UW Research

Forms and Templates

WORKSHEET Consent Requirements and Waivers


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

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Remove outdated template language for FDA-regulated device clinical trials – 08.04.2022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
Minor revision to language regarding consent material requirements when documenting consent via eSignature – 03.25.2021
Added elements for electronic consent – 01.21.2021
Added information about NIH human fetal tissue policy – 12.13.2019
Added #3.4 – 12.28.2018
Expanded and remodeled to include revised Common Rule – 11.30.2018
Removed reference to in vitro diagnostic devices – 10.27.2017
Updated per new FDA guidance regarding waiving consent for minimal risk FDA-regulated studies – 08.25.2017
Added link, updated committee drop down list, removed “initial application” from submission type – 05.11.2017