I think that it is critical here to make the distinction between "minimal risk" and "Exempt". If the study is Exempt, you should follow what your organization's HRPP program requires. If the study is minimal risk but non-Exempt, you should follow 45 CFR46.117(c).
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Daniel R. Kirienko, Ph.D.
Preferred pronouns: he, him, his
IRB Compliance Lead
Office of Research Integrity
Rice University| 350 Allen Center | 6100 Main Street, MS 16 | Houston, TX 77005
Tel: 713.348.3586
dk32@rice.edu------------------------------
Original Message:
Sent: 03-04-2024 10:56
From: Anonymous Member
Subject: Waivers of Consent Documentation and E-consent
This message was posted by a user wishing to remain anonymous
Greetings All,
After some internal discussions/debates, I wonder how other institutions manage documentation waivers. For example, a minimal-risk study plans on collecting handwritten consent for interviews, but those participants who participate via Zoom will the PI plans to obtain a written signature via electronic means, not just click "agree to participate" like for surveys. Would your HRPP/IRB still require a waiver of consent documentation?