Research Services Office
2500 University Drive NW
3rd Floor MacKimmie Library Tower
Calgary, AB, Canada T2N 1N4
nihgrant@ucalgary.ca
National Institutes of Health (NIH)
Lead site Application Checklist
General Information
Objectives
NIH funds foreign institutions for projects having specific relevance to the objectives of the Institutes
and Centers (IC) and has the potential for significantly advancing the health sciences in the United
States. This checklist applies to NIH grants in which University of Calgary is the submitting institution,
applying to receive funds directly from NIH through a Notice of Award.
Eligibility
 Read the Eligibility Section of the Funding Opportunity Announcement (FOA) to ensure non-U.S.
entities are eligible to apply.
 Principle investigators must be registered in eRA Commons. Please contact Research Services to
register.
Common Types of NIH Applications:
R01 – Research Grant
 Used to support a discrete, specified research project
 NIH’s most commonly used grant program
 Budget – costs appropriate for the project, typically <$500,000 per year
 Generally awarded for 3-5 years
R21 – Exploratory Research Grant
 New, exploratory & development projects, supports early stages of project
 Limited to up to two years of funding
 Budget for direct costs for the two year project period up to $275,000
U01 – Research Project Cooperative Agreement
 Supports discrete, specified projects to be performed by investigator(s) in an area representing
specific interests and competencies
 No specific dollar amount – amount and years specified in FOA
Application Deadline to Research Services Office:
 The internal deadline for a detailed administrative review and institutional approval is 2 weeks
prior to the agency deadline. The 2 week deadline is required for lead application with
consortium applicants. This extended deadline is to ensure there is sufficient time to request
and receive all required documents from the sub-sites (signed facepage, letter of intent to
collaborate, budgets, budget justifications, bio sketches).
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The detailed administrative review includes a detailed review of the application, checking for
eligibility and UofC commitments and risk, compliance with program guidelines, completeness of
application, and the opportunity for feedback to improve the application.
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For lead application without consortium components, the final deadline for a basic review is 4
business days (noon) prior to the agency deadline. Please note, these 2 additional days are
required to ensure an error-free submission of the application. Applications will not be accepted
after this time. Please check with your Department and Associate Dean Research office for
timelines and processes to obtain signatures prior to submitting to Research Services.
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The basic administrative review involves a minimal check of the application for eligibility and any
UofC commitment or risk.
Additional Information:
 Unsolicited Applications (Parent Announcements)
 Funding Opportunities and Notices
 Grant Application Basics
 Application Guide
 Grants.gov
 eRA Commons
 Peer Review Process
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Application Checklist
To apply, submit a completed electronic application, downloaded from the Funding Opportunity
Announcement (FOA) webpage and a complete, signed Research Funding Application Approvals. Click
here for full instructions.
Application Overview
Grant Application Package
SF 424 (R&R)
PHS 398 Research Plan
PHS 398 Cover Page Supplement
Research & Related Senior/Key Person Profile (Expanded)
Research & Related Other Project Information
Project/Performance Site Location(s)
Research & Related Budget
Attachments
Specific Aims
Research Strategy
Resource Sharing Plan
Biographical Sketch for Senior/Key Personnel
Foreign Justification
Project Summary
Project Narrative
Facilities and Other Resources
Equipment
Budget Justification
Formatting Attachments
Font: Use Arial, Helvetica, Palatino Linotype, or Georgia typeface in black font color. After text
attachments are converted to PDF, font size in each final PDF document must be at least 11 points.
Margins: The final PDF document should have at least one-half inch margins (top, bottom, left, and
right) for all pages. No information should appear in the margins, including the PI’s name and page
numbers.
A. Create an Application
1. Follow the “Apply for Grant Electronically” button Funding Opportunity Announcement (FOA).
Click “Proceed to Grants.gov to Download Application.” Click “Download.” Either submit email,
or check that you do not wish to provide your email. Click “Download Application Package.”
2. Check the Research & Related Budget. Click “Add Period” on budget until all budget periods are
included.
3. Check all other optional forms that apply to your application to add them.
B. Complete the Application
1. Include title under application filing name.
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SF 424 (R&R)
1. Type of submission
Pre-application – do not use Pre-application unless specifically noted in FOA.
Application – use for first submission attempt
Changed/Corrected Application – use Changed/Corrected when correcting eRA errors/warnings. If
submitting a Changed/Corrected, include 3.c. the Previous Grants.gov Tracking ID.
5. Applicant Information
Legal Name: Governors of the University of Calgary
Address: 2500 University Drive NW, Calgary, Alberta, CAN: CANADA T2N 1N4
Person to be contacted: Anna LeMarquand
Address: 2500 University Drive NW, Calgary, Alberta, CAN: CANADA T2N 1N4
Phone number: 403-210-9815 Fax number: 403-289-0693
Email: nihgrant@ucalgary.ca
6. University of Calgary Employer Identification: 23-7067592
7. Type of Applicant: W: Non-domestic (non-US) Entity
8. Type of Application: See Application Guide for definitions
11. Title: NIH only saves first 81 characters of Project Title.
 If revision, provide exact title (including punctuation and spacing) as provided for awarded grant.
12. Proposed Project: Ensure that dates match those given in the budget
13. Congressional District: 00-000
15. Estimated Project Funding: give total requested funds, including direct and indirect costs
16. Is Application subject to review?: Check NO, Program is not covered by E.O. 12372
19. Authorized Representative
Lorna Very, Director, Grants, Awards and Ethics
2500 University Drive NW, Calgary, Alberta, CAN: CANADA T2N 1N4
Phone number: 403-220-4121 Fax number: 403-289-0693
Email: very@ucalgary.ca
21. Cover Letter Attachment: Required for re-submissions, recommended for new applications to
request application be directed to a specific institute and study section
PHS 398 Research Plan
1. Introduction: Provide for Resubmission or Revision only. Maximum of 1 page for revision, as well
as for resubmissions, unless indicated otherwise in the FOA.
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Resubmission: Summarizes the substantial additions, deletions, and changes to the application.
Resubmission: Response to issues and criticisms.
Revision: Describe nature of the supplement and how it will influence the specific aims, research designs,
and methods of the current grant.
2. Specific Aims: Required unless otherwise specified in FOA. Limited to 1 page.
 State the goals of the proposed research, the expected outcomes, the impact of the research field(s)
involved and the specific objectives.
3. Research Strategy: 12 pages for R01 and U01, 6 pages for R21, or following FOA instructions.
 Start each section with the appropriate section heading: Significance, Innovation, Approach.
 Significance: The importance of the problem, how the proposed project will improve knowledge, capacity
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and/or practice, and how the field will be changed if proposed aims are achieved.
Innovation: How the application challenges and shifts current research or practice, describe any novel
concepts, methods or instrumentation, and explain any improvements or new applications.
Approach: Describe overall strategy, methodology, and analyses, address Research Sharing Plan (unless
submitting as separate attachment), discuss problems, strategies and benchmarks for aims, and
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procedures, situations or materials that may be hazardous.
If there are multiple Specific Aims, Significance, Innovation and Approach may be addressed for each
Specific Aim.
Include information on Preliminary Studies (not required for R21 applications).
Renewal/Resubmission: provide a Progress Report with beginning and end dates. If providing a Progress
Report, attach a Progress Report Publication List.
4. Human Subjects section - If you answered “yes” to the question “are human subjects involved?”
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On the R&R Other Project Information Form, you must provide a) Protection of Human Subjects, b)
Inclusion of Women and Minorities and c) Inclusion of Children attachments. If you answered “no” to the
question “are human subjects involved?” but your research involves human specimens and/or data, you
must provide justification in the Protection of Human Subjects attachment that no human subjects are
involved.
5. Vertebrate Animals - If you answered “yes” to the question “are Vertebrate Animals Used?”
 On the R&R Other Project Information Form, you must address five points: a) a detailed description of
animals’ species, strains, ages, sex, and numbers, b) justify the choice of species and numbers, c)
veterinary care information, d) procedures for minimizing discomfort, pain, and injury, and e) method of
euthanasia.
 Although no page limit applies, be succinct.
6. Multiple PD/PI Leadership Plan – must be included if designating multiple PD/PIs.
 Describe rationale for choosing a multiple PD/PI approach.
 Describe the governance and organization of the team, including procedures for resolving conflicts.
 If budget allocation is planned, delineate the distribution of resources.
7. Resource Sharing Plan: Include as a separate attachment, if not discussed in Approach section of
Research Strategy.
 Data sharing plan: investigators seeking $500,000 USD or more in direct costs in any year are expected to
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include a brief 1-paragraph description of how final data will be shared, or explain why data sharing is not
possible.
Sharing Model Organisms: Regardless of the amount requested, all applications for the development of
model organisms must include a specific plan for sharing or distributing organisms, or state why such
sharing is restricted, or not possible.
Genome Wide Association Studies (GWAS): Applicants seeking funding for a genome-wide association
study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or an explanation why submission is not possible.
PHS 398 Cover Page Supplement
1. Project Director/Principle Investigator (PD/PI): First and last name are required fields.
2. Human Subject: Indicate whether it is a clinical trial.
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Phase III studies are done to study the efficacy of the biomedical or behavioral intervention in large groups
of human subjects (from several hundred to several thousand) by comparing the intervention to other
standard or experimental interventions as well as to monitor adverse effects, and to collect information
that will allow the intervention to be used safely.
3. Disclosure Permission Statement: check “yes” or “no.”
4. Program Income: Indicate if program income is anticipated, if so enter the budget period, amount
and sources in the columns.
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The total amount should match amount given in field 15. of SF 424 (R&R) form.
If the application is funded, the Notice of Grant Award will provide specific instructions regarding the use
of such income.
5. Human Embryonic Stem Cells: If “yes” is indicated, then either the “cannot be referenced box”
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must be checked, or approved cell line entries must be included.
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An error will be generated stem cell lines given provided in chart are not listed on
http://grants.nih.gov/stem_cells/registry/current.htm at the time of submission.
If cell lines cannot be referenced, provide a strong justification for why an appropriate cell line is not available
from the Registry at this time. The justification should be included as part of the Research Strategy or Program
Plan as appropriate.
6. Inventions and Patents: only required for renewal applications.
7. Change of Investigator/Change of Institution: not generally applicable to a “new” application
Research & Related Senior/Key Person Profile (Expanded)
1. Organization - name and complete address is required for PD/PI and all Sr/Key entries.
2. Credential – eRA Commons username is required for all PD/PIs.
3. Project Role – must be listed as PD/PI for first entry.
4. Biographical Sketch – attach for each person. Limited to 5 pages.
 Include each section (A - Personal Statement; B – Positions and Honors; C – Contributions to
Science; D – Research Support or Scholastic Performance)
 A: Applicant may identify up to four peer reviewed publications that specifically highlight your
experience and qualifications for this project.
 C: Include no more than 5 contributions to science with no more than 4 citations per
contribution
 For each contribution, indicate the historical background that frames the scientific problem; the
central finding(s); the influence of the finding(s) on the progress of science or the application of
those finding(s) to health or technology; and your specific role in the described work
 Ensure that if you include the optional link to a full list of your published work in a site like My
Bibliography that the URL is public, accessible without providing any login or personal
information.
 D: List both selected ongoing and completed research projects for the past three years. Briefly
indicate the overall goals of the projects and responsibilities.
5. Current & Pending Support – only provide if specifically requested in FOA.
Research & Related Other Project Information
1. Human Subjects – If “yes” is indicated
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Include a “Protection of Human Subjects” in PHS 398 Research Plan attachments. “Inclusion of Women
and Minorities,” “Targeted/Planned Enrollment Table,” and “Inclusion of Children” may also be
required, if applicable.
University of Calgary Human subject assurance number: 00000810
2. Vertebrate Animals – If “yes” is indicated, then include “Vertebrate Animals” in PHS 398
Research Plan attachments.
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University of Calgary Animal welfare assurance number: A5018-01
6. International collaborators – Indicate “yes.”
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6.a. – Add “Canada”
6.b. – Add “Please refer to Foreign Justification statement”
7. Project Summary/Abstract - Typically 30 lines or less. System will give error if over 1 page.
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Should serve as a succinct description of the proposed work when separated from the application. State
the application's broad, long-term objectives and specific aims, making reference to the health
relatedness of the project (i.e., relevance to the mission of the agency). This section should be
informative to other persons working in the same or related fields and insofar as possible
understandable to a scientifically or technically literate reader.
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8. Project Narrative - Typically 2-3 sentences. System will give error if over 1 page.
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Describe the relevance of this research to public health. Be succinct and use plain language that can be
understood by a general, lay audience.
9. Bibliography & References Cited - Provide all publications cited throughout application.
10. Facilities & Other Resources – Shows capability of the organizational resources available for
the effort proposed.
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Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If
appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability
to the project. Describe only those resources directly applicable to the proposed work.
If applicable, describe any special facilities used for working with biohazards or other potentially
dangerous substances.
If there are multiple performance sites, describe the resources available at each site.
For Early Stage Investigators (ESIs), describe institutional investment in the success of the investigator.
See http://grants.nih.gov/grants/new_investigators/
11. Equipment - List major items of equipment already available for this project and, if appropriate
identify location and pertinent capabilities.
12. Other Attachments – Attach file named “Foreign Justification” to this section.
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Begin the section with a heading indicating “Foreign Justification.”
Describe special resources or characteristics of the research project (e.g., human subjects, animals,
disease, equipment, and techniques), whether similar research is being done in the United States and
whether there is a need for additional research in this area.
Can highlight here that as F&A rate is only 8%, doing research in Canada provides considerable savings.
Project/Performance Site Location(s)
Project/Performance Site Location
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Organization Name: The Governors of the University of Calgary
DUNS Number: 2076639150000
Address: 2500 University Drive NW, Calgary, Alberta, CAN: CANADA, T2N 1N4
Congressional District: 00-000
If sub-sites are involved on application, include their addresses below
Research & Related Budget
R &R Budget – To add this budget, check the “Research & Related” box in the Optional forms section
on page 1 of the application package.
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Foreign institutions are not eligible to use the “PHS 398 Modular Budget”
Additional Budget Periods must be added to the application by checking the “Add Period” button on the 3 rd
page of this attachment. This process must be repeated for all subsequent periods.
DUNS Number: 2076639150000
Organization Name: The Governors of the University of Calgary
Budget Type: check “Project”
Ensure Budget Periods match those given on SF 424 (R&R).
A detailed budget must be completed for each year of support requested. Budget periods are usually 12
months.
While the dollar fields allow cents to be entered, all dollar fields should be presented in whole numbers.
Round to the nearest whole number.
All requests for Funding and Payment, including the budget contained in the application, must be stated
in U.S. Dollars.
Ensure that the total project period does not exceed that given on “Section II. Award Information” of the
FOA.
Ensure that the direct costs for any single year and the cumulative budget do not exceed the max. request
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noted in “Section II. Award Information” of the FOA.
Revision (Supplemental) Application: show only those items for which additional funds are requested.
A. Senior/Key Person
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This section should include the names of all senior/key persons at the applicant organization who are
involved on the project in a particular budget year. Include all collaborating investigators, and other
individuals meeting the senior/key person definition if they are from the applicant organization.
Details of collaborators at other institutions will be provided in the Subaward budget for each
subaward/consortium organization.
Personnel listed as Other Significant Contributors who are not committing any specific measurable effort
to the project should not be included in the Personnel section of the budget since no associated salary
and/or fringe benefits should be requested for their contribution.
Base Salary: An applicant organization may choose to leave this blank; however, NIH staff will request this
information prior to award for personnel requesting salary.
If requesting salary, ensure that this amount does not exceed the NIH Salary cap, set at approx. $180,000.
A salary cap calculator is available online.
Calendar Months: Use either calendar months OR a combination of academic and summer months to
indicate percent of effort. Q&A and a conversion calculator are available at:
http://grants.nih.gov/grants/policy/person_months_faqs.htm.
Project Roles - Principle Investigators role must be PD/PI, not PI. PI will generate an error which will
prevent submission to NIH.
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Multiple PI applications: Co-PD/PI not an applicable role for NIH applications. List Co-PIs as PD/PI.
B. Other Personnel
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Calendar Months: Use either calendar months OR a combination of academic and summer months to
indicate percent of effort.
C. Equipment Description
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Equipment is defined as an item of property that has an acquisition cost of $5,000 or more, and an
expected service life of more than one year.
If a short service life (< 1 year), even if it costs more than $5,000, can instead be listed as “supplies”.
No F&A charged on Equipment over $5,000. Do not include in indirect cost base in Section H.
Justify the need to buy instead of rent.
D. Travel
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Travel to Canada, the US and Mexico all considered domestic.
F. Other Direct Costs
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Materials and supplies: categories of less than $1,000 do not need to be itemized.
Subawards/Consortium/Contractual Costs: This line item should include both direct and indirect costs for
all subaward/consortium organizations.
NIH policy provides for exclusion of consortium/contractual F&A costs when determining if an applicant is
in compliance with a direct cost limitation. See the Supplemental Instructions, Part III, Section 1.1 for
additional information.
Equipment or facility Rental/User Fees: Rental costs are allowable to the extent that the rates are
reasonable at the time of the decision to lease.
Alterations and Renovations: Costs for any A&R were previously unallowable on applications from foreign
institutions. However, an HHS policy change now allows for minor A&R (≤$500,000) on these applications.
H. Indirect Costs
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Indirect cost type: F&A foreign rate
Indirect cost rate: 8
Indirect cost base: Total direct costs, excluding equipment (over $5,000 USD)
K. Budget Justification
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Budget justification attached only to “Budget Period 1,” but should describe all project periods.
Consortium application: Check “R & R Subaward Budget Attachment(s)” box in the Optional forms
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section on page 1 of the application package.
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Budget Type: check “Subaward/Consortium”
Ensure that the Budget Period dates match for the Project and Subaward budgets.
Budget justification should be included for consortium site.
C. Submitting the Application to NIH
Complete the internal University of Calgary Research Funding Application Approvals form, with signatures of PI,
Department Head, and Dean or Associate Dean (Research) and email the form and NIH application PDF to
nihgrant@ucalgary.ca
 Once RSO receives both the application PDF and the internal approvals form, your application will be
placed in a queue for review and approval.
 If submitted 2 weeks prior to the agency deadline, it will receive a detailed review.
 Applications submitted less than 2 weeks prior to the agency deadline will receive a basic review only,
checking for errors that will prevent submission to Grants.gov, as well as eligibility, U of C commitments,
and risk.
 The final deadline for RSO to receive applications is 4 business days prior to the agency deadline.
 Once Research Services has approved and submitted your application to NIH, an email will be sent to the
PI with the Grants.gov tracking number, once processed through the system.
 If any errors or warning are detected during submission to NIH, an email with be sent to RSO and the PI.
Errors will prevent submission and must be corrected, whereas warnings will not prevent submission. As it
can take time for errors or warning to be detected, early submission to NIH is highly recommended.
REVIEW CRITERIA
Initial peer review of NIH grant applications is coordinated by the Center for Scientific Review (CSR) or another NIH
IC. The initial peer review is an assessment of scientific and technical merit, conducted by a Scientific Review
Group (SRG) composed primarily of non-federal scientists who have relevant expertise. The outcome of the initial
review is provided to the PI in a NIH Summary Statement, which contains written critiques and criterion scores
from at least 3 reviewers, the final score and meeting rooster. It may also contain a summary of the discussion at
the SRG meeting.
The second level of review, known as Council review, is conducted by IC National Advisory Councils or Boards,
composed of both scientific members and public representatives. Reviewers provide an Overall Impact score to
reflect “the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.”
All NIH applications are rated according to the standard review criteria. The NIH uses a nine-point scoring system
(1 = highest impact, 9 = lowest impact) for all applications.
1. Significance
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2.
Does the project address an important problem or a critical barrier to progress in the field?
If the aims are achieved, how will scientific knowledge, technical capability, and/or clinical practice be
improved?
How will successful completion change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?
Investigator(s)
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Are the PD/PIs, collaborators, and other researchers well suited to the project?
If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they
have appropriate experience and training? If established, have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)?
If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated
expertise; are their leadership approach, governance and organizational structure appropriate for the
project?
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3.
Innovation
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Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of
research or novel in a broad sense?
Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?
4. Approach
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5.
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success presented?
If in the early stages of development, will the strategy establish feasibility and will particularly risky
aspects be managed?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1)
the protection of human subjects from risks, and 2) the inclusion (or exclusion) of individuals on the basis
of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of children, justified in terms of the
scientific goals and research strategy proposed?
Environment
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Will the scientific environment in which the work will be done contribute to the probability of success?
Are the institutional support, equipment and other physical resources available to the investigators
adequate for the project proposed?
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Will the project benefit from unique features of the scientific environment, subject populations, or
collaborative arrangements?