UW Research

Policies, Procedures and Guidance

GUIDANCE Consent Elements for Externally Reviewed Studies

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The University of Washington has no institutional requirements for the format of consent materials and strongly supports flexibility for consent format and content. For studies reviewed by an external IRB, it is typically most efficient to add the UW required elements to the sponsor or reviewing IRB’s template consent forms. The UW study team is responsible for ensuring that any applicable elements are included in the consent materials reviewed by the external IRB. The UW Consent Form Template provides general sample language and suggested organization, but these are not required, except as described in this document.

Change Notes

Addition of information to facilitate e-consent – 10.15.2020
Added language to conform with the revised Common Rule – 11.30.2018