Questions and Answers for RFA-AI-18-036, Leadership Group for a Clinical Research Network on Antibacterial Resistance (UM1, Clinical Trial Required)

NIH published this funding opportunity announcement (FOA) in a July 9, 2018 Guide announcement

Table of Contents 

Questions Published on October 11, 2018

Questions Published on September 21, 2018

Question Published on September 11, 2018

Question Published on September 7, 2018

Question Published on August 22, 2018 

Questions Published on July 9, 2018 

Questions Published on October 11, 2018

Are antifungal resistance studies allowed for this FOA?

Yes. You may propose research to address antifungal resistance.

To emphasize the strength of collaborating institutions, may we name or describe resources that are not involved with our plans for the Antibacterial Resistance Leadership Group (ARLG)?

No. Your application should describe only the resources (and associated key personnel) that would support the proposed work. We advise you to clearly differentiate between what your project will use and what your project might use.

Questions Published on September 21, 2018

Is this FOA a request for research clinical trial proposals or a request for leadership groups? Is it meant to recompete the current Antibacterial Resistance Leadership Group (ARLG)?

The FOA’s overall purpose is to recompete the program currently known as ARLG. Note that we may make up to two awards.

Should we propose clinical trial research?

Yes. As part of your leadership group application, include a research agenda proposing at least one clinical trial (though it may be delayed onset). Follow the FOA’s instructions for the Research Strategy, Subsection B:

Research Agenda and initial project portfolio

In detail, clearly describe the comprehensive AR clinical research agenda for the LG. Address how current efforts by others in the field were considered in developing the research agenda, how the research agenda will address key knowledge gaps and future opportunities in the field of AR clinical research, and any innovative aspects of the agenda. In addition, include descriptions of high-priority concept areas to be included as part of the initial project portfolio. For human subjects and clinical trials information associated with a specific study (ies) of the initial project portfolio, including delayed onset, applicants are required to address within the Study Record.

Question Published on September 11, 2018

Does the FOA allow any studies focused on parasites, viruses, and mycobacteria, including non-tuberculous mycobacteria (NTM)?

No. These study types are outside of this FOA’s scientific scope.  They are supported by other NIAID programs

Question Published on September 7, 2018 

As I develop my application, may I safely assume that I should designate Protocol Funds only for those activities that meet the NIH definition of a clinical trial?

Yes. In the budget justification, provide a budget breakout for all activities under one of two major headings:

  1. Core Funds, for all costs not related to clinical trials
  2. Protocol Funds, for all costs associated with the conduct of trials that comply with NIH’s Definition of Clinical Trials

Question Published on August 22, 2018 

The FOA says “Do not name or contact potential collaborators that are not already key personnel in the application” and “Do not name or contact potential committee members that are not already key personnel in the application.” Would you clarify whom we can name or contact?

In your application, you may name or contact only those who have committed to serving a role (e.g., key personnel, providing a service with a Letter of Support). You may include this information in the application. However, do not name or contact groups or individuals who may potentially provide a service or merely be appropriate for a role.

Questions Published on July 9, 2018 

Scientific Focus and Structure 

What types of studies are permissible: only clinical trials or other types of clinical research as well? 

The scope of the FOA covers all clinical research related to antibacterial resistance, spanning clinical studies and clinical trials. At least one immediate, delayed start, or delayed onset trial must be proposed. Also see the question Must an application propose a clinical trial to be responsive to this FOA? below. 

May the four centers of the Leadership Group (LG) be based at different institutions?  If so, may each center have elements that are housed at different institutions?  Under this scenario, how will indirect cost rates be calculated? 

Yes, the four centers (Scientific Leadership Center, Clinical Operations Center, Laboratory Center, and Statistics and Data Management Center) could each be based at a different institution.   

The indirect cost rate for each center is the rate applicable at the institution where the activity is based. 

Previous versions of the LG were required to use the Vaccine Treatment Evaluation Units (VTEUs) for “high resource” clinical trials. Is this still required?  

Due to the diverse nature of LG studies and required patient populations, we expect that performance sites for implementing interventional clinical trials will be located at the applicants’ institution(s) or at directly subcontracted protocol-specific sites, managed by the Clinical Operations Center. However, applicants still have the option to use other NIAID clinical research sites, such as the VTEUs or the DAIDS Clinical Trials Units, on a case-by-case basis.  

Are international sites allowed to be part of the group?  

Yes, while an international investigator cannot be the lead principal investigator, the network structure may include international investigators and sites. 

Study and Trial Issues  

Must an application propose a clinical trial to be responsive to this FOA? 

Clinical trials are required under the FOA; however, the applicant does not need to propose a trial at the time of application submission. The applicant must enter at least one immediate start, delayed start, or delayed onset study record into FORMS-E.  

Note that for a delayed onset trial, limited information is required in FORMS-E.

For clinical studies and trials, what information should be provided in the body of the application? 

Provide an outline of the initial project portfolio (clinical studies, clinical trials, and delayed onset studies and trials) as a part of the research agenda in the Scientific Leadership Center subsection of the application.  

Include study records containing additional study information in FORMS-E following the general FORMS-E instructions and the FOA-specific instructions in section IV.2 PHS Human Subjects and Clinical Trials Information for all specific clinical studies and trials proposed in the application (immediate onset, delayed start, and/or delayed onset).  

After award, NIAID staff will request a full protocol for each immediate-onset study included in the initial project portfolio. In addition, for each clinical trial (not delayed onset), NIAID staff will request updated information on the following:  

  • Project management and communication plans 
  • Composition of the study team, including roles and responsibilities 
  • Timelines and budgets 
  • Recruitment and Retention plan 

For clinical trials, can you clarify what the grantee will be expected to provide and what support services will NIAID provide? 

NIAID will convene the safety oversight committee (Safety Monitoring Committee or Data and Safety Monitoring Board) and will conduct pharmacovigilance (Serious Adverse Event reporting) for all clinical trials the LG conducts.  

For clinical trials requiring an Investigational New Drug (IND) or Device Exemption (IDE), NIAID will also provide support services including IND/IDE sponsorship, data management, management of clinical agents and specimens, and clinical site monitoring. For these trials, the LG is expected to provide the clinical sites and statistical leadership and analysis.  

For clinical trials that do not require an IND/IDE, the LG will provide data management, management of clinical agents and specimens, and clinical site monitoring. For clinical studies, the LG will provide all necessary support services.  

The specific clinical support services to be provided for each trial will be determined in consultation with NIAID Division of Microbiology and Infectious Diseases (DMID) staff. DMID reserves the right to modify these guidelines.  Funds for services that NIAID provides should not be requested in the budget. 

Who will decide whether proposed clinical trials should be conducted under IND/IDE?  

DMID will make that determination in consultation with the LG after it approves the study but before protocol development begins. 

The FOA states that NIAID will be responsible for domestic regulatory filing. If other countries require regulatory or health authority filings, who will interact with those authorities?  

The grantee or appropriate subcontractor to the grantee will be responsible for fulfilling these obligations. 

Whom do I contact for more information on this FOA?  

NIAID’s scientific/research contact for this opportunity is Dr. Jane Knisely. 

Content last reviewed on October 11, 2018