Birdwatch Note Rating
2024-01-26 18:03:10 UTC - HELPFUL
Rated by Participant: 77F3621FF8FA173FA4ACD668DF010C276EAE695AC375074FD5F7766FA71A337C
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