
work, bios, letter of collaboration signed by
authorized organizational representative (AOR)
R&R Subaward Budget
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information developed (for the application) and
gathered (during an award budget period) from
other human subjects instruments.
What is clinical research for NIH purposes?
http://grants.nih.gov/grants/funding/women_min/women_min_qa.ht
m#3877
See also:
http://grants.nih.gov/grants/funding/women_min/women_min.htm
http://grants.nih.gov/podcasts/All_About_Grants/episodes/race_vs_ethnicit
y_July_2013.htm
PHS 398 Cumulative Inclusion Enrollment Report
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Required for Renewal or Revision applications
involving clinical research.
For each protocol, present actual enrollment to
date of research subjects and their distribution by
ethnicity/race and sex/gender on the Cumulative
Inclusion Enrollment Report.
Feb 2014
Required when there is a subaward. To be
completed by proposed subrecipient and provided
to OSP.
Subawardees service guidelines may differ from
SU’s (e.g., all materials final 10 business days before
deadline). These will trump SU’s.
Planned Enrollment Report
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Required for new applications when women or
minorities will be enrolled in human subjects clinical
research.
Provide one form for each human subjects protocol
anticipated.
Helps NIH and grantees adhere to and NIH monitor
the Women and Minority enrollment policy.
Targets for enrollment – consider 1) purpose of
research project; demographics of population in
accrual area; national demographics.
These forms are *not* the instruments to be used
with human subjects, but rather summarize
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