Birdwatch Note Rating
2024-02-10 22:38:36 UTC - HELPFUL
Rated by Participant: B43B0910668E4BBA6D7F50676437FE316B7551544B464DC4D99C8782704447D6
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