Version Date: August 2, 2011
Guidance on the application type of training grant, umbrella grant or core grant
The IRB utilizes umbrella reviews for compiling sub-studies under a single grant. Umbrella review may be relied on when the UW distributes funds from one grant among several sub-studies that independently require IRB review and approval, including IRBs at other institutions. An umbrella approval does not grant approval for the conduct of human subjects research; rather, it provides acknowledgement of the intent of the grant application to pursue such activities.
Applications for umbrella review must include as much detail as possible regarding each sub-study. Each principal investigator (PI) who is responsible for an individual sub-study must submit that study independently for IRB review and approval. Sub-study applications must include a copy of the appropriate section of the grant. If a sub-study falls outside the UW IRB’s purview, proof of outside IRB review and approval must be submitted to the UW IRB. Each sub-study will be conducted in accordance with all applicable UW human research protection policies and procedures. For each sub-study, the informed consent documents must be submitted with the initial application for review or a request for a waiver of consent should be submitted according to IRB policies and procedures.
Umbrella reviews are subject to annual continuing review. Each sub-study covered by the umbrella review must be kept current for continuing review approval to be granted. An umbrella review may be closed when all sub-studies are completed or terminated.