On This Page
Resubmissions
Are resubmissions to PAR-25-311 permitted?
Yes. Resubmissions to PAR-25-311 are permitted. The resubmission must be submitted within 37 months of the original new application submission. It is also important to note that the receipt date for the A1 applications is the same receipt date as for the A0 applications for PAR-25-311 and not a month later as is typical for many R activity codes. Potential applicants are advised to review the NIH/AHRQ Application Submission/Resubmission Policy (NOT-OD-18-197) and the Frequently Asked Questions (FAQs): Resubmissions of NIH Applications page.
Budget
Are indirect costs permitted on capitation funding provided to the enrolling Clinical Research Centers and sites?
Yes. Applicants are strongly encouraged to consult with your sponsored programs office within your own institution to ensure costs for your institution and for any subcontracts/sub-grant institutions are proposed in accordance with applicable cost principles, consistent with allowable and unallowable costs under NIH grants as provided in the NIH Grants Policy Statement, Section 7.2 The Cost Principles, Statement under Cost Considerations, and conform to your organization's negotiated F&A (indirect cost) rate agreement. Please check these policies prior to submission to ensure the applications are consistent with current policies.
Given that capitation indirect costs are direct costs within the grant application, should they be considered in the $6.25 million total direct cost cap?
Yes, applicable indirect costs for capitation will be considered as part of the direct cost budget, and they are applicable to the cap. As described in PAR-25-311, “application budgets are limited to direct costs of $6,250,000 for the entire project period (both phases), but need to reflect the actual needs of the proposed project. Direct costs should include capitation dollars to conduct the research as well as the indirect costs on that capitation funding.”
Applicants are strongly encouraged to consult with your sponsored programs office within your own institution to ensure costs are proposed in accordance with applicable cost principles, consistent with allowable and unallowable costs under NIH grants as provided in the NIH Grants Policy Statement, Section 7.2 The Cost Principles, Statement under Cost Considerations, and conform to your organization's negotiated F&A (indirect cost) rate agreement.
Can applications request a budget in excess of the $6.25 million total direct cost cap?
Yes. However, as described in PAR-25-311, “projects requiring direct costs exceeding $6,250,000 may be proposed, but will require additional NICHD approval as part of the pre-application process.” Budgets need to be submitted and approved by NICHD at least one month prior to the grant receipt date as described on the NICHD Clinical Research Pre-Application Process page under Timelines.
Junior Investigators
Can a K-award recipient participate in and be paid for activities on grant applications submitted in response to PAR-25-311?
Yes. K-award recipients can engage in and be compensated for activities on other grants including PAR-25-311, but they must maintain a minimum of 75% effort on the K award, ensuring that career development remains the primary focus. The remaining effort (up to 25%) can be allocated to other professional activities, but this cannot exceed 100% total effort. Additionally, there must be no overlap in costs or activities between the K award and other grants. Any additional involvement in other projects should be appropriately documented and justified to avoid conflicts with K award requirements.
If there is any uncertainty regarding specific situations, K award recipients should review Guide Notice NOT-OD-17-094 and consult their NIH program officer or grants management specialist for further clarification.
Can junior investigators include their Network participation on their K-award Development Plan?
Yes. If participation in a Network project aligns well with the career goals and research interests of the recipient of a K-award, that participation may be included as part of their K-award Development Plan on a case-by-case basis. The role in the Network project should be clearly described in both the Network application and the K-award Development Plan. The K-awardee’s participation in a Network project must be consistent with current NIH guidance, NIH Grants Policy Statement, relevant NIH Guide Notices including NOT-OD-17-094 and the NIH Research Career Development Awards (K) Kiosk.
Are biosketches required in the grant application submitted in response to PAR-25- 311 for all junior investigators or just those participating to a significant degree?
Biosketches are only required for those junior investigators who are being proposed to serve as senior/key personnel. Junior investigators who are only attending Steering Committee Meetings as their role in the project need not provide biosketches. All required biosketches must be provided in accordance with NOT-OD-24-163. Further guidance on biosketch preparation and submission can be found at the NIH Biosketch Format Pages, Instructions, and Samples page.
Does each enrolling site need to provide a junior investigator to participate in the proposed study or simply the funded clinical research centers?
One junior investigator needs to be identified from each of the Clinical Research Centers of the Network (i.e. the Centers that received the primary Notice of Grant Award) and not from the each of the satellite or enrolling sites. The junior investigator may be identified from the primary Clinical Research Center or any of the satellite sites for the primary Clinical Research Center, but only one junior investigator needs to be identified from each of the primary Clinical Research Centers. The junior investigator may take on any number of roles in the project, but their role should be clearly defined.
Process
Has the pre-application process changed with the issuance of PAR-25-311?
The pre-application process for PAR-25-311 is essentially the same as that used for PAR-23-037 with the process still delineated on the NICHD Clinical Research Pre-Application Process page. The only significant change will be in the timelines from the Letter of Inquiry receipt until the Grant Application receipt date. Any interested investigator is strongly encouraged to review the content on that website prior to initiating the process and/or to contact the Program Officials via the Network Clinical Research e-mail box at nichd-network-clinicalresearch@mail.nih.gov.
Is a Plan for Enhancing Diverse Perspectives required for applications submitted in response to PAR-25-311?
No. Applications submitted in response to PAR-25-311 are not required to submit a Plan for Enhancing Diverse Perspectives.
BACK TO TOP