Birdwatch Note Rating
2024-01-26 02:57:11 UTC - NOT_HELPFUL
Rated by Participant: ED3A6AD361DC7110F98B42DC49C2A44149B601C678FCAD35504CBE626DCC3149
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