Birdwatch Note Rating
2024-01-27 05:28:48 UTC - NOT_HELPFUL
Rated by Participant: 87ED80D118819C5FA166ED7C03F6D63432355A5B3A1E60A2D38FDBCC7DA22C98
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 https://www.jdsupra.com/legalnews/fda-issues-final-rule-permitting-irb-9116244/ https://www.kslaw.com/news-and-insights/fda-issues-final-rule-permitting-irb-waiver-or-alteration-of-informed-consent-for-certain-minimal-risk-clinical-investigations https://www.fda.gov/news-events/fda-voices/increasing-options-clinical-research-facilitate-medical-product-development
All Note Details