Birdwatch Note Rating
2024-02-10 20:24:15 UTC - NOT_HELPFUL
Rated by Participant: 910B90FE9AD963899CED052578CD0820D35D5170047B086BA466FBDC6034FF3A
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