Birdwatch Note Rating
2024-01-30 16:36:45 UTC - HELPFUL
Rated by Participant: 2CD7B8F145D69CF7A080ECA25249BA4F826F103170A8CBFCA6C10F06B2F46167
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