RFA 19-OD-025 and RFA 19-OD-026 Frequently Asked Questions

Yes. In the funding opportunity announcement (FOA), listed under Section III. Eligibility Information under the sub-heading Eligible Individuals (Program Director/Principal Investigator), you will find specific guidance on the MPI.

Also see: Office of Extramural Research (OER) https://grants.nih.gov/grants/multi_pi/

If a single Program Director/Principal Investigator (PD/PI) is proposed, that PD/PI must be a board-certified pediatrician. If multiple PDs/PIs are proposed, at least one of the PDs/PIs must be a board-certified pediatrician. Additional PD/PIs may be PhDs or Family Medicine physicians.

A board-certified pediatrician may be board certified in general pediatrics or in any sub-specialty of pediatrics (e.g., pediatric infectious disease, pediatric cardiology, neonatology).

Multiple PD/PIs (MPIs) are allowed (see above). Co-investigators are allowed.

At least one PD/PI board certified pediatrician must commit 15% effort (1.8 persons months per year for 5 years) to the network. The applicant may propose additional MPIs with % effort commensurate with the MPI role.

At least one PD/PI must attend every Steering Committee meeting and Face-to-Face meeting. If MPIs are proposed, not all PIs must attend every meeting.

The Senior Faculty Development Leader must be able to commit a minimum of 5% effort. The 5% commitment should not be split between two or more individuals.

The applicant may propose that the Senior Development Faculty also serve in the role of PI or MPI, but the duties of the Senior Development Faculty should be a separate 5% effort from the duties of the 15% effort for the contact PI.

While the term Junior Faculty is not specifically defined in the RFA, the intent is that Junior Faculty member would meet the NIH Early Stage Investigator (ESI) criteria. An ESI is an individual who has not served as PD/PI for a substantial NIH independent research award, such as an R01 or U01, and has completed their terminal research degree or end of post-graduate clinical training within the past 10 years. See here for the ESI definition: https://grants.nih.gov/policy/early-investigators/index.htm.

The Junior Faculty member could serve as multiple PD/PI. See points to consider: https://grants.nih.gov/grants/multi_pi/faq.htm and
https://loop.nigms.nih.gov/2017/09/multiple-principal-investigator-mpi-application-when-is-it-the-right-choice/

Each Junior Faculty member proposed should have 15% effort (1.8 person-months) for each year that he or she is proposed as Junior Faculty in the application.

Yes. The Junior Faculty member may have either a PhD or an MD. However, note that the intent is to develop the Junior Faculty into a future pediatric clinical trial investigator.

Yes, the Junior Faculty might be a postdoctoral fellow. Please check with your own institution to determine whether your institution allows postdoctoral fellows to serve in this capacity.

The Junior Faculty member should be willing to build clinical trials development and implementation skills during the funding period with the guidance of senior level faculty. Junior Faculty members identified on the application should be able to make a substantial commitment to the Network (a minimum of 1.8 person months per year for each faculty member included). The Junior Faculty positions are not limited to only Pediatricians. The intent is to develop the Junior Faculty into a future pediatric clinical trial investigator.

No, the commitments are not cumulative. The applicant should ask for at least 1.8 months of support for the Junior Faculty member in his/her application. The institution should provide a letter of commitment that they will allow the Junior Faculty to have this NIH funded time for ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) activities.

Yes. The ≥ 1.8 months of person-time for the Junior Faculty can be supported with institutional resources and do not need to draw from IDeA application funds as long as the institutional letter provides this commitment.

Yes, that is also acceptable if commitment is clear for financial support.

No. The project that the Junior Faculty member will propose in Year 2 is to be developed during the grant period. It does not need to be described in the Research Plan of the application. The project that the Junior Faculty will propose in Year 2 is not the same as the Clinical Trial proposal in the research plan of the application.

The Data Coordination and Operations Center will provide a review and recommendation process, and the ISPCTN Steering Committee will consider all pilot proposals from the Junior Faculty at all sites and will select about five for implementation during the remainder of the funding cycle.

The costs for the approximately 5 selected pilots will be supported with funds by the Data Coordination and Operations Center.

You must propose 100% research coordinator time. At least one of the research coordinators proposed must be a nurse. You may allocate the percent effort between at least one research coordinator who is a nurse and one or more research coordinator(s) who are not. However, applicants should ensure that they would have adequate nurse coverage for their site(s).

The biographical sketch of any coordinator proposed should reflect qualifications through training, background, and research experience. It is appropriate to describe the experience, skill set, and accomplishments of individuals who may not have had clinical research experience, but who have the potential to be strong research coordinators.

The intent of the term “Research Nurse Coordinator” is that the research coordinator is a nurse.

We encourage you to use your best judgement for the length of the Clinical Trial proposal. The Clinical Trial Proposal is one of the 5 subsections of the Research Plan specified in the FOA. The total maximum length of the Research Plan is 12 pages.

See the following notice as to appendices allowed: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html

NIH can withdraw applications with noncompliant appendix material.

The Clinical Trial proposal should be considered a delayed onset study. Please see the instructional video here: https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm

No. As stated in the FOA, the applicant should propose “a multicenter clinical trial that the ISPCTN will conduct during the funding cycle.”

The Clinical Trial Proposal should be a proposal for a “multicenter clinical research trial that the ISPCTN will conduct during the funding cycle.” The proposal could be for a multicenter pilot/feasibility study or for a full-scale multicenter clinical trial, as the applicant sees most fit.

No. The Research Strategy as a whole should have a specific aims page. However, the specific subsections, including subsection 5, do not each require a separate specific aims page.

The awardee DCOC will need to implement a Single Institutional Review Board.

Yes. Submit a full budget with budget justification.

NIH intends to fund 1 award, corresponding to a total of up to $8,000,000 (Total Costs), for fiscal year 2020. An applicant for the DCOC may request a budget for up to $1,750,000 per year in direct costs plus $3,500,000 per year in direct costs for capitation fees for distribution to the Clinical Sites, and for necessary monitoring, DSMB visits, and Protocol Review Committee activities.

The DCOC will receive all human subjects data for trials conducted during the award period. However, because the research studies that the ISPCTN will conduct during this award period have not been determined, applicants should report delayed onset for this section. Please see the instructional video here: https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm

Yes. However, the NIH will not accept duplicate or highly overlapping applications under review at the same time.

No. Reviewer rosters will be available on the NIH Center for Scientific Review website 14 days prior to the review meeting date. The date for the review has not yet been set.

No. The Specific Aims page is separate from the research strategy and is not included in the 12-page Research Plan.

Yes. The 5 subsections identified in the research plan should all be included in the 12-page Research Plan.

A reasonable approach would be to join the two approaches together in some way.

Yes, Other Support documentation is only required for key personnel. Key personnel include the PI/PD, any MPI proposed, The Senior Faculty Development Leader, Junior Faculty proposed, and the Research Nurse Coordinator(s).

Yes. The slides from the webinar will be released on the on NIH ECHO website: https://www.nih.gov/echo/funding

Centers of Biomedical Research Excellence (COBREs) and IDeA Networks of Biomedical Research Excellence (INBREs) are IDeA state programs and applicants may propose collaborations with those programs if they feel that it helps to strengthen their application. Among possible collaborators, the FOA encourages applicants to collaborate with IDeA Program-Infrastructure for Clinical and Translational Research (IDeA-CTR) awardees or a Clinical and Translational Science Award program in their own state or in another IDeA state.  See below for exact language from the FOA.

“To enhance research expertise and potential to build capacity at Clinical Sites, to include needed expertise on clinical trial proposals, and to enhance capacity to recruit rural participants into clinical research, applicants are encouraged to propose collaboration with other institutions. Applicants may collaborate with IDeA states institutions in their own state or other IDeA states. Applicants are encouraged to propose collaboration with an IDeA Program-Infrastructure for Clinical and Translational Research (IDeA-CTR) awardee (https://www.nigms.nih.gov/Research/DRCB/IDeA/Pages/IDeA-CTR.aspx) or a Clinical and Translational Science Award program (see www.ctsaweb.org) in their own state or in another IDeA state.”

It’s strongly encouraged that you give the Reviewers the fullest picture of populations available for Clinical Studies/Trials in your site or sites.

In the FOA you will find the following:

“Populations available for Clinical Studies/Trials
Applicant Clinical Sites must describe their access to community practices that serve a minimum of 30 percent children from rural homes.

Provide the specific pediatric population available for study by the Clinical Site. Include information for the year 2018 in tabular format.

• The number and percent of children (0-18 years) in the catchment area of the applicant Clinical Site that live in a rural area; describe the catchment area, definition used for rurality, and a brief methodology for this calculation.
• The number of births in your Clinical Site’s hospital (or hospitals).
• The number of discharges from your Clinical Site’s hospital (or hospitals) with a diagnosis of asthma who were children or adolescents.
• The number of ambulatory visits in your Clinical Site among children and adolescents with ECHO-relevant outcomes, for example, pre-term birth, asthma, attention-deficit/hyperactivity disorder, autism spectrum disorder, obesity, well-child checks.

Be specific about your methodology, including the number of clinics or institutions included in your estimates if more than one. Report separately for each location, as well as overall.”

No. There is no page limit on that specific section.

Yes. It is the institution’s responsibility to ensure the individual listed on the application is eligible to work at the submitting entity in the role proposed.

Facilities and Other Resources and highlighted subsections provide an opportunity, not only to report a more complete list of funded clinical research than would appear in your biosketch, but more importantly, how the institution has supported the clinical research in your list. Additionally, the section allows applicants to show how your IDeA institution has demonstrated effectiveness and ability to garner federal or non-federal funds to support and foster clinical research activities at your institution. Your list does not need to include every grant your institution has received but should give an indication of clinical research activities at your institution. Refer to Section V. Application Review Information, subsection 1.Criteria, under the subheading Environment to determine what information may be relevant to your application.