Birdwatch Note Rating
2024-01-30 18:46:21 UTC - HELPFUL
Rated by Participant: 4EFCADA850DB3962E6899320A025E447AC2F39CB7427292B913A6234607BA855
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