Birdwatch Note Rating
2024-02-11 06:49:18 UTC - NOT_HELPFUL
Rated by Participant: 45EEF9615FE2F3B7D1E98FEA661699D617870D2A9F1EF3ADE39E5A6E9E91C4FB
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