Forms and Templates

WORKSHEET Consent Requirements and Waivers

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This worksheet provides support to researchers, the UW IRB, and the Human Subjects Division staff by:

1. Identifying general requirements and elements of consent and consent documentation that are required and in what circumstances.
2. Listing the criteria that the IRB must apply when deciding whether to grant waivers related to consent, parental permission, assent, and documentation.

Change Notes

Update regulatory reference where FDA harmonized its minimal risk waiver with the Common Rule – 02.01.2024
Simplify worksheet; transfer content from PDF to Word; move embedded guidance to new, GUIDANCE Designing the Consent Process – 06.01.2023 posted; 10.01.2023 implemented
Remove outdated template language for FDA-regulated device clinical trials – 08.04.2022
Minor updates throughout – 10.08.2021
Minor update for prisoner populations – 04.29.2021