NIH Foreign Subrecipient Policy

Where Pre Award support roles are involved in assisting  PI’s with  administrative elements of the Grant life cycle, responsibilities include:  

• Proposal Stage: Coordinating with subrecipient grant administration staff to ensure that the subrecipient Statement of Intent (SOI) includes the required language indicating the foreign subrecipient is aware of the data access requirements and is willing to abide by all requirements should an award be issued. (Note: if the subrecipient SOI does not include this language, Imperial’s SOI wording should be used) 

• Proposal Stage: Coordinating with subrecipient grant administration staff to ensure that the subrecipient PI LOS includes the expected language confirming the foreign subrecipient PI is aware of the data access requirements and is willing to abide by all requirements should the application be successful.  

Academic Department – Post Award Support 

• Award Stage: Informing the PI of the requirement to develop an implementation plan with the foreign subrecipient. Ensuring Contracts Team have all documents required for an outgoing subaward or sub amendment.  

• RPPR Stage: Facilitating the completion and submission of the RPPR before the deadlines and confirming the PI has attested to the receipt and review of the subrecipient data and documentation that supports the research outcomes reported in the progress report. 

Where Imperial are the Lead party and have foreign subrecipients as partners/collaborators the following wording is suggested; 

Proposal Stage:  

Statement of Intent (SoI) 

The following provision is required for all new NIH subaward/consortium Statement of Intent (SOI) forms from foreign subrecipients in response to NIH’s policy expectations:  

The subrecipient organisation agrees to abide by the requirements of the NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreement (NOT-OD-23-182), and will provide access to copies of all lab notebooks, all data, and all documentation that support the research outcomes as described in the progress report, to the primary recipient with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission. Such access may be entirely electronic. 

Letter of Support (LoS) 

The following provision is required for inclusion on all new subaward/consortium Letters of Support (LOS) from foreign subrecipients’ Principal Investigators (PIs): 

I agree to provide you with access to copies of all lab notebooks, all data, and all documentation that support the research outcomes as described in the progress report, with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission. Such access may be entirely electronic. 

Award and Subcontract Stage: 

By signing this subrecipient agreement, [Subrecipient name] agrees to provide access to copies of all lab notebooks, all data, and all documentation that support the research outcomes as described in the progress report, to [primary recipient] when requested and with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report described in [reference section of contract that provides timing of report submission]. [Subrecipient name] will make such data available via [insert recipient’s preferred method here which can be electronic (e.g., Sharepoint, Teams, Box, etc.)] 

Principal Investigators take primary responsibility for ensuring compliance with NIH regulations as well as the monitoring of subrecipient progress, expenditures, timely correction of errors, and proper allocation of expenses. Within the context of this Policy, the PIs’ responsibilities include: 

Where Imperial is the Lead/Prime Recipient;  

• Ensuring  foreign subrecipients are aware of the NIH Policy requirements. 

• Develop a data access plan with the PI of the foreign subrecipient. 

We suggest  that this includes: 

• Means of access to the records (all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report) 

• A provision detailing the proposed access frequency of records/data supporting the research outcomes. 

• If the subrecipient’s records include personally identifiable information and/or information in a foreign language, the data access plan must also include a provision requiring the foreign subrecipient to anonymise information and/or translate the information into English, to meet regulatory requirements. 

• A template data access checklist has been devised (NIH foreign subaward checklist) that can be used to record and keep track of data and records relevant to the NIH award 

• Review the relevant records at least annually to confirm that the performance outcomes that are reported in the RPPR are accurate, complete, and properly reflect project goals. 

Where Imperial is the Foreign Subrecipient;  

Develop a data access plan with the PI of the Lead Party that includes: 

• Means of access to the records (all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report) 

• A provision detailing the proposed access frequency of records/data supporting the research outcomes 

• If Imperial’s records include personally identifiable information, the data access plan must also include a provision requiring the foreign subrecipient to anonymise information to meet local regulatory requirements 

•  A template data access checklist has been devised (NIH foreign subaward checklist) that can be used to record and keep track of data and records relevant to the NIH award 

• RO will follow up and communicate updates and guidance from NIH on this policy 

• Share up-to-date news and best practice to keep Stakeholders informed 

• Monitor subrecipient compliance during annual monitoring on NIH awards