Questions and Answers for RFA-AI-19-073, Childhood Asthma in Urban Settings—Clinical Research Centers (U01 Clinical Trial Optional)

NIH published this CAUSE Clinical Research Centers (CAUSE-CRCs) U01 funding opportunity announcement (FOA) in a January 29, 2020 Guide notice.

The companion CAUSE Leadership Center (CAUSE-LC) UM1 FOA has separate Questions and Answers for RFA-AI-19-074.

Updated June 12, 2020. We added three new questions to the top of the Questions and Answers Common to Both CAUSE FOAs section and five new questions to the top of the Questions and Answers Specific to CAUSE-CRCs RFA-AI-19-073 (U01) section.

Table of Contents

Questions and Answers Common to Both CAUSE FOAs

I am having difficulty staying within the five-page requirement for the biosketch and including data about all of my current studies. How detailed does this information need to be in the biosketch?

When you Create Biosketches, do not go over the five-page limit. Applications containing one or more biosketches that do not conform to the required format may be withdrawn (per NOT-OD-15-095 policy). 

The details in the biosketches need to be sufficient to let the reviewers evaluate if the investigators are well suited to the project and have appropriate training and experience to carry out the proposed study. If you cannot include all data/information about your current studies, consider including examples of the most relevant work. 

Also refer to the FOA’s Section V (Application Review Information), Investigator(s) criterion, as the questions stated there will be used by reviewers during the evaluation.

(Question and answer added on June 12, 2020.)

To whom should the Letters of Support be addressed?

Address the Letters of Support to the PD/PI of the application and include them in the application. If the application has Multiple Principal Investigators, you may address the letters to the contact PI or to all the PIs.

(Question and answer added on June 12, 2020.)

May I serve in two different roles on two different applications responding to these FOAs?

The FOAs do not limit your ability to be named as a co-investigator or serve other Team Roles on more than one application.

Note, however, that only one application may be submitted from an institution. You may be named on applications submitted from different institutions, presuming the projects proposed are distinct.

If you are named on more than one application, it is your responsibility to demonstrate to the reviewers that you have the ability to adequately commit to the projects if both applications are funded.

(Question and answer added on June 12, 2020.)

Will NIAID accept late applications to the CAUSE FOAs?

The application due date for both funding opportunities is June 19, 2020. However, according to NOT-AI-20-053, NIAID will accommodate late submission of applications to both CAUSE FOAs through 5 pm local time on July 6, 2020.

If you submit a late application, it is helpful but not required to reference NOT-AI-20-053 in your cover letter. No applications will be accepted after July 6, 2020.

(Question and answer added on June 1, 2020.)

Would you clarify the NIAID-DAIT Data, Clinical Safety, and Statistical Center(s) (DAIT Data Management Center(s)) support for the LC and CRCs?

The NIAID-DAIT Data, Clinical Safety, and Statistical Center(s) (DAIT Data Management Center(s)) will provide clinical research support services for all CAUSE network-wide clinical studies and trials, as well as for some CAUSE-CRC center-specific clinical trials, if NIAID chooses to be the sponsor for the latter.

The clinical research services include support for the design and organization of each applicable study including support for protocol development; development of protocol-related materials; data collection, management, and quality control; clinical site monitoring; safety monitoring and reporting; data analysis; and manuscript development.

Do I need to submit two separate applications for LC and CRC RFAs?

There are two distinct requests for applications (RFAs), RFA-AI-19-074 (UM1) and RFA-AI-19-073 (U01). Each will provide a distinct award and will require a separate application. If you want to compete for both types of awards, you must submit two applications, one for the LC and one for the CRC RFA.

The clinical projects proposed in the CRC application must be different from the clinical projects proposed in the LC application.

How will mechanistic studies to support LC or CRC clinical projects be conducted and funded? 

Mechanistic studies associated with network-wide clinical trials or studies should be proposed as part of the LC application. If those studies are to be conducted in collaboration with sites other than the LC’s institution, consortium agreements/subawards will need to be established. Applicants are expected to detail their proposed collaborations as part of the application.

Similarly, if clinical mechanistic studies are included in the center-specific CRC projects that will be conducted at sites other than the CRC’s institution, the CRC application should include detailed proposed collaborations for consortium arrangements/subawards as part of the grant application.

May a non-U.S. institution apply for the LC or CRC RFA?

No, non-U.S. institutions are not allowed to apply in response to the LC or CRC RFA. However, non-U.S. components are allowed in both the LC or CRC applications only to provide services in support of clinical study or clinical trial activities. Foreign components cannot conduct clinical trials or clinical studies.

May applicants to the LC or CRC RFA cross-reference applications to the CRC or LC RFA?

No. Each LC and CRC application must be distinct, complete in itself, and submitted independently. Each should have no relationship to any other application, including an application for a CRC or LC submitted by the same institution, and should be self-contained.

May the LC or CRC be a multiple-PD/PI application?

Yes, the LC or CRC can be a multiple-PD/PI application.  If submitting a multiple PD/PI application, applicants need to submit a Multiple-PD/PI Leadership Plan, including a plan for conflict resolution for the leadership. Reviewers will consider this plan as part of the scored review criteria for the overall application. See the Tips for Writing a Strong Multiple PI Leadership Plan section of NIAID’s Multiple Principal Investigators page.

May we have more than two PD/PIs in a multiple-PD/PI LC or CRC application?

Yes, the plan may have more than two PDs/PIs, but applicants must adequately justify the inclusion of each PD/PI in the Multiple-PD/PI Leadership Plan. Each PD/PI is evaluated under “Investigator(s) Review Criterion” as a PD/PI. Learn more from NIH’s “Is there a ceiling on the number of PD/PIs?

If the LC or CRC is a multiple-PD/PI application, do the PD/PIs need to be from the same institution?

No. The LC or CRC can involve more than one institution and have PD/PIs from different institutions, but the role of each institution should be clearly specified and justified. Notably, the one or two small center-specific clinical studies that are required by the FOA and will be conducted by a CRC must be single-site projects, but might include associated mechanistic studies performed at another institution.

Whom do I contact for more information on these FOAs?

Direct your questions to the scientific/research contacts shown in Section VII: Agency Contacts of each FOA.

Questions and Answers Specific to CAUSE-CRCs RFA-AI-19-073 (U01)

If I am proposing more than one study for my site-specific projects, do I need to submit a separate PHS Human Subjects and Clinical Trials Information form for each of the studies?

No. When preparing the application, there is only one PHS Human Subjects and Clinical Trials Information section. However, the applicants must include human subjects study record(s), using the Study Record: PHS Human Subjects and Clinical Trials Information form (or Delayed Onset Study record form). The applicants must add a study record for each proposed study involving human subjects. 

Also, as required by the FOA, all applicants must upload a study record for an existing IRB-approved, active protocol that allows recruitment and clinical characterization of pediatric patients with asthma, as well as healthy volunteers.

For more information on completing the form and preparing study records, refer to the following:

(Question and answer added on June 12, 2020.)

May we have three PD/PIs in the application?

Yes. There is no upper limit on the number of PD/PIs, although it is not often that an application has more than two or three PD/PIs. 

Importantly, the involvement of each PD/PI should be justified by the aims of the project. Applications that involve more than one PD/PI must include a Leadership Plan that describes the roles, the responsibilities, and the working relationship of the identified PD/PIs. Learn more here:

Please note that the FOA specifies that “For multi-PD/PI applications, one of the PD(s)/PI(s) must commit a minimum of 2 person-months for CAUSE-CRC activities”.

(Question and answer added on June 12, 2020.)

Should we have one overarching Aims page or separate Aims pages for Subsection A and Subsection B? What if we are planning to submit two site-specific projects in our application? Is it acceptable to submit two separate Specific Aims pages?

No. As specified in the FOA, there is one Specific Aims section in the application. 

Therefore, the application should have only one overarching Specific Aims page, including specific aims for Subsection A and Subsection B separately. Alternatively, the Specific Aims page could describe the overall Clinical Research Center (including infrastructure, ability to serve as a CRC, and/or the clinical trial operation capability), and include specific aims for the site-specific research projects (Subsection A and Subsection B, respectively).

Find NIAID information and advice on how to Draft Specific Aims.

(Question and answer added on June 12, 2020.)

Should we budget only for the CRC-specific project(s) work, or all the work of our CRC site on the multi-center studies? 

The CRC budget should include funds for FTE required for site participation in the Network (PI and coordinator, as specified in the FOA), and for any personnel and materials funds required for the site-specific study or studies proposed.

(Question and answer added on June 12, 2020.)

Do we need to include travel for meeting, costs of publications, compensation for participant visits, or supplies for the network projects in the budget? 

As specified in the FOA, the applicants need to budget funds for travel and other expenses for CAUSE-CRC Senior/Key Personnel to attend two (2) one and a half (1.5) day CAUSE Steering Committee meetings per year. The budget should also include additional personnel and lab supplies required to support the proposed site-specific projects. 

Other funds (e.g., publications, compensation for participant visits, supplies for the network projects) will be paid for through sub-award from the Leadership Center to the applicant’s site post-award.

(Question and answer added on June 12, 2020.)

What is the definition of a junior faculty investigator? 

The FOA does not define the term “junior faculty.” It is expected that the applicants will provide adequate information for the reviewers to judge whether a particular co-investigator can be regarded as junior. This information can be included wherever it is applicable, for example, in the biosketches, budget justification, or description of the investigators in the Research Strategy.  

In general, faculty members who are full professors would not be considered junior faculty.  

The FOA indicates that CRC center-specific projects “should involve junior faculty investigators in key roles.” Is this a requirement or optional?  

It is highly recommended that junior faculty investigators are included in key roles. 

Do I need to upload the full clinical protocol for the requested active, IRB-approved protocol for recruitment and clinical characterization of children with asthma? 

No. The RFA does not ask for submission of this full clinical protocol. The information that applicants must include is a study record for an existing IRB-approved, active protocol that allows recruitment and clinical characterization of pediatric patients with asthma, as well as healthy volunteers. They will need to use Study Record: PHS Human Subjects and Clinical Trials Information form to do this, and this information should not be included in the Appendix. 

Is the application budget limited to $300,000 in direct costs per year or for the duration of the award? 

Application budgets are limited to $300,000 in direct costs per year for this 7-year award.

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