Birdwatch Archive

Birdwatch Note Rating

2024-01-30 19:08:51 UTC - SOMEWHAT_HELPFUL

Rated by Participant: E750829AA120B6545B6FF3BC539238CB77172C9F452150C3211A195224D00E1A
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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