Birdwatch Note Rating
2024-01-31 01:19:58 UTC - SOMEWHAT_HELPFUL
Rated by Participant: 1F19112D4D120B3E8A09EC0F1C770B1E52020173A9CEEAFE49D21A6305D49B79
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