Birdwatch Note Rating
2024-02-10 22:42:12 UTC - HELPFUL
Rated by Participant: 9578F4AD296F1A88A38917F5211E2714FFE4518D54B498FA2D9D7B8BA85A4607
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