NIH published this funding opportunity announcement (FOA) in a March 8, 2018 Guide announcement.
Table of Contents
Questions Published on March 21, 2018
- Questions About the Autoimmunity Centers of Excellence
- Will NIAID post additional frequently asked questions (FAQs)?
- Do these FAQs replace individual investigator contacts with NIAID?
- Do these FAQs modify or add instructions?
- As a program director/principal investigator (PD/PI) or as one of the PDs/PIs of a multiple-PD/PI application, may I submit both a basic U19 application and a clinical UM1 application?
- May the PD/PI on one application be a project leader on another application?
- What distinguishes new from renewal applications?
- May renewal applications propose to continue ongoing projects?
- Should I write a progress report if I am currently involved in the ACE?
- May an institution submit more than one application to one RFA?
- Are renewals preferred over new applications?
- Do the ACE FOAs require study of more than a single autoimmune disease?
- Are studies using animal models of human disease or using humanized mice allowed?
- Should members of advisory panels be named in the application?
- For the collaborative project, is it better to identify collaborators by name or refer only to general types of collaborations?
- May an ACE include collaborators from another institution?
- If I believe that my research would make a good contribution to the ACE, may NIAID suggest me as a potential collaborator?
- Will the clinical UM1 and basic ACE U19 applications be reviewed together?
- Should studies within the basic U19 or clinical UM1 be tied to clinical projects proposed within the UM1?
- Is there public information on what the current ACE awardees proposed in their applications?
- Is there a public website for the ACE?
- For the administrative core, should I include the PI’s 1.2 person months effort in the $50,000 cap or is that in addition to the cap?
- Does NIAID award funds for the collaborative projects directly to the applicant institution?
- What projects will the Steering Committee review and how are approved proposals funded?
- Should the application include the budget for the ACE Funds Management Core (AFMC) in the total requested figures on the cover page?
- How should indirect costs of consortium agreements for the collaborative projects be included in the AFMC budget?
- If my application is funded, will I be expected to share my data publicly?
- Questions About the Basic Research Program U19 FOA
Questions Published on March 21, 2018
Questions About the Autoimmunity Centers of Excellence
Perhaps. If new FAQs are posted, we will add a note at the top of this document along with the date of the revision.
No, investigators are welcome to contact NIAID staff with questions that are not answered here. The RFAs contain contact information for staff members responsible for review, grants management, and program. Questions posed to staff that are of general interest may be posted as a FAQ.
No, these FAQs do not modify or add any instructions. These answers are intended to help investigators understand and follow the instructions in the RFAs.
No, you can be a PD/PI on only one application to one FOA. The FOAs explicitly forbid a PD/PI from submitting applications to both FOAs as explained in Part 2, Section III, 1 Eligible Individuals (Program Director/Principal Investigator).
Yes, a PD/PI on one application may serve as project leader on another application, led by another PD/PI.
- If an institution holds a current ACE and submits an application that seeks to continue the current science with the same or new PD/PI and the same mechanism (U19 or UM1), then it is a renewal application. Note that a Clinical ACE (UM1) must propose new clinical projects but may continue the same science in scope and theme.
- If an institution holds a current ACE and applies proposing entirely new science, then it is a new application.
- If an institution holds a current ACE and applies to the other funding mechanism, UM1 grant to U19 application (or the reverse), then the application to the other mechanism is a new application.
- For collaborative projects, yes. Renewal applications may propose either to continue ongoing projects or begin entirely new projects.
- For clinical projects, no. Renewal applications must not propose an ongoing clinical project as one of the required projects. Ongoing clinical projects will be continued to completion as legacy projects.
Yes, if you are supported by the current ACE and you are applying to continue your current research, you must provide a report on your progress as required by the U19 and UM1 FOAs.
No, the RFAs forbid more than one application from an institution (Part 2, Section III, 3: “Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed”). However, an institution may submit applications to both RFAs (one UM1, one U19).
No, there is no preference between new or renewal applications.
- For a U19, no. There is no requirement to study more than one autoimmune disease in a Basic ACE.
- For a UM1, yes. “The Primary and Alternate clinical projects must address different diseases and have different leaders, though both projects may be within one clinical specialty.” (Part 2, Section I).
No, studies using animal models of human disease as well as “humanized mice” are expressly forbidden. The scope states that all “projects must investigate autoimmune disease in humans”.
- For new applications, no. Do not name or contact potential members of advisory panels. Instead, state the type of expertise that you will seek for the panel.
- For renewal applications, yes. If a panel is already formed, then the members of the panel must be named in the application.
It is probably better to provide only general types of collaborations with other ACEs for the collaborative project.
Yes. You may have collaborators from another institution. However, neither FOA allows co-investigators or collaborators from foreign institutions.
No. NIAID will not suggest potential collaborators.
NIAID will decide after receiving the applications.
The basic U19 FOA states that basic research “Projects may use samples from previously completed clinical trials or studies…”
Yes, public information on all awarded NIH grants is available from NIH RePORT (Research Portfolio Online Reporting Tools). Find abstracts of the current ACE projects by searching for the FOAs RFA-AI-12-059 (UM1) and RFA-AI-12-060 (U19). Also, find the ACE Collaborative Agenda and the annual progress reports on the public ACE Research Plan 2015-2019 page.
Yes, at Autoimmunity Centers of Excellence. This site also has links to the SACCC (Statistical and Clinical Coordinating Center) and to ACE clinical trials at ClinicalTrials.gov.
You must include the PI’s 1.2 person months effort in the $50,000 cap.
No, the costs of the collaborative projects will be awarded by NIAID to one recipient to fund the ACE Funds Management Core. However, each applicant must include a detailed budget for direct costs and justifications for collaborative projects. For submission purposes, applicants should include their Institution’s facilities and administrative (F&A) costs.
The Steering Committee will review the development, final design, and budgets of the clinical projects, including the clinical trial and the mechanistic studies. The Steering Committee will also review the final designs of the collaborative projects. Clinical projects and collaborative projects approved by the Steering Committee will be paid by the ACE Funds Management Core (AFMC) from the respective Funds. The Steering Committee will also review applications for expanded or new collaborations, which will be paid from the collaborative project Fund.
Yes, include the AFMC budget in the requested direct costs and total costs on the cover page. For purposes of review and administration, clearly distinguish the AFMC budget and justifications from the other budgets in the application.
As stated in the FOAs, the actual consortiums for collaborative projects may be unknown at the time of submission. We encourage you to include direct costs up to $3.2 million for unknown consortiums as other direct costs. For submission purposes, the applicant organization will assume full F&A for the other direct costs.
Yes, we expect all investigators funded under this FOA to share their data publicly through ImmPort or other public portals approved by NIH. Therefore, the data sharing plan should include a summary of how the applicant will manage data submission and interactions with ImmPort or another NIH-approved public portal.
Questions About the Basic Research Program U19 FOA
There is no renewal process planned for the two-year pilot projects. Leaders of successful pilot projects may apply to the Steering Committee for continued support from the collaborative project Fund which will be awarded to the AFMC.
Applicants must use SF 424 (R&R) Version E forms and follow the Application Guide instructions to provide information on human subjects. Also see the instructions for PHS Human Subjects and Clinical Trials Information (Overall) in Section IV.2 of the March 8, 2018 Guide announcement.
Yes. Overlap submission within the same funding round is permitted between multiproject (e.g., the ACE) and single project (e.g., R01) applications. However, NIH will not fund overlapping science. See the NIH Center for Scientific Review guidance Evaluation of Overlapping Applications. As NIAID explains at Option to Submit Simultaneously as an R01 Application, policy mandates that if both grants are to be awarded, overlap must be removed from the single project grant to preserve the scientific integrity of the multiproject grant.
NIAID’s scientific/research contact for this opportunity is Dr. David Johnson.