Read a collection of FAQs from the NICHD webinar on PAR-23-037: Multisite Clinical Research: Leveraging Network Infrastructure to Advance Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (U01 Clinical Trial Optional).
General
Is there a recording of the February 15, 2023, pre-application webinar for those who were unable to attend?
Yes. A recording of the webinar is available on the NIH VideoCast website.
Can implementation studies be proposed in response to PAR-23-037?
The purpose of PAR-23-037 is to invite applications for multisite clinical trials and large-scale observational studies developed in conjunction with NICHD networks. Implementation studies will be considered on a case-by-case basis.
Submissions
Can an investigator representing another network submit a concept proposal?
Yes. Any investigator in the extramural community (including NICHD network investigators) with the skills, knowledge, and resources necessary to carry out the proposed research may submit a letter of inquiry and, if approved, a concept proposal.
Can an investigator suggest a project that may include more than one NICHD network?
Yes. Projects involving more than one network are encouraged.
Can I choose what network to approach with my concept proposal?
An investigator may suggest the network(s) to be leveraged in their letter of inquiry; however, NICHD makes the final decision on which network(s) to assign the project.
If an investigator proposes a project for two networks, do they need to work with both networks?
NICHD will decide which network aligns best with the project with input from the respective networks. The decision on how networks will work together will be made on a case-by-case basis.
Are foreign entities (institutions) eligible to apply? Are foreign components able to participate?
Non-domestic entities (non-U.S./foreign institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Does the proposed project have to align with one of the networks listed on PAR-23-037?
It is expected that additional NICHD networks and consortia will be added to this initiative. If an investigator is considering a project that aligns with another NICHD network or area of science not directly aligned with the listed networks, please contact us at NICHD-Network-ClinicalResearch@nih.gov.
Concept Proposals
Can the concept proposal be longer than five pages? Does the five-page concept proposal include references?
No. The concept proposal should consist of no more than five pages using standard formatting guidelines described in NOT-OD-17-030: NIH & AHRQ Update Font Guidelines for Applications to Due Dates On or After January 25, 2017. NICHD will not accept concept proposals that do not follow these guidelines. A sixth page should be added to provide pertinent references.
Where do I find the information to be included on the concept proposal?
Concept proposal requirements are listed at Network Multisite Clinical Research Concept Proposal: Required Information.
How does a non-network investigator submit the concept proposal?
The Authorized Organizational Representative of the investigator’s institution must submit the concept proposal via email to NICHD-Network-ClinicalResearch@nih.gov.
If there is information for the concept proposal that can only be provided by the network, how do I acquire this information?
Concept proposals are not intended to be fully developed protocols or grant applications. They should provide enough information to determine scientific importance and relevance and highlight potential feasibility issues. Once a concept proposal receives approval, the investigator(s) will work with network researchers and the Data Coordinating Center (DCC) to develop a full protocol through robust interactions, multiple revisions, and collaborative development. The investigator(s) and the DCC will collaboratively draft a grant application.
Does the pre-application process require Institutional Review Board (IRB) approval before a concept proposal can be submitted?
No. IRB approval is not necessary during the pre-application process.
For studies requiring a U.S. Food and Drug Administration (FDA) investigational new drug or investigational device exemption approval, does this need to be in place before submitting a concept proposal or grant application?
For concept proposals, FDA approvals are not required prior to submission.
For grant applications, FDA approvals are not required for submission, but are highly recommended. FDA may require additional testing, follow-up examinations, and other items that need to be factored into the protocol, budget, staffing, etc. FDA approvals are required prior to release of a notice of grant award.
Grant Applications
Does the application have to be submitted as a multi-principal investigator (PI) application?
Yes. Applications must be submitted as investigator-initiated, multi-PI grant applications with the network DCC PI as the contact PI. If awarded, the DCC institution will be the recipient of the notice of grant award. The investigator who initially proposed the project will be a PI as part of the multi-PI application.
Can an investigator propose additional sites to participate in the project with the network sites?
Yes. A non-network PI may propose additional sites (including another network) to participate in the project. Those sites will initially be vetted as part of the pre-application process and will also be part of the application submission and review.
Will the applications go through an NIH peer review special emphasis panel?
Applications submitted in response to PAR-23-037 will be reviewed by a recurring Special Emphasis Panel established by NICHD’s Scientific Review Branch.
Budget and Funding
Should single IRB (sIRB) costs be included in the protocol application budgets?
Yes. Given that sIRB costs are specific to each study, these costs should be included in the grant application’s budget per NIH policy. Guidance on the budgeting for the sIRB can be found in NOT-OD-16-109: Scenarios to Illustrate the Use of Direct and Indirect Costs for sIRB Review under the NIH Policy on the Use of an sIRB for Multi-site Research. Overall guidance for the implementation of the sIRB can be found at Single IRB for Multi-Site or Cooperative Research.
How will funding decisions be made?
All projects are required to go through the pre-application process and be approved before investigators can submit a grant application. All applications will go through NIH peer review. NICHD will then make final funding decisions, based on the following:
- Scientific and technical merit of the proposed project as determined by scientific peer review
- Relevance of the proposed project to NICHD priorities
- Compliance with resource-sharing policies
- Availability of funds
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