NIAMS Policy for Acceptance of Letters of Request (LORs) for Large Grants
Grants with Budgets of $500,000 Direct Costs or More in any One Budget Period within a Competitive Segment
This policy has been updated to change the procedures by which the NIAMS considers Letters of Request (LORs) for acceptance of grant applications that request $500,000 or more in direct costs (excluding consortium F&A costs) in any one-year budget period within a competitive segment. The new procedure requires use of the NIH Prior Approval Module in the eRA Commons.
The NIH policy states that applicants are required to seek agreement to accept assignment from Institute/Center staff at least 6 weeks prior to the receipt date of the application. NIAMS policy requires that 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.
The NIAMS will consider acceptance of LORs 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 LOR.
- This policy applies to every investigator-initiated new, resubmission (amended), renewal (competing continuation), and revision (competing supplement) application.
- The submission cycle requested by the applicant in the LOR 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 communicated to the applicant in the NIAMS decision letter.
Although applicants can ask for up to $499, 999 without our approval, they should contact the Program Officer if the anticipated request comes anywhere close to that level for the following reasons:
- A future year may exceed $500,000.
- The system may round up dollar figures which could cause the budget to go over $500,000.
- The Institute may not have funds available for applications close to $500,000. NIAMS funds only a small number of large grants each year because they strain the budget and may necessitate reducing the total number of grants we can award.
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.
The Principal Investigator (PI) initiates the process by sending a request to the Program Officer (PO) listed in the Funding Opportunity Announcement (FOA) under Scientific/Research Contacts, who can advise the PI on the feasibility of successfully competing for an award. NIAMS will then initiate the request electronically, in the eRA Commons. The PI will then receive an invitation to submit the required material through the Prior Approval Module.
Please consult the Prior Approval User Guide for additional information about the Prior Approval Module.
WHAT TO INCLUDE IN THE LOR:
- The intended application submission date.
- A descriptive title of the proposed research.
- Name, institutional affiliation, email address, and telephone number of the Principal Investigator.
- Names of all key personnel and participating institutions.
- 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 humans across the lifespan 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), F&A (indirect costs), and total costs for each year of the requested application.
- A brief narrative justification for each budget category.
Investigators who are considering applying for a Clinical Trial with a budget of $500,000 or more in direct costs in any year should also include the following:
- Any refinements or changes in the Principal Investigator(s), rationale, objectives, protocol, study sites, and industry partners for the proposed trial, from that outlined in the R34/U34 application (if applicable).
- A table that details the requested budget—include major budget categories (key/senior and other personnel, equipment, travel, trainee support, other direct costs), F&A (indirect costs), and total costs for each year of the requested application.
- A separate page with the title of the proposed research and a one-page synopsis of the likely impact of the proposed study on disease prevention, diagnosis, or treatment.
- A separate document that summarizes each of the planning Milestones and provides a status of each task. Any tasks that remain to be completed must be detailed and justified before the trial can open for recruitment. Please use the Clinical Trial Planning Milestone Checklist to submit this information.
All LORs 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.
CRITERIA FOR ACCEPTANCE
The following general criteria will factor 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 NIAMS 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 to complete the proposed work.
- 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 on Inclusion Across the Lifespan.
- 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 LOR process 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 LOR described above, is received and reviewed by the Institute. Notification of the NIAMS’ decision will be provided in writing after a decision has been made. If you have any questions about this policy, please contact the appropriate NIAMS Program Officer. If you have questions about this policy as it relates to clinical trials, please contact NIAMSclinicaltrials@mail.nih.gov