Birdwatch Note Rating
2024-01-26 23:47:12 UTC - NOT_HELPFUL
Rated by Participant: 837E94B73F20865791415197C955BE08CB4A5576CD1EB12042E8D3D78D82120C
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