Birdwatch Note Rating
2024-01-30 14:33:01 UTC - NOT_HELPFUL
Rated by Participant: 02BCF054315D0010B685CD0638887F5F15787BF8090D3A2731DE2F9C97D96366
Participant Details
Original Note:
The new rule harmonizes the differences between HHS and FDA Human Subject regulations. It does not eliminate informed consent for trials with greater risk than minimal risks. Importantly, the rule allows for analyzing data/specimens collected during previous trials. https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical
All Note Details