Birdwatch Note Rating
2024-01-25 18:06:55 UTC - NOT_HELPFUL
Rated by Participant: 49BF3CE85942DA914876A78581E9B56B4A56D04D7045B03C1A8FF6741145C8C2
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