Options for IRB Oversight

In general, each of the options below is finalized after the investigator in question has left the NIH and it may require them to submit a request in parallel at their new institution.

What? A written agreement between institutions that identifies which institution will serve as the Reviewing IRB and which will cede IRB review i.e., Relying Institution. Provides a mechanism for the leaving investigator’s new institution to cede IRB oversight to the NIH IRB for the on-going research activities. The agreement is negotiated and finalized by the respective Human Research Protections Program’s. It is an option only available to FWA-holding institutions.

How? The NIH PI needs to submit a reliance application to the NIH OHSRP requesting that the external institution rely on the NIH IRB. The OHSRP Office of IRB Operations (IRBO) will review the request, issue the agreement, and work with the external institution to finalize. Once in place, an action is submitted to the NIH IRB to add the new institution as a Participating Site. The submission will document the reliance arrangement in the PROTECT, identify the investigator as the Site PI for their new institution, and updates the NIH protocol to ensure there is a description of the HSR that will be conducted by the former NIH investigator under the external institution’s FWA.

What? The FWA Coverage Agreement is used by the NIH to extend its FWA to those leaving NIH if all the following are met:

1. The research to be performed will be part of the same NIH protocol that the leaving investigator was involved in when at the NIH;
2. The research is limited only to the analysis of identifiable data* from that same NIH protocol;
3. The research will be conducted under the oversight of the NIH PI; and
4. If the leaving investigator has moved to a FWA-holding institution, that institution must provide written verification that it agrees with the activities being conducted under the oversight of the NIH.

This agreement is an option for investigators who are moving institution or roles not covered by an FWA and to those at an FWA-holding institution provided the new institution is comfortable for their new employee to be covered by the NIH's FWA for HSR on an NIH protocol.

How? To request an FWA Coverage Agreement, the NIH PI or designee needs to complete a FWA Coverage Agreement Request Form. IRBO reviews the requests, confirms if the agreement is appropriate, and communicates that to the NIH PI and OHSRP Director. If OHSRP agrees to extend the NIH FWA, an agreement is issued and signed by the NIH PI, the non-NIH investigator, and the OHSRP Director.

*In this context, the analysis of identifiable data encompasses working with coded data with access to the code key; and circumstances where an investigator will be working with coded/ de-identified data with no access to the code key but can reidentify subjects based on their prior role in the protocol.

What? An IIA is the appropriate mechanism to extend NIH’s FWA if the HSR to be conducted by the former NIH investigator will go beyond working with identifiable data and they will not be covered by any other institution’s FWA. It can also be used for investigators not associated with an FWA-holding institution.

How? The extension of the NIH FWA to a non-NIH investigator using this mechanism is considered on a case-by-case basis and is ultimately at the discretion of the NIH IO/ designee. The NIH PI/ designee should consult with the Reliance & sIRB Team to determine if this is a viable option. If OHSRP agrees to extend the NIH FWA, an agreement is issued and signed by the NIH PI, non-NIH investigator, the non-NIH investigator’s employer/supervisor (if applicable), and the OHSRP Director.

What? Local IRB Review means that an investigator’s home institution reviews their conduct of HSR on a protocol. The FWA-holding institution may determine that they want to review their investigator’s HSR on the NIH protocol, or the NIH might determine that its IRB cannot be relied upon via a Reliance Agreement. This is only an option if the NIH protocol is not subject to any single IRB mandates – the requirement that multi-site research be reviewed by a single IRB.

How? To determine if a protocol is subject to an sIRB mandate, consult with the Reliance & Single IRB (sIRB) Team.

See NIH Policy 109 to learn about the mechanism for extending the NIH FWA and to review the responsibilities of the NIH PI and the non-NIH investigator when this is done.