Birdwatch Note Rating
2024-01-26 03:21:35 UTC - HELPFUL
Rated by Participant: 8EBAF36639123F450B6BD17DA0CEBEF0170C1F367700B866090B485D704D69FA
Participant Details
Original Note:
While vaccines are a part of clinical investigations, it must be noted that the rule applies to clinical investigations that pose no more than minimal risk to the human subject and include safeguards to protect the rights, safety, and welfare of human subjects. 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