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

Questions about Principal Investigator/Multiple Principal Investigators

Can I/we use a Multiple Principal Investigator (MPI) Application (Plan)?

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/

Do all Principal Investigators need to be pediatricians? Can a PhD or Family Medicine Physician be a 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.

To meet the requirement that a PI be a board-certified pediatrician, does the PI need to be board certified in general pediatrics?

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).

Are Co-PIs allowed?

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

Can MPIs have a combined effort of 15%?

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.

Are travel requirements the same for all MPIs?

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.

Questions about Senior Development Faculty

Can the Senior Development Faculty position funding be divided between two individuals? Or does one Senior Faculty have to have 5%?

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.

Senior Development Faculty are specified with a minimum of 5% effort. Can this person be a PI or MPI or does this person need to be a specific non-PI role?

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.

Questions about Junior Faculty

What is the definition of a Junior Faculty member?

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.

Can a Junior Faculty member also be a co-PI?

Does each Junior Faculty member have to be at 1.8 month (15% effort), or does only one have to be at 15% and the second can be less? Can the total of 15% be split between two Junior Faculty?

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.

Can the Junior Faculty member have a PhD and not an MD with research in one of the focus areas?

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.

Can the Junior Faculty member be a postdoctoral fellow?

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.

What factors make a Junior Faculty member compelling as part of the application?
— Pediatrician vs Family Medicine?
— Basic science vs clinical science?
— Pursuing NIH funding vs pursuing pharma trials?

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.

For Junior Faculty, are the ≥ 1.8 months of person-time commitment independent of the institution’s commitment, or are the individual and institutional commitment cumulative, requiring a total commitment of 3.6 months?

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.

Can the Junior Faculty member be supported for the ≥ 1.8 months of person-time commitment by the institution and not by the grant, as long as the institutional letter provides this commitment?

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.

Could a Junior Faculty member be supported by a combination of institutional support and grant support?  For example, could the budget justification request 5% salary (0.6 person months) from the grant, and combine with a letter of support from the institutional chair to supply the other 10% (1.2 person months) to total 15% (1.8 person months)?

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

Junior Faculty are specified to propose a project in Year 2. Is it expected that any details of the project would be included in the 12-page Research Plan required in the application?

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.

One Junior Faculty member at each institution will propose a pilot study in Year 2 of the award. Who will select which pilot study will be implemented?

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.

Will the costs for the approximately 5 selected pilot studies be covered by local site budgets or will they be covered by the Data Coordination and Operations Center?

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

Questions about Research Nurse Coordinator(s)

Do we have to use a 100% Research Nurse Coordinator, or can we split the percent effort with a research coordinator who is not a nurse?

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 term “Research Nurse Coordinator” is ambiguous. Does this mean a research coordinator who is a nurse, or does this mean a person who coordinates research nurses?

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

Questions about Clinical Trial Proposal

What percentage of the full application should be the Clinical Trial Proposal?

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.

Can the Clinical Trial Proposal extend into an appendix or must the entirety of the proposal be contained within the 12-page limit of the research plan?

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.

For the Clinical Trial proposal, do we need a full human subjects section, or should this be considered a delayed onset study since we may not be able to effectively describe the study with respect to all of the possible sites it would be performed at? If we should select “delayed onset,” what information should be included in the required attachment?

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

Could the Clinical Trial Proposal be a proposal for a single center pilot that might lead to a multicenter trial?

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

Can the Clinical Trial Proposal be a feasibility assessment or pilot of a clinical trial versus a full-scale clinical trial?

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.

Should Subsection 5: Clinical Trials Proposal of the Research Strategy include a specific aims page?

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.

Questions about the Data Coordination and Operations Center (DCOC)

The FOA states that the DCOC will “implement Single Institutional Review Board (IRB).” Is a Single Institutional Review Board already established for the ISPCTN?

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

Do applicants for the DCOC need to submit a full budget with budget justification?

Yes. Submit a full budget with budget justification.

What is the budget for the DCOC?

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.

How should applicants for the DCOC complete the section on human subjects research?

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

Questions about other topics

For RFA-OD-19-026, can an institution submit more than one application?

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

Will the reviewer roster be available prior to the application deadline?

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.

Should the Specific Aims be part of the 12-page Research Plan?

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

Are the 5 subsections of the research plan mentioned in the RFA all to be included in the 12-page limit?

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

The RFA instructions say to follow the usual SF 424 format (significance, innovation, approach, environment, previous studies, progress report for renewals) but also to include the specific 5 subsections (overall plan, readiness, research skills development plan, rural engagement plan, and concept proposal). Can you clarify if this is an either-or situation (i.e. we should follow one of these formats, but not both) or should these two approaches be joined together in some way?

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

Is Other Support documentation only required for key personnel?

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).

Will the slides from the webinar be made publicly available?

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

Could a proposed IDeA collaboration be with any IDeA project — COBRE, INBRE as well as CTR?

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.”

Regarding “populations available for Clinical Studies/Trials,” we are planning to get data from different institutions. Should we also get data from all the sites?

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

Regarding “populations available for Clinical Studies/Trials,” is there an example of the type of “tabular data” they are looking for from these 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.”

Are there any guidelines as to how long the resources and facilities section needs to be?

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

Can key personnel on an application be a non-US citizen?

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.

Under “Facilities and Other Resources”, there is a subheading: “other support.” What needs to be reported here?

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.

This page last reviewed on November 7, 2019