Birdwatch Note Rating
2024-01-30 23:49:45 UTC - NOT_HELPFUL
Rated by Participant: 856F13DE792F1AED3BD68E14FBD6B88B3D9B65A95FF106021D239850CB764970
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