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), The Common Fund, 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 NIH-funded awards to conduct preparatory activities that enable high-fidelity replication studies using independent contract research resources, which will be supported by the Common Fund.

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 NIH-funded 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 demonstrated 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).  
 
A modest budget (described below) may be requested to support conducting activities and providing materials to a CRO engaged by the Common Fund. The Common Fund will provide funds directly to the CRO to conduct the replication study. 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 NIH award 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 (see exclusions below).
• 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

Eligible Activity Codes:

Additional funds may be awarded as supplements to parent awards using any Activity Code that is listed in PA-20-272, with the following exceptions: Small business activity codes (e.g., R41, R42, R43, R44, U43, U44, Fast Track, SB1, UB1, UT1, and UT2) are NOT ELIGIBLE. Note that not all participating NIH Institutes and Centers (ICs) support all the activity codes that may otherwise be allowed. Applicants are therefore strongly encouraged to consult the program officer of the parent grant to confirm eligibility. 

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 in the Research Strategy:
  • 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-24-013.”
• For funding consideration, applicants must include “NOT-RM-24-013” (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 NIH-funded 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 CF-Replication@od.nih.gov.

• Application Receipt Date: All requests, regardless of parent award funding mechanism, will be due November 15, 2024, by 5:00 PM local time.
• Late applications will not be accepted.

Review and Selection Process

The Common Fund will conduct an administrative review of applications 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.

Inquiries

Please direct all inquiries to:

Sahana N. Kukke, PhD
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Email: CF-Replication@od.nih.gov

Michelle R.J. Hamlet, PhD
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Email: CF-Replication@od.nih.gov