Questions and Answers for RFA-AI-18-003, Autoimmunity Centers of Excellence, Clinical Research Program (UM1, Clinical Trial Required)

NIH published this funding opportunity announcement (FOA) in a March 8, 2018 Guide announcement.

Table of Contents

Questions Published on June 12, 2018

Questions Published on March 21, 2018

Question Published on June 12, 2018

Question About the Clinical Research Program UM1 FOA

How is a clinical ACE UM1 application structured?

NIH uses the UM1 activity code to support cooperative agreements involving large-scale research activities with complicated structures that cannot be appropriately categorized into an available single component activity code. =

Therefore, a clinical ACE UM1 application is structured as a single application with multiple elements that are not independent of each other. Use this structure for the Research Plan:

1)      Specific Aims: Describe Specific Aims for all elements in the clinical ACE UM1 application including Overall, two Clinical Projects (Primary and Alternate), Collaborative Project, Administrative Core, and ACE Funds Management Core.  (1-page limit)

2)      Research Strategy: The Research Strategy section must consist of sections A through F:

a.       Section A. Overview of the Proposed ACE Clinical Research Program (12-page limit)

b.       Section B. Administrative Core (6-page limit)

c.       Section C. ACE Funds Management Core (AFMC) (6-page limit)

d.       Section D. Primary Clinical Project (12-page limit)

e.       Section E. Alternate Clinical Project (12-page limit)

f.        Section F. Collaborative Project (12-page limit)

Follow all instructions in the SF424 (R&R) Application Guide and the additional Instructions provided in this FOA.

Questions Published on March 21, 2018

Questions About the Autoimmunity Centers of Excellence

Will NIAID post additional frequently asked questions (FAQs)?

Perhaps.  If new FAQs are posted, we will add a note at the top of this document along with the date of the revision. 

Do these FAQs replace individual investigator contacts with NIAID? 

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.

Do these FAQs modify or add instructions?

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.

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? 

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). 

May 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 on another application, led by another PD/PI. 

What distinguishes new from renewal applications?

  • 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. 

May renewal applications propose to continue ongoing projects?

  • 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.

Should I write a progress report if I am currently involved in the ACE?

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. 

May an institution submit more than one application to one RFA? 

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). 

Are renewals preferred over new applications? 

No, there is no preference between new or renewal applications. 

Do the ACE FOAs require study of more than a single autoimmune disease?

  • 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).

Are studies using animal models of human disease or using humanized mice allowed?

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”.

Should members of advisory panels be named in the application?

  • 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. 

For the collaborative project, is it better to identify collaborators by name or refer only to general types of collaborations?

It is probably better to provide only general types of collaborations with other ACEs for the collaborative project.

May an ACE include collaborators from another institution?

Yes.  You may have collaborators from another institution.  However, neither FOA allows co-investigators or collaborators from foreign institutions.

If I believe that my research would make a good contribution to the ACE, may NIAID suggest me as a potential collaborator?

No.  NIAID will not suggest potential collaborators. 

Will the clinical UM1 and basic ACE U19 applications be reviewed together?

NIAID will decide after receiving the applications. 

Should studies within the basic U19 or clinical UM1 be tied to clinical projects proposed within the UM1? 

The basic U19 FOA states that basic research “Projects may use samples from previously completed clinical trials or studies…”

Is there public information on what the current ACE awardees proposed in their applications?

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.  

Is there a public website for the ACE?

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.

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?

You must include the PI’s 1.2 person months effort in the $50,000 cap.

Does NIAID award funds for the collaborative projects directly to the applicant institution?

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. 

What projects will the Steering Committee review and how are approved proposals funded?

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.

Should the application include the budget for the ACE Funds Management Core (AFMC) in the total requested figures on the cover page?

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.   

How should indirect costs of consortium agreements for the collaborative projects be included in the AFMC budget?

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.

If my application is funded, will I be expected to share my data publicly?

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 Clinical Research Program UM1 FOA

Must the clinical project include a clinical trial or would a clinical study also work?

Each clinical project must include a clinical trial, i.e., "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes" (Part 2 Section I). The full NIH definition of "clinical trial" is linked from Part 2 Section I of the March 8, 2018 Guide announcement.

May two applications to the clinical UM1 propose a shared clinical project?

No, two applications may not propose a shared clinical project (Part 2, Section I). However, a clinical project may propose collaborations with other investigators. The clinical project must be entirely contained within and supported by one application.

The FOA says that development of clinical projects will "involve the ACE in the design and performance of the clinical trial and mechanistic study." What does that mean?

The full development of clinical projects after award will allow the ideas and expertise of the entire ACE to provide additional clinical and scientific opportunities for the study.

Should applicants expect more than the application's $700,000 total direct costs 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 and the availability of funds.

Are the funds for clinical projects awarded directly to the PI's institution?

No, the costs of the clinical projects will be awarded to one recipient by NIAID to fund the ACE Funds Management Core. However, each applicant must include detailed budgets for direct costs and facilities and administrative (F&A) as well as budget justifications.

Should I provide a budget for pharmacy costs within the clinical project budget?

Yes. Applicants must budget for purchasing drugs and any special handling beyond standard storage and distribution.

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)?

You may need statistical support when designing clinical projects. After award, clinical project investigators will work with the SACCC, which has final responsibility for trial design, data collection, management, and analyses.

May a clinical UM1 application include a proposed clinical trial in which one of the treatment arms requires products that have not been FDA-approved?

Yes. You may propose use of products that do not have FDA-approval for use in clinical trials. However, the proposed trials must be ready for full development when you submit your application. If the product is not approved for use in any condition, or not approved for the proposed use, or never used in man, then the study will be conducted under an investigational new drug (IND) application. Complete all preclinical data that the FDA requires for an IND application before you submit the application. If industry is involved, you must document that commitment.

How should we structure budgets for the clinical research projects?

We expect clinical projects to require support for between two and five years with a maximum of $700,000 direct costs per year. Budgets should be based on per-patient costs and include the other costs of performing the trial (clinical research tests, coordinator and PD/PI time, drug costs if applicable, pharmacy costs, mechanistic study costs, etc.).

How are the PHS Human Subjects and Clinical Trials Information (Study Record) sections connected to each proposed clinical project?

Describe the Primary and Alternate clinical projects in separate sections, Section D: Primary; Section E: Alternate. Note that for each clinical trial, applicants must provide specific information in a corresponding Study Record (PHS Human Subjects and Clinical Trials Information section). The Research Strategy section should not duplicate this information.

How can clinical UM1 applicants address enrollment challenges?

We encourage applicants to adopt recommendations of the Institute of Medicine experts (Envisioning a Transformed Clinical Trials Enterprise in the United States, Workshop Summary), including the following:

  • Identifying and engaging patients and physicians, perhaps through outreach to community clinics and practices;
  • Promoting public involvement through web-based information (such as social media), education, and outreach; and
  • Incorporating advanced clinical trial designs, such as adaptive design that uses information gathered in the course of the trial to adjust placebo and drug assignment groups.

Whom do I contact for more information on this FOA?

NIAID’s scientific/research contact for this opportunity is Dr. David Johnson.

Content last reviewed on June 12, 2018