*Separate Key Information Consent Template (more than 2,000 words)
This template should be used for studies that are required to have a distinct Key Information section at the beginning of the form per UW IRB policy.
This template is appropriate for complicated, higher risk studies that require the consent form to be more than 2,000 words in order to explain that complexity.
The separate Key Information section helps prospective participants focus up-front on the information that is most likely to influence their decision. The rest of the form fills in additional details and provides other information that may be of interest and/or is required by the regulations.
Change Notes
Revise Key Information section to align with draft OHRP/FDA guidance – 05.30.2024
Add guidance about alternatives to participation per FDA consent guidance – 11.29.2023
Minor updates in response to feedback about new consent guidance and templates – 09.19.2023 posted; 10.01.2023 implemented
Add instructions about requirements for describing procedures, risks, and costs for experimental device research – 08.31.2023, 10.01.2023 effective date
New consent template – 06.01.2023 posted; 10.01.2023 implemented