Birdwatch Note Rating
2024-01-31 08:08:20 UTC - NOT_HELPFUL
Rated by Participant: B039E5E6405AEEA2623AA7AE55BDF86D88D8339B03052C792C95F55EBFC471FA
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