Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272

Issued by

Office of Strategic Coordination (Common Fund)

Purpose

The Office of Strategic Coordination (OSC) seeks to enhance the validity of the impactful lines of biomedical research it supports. The purpose of this Notice of Special Interest (NOSI) is to provide administrative supplements to active Common Fund-supported awards to conduct preparatory activities that enable high-fidelity replication studies using independent contract research resources, which will be supported by NIH.

Background

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. Many Common Fund initiatives invite investigators to develop bold and innovative approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

Reproducibility of biomedical research is a critical feature in the advancement of knowledge (see https://grants.nih.gov/policy/reproducibility/guidance.htm). The use of rigorous research and design principles coupled with transparency in reporting methods and outcomes enables important lines of biomedical research to be replicated by other researchers. Replication studies are a core part of the scientific process and critical in assessing the validity of novel research outcomes, particularly those that form the basis of evidence-based practices to improve public health. Preclinical research is particularly ripe for independent replication because it is thought to be the area most susceptible to reproducibility issues (Collins and Tabak, 2014).

Objective

The objective of this Notice is to provide support for necessary preparatory activities to enable replication of impactful Common Fund-supported biomedical studies by an independent contract research organization (CRO). Applications must identify a preclinical study with high potential impact on public health that is amenable to replication by an independent CRO. The capabilities of the CRO are listed on the Common Fund website (https://commonfund.nih.gov/replication-initiative/faq). The study to be replicated may be an experimental study (e.g., replicating an experiment) or a validation study (e.g., replicating a demonstration of the capabilities of a novel tool, technology, or method) and must be completed within the one-year budget period. The applicant must be prepared to engage with the CRO immediately after the start of an award, and provide required research methods, protocols, and unique experimental materials as soon as possible. They must be available for consultation with the CRO throughout the period of award to ensure that the replicated study has high fidelity to the original study. The methods and results of the replication studies conducted through this NOSI will not be made public without the consent of the principal investigator(s). The CRO will provide NIH with anonymized, aggregated data on the replicability of the selected studies. 

A modest budget (described below) may be requested to support activities and materials required to enable a replication study by the CRO. The Common Fund will only support replication/validation of preclinical research studies and will prioritize studies that have the potential for translation to clinical use. Human subjects studies will not be supported. There is no limit on the number of applications from each awardee that can be submitted in response to this NOSI, but each application must propose to have a unique study replicated. To help NIH understand the utility of this approach for replication research, the Common Fund may request feedback from awardees related to the impact of this activity on their research program.

Budget and project period

• The supplement budget request must reflect the actual needs of the proposed one-year project and are limited to $50,000 direct cost per project.
• Requests may be for one year of support only.
• The parent award must be an active award supported by the Common Fund that is able to receive funds at the time of the earliest start date (see table below) and be active throughout the one-year project period.
• The parent award may be in an extension period (e.g., cost or no-cost extension). However, requests for no-cost extensions on the parent award to accommodate a supplement will not be permitted.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Notify the following parties about your planned application as you prepare your submission:
  • The scientific contacts listed at the bottom of this NOSI to confirm the availability of contract resources to support your proposed study for replication.
  • The program and grants management contacts at the Institute, Center, or Office administering the parent award to understand their requirements and limitations and facilitate efficient processing of the request.
• Applications must address the following topics and include the subsections below:
  • Original Study: Provide the goals and a description of the original study to be replicated. The studies may be published or unpublished. Indicate the ways in which the goals of the original study and the parent award are enhanced through replication. Indicate and explain any features of the study that may pose challenges to replication and provide any potential solutions.
  • Impact on Public Health: Indicate the significance of the original study as it relates to advancing public health, and the potential impact of replicating the original study on public health.
  • Collaboration: Provide a statement of commitment to supply the CRO with the necessary protocols, contextual information, and materials (where appropriate) to ensure that the replication study is conducted as intended in the original study. Provide a timeline for planned engagement with the CRO, including how engagement with the CRO will begin immediately upon award. 
• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-RM-24-009.”
• For funding consideration, applicants must include “NOT-RM-24-009” (without quotation marks) in the Agency Routing Identifier field (Box 4B) of the SF424 R&R form. Applications without this information in Box 4B will not be considered for this initiative.
• Page limits: The Research Strategy section of the application is limited to 6 pages (excluding references).
• If the budget includes a request for salary support, it should include a justification and clear details on what each person will be responsible for.
• R&R Other Project Information form: Attach a PDF document in the Other Attachments field entitled “Required Capabilities.” The Required Capabilities document must list the capabilities, including equipment and materials, required by the CRO to replicate the original study. This document will be provided to the CRO for feedback on feasibility during application review. Only the Required Capabilities document will be shared with the CRO. The rest of the application will not be shared with the CRO. The Required Capabilities document may be no more than 2 pages in length and is not included in the 6-page limit for the Research Strategy.
• Applicants must be requesting administrative support to an active Common Fund-supported parent award to be eligible under this NOSI. Common Fund support is indicated on the Notice of Funding Opportunity (NOFO) through which the parent award was made. For any questions on eligibility, please contact [email protected].

• Application Receipt Window: All requests, regardless of parent award funding mechanism, will be accepted starting on the first available start date (see Key Dates above) through September 30, 2024, by 5:00 PM local time, with applications reviewed in two batches (see table above).
• Late applications will not be accepted.
•  

Review and Selection Process

The Common Fund will conduct 2 batches of administrative review of applications (see table above) and will support meritorious applications based upon the availability of funds. Review of applications will consider the following factors:

• The ability of the proposed replication study to increase the overall impact of the parent award.
• The public health impact of replicating the original study.
• The potential for a successful collaboration with the CRO to support a high-fidelity replication study.
• A realistic scope of work, given the time and budget requested.
• Readiness to launch the replication activities for the proposed study.

Website and Technical Assistance Webinar

Website: https://commonfund.nih.gov/replication-initiative

A technical assistance webinar will be held with NIH staff to discuss this supplement opportunity and answer questions about available research capabilities and the supplement review process. Questions may be submitted ahead of time to [email protected]. Additional questions may be taken during the webinar if time allows. Details about the webinar, including registration information and frequently asked questions and answers are posted and will be periodically updated at the website https://commonfund.nih.gov/replication-initiative/faq. Webinar materials will be available after the webinar on the same website. Applicants are strongly encouraged to monitor the Replication Initiative website for updates when preparing applications and before final submission.

Inquiries

Please direct all inquiries to:

Sahana N. Kukke, PhD
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Email: [email protected]

Michelle R.J. Hamlet, PhD
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Email: [email protected]