UTHSC – College of Dentistry: Bioscience Research Center
Checklist for NIH (R01) Grant Submission:
Please check each relevant item as completed; fill in necessary information in the “Details” column.
PD/PI Name: ________________________________________________________________________________
Title of Grant: ________________________________________________________________________________
NIH Due Date: ________________________________________________________________________________
ITEM
DETAILS
MANDATORY ORA DOCUMENTS:
Routing Sheet
Mandatory sheet to be completed for
ALL grant/clinical research paperwork.
Must include:
- Investigator Signature (PI; CI)
- Department Head
- Dean
- Business Manager
- Dr. Debbie Smith’s (ORA)
PI Assurance
Mandatory signature form for all
investigators (either PI or CI on a grant).
Available on Dental Research/ORA
websites.
Statement of Work
Mandatory statement on ALL the work
to be done at UTHSC or by UTHSC
investigators or research team
members.
NIH GRANT BASICS:
Cover Letter
Not mandatory, but strongly
encouraged. Include:
- Application Title
- Funding Opp. Announcment
(FOA)
- Request of assignment or
referral to a particular IC
- List of individuals who SHOULD
NOT review the application and
why
- Disciplines (if multidisciplinary)
- Statement of special NIH
approval (including approval for
request of over $500k
- Explanation of Late Submission
(if applicable)
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NIH (R01) Grant Proposal Checklist
COMPLETED
Human Subjects Use Approval
IF using human subjects, you must
have:
- CITI certification for ALL
research staff and coordinators
- IRB Approval OR exemption
For more information and instructions, visit:
(Note: Provide IRB Assurance #
http://www.uthsc.edu/research/research_compliance/IRB/
or Exemption #):
Vertebrate Animal Use Approval
For access to AALAS Training, contact: Mary Braslow
(mbraslow@uthsc.edu) AND complete the Occupational
Health Program (to register call Vada Singleton: 8-5151)
IF using vertebrate animals in research,
you must have:
- AALAS Online Training for ALL
personnel who will interact
with animals
- Occupational Health Program
completion for ALL personnel
who will interact with animals
- IACUC approval (submit
protocol at UTHSC IACUC
website)- provide #:
Register with eRA Commons
Provide eRA Commons ID:
Biographical Sketches
(*Need one for EACH individual listed as Key Personnel)
Use the NIH Form and Instructions to
complete/update your biosketch.
*Note: Biosketch components changed
for the 2010 grant cycle. Please update
your biosketch.
Letters of Support
Provide Letters of Support from each
Key Personnel listed on the grant.
Personnel Justification
Each institution participating in the
grant should prepare a personnel
justification for its staff, including
percent effort (in calendar, academic,
or summer months)
Performance Site Information
For each site where research will take
place, provide the address and DUNS#.
Resources and Facilities Document
For each site where research will take
place, provide information about the
facilities and resources available. Also,
provide a statement of how the
scientific environment will contribute
to the probability of success of the
project.
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NIH (R01) Grant Proposal Checklist
Equipment
For each site where research will take
place, provide information about the
existing equipment relevant to the
project and provide description and
justification for any equipment over $5k
that will be purchased by the grant
funding.
UTHSC Abstract
Provide a brief (1-3 sentences) abstract
about the project, written in lay terms,
to be included with the UTHSC ORA
Routing Sheet.
RESEARCH PLAN:
Introduction (for resubmissions or revisions only)
(max. 1 page)
Project Abstract/Summary
(max. of 30 lines)
Project Narrative
(max. of 3 sentences)
Specific Aims
(max. of 1 page)
Research Strategy
(max. of 12 pages)
Bibliography and References Cited
For works available on PubMed Central,
provide PMCID numbers.
OTHER RESEARCH PLAN DOCUMENTS:
Human Subjects Documents
- Protection of Human Subjects
Details for each:
- Must include for all research
involving human subjects. Only
document needed if research is
a #4 exemption from IRB.
-
Inclusion of Women and Minorities
-
Please see NIH website for
guidance.
-
Targeted/Planned Enrollment
-
Please see NIH website for
guidance.
-
Inclusion of Children
-
Please see NIH website for
guidance.
Vertebrate Animals
IF CONDUCTING RESEARCH WITH
ANIMALS: Must address 5 key points in
animal research. Please see NIH website
for guidance on 5 key points.
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NIH (R01) Grant Proposal Checklist
Select Agent Research
IF USING SELECT AGENTS: Must address
key points laid out by NIH. Please see
NIH website for guidance.
Multiple PD/PI Management Plan
For proposals designating multiple
PD/PIs, must provide leadership plan.
Please see NIH website for guidance.
Resource Sharing Plans
Must include this document if:
- Total direct cost request is over
$500k
- Research includes the
development of model
organisms
- Research is Genome Wide
Association Study (GWAS)
Please see NIH website for guidance.
Consortium/Contractual Agreements
Include 398 Face Sheets for each
participating institution OR provide
Letters of Intent from each head of
department/dean/chancellor for key
personnel listed.
Consortium Justification
IF grant includes consortium, must
explain the programmatic, fiscal, and
administrative arrangements to be
made between the applicant
organization and the consortium
organization(s).
Budget
Even though the budget document is
optional, you MUST provide a budget
with every NIH grant proposal.
- Use the Modular budget when
the total direct costs for the 1st
yr. are less than $250k.
- Use the R&R Budget when 1st
year total direct costs are more
than $250k.
- When using the R&R Budget
AND have consortium/
contractual agreements, must
also include R&R Subaward
Budget for each institution.
- For total funds requested are
more than $500k, must request
permission from NIH. (include
approval letter with grant).
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NIH (R01) Grant Proposal Checklist
Budget Justification
For each institution, must include a
budget justification.
OTHER APPROVALS:
Recombinant DNA Approval
Must get rDNA Committee Approval.
(Note: Provide approval date and
assurance #):
Radioactive Materials Use Approval
Must get Radiation Safety Committee
Approval.
(Note: Provide proof of approval):
Select Agent Use Approval
Must get Select Agent Use Approval.
(Note: Provide date of approval):
RBL/BSL3 Facility Use Approval
Must provide approval letter:
For grant assistance, visit the UT Health Science Center Office of Research Administration (ORA) website:
http://www.uthsc.edu/research/research_administration
For UTHSC College of Dentistry grant assistance, contact:
Laurel Wedel, MHC
Grants & Clinical Research Coordinator
lwedel1@uthsc.edu / 448-2210
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NIH (R01) Grant Proposal Checklist