Birdwatch Note Rating
2024-01-30 19:08:51 UTC - SOMEWHAT_HELPFUL
Rated by Participant: E750829AA120B6545B6FF3BC539238CB77172C9F452150C3211A195224D00E1A
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