This worksheet provides support to researchers, the UW IRB, and the Human Subjects Division staff by:
- Identifying general requirements and elements of consent and consent documentation that are required and in what circumstances.
- Listing the criteria that the IRB must apply when deciding whether to grant waivers related to consent, parental permission, assent, and documentation.
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Remove outdated template language for FDA-regulated device clinical trials – 08.04.2022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