Yale and Yale New Haven Health System (YNHHS) investigators may wish to use an external Institutional Review Board (IRB) in lieu of the Yale IRB to oversee a research study (e.g., for NIH funded studies requiring use of a single IRB, or industry sponsored research utilizing a central IRB). Prior authorization from the Yale Human Research Protection Program (HRPP) is required to use the external IRBs. The HRPP will work with the proposed external IRB on a reliance agreement if one is not yet in place. Requests for an external IRB review for an initial study must be submitted in IRES IRB. Instructions and required forms are available in the IRES IRB Library and Help Center.
Even when an external IRB is used for review of a research study, compliance with the local requirements regarding research remain the institutional responsibility. As such, the Principal Investigator is responsible for ensuring that investigators and research staff meet the Yale training and conflict of interest (COI) disclosure requirements, all ancillary reviews (e.g. PPRC, PRC, MRRC) are obtained, and the record is updated in the IRES IRB system. The HRPP will verify compliance with these requirements prior to issuing the authorization.
Certain changes to research protocols approved by external IRBs will need to be submitted to Yale HRPP for verification. These include changes to personnel and updates to the research plan affecting local requirements (e.g., change in PI, changes to radiation necessitating a new RSC review). A detailed description of the post-approval responsibilities are outlined in the Investigator Manual.