UW Research

Policies, Procedures and Guidance

GUIDANCE Human Subjects Regulations

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This document lists the regulations for which HSD and the UW IRB are responsible and a few regulations for which it is often mistakenly believed that HSD and the UW IRB are responsible.

Change Notes

Update references to DoE regulations; minor updates to CoC section; add NIH DMS policy; note legal opinion about the relationship between RCW 70.02 and HIPAA – 03.02.2023
Add reference to new NIH notice regarding fetal tissue regulation – 04.29.2021
Addition of e-signatures – 10.15.2020
Minor updates throughout – 04.24.2020
Minor revisions related to Single IRB and RCW 9.73.030 – 02.28.2020
Added information about NIH human fetal tissue policy; remove reference to NIH RAC requirement; note expanded definition of who may serve as LAR per WA state law – 11.15.2019
Removed all references to Confidentiality Agreements and to state law RCW 42.48 – 07.28.2019
Added extensive information to beginning – 11.30.2018