This Notice announces a change in the procedures by which the NIAMS considers requests for acceptance of grant applications that request $500,000 or more in direct costs for any project year.
The most recent NIH policy on the acceptance of applications requesting direct costs of $500,000 or more for any one year states that effective with the January 1, 2002, receipt dates, NIH requires applicants to seek agreement to accept assignment from Institute/Center staff at least 6 weeks prior to the anticipated submission. Applicants proposing clinical trials with budgets of $500,000 or more for any one year should request the agreement at least 10 weeks in advance.
Previously, the NIAMS accepted such large budget applications during two of the three grant cycles each fiscal year. Under this revised policy, the NIAMS will consider acceptance of requests for all three grant cycles. All applicants interested in submitting an application with $500,000 or more in direct costs for any year should contact the appropriate NIAMS Program Director well in advance of submitting the application and the formal Request for Acceptance.
- This policy applies to new, resubmission (A1), renewal, and revision applications (definitions).
- To facilitate review of requests by staff, requests for acceptance must be made in writing Applicants are advised that the NIAMS is less likely to grant permission for submission of an application for the February 5/March 5 receipt dates (Cycle I) due to the timing of application cycles relative to formulation of fiscal year budgets.
- The submission cycle requested by the applicant in the Letter of Request does not obligate the NIAMS to accept an application for that cycle. NIAMS staff may determine that the application should be submitted for a different receipt date, and should this be the case, it will be indicated to the applicant in the NIAMS decision letter.
This policy does not apply to applications submitted in response to Requests for Applications (RFAs). Applications submitted in response to the Omnibus Solicitations for Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications are also exempt.
What to Include in the Request for Acceptance
The formal Request for Acceptance of a large budget application should be sent by email to the relevant NIAMS Program Director, with a request for acknowledgement of the receipt of the email. The formal request should contain each of the following components:
- The intended application submission date.
- A descriptive title of the proposed research.
- Name, institutional affiliation, email address, and telephone number of the Principal Investigator.
- A description of the proposed research or training program (one page or less).
- For clinical studies, include a brief description of the plans for considering gender, minority status and children in the enrollment.
- A table that details the requested budget - include major budget categories (key/senior and other personnel, equipment, travel, trainee support, other direct costs), indirect costs, and total costs for each year of the requested application.
- A brief narrative justification for each budget category.
In addition, the Request for Acceptance should address:
- The relevance of the proposed research to the NIAMS mission.
- Why the information gained through this research will provide a valuable addition to the existing knowledge base.
For clinical trials, additional information is required. For submission materials, please refer to the following page: https://www.niams.nih.gov/grants-funding/clinical-research/grants/letters-request
Criteria for Acceptance
The following general criteria will enter into the consideration of all applications subject to this policy:
- The proposed research or training program is relevant to the NIAMS mission.
- The results of the proposed research or training program will provide a valuable addition to the existing knowledge base or will address needs in the research workforce.
- The proposed research or training program complements ongoing program activities of the Institute and is likely to have a positive impact on program balance.
- For all proposed research involving human subjects, the outcome is likely to have public health applicability.
- The annual costs for each year of support for the proposed research are reasonable.
- For clinical research, study population plans comply with the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research and the NIH Policy in Inclusion of Children as Participants in Research Involving Human Subjects.
- The NIAMS budget has sufficient funds to support the project or training program, taking into consideration other financial obligations.
Obtaining NIAMS agreement to accept an application is only the first step in the process of applying for support. The ultimate decision regarding an award is dependent upon the results of peer review for technical/scientific merit and impact, and subsequent consideration by the NIAMS Advisory Council. The Request for Acceptance is not part of the peer review for technical/scientific merit and impact.
The Institute recognizes that a request will often be preceded by informal discussions with NIAMS scientific staff regarding the proposed research; however, no official action will be taken until a formal request, in the form of the complete Request for Acceptance described above, is received by the appropriate Program Director and the Request for Acceptance has been reviewed. Notification about the NIAMS decision will be provided in writing (email) after staff has met.