Overview of Changes
Under National Institutes of Health (NIH) projects, JHU frequently collaborates with foreign organizations for scientific research. This important collaboration has boften been funded in the traditional grant subaward/consortium structure, in which JHU issues a NIH federal subaward for a portion of the grant award to each respective foreign entity performing a unique scope of work.
The NIH will no longer accept applications which plan to issue a subaward to a foreign entity.
Instead, foreign entities who intend to collaborate with JHU on NIH-funded projects will receive their own grant directly from the NIH, and maintain a direct relationship with NIH to manage and report on the grant. This is a substantial change in relationship and requires each foreign organization to complete additional registrations with the United States Government.
Under this new funding method, JHU would still submit a combined proposal (PF5 Collaborative International Research Project), representing the domestic research component, the foreign organization’s component, and an overall coordination component.
After the standard scientific review, the combined proposal will be disaggregated into its components for further evaluation. If a proposal is selected for possible funding, the NIH will request additional information from the foreign organization (Just-In-Time request, approximately nine months after submission), and the registrations described below. These will not be required if the proposal is not accepted for funding.
Any component of the proposal may or may not be funded. Each organization will be direct funded with a unique NIH grant number and each organization will be independently responsible for all financial management and reporting. While foreign organizations would still collaborate with JHU on the research, the direct grant from NIH would be labeled as an RF2 Linked International Research Project.
The following resources are available to guide JUH’s foreign collaborators, in navigating these changes and completing the required registrations.
Timeline
These policies have already taken effect, and no new subawards will be issued to foreign entities from newly awarded NIH proposals. If you currently collaborate with Johns Hopkins Investigators on an NIH-funded project, the next proposal submission will move to a component structure, and you should begin all required registrations right away.
If you plan to collaborate with Johns Hopkins Investigators on a future NIH research project, you should begin all required registrations right away.
At proposal submission you must:
- Have a Unique Entity Identifier (UEI) or have requested one
- Submit a letter signed by your Authorized Official, that you will complete the registrations and host the final RF2 grant
At Just-In-Time (about 6-9 months after submission) you must:
- Have finished the full entity registration in SAM.gov and have an ‘active’ status
- Have finished the entity registration in eRA Commons and have an Authorized Official and your Investigators affiliated
At award (about 10-12 months after submission) you must:
- Have finished the entity registration in GRANTS.gov
Required Registrations
1. SAM.gov registration is required.
The first step in this process is the Unique Entity Identifier, which you may already have. Once assigned, you can begin the complete SAM.gov registration. A detailed checklist is available on their website.
The second step is to apply for and receive a complete profile with an ‘active’ status. This is a complicated process, as it involves several additional steps, such as applying for an NCAGE code. Please review the checklist carefully to ensure you have time to complete all steps. It may take up to six months to complete the registration and receive an ‘active’ status.
The SAM.gov site offers additional resources, including their “Entity Registration Checklist” and their “Quick Start Guide for Foreign Organizations.” The downloadable PDF version of this page includes a SAM.gov checklist.
2. eRA Commons registration is required.
The steps of this process can be found on the NIH eRA website. Once the registration is complete, assign an Administrative Official. Each of your personnel should create a personal eRA Commons account and then be affiliated with your organization. This process might take one-two days.
3. GRANTS.gov registration is the final registration required.
You must have an active SAM.gov registration to begin. This is generally a one-day process.
Project Leadership and Roles
In this new funding structure, your foreign organization should have personnel identified who will fill the role of Project Director / Principal Investigator for your portion of the research. These individuals will be identified as “Project Leads” on the submission. They will become a PD/PI on the final RF2 direct NIH award.
This leadership structure allows your organization approximately nine months between the time of submission and the Just-In-Time request, to complete the required registrations. However, if your foreign personnel will be named co-PD/PI over the entire PF5 project, then these registrations must be completed at the time of submission.
Letter of Attestation for Submissions
At the time of submission, your organization must submit a letter of attestation (see policy) (download JHU Letter of Support Template). This letter serves as your official agreement to be the direct applicant on the future RF2 direct NIH award. This letter should state that your organization understands that, should the application be accepted for funding, your foreign organization will fill the role of recipient. This letter should also state that you will complete all necessary requirements before the award can be issued.