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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 Servicesto 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
New, Resubmission, Renewal and Revision applications:
§ New:
§ Resubmission: NIH policy allows a thirty-seven month window for resubmissions (A1 applications).
§ Renewal:
§ Revision:
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).
· 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.
§ 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.
· 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
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 OverviewGrant 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 on the 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 the Assignment Request Form if you would like to provide information to help NIH refer and review your application.
4. Check all other optional forms that apply to your application to add them.
B. Complete the Application
1. Include title under application filing name.
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: Dallas Callaway
Address: 2500 University Drive NW, Calgary, Alberta, CAN: CANADA T2N 1N4
Phone number: 403-210-9815 Fax number: 403-289-0693
Email:
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
9. Name of Federal Agency: National Institutes of Health
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, and are not prior to the earliest start date given in the FOA.
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
17. This box must be checked by the applicant
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:
21. Cover Letter Attachment: Required for re-submissions, can to used to communicate issues, such as reasons for late submission.
PHS 398 Research Plan
1. Introduction: Provide for Resubmission or Revision only. First time (new) applications should not include an Introduction unless specified in the FOA. Maximum of 1 page for revision, as well as for resubmissions, unless indicated otherwise in the FOA.
· 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 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 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?”
· 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?”
· Address 3 points: a) Description of Procedures - Identify the species, strains, ages, sex, and total numbers of animals, b) Justifications - why the research goals cannot be accomplished using an alternative model (e.g. computational, human, invertebrate, in vitro), and c) Minimization of Pain and Distress.
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 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.
8. Authentication of Key Biological and/or Chemical Resources -
These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics.
It should state, in one page or less, how you will authenticate key resources, including the frequency, as needed for your proposed research. The resources that require authentication will vary depending on the reagent/resource and the experimental context in which it will be used.
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.
· 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.
· 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” must be checked, or approved cell line entries must be included.
· 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.
· B: Ensure that position at U of C is listed.
· 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
· 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.
· University of Calgary Animal welfare assurance number: A5018-01
6. International collaborators – Indicate “yes.”
· 6.a. – Add “Canada”