Birdwatch Note Rating
2024-02-13 00:41:58 UTC - NOT_HELPFUL
Rated by Participant: 40AD267E7D1B40FFAC2129B33CE64D2241A54AE72EDC2C163628805B2B21CDBB
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