National Institutes of Health (NIH)

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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

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.

1. 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.

1. Complete the Application

• If revision, provide exact title (including punctuation and spacing) as provided for awarded grant.

• 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.

• State the goals of the proposed research, the expected outcomes, the impact of the research field(s) involved and the specific objectives.

• 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.

• 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 youanswered “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.

• 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.

• 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.

• 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.

• 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.

• 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.

• An error will be generated stem cell lines given provided in chart are not listed on 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.

• 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

• University of Calgary Animal welfare assurance number: A5018-01

• 6.a. – Add “Canada”
• 6.b. – Add “Please refer to Foreign Justification statement”

• 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.

• Describe the relevance of this research to public health. Be succinct and use plain language that can be understood by a general, lay audience.

• 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

• 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.

• 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

• 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 3rd 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.
• Revision (Supplemental) Application:show only those items for which additional funds are requested.

• 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: .

• Multiple PI applications: Co-PD/PI not an applicable role for NIH applications. List Co-PIs as PD/PI.

• Calendar Months: Use either calendar months OR a combination of academic and summer months to indicate percent of effort.

• 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.

• Travel to Canada, the US and Mexico all considered domestic.

• 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.