Birdwatch Note Rating
2024-02-11 00:37:00 UTC - NOT_HELPFUL
Rated by Participant: C628E8A07D48B86D988A85E25CF2168F71308182BDB631B94C0A2CC47FA924E9
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