Training Grant, Umbrella Grant or Core Grant

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, including a complete copy of the grant. 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.

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Keywords:umbrella grant, training grant, core grant   Doc ID:19535
Owner:Stella K.Group:Health Sciences IRBs
Created:2011-08-03 19:00 CDTUpdated:2015-10-13 15:15 CDT
Sites:Health Sciences IRBs
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