Pre-Application Process for NICHD Network Multisite Clinical Research

Any investigator planning to submit an application in response to an NICHD network clinical research FOA must first submit a letter of inquiry at least 120 calendar days before the application due date (NIH Application Standard Due Dates for U01).

Please note the following about the letter of inquiry:

• The scientific contact named in the FOA must receive the letter through email to NICHD-Network-ClinicalResearch@mail.nih.gov.
• The time between submitting the letter of inquiry and the application due date is meant to allow ample time for application development.
• The letter of inquiry may be an attached file, or the required information can be in the body of the email.
• The letter of inquiry must include the following:
  • Project title
  • Specific aims
  • Study population
  • Estimated sample size
• It would be useful if the investigator also included in their letter of inquiry how they learned about PAR-23-07.
• The letter may suggest a network(s) to be leveraged; however, NICHD makes the final decision on assigning the project to a network(s).

After reviewing the letter of inquiry, NICHD will either: 1) invite the investigator to submit a more detailed concept proposal using the process outlined in Step 2; or 2) advise the investigator to pursue alternative funding options.

NICHD will attempt to provide its response in writing within 10-15 business days of receiving the letter of inquiry.

The concept proposal provides an overview of the project to allow assessment of the:

• Feasibility of performing the project within an NICHD network(s)
• Importance and relevance of the science to the field and to the mission of the network(s) and NICHD

Please note: The final decision about whether a concept proposal can proceed to become a full grant application lies solely with NICHD. Although it will consider the network(s) feedback, NICHD decides which proposals will move forward.

Visit the Concept Proposal Information to find out what content is required.

Consider the following when drafting a concept proposal:

• Only the institution’s Authorized Organizational Representative can submit the concept proposal.
• The concept proposal should consist of no more than five pages using standard formatting guidelines described in NOT-OD-17-030. Proposals that do not follow these guidelines will not be accepted.
  • A sixth page should be added to provide pertinent references.
• Although all requested content must be provided, the information may be distributed across the five pages in whatever manner the investigator believes will result in the strongest concept proposal.
• Concept proposals are not intended to be fully developed protocols or grant applications. They should provide enough information to determine feasibility and importance/relevance.
  • Once the concept proposal is approved, the investigator(s) will work with network researchers, the data coordinating center (DCC), the network steering committee, etc., to develop a grant application and full protocol through robust interactions, multiple revisions, and collaborative development.
• Similarly, NICHD recognizes that the input of the network DCC and steering committee will be needed to provide more accurate information for some of the content in the concept proposal (e.g., budget information); that input will be provided once the concept proposal is approved and/or as part of the pre-application review.
• NICHD intends for this process to mirror traditional standard operating procedures for network concept proposals to help ensure development of grant applications and protocols in the most timely and cost-effective manner.
• Projects involving more than one network are encouraged.
• The role of the Network Project Scientist in this process is the same for all concept proposals, independent of whether they are submitted by a network or non-network researcher.

Review of the concept proposal includes the following activities:

• The NICHD scientific contact receives the concept proposal and reaches out to the proposed network(s) investigators and research coordinators.
• Network researchers and coordinators declare any conflicts of interest and attest that they will keep the concept proposal and all discussions confidential.
• The scientific contact shares the concept proposal with network investigators and coordinators via a secure system, only after declarations and attestations are received.
  • If the concept proposal is applicable to more than one network, it will be shared with other networks in the same manner.
• The network steering committee and other network researchers review the concept proposal in a process determined by the network.
  • The submitting investigator may be invited to present their concept proposal at a steering committee meeting.
• Following the review, the designated network representative provides feedback to NICHD about the concept proposal in a similar manner to a Study Review Group Resume. Individual comments may also be provided as part of the feedback.
• NICHD expects that the network will share feedback on a concept proposal within 60 calendar days of the network getting initial access to the concept proposal, although the exact time for network review may vary based on schedules and complexities of the concept proposal.
  • If more time is required for review, the network will notify NICHD, in writing, of the reason for the delay and the submitting investigator will be notified.
• After considering the feedback provided, NICHD renders the final decision on whether the concept proposal can proceed to become a full grant application.
• The NICHD scientific contact notifies the submitting investigator/authorized organizational representative and the proposed network(s) of the NICHD’s final decision.

Approved concept proposals will be developed into U01 applications, which will be jointly submitted and reviewed for scientific merit and study design by a NIH Study Review Group.

Please note: Approval of the concept proposal and permission to apply should not be perceived as a suggestion or guarantee that the application will be funded. Funding decisions are only made after NIH peer review, based on standard criteria.

Once a concept proposal is approved, the investigator proposing the project will work with the network(s), and potentially other NICHD-supported resources (such as NICHD’s Maternal and Pediatric pRecision IN Therapeutics [MPRINT] Hub), to collaboratively develop a grant application that will be submitted in response to the FOA. NICHD will not accept any applications for network clinical research FOAs unless the concept proposal has been approved in the pre-application phase.

The jointly prepared grant application will later be submitted as a multiple Principal Investigator (PI) or multi-PI application as described in the FOA (PAR-23-037).

NICHD will use this same pre-application review and development process for proposed projects independent of whether they are proposed by researchers already funded through the network or independent investigators.

Please note the following about the application development process:

• The submitting investigator will be asked to participate in network steering committee meetings and other network activities as it pertains to the proposed project only.
• The actual proposed budget will be developed as part of this pre-application process with the input of the network.
  • NICHD intends for many, if not all, of the services required of the network DCC and the network clinical research centers for a proposed project to be supported by existing infrastructure grants.
• A non-network PI may propose additional sites (including those of another network) to participate in the project and those sites will initially be vetted as part of this development process.
• The approved concept proposal must be shared with the Network Community Engagement Board for their input prior to submitting the grant application.
• Applications proposing to assess maternal or pediatric therapeutic interventions are encouraged to utilize the many resources available via NICHD’s MPRINT Hub. Those resources include, but are not limited to the:
  • Knowledge and Portal Core that is developing common data elements and ontologies for these data
  • Pharmacometrics and Clinical Trial Design Core that provides expertise in pharmacokinetic and pharmacodynamic modeling, biostatistics, and clinical trial design
  • Real-World Evidence Core that can support a variety of studies through leveraging and building upon expertise and robust real-world data resources
  • Phenotyping Core that provides expertise in using electronic health records and techniques including clinical terminologies, natural language processing, and machine learning to better understand response to medications
  • Milk Analytics Core that has expertise in collecting and processing human milk samples and performing a variety of human milk assays
  • Pharmacometrics and Analytical Chemistry Core that performs quantitative and metabolite assays in small volumes and heterogenous matrices

The application will be submitted as a multi-PI application with the network DCC as the contact PI, and the DCC institution/organization will be the recipient of the Notice of Grant Award (if the application receives a meritorious score and is able to be funded).

The funding requested to support the submitting PI and their institution’s role in the project will be awarded as a subcontract to the DCC award.

The Network Project Scientist cannot attend the Study Review Group discussion of the grant application, per standard practice. In addition, Network Project Scientists will not be involved in stewardship of the grant award.