Birdwatch Note Rating
2024-01-30 19:03:47 UTC - HELPFUL
Rated by Participant: CEA670ADF52F3491EFB23360DDF600AC29DFDC5DAAFBBDAA587B83BA6E55A3C4
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