Birdwatch Note Rating
2024-01-25 23:02:03 UTC - HELPFUL
Rated by Participant: 77F3621FF8FA173FA4ACD668DF010C276EAE695AC375074FD5F7766FA71A337C
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