Pre-Application Process for NICHD Network Multisite Clinical Research

Any investigator planning to submit an application in response to an NICHD network clinical research notice of funding opportunity (NOFO) must submit a letter of inquiry at least 4 to 8 months before the application due date (NIH Application Standard Due Dates for U01). Results from the pilot phase of the revised pre-application process showed that  moving from the letter of inquiry through the pre-application process took approximately 8 months. Please review the Timelines information for projected timelines based on grant application receipt dates.

Please note the following about the letter of inquiry:

• The scientific contact named in the NOFO 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 information:
  • Project title
  • Specific aims
  • Study population
  • Estimated sample size
• Non-network investigators are encouraged to include how they learned about PAR-23-037 in their letter of inquiry.
• The letter may suggest a network(s) to be leveraged; however, NICHD makes the final decision on assigning the project to a network(s).
• NICHD will not consider any additional information provided with the letter of inquiry; investigators are encouraged not to include any additional content in their letters of intent.

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.

If the investigator is invited to submit a concept proposal, NICHD will provide a date by which the concept should be submitted. If the investigator is unable to complete the concept proposal by the assigned date, the investigator should inform NICHD in as timely a manner as possible, so they can be considered for a subsequent application receipt date cycle.

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
• Budget required to conduct the project

Note: The final decision about whether a concept proposal can proceed to a full grant application lies solely with NICHD. Although it will consider and values 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:

• 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, again using standard formatting guidelines described in NOT-OD-17-030.
• 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. Full protocols or other more extensive concept proposals will not be accepted for consideration.
• The concept proposal should provide enough information to determine feasibility and scientific 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.
• 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 as part of the protocol and application development process.
• NICHD also recognizes that the budget included in the concept proposal is an early and general estimate and that a final budget can only be determined in conjunction with the development of the full protocol.
  • All final budgets must be submitted to NICHD no later than 1 month prior to the grant submission receipt date.
  • Any final budget that exceeds the proposed budget in the concept proposal and/or requires a waiver of the $500,000 direct cost cap will undergo additional NICHD review prior to acceptance of the grant application.  
• Projects involving more than one network are encouraged.
• Submitting a concept proposal by the assigned due date optimizes the likelihood that the full grant application will be submitted for the targeted receipt date. However, submitting the concept proposal by the assigned due date is not a guarantee that the full application will be submitted by the targeted receipt date.
• The assigned due date for the concept proposal will usually be 6 to 8 weeks after the letter of inquiry has been approved.
• 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, efficient, and cost-effective manner.

Review of the concept proposal includes the following activities:

• After receiving a concept proposal, the NICHD scientific contact shares it via a secure system with  network investigators. To access the secure system, network investigators must declare any conflicts of interest and attest to maintaining confidentiality (PDF 227 KB) prior to reviewing the proposal.
  • If the concept proposal is applicable to more than one network, it will be shared with all 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 will be invited to present their concept proposal at a network 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.
• NICHD expects that the network will share feedback on a concept proposal in as timely a manner as possible. The goal is for the network to share their feedback within 2 months of the network obtaining 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 of the reason for the delay.
• After considering the network feedback, NICHD renders the final decision on whether the concept proposal can proceed to become a full grant application.
• NICHD will work to provide decisions on all concept proposals within 3 months of receipt, although the exact time for rendering a decision may vary based on a number of parameters.
• The NICHD scientific contact notifies the submitting investigator and the proposed network(s) of NICHD’s final decision.
• Concept proposals need approval at least 3 months prior to the application receipt date to allow the network DCC and other network committees ample time to prepare the strongest application possible. However, it is anticipated that even concept proposals approved 3 months prior to the targeted application receipt date will frequently not be ready for grant application submission until a subsequent application receipt date. If the application is not ready for the intended receipt date, the investigators will be permitted to submit their grant application for a subsequent receipt date. Please review the Timelines information for projected timelines based on grant application receipt dates.
• Approved concept proposals will be developed into U01 applications, which will be jointly submitted (review Steps 4 and 5) and reviewed for scientific merit by an NIH Scientific Review Group.

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, including program priorities and availability of funds.

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 PAR-23-037. NICHD will not accept any applications for the network clinical research NOFO unless the concept proposal has been approved in the pre-application phase.

The jointly prepared grant application will be submitted as a multiple Principal Investigator (PI) or multi-PI application as described in the NOFO (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 by independent investigators. For proposals from non-network investigators, the NICHD network will collaborate with these researchers to develop a grant application. It is important to have a collegial environment, open communication, and strong teamwork to achieve the NICHD strategic goals and completion of these research projects. NICHD clinical network operations will help to ensure collegial interactions and to mediate any disputes/disagreements between the lead investigator(s) and the network.

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 final proposed budget will be developed as part of this pre-application process with the input of the network.
  • Resources provided by the existing network DCC and clinical research center infrastructure grants will be leveraged to the extent possible to conduct the proposed research.
  • NICHD recognizes that the budget included in the concept proposal is an early and general estimate and that a final budget can only be determined in conjunction with the DCC and the development of the full protocol.
    • All final budgets must be submitted to NICHD no later than 1 month prior to the grant submission receipt date.
    • Any final budget that exceeds the proposed budget in the concept proposal and/or requires a waiver of the $500,000 direct cost cap will undergo additional review prior to acceptance of the grant application.
• A non-network PI may propose additional sites (including those of another network) to participate in the project.
• The approved concept proposal must be shared with the Network Community Engagement Board for their input prior to submitting the grant application (once the Community Engagement Board is established for the network).
• 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.

Reminder: A network can submit no more than two grant applications per review cycle.

June 5 Grant Application Receipt Date

• Letter of inquiry receipt date preferably before November 15 and no later than February 5
• Concept proposal approval date no later than March 5
• Final budgets are due no later than May 5

October 5 Grant Application Receipt Date

• Letter of inquiry receipt date preferably before February 5 and no later than June 5
• Concept proposal approval date no later than July 5
• Final budgets are due no later than September 5

February 5 Grant Application Receipt Date

• Letter of inquiry receipt date preferably before June 5 and no later than October 5
• Concept Proposal Approval date no later than November 5
• Final budgets are due no later than January 5

Although these timelines are organized by grant receipt dates, it is anticipated that the final protocol and grant application will often require additional time and submission of the grant application for a subsequent receipt date.

Pre-Application Webinar for PAR-23-037: In addition to the information provided on this page, NICHD hosted a pre-application webinar on February 15, 2023.

Note: Any timelines mentioned in the webinar are superseded by those on this webpage.

• Access the VideoCast recording of this webinar
• Email NICHD-Network-ClinicalResearch@nih.gov to request the webinar PDF
• Read the Frequently Asked Questions page for additional information on this webinar and the pre-application process