Birdwatch Archive

Birdwatch Note Rating

2024-02-10 20:30:09 UTC - NOT_HELPFUL

Rated by Participant: 4ABE6203F10279A89C2A3C09E70B746A68D327698E0FC5F06B79365FFE86469B
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

Original Tweet

All Information

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