Please note: The primary source of all information regarding RFA-TR-22-012: Emergency Awards: HEAL Initiative-Limited Competition: HEAL Initiative Resource Centers for the Pain Management Effectiveness Research Network (ERN) (U24 Clinical Trial Not Allowed) is the funding opportunity itself and any notices (i.e., NOT-TR-22-018) linked therein.
Eligibility for this FOA is limited to current NCATS TIN recipients. The FOA does not limit who may serve as PI. However, there is a clear expectation that the program director(s) and/or PI(s) have expertise and experience conducting multicenter trials or analysis of clinical data to achieve the scientific objectives of the HEAL ERN, as well as significant experience for the type of HEAL Resource Center specified.
Relevant text from RFA-TR-22-012: Eligibility to apply to this FOA is limited to current NCATS TIN recipients supported under RFA-TR-15-002 and RFA-TR-15-004.
Correct: Applications may not exceed the prescribed limitations. The Research Strategy section is limited to 12 pages plus one page for the Specific Aims.
Relevant text from RFA-TR-22-012: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The earliest start date will be July 2022.
Yes. Please see the companion RFA (RFA-AT-22-005) to learn more about the possible two new trials that would begin planning in Year 1.
Relevant text from RFA-TR-22-012:
Years 1–5: The budget must include allocations to continue support for the trial currently funded through RFA-NS-20-028 and two additional HEAL ERN trials/studies estimated to begin the first planning phase in Year 1. Note: There is an expectation that annual budgets will decrease as enrolling studies are completed and that final budgets will depend on the number of new trials beginning the planning phase in Year 1.
Data Coordination Resource Center (DCRC)
Year 1: Not to exceed $2 million direct costs; Total Direct Costs for 5 years not to exceed $8 million.
Clinical Coordinating Resource Center (CCRC)
Year 1: Not to exceed $2 million direct costs; Total Direct Costs for 5 years not to exceed $6.5 million.
Statistical and Safety Resource Center (SSRC)
Year 1: Not to exceed $1.5 million direct costs; Total Direct Costs for 5 years not to exceed $4.5 million.
Recruitment Resource Center (RRC)
Year 1: Not to exceed $750,000 direct costs; Total Direct Costs for 5 years not to exceed $2.5 million.
For Years 2–5, there are no direct cost limits per year; however, the total direct costs for the five-year budget period cannot exceed the limitations prescribed above.
Relevant text from RFA-TR-22-012:
Years 1–5: The budget must include allocations to continue support for the trial currently funded through RFA-NS-20-028 and two additional HEAL ERN trials/studies estimated to begin the first planning phase in Year 1. Note: There is an expectation that annual budgets will decrease as enrolling studies are completed and that final budgets will depend upon the number of new trials beginning the planning phase in Year 1.
Years 2–5: The budget also must include designated expenses in Years 2–5 to provide HEAL ERN Resource Center services for currently funded HEAL ERN clinical trials with active participant enrollment supported through RFA-NS-19-021.
Current Trial Innovation Network (TIN) award unexpended balances will provide support for the four UH3 trials that were funded starting in fiscal year (FY) 2019 (SurgeryPal, POSITIVE, RESOLVE and SKOAP) through June 30, 2023. Starting July 1, 2023, these four trials will be supported by funds from the new U24 awards solicited by RFA-TR-22-012.
Funds for support of TIN infrastructure for the Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain study and two new sickle cell pain management trials will be provided by awards funded through RFA-TR-22-012, starting in FY 2022.
PLEASE ALLOW ADEQUATE TIME TO REQUEST USE OF ANY UNOBLIGATED BALANCES FROM THE CURRENT TIN AWARDS.
The RFA lists a specific activity for the Clinical Coordinating Resource Center (CCRC), Data Coordination Resource Center (DCRC) and Statistical and Safety Resource Center (SSRC) to plan to act as the single Institutional Review Board (sIRB) for at least one ERN study. All three Resource Centers are currently supporting one sIRB, but only two additional trials are anticipated. Therefore, it makes sense for only the DCRC and CCRC to budget for an additional sIRB. All three Resource Centers would continue the sIRB support that we are already providing for existing studies.
Is it acceptable that the SSRC not be required to plan for an additional sIRB?
The CCRC, DCRC and SSRC should each present a plan to provide new and/or continuing sIRB support to HEAL ERN trials.
There is an obvious intent for collaboration among the four Resource Centers if the award is made, and the four Resource Centers have been collaborating for several years to support HEAL ERN trials. Because applicants are supposed to demonstrate synergy, it seems sensible that grant proposals should contain “common items,” such as the anticipated timeline for trial activities in all seven trials and the summary information about ERN accomplishments to date. This could result in sections of our four proposals that are identical, facilitating review of the applications. However, we do not want to create a perception of inappropriate collusion that would be problematic. In the original HEAL supplement applications, the first several pages of our applications were identical, but these were reviewed administratively, not by a study section.
Is it acceptable for us to incorporate common identical components in our applications?
Each application is evaluated individually and needs to contain within it all information needed for its review.
No. The unexpended funds from the current Trial Innovation Network (TIN) awards cannot be transferred to this new award.
Please note that any current TIN award unexpended HEAL supplement funds from previous years or Year 7 HEAL supplements must be expended by the end of the project period (June 30, 2023).
The expectation is that the Year 7 HEAL supplements for the current TIN awards will be the committed level stated in the Notice of Award minus any HEAL unobligated balances.
The goal is to expend all HEAL supplement dollars obligated to the current TIN awards by the end of the project period (June 30, 2023). Therefore, NCATS will aim to utilize any remaining HEAL unobligated balances as an offset for the final Year 7 award.
Future potential extensions or cost extensions may be permitted per Section 126.96.36.199 of the NIH Grants Policy Statement.