The University of Rochester has a Federalwide Assurance with the Office for Human Research Protections (OHRP). Under the FWA, the University operates four internal institutional review boards (IRBs) and one external, contract IRB (Western IRB). The Investigator Guidance document provides details on which studies are reviewed internally and which are reviewed by WIRB. Generally speaking, WIRB is the University of Rochester's IRB of record for industry-sponsored, industry-initiated research involving FDA-regulated drugs and devices posing greater than minimal risk to subjects. The Research Subjects Review Boards (RSRBs) are the university's IRBs of record for all other studies, including those that receive federal support of any kind (e.g., NIH grants), department studies, non-funded investigator-initiated studies, and foundation grants.

Certain categories of research have been identified in the federal regulations for the protection of human subjects as exempt from IRB review. The University of Rochester recognizes the exempt categories, and the RSRB reviews applications to determine that an exemption is appropriate.

All research -- whether reviewed by the RSRB or WIRB, or whether qualifying for exemption -- needs to be submitted via the electronic system. You may access this system at: (rsrb01.urmc.rochester.edu).

If you have any questions about which IRB you should submit to, or whether your research may qualify for exemption, you may also call the RSRB Office at 585/275-2398.