Birdwatch Note Rating
2024-01-30 19:30:10 UTC - NOT_HELPFUL
Rated by Participant: 6FA541D823798553A43DED316E95060066DCC3F36F4FCBA5485D2D7D04EEC268
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