Volunteer for NIAID-funded clinical studies related to autoimmune diseases on ClinicalTrials.gov.
These FAQs refer to the issue of the clinical (UM1) request for applications (RFA), RFA-AI-12-059, and the basic (U19) RFA, RFA-AI-12-060.
Additional FAQs were added in May 2013.
Does this webinar replace individual investigator contact with NIAID?
No, this webinar is not intended to replace individual contact with NIAID staff. Investigators are welcome to contact NIAID staff with questions regarding review, grants management, and program before or after the webinar. Both the UM1 and U19 RFAs contain contact information.
Will this webinar modify or add instructions or guidance to those stated in the RFAs?
No, the webinar (and these FAQs) will not modify or add any instructions or guidance. When possible, NIAID staff will cite the text of the RFAs, the notices (linked to the RFAs), or policy.
Will additional FAQs be posted after the webinar?
Yes, the updated FAQs and a list of participants will be linked from the NIAID autoimmunity portal.
As the program director/principal investigator (PD/PI) or as one of the PD/PIs of a multiple PD/PI application, may I submit both a basic U19 application and a clinical UM1 application?
No, you can be a PD/PI on only one application. The RFAs explicitly forbid a PD/PI submitting two applications (Part 1, Funding Opportunity Purpose).
Can the PD/PI on one application be a project leader on another application?
Yes, a PD/PI on one application may serve as project leader (not PD/PI) on another application, led by another PD/PI.
What is a new application and what is a renewal application?
If an institution holds a current ACE and submits an application that seeks to continue the current science, it is a renewal U19 application.
If an institution holds a current ACE and submits an application with a new PD/PI with entirely new science, that is a new U19.
Any UM1 is a new application.
Should I write a progress report if I am funded by the current ACE?
Yes, if you are supported by the current ACE, you must provide a report on your progress, as required by the U19 or UM1 funding opportunity announcement (FOA).
Can an institution submit more than one application to either RFA?
No, the RFAs forbid more than one application from a single institution (Section III, 3, Additional Information on Eligibility). However, an institution may submit one application for each RFA (i.e., one UM1, one U19).
Must the clinical project include a clinical trial, or would a clinical study also work?
Both clinical projects must include clinical trials (Part 2 Section I, Introduction). Furthermore, "clinical trial" is defined within the UM1 RFA as "medical research study in humans to evaluate the effects of one or more interventions for treatment of an autoimmune disease" (Part 2 Section I).
Can two applications to the clinical UM1 propose a shared clinical project?
No, two applications may not propose a shared clinical project (see Notification of Clarification and Correction to RFA-AI-12-059, NOT-AI-13-033). However, a clinical project may propose collaborations with other investigators. The clinical project must be entirely contained within and supported by one application.
What does it mean that the clinical projects "should not be fully developed in the application but must be ready to be fully developed by the entire ACE after award"?
The clinical projects may provide additional scientific opportunities for other ACEs to participate. Full development after award will incorporate the ideas and expertise of the entire ACE.
Can applicants plan on more than the application's $700,000 budget for the "fully developed" clinical project?
The budget for each clinical project is capped at $700,000 per year. The budgets may be revised upward or downward during full development, depending on the judgment of the ACE Steering Committee.
Are the funds for clinical projects awarded directly to the PI's institution?
No, the costs of the clinical projects will be paid from a "Clinical Project Fund that will be awarded separately" (Section IV, Number 2, Clinical and Collaborative Projects, Form Page 4 and 5, Clinical Projects).
Are renewals preferred over new applications?
Is it required to study more than one autoimmune disease?
For the UM1, yes, "[t]he two Clinical Projects must have different leaders and they must address different diseases, though they may be within one clinical specialty" (Part 2, Section IV, description of the Research Plan for the Clinical and Collaborative Projects).
For the U19, no.
Animal models of human disease are expressly forbidden, but are studies using humanized mice permitted?
Yes, studies using "humanized mice" are permitted. The studies must focus on the human cells and molecules and their interactions.
What projects will the steering committee review, and how are proposals they approve funded?
The ACE Steering Committee will review the development, final design, and budgets of the clinical projects, including the clinical trial and the mechanistic studies. Clinical projects will be paid from the clinical project fund. The ACE Steering Committee will also review applications for expanded or new collaborations, which would be paid from the opportunity fund.
Should members of advisory panels be named in the application?
In a new application, do not name members of advisory panels because the individuals and their collaborators will be automatically excluded as potential reviewers. Instead, state the type of expertise that will be sought for the panel.
If a panel is already formed, such as in the case of a renewal application, then the members of the panel must 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?
It may be better to provide only general types of collaborations with other ACEs for collaborative project.
Will the clinical and basic ACE applications be reviewed together?
NIAID will make that decision after receipt of the applications.
Is it a strength, or would it add risk, to tie the mechanistic studies within the U19 to projects proposed within the UM1?
No, the RFA states "Principal, Pilot, and Collaborative Projects…may use samples from previously completed clinical trials but they may not support a clinical trial."
What is the role of statistical support at the individual ACEs, and how should center statisticians plan to work with the Statistical and Clinical Coordinating Center (SACCC)?
Competitive applications will need statistical support to help design clinical projects. After award, clinical project investigators also will work with the SACCC, which is responsible for the final trial design, data collection, management, and analyses.
Is there public information on what the current ACEs proposed in their applications?
Yes, public information on all awarded NIH grants is available at projectreporter.nih.gov. You can find the abstracts to the current ACE projects by searching NIH RePORT for the FOA, RFA-AI-12-059.
Is there a public website for ACE?
Yes, www.autoimmunitycenters.org. This site includes links to the SACCC and to active trials listed at clinicaltrials.gov.
Where can UM1 applicants request support for clinical project development?
UM1 applicants may request up to $50,000 support for clinical project development within the administrative core, raising the overall cap for the admin core to $100,000. See Notice of Correction for Reporting Progress and Requesting Support for the Development of Clinical Projects for RFA-AI-12-059, NOT-AI-13-041.
Should applicants to the UM1 report their progress if they are part of the current ACE?
Yes, applicants who are supported by the current ACE must include a report on their progress during the period of support. The report should be included within the "Research Strategy" section of the Center Research Agenda. See Notice of Correction for Reporting Progress and Requesting Support for the Development of Clinical Projects for RFA-AI-12-059, NOT-AI-13-041.
Will reviewers review the entire grant or only individual projects and cores?
ACE applications will be reviewed as multi-project grants: Reviewers are assigned specific projects and cores and provide critiques and preliminary scores in advance of possible discussion. All reviewers will score all projects and cores, as well as the application as a whole.
Regarding the optional ACE funds management core, should the application include the budget for this core in the total requested figures on the face page?
Yes, include the funds management core budget in the requested amount on the face page and checklist. For purposes of review and administration, clearly distinguish this core budget from the others in the grant.
Because the SACCC-ADCT handles pharmacy matters such as drug storage and distribution for the clinical trials, does the applicant need to provide a budget for other pharmacy costs within the clinical project budget?
Yes. The applicant must budget for purchasing drugs and any special handling beyond standard storage and distribution.
The SACCC-ADCT will provide statistical support during final development and conduct of the clinical project. Therefore, does the application need to include statistician effort?
If the applicant needs any support for the clinicalp project or for any other work, that should be included within the application.
Can an ACE project overlap with a project submitted as an RO1?
Yes. Overlap is permitted between multi-project (e.g., the ACE) and single-project (e.g., R01) applications. You should describe the extent of overlap in the "Other Support" section of the Biosketch and state that you will either withdraw or modify the single project grant to eliminate overlap if the multi-project grant is awarded. See "Examples of Situations Where Concurrent Applications Are Allowable" on the Center for Scientific Review's Evaluation of Unallowable Resubmission and Overlapping Applications.
For the admin core, is the PI’s 1.2 person months’ effort in addition to, or included within, the $50,000 cap?
The PI’s 1.2 person months’ effort must be included within the $50,000 cap.
If an investigator believes that his/her research would make a good contribution to the ACE, can NIAID suggest a potential collaborator?
No. NIAID cannot suggest potential collaborators.
Can an ACE include co-investigators from an unrelated institution?
Yes. You may have ACE co-investigator(s) or collaborators from another institution.
Can a UM1 application include a proposed clinical trial in which one of the treatment arms requires products that have not been FDA-approved?
Yes. Products that do not have FDA-approval may be proposed in the application for use in clinical trials. However, the proposed trials must be "ready for full development" at the time the application is submitted. If the product is not approved for use in any condition, or not approved for the proposed use, or never used in humans, then the study will be conducted under an IND. All pre-clinical data that is required by the FDA must be completed before submission of the UM1. If industry is involved, then their commitment must be documented.
Last Updated May 17, 2013