Birdwatch Note Rating
2024-01-30 13:48:45 UTC - NOT_HELPFUL
Rated by Participant: 78838FF0318EC521B9D08B6B4CD315B47EEE45C4583C4D32EDDD5633461CE726
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