GUIDANCE Consent Elements for Externally Reviewed Studies
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
Clarify HIPAA language – 01.04.2024
Add references to new consent template language and guidance – 06.01.2023
Add information for studies using fetal tissue from elective abortion; add template language for costs to subjects or their insurance when participating in a clinical trial – 03.30.2023
Revise GDS language and update other sections for clarity – 12.29.2022
Revise CoC template language – 10.27.2022