FDA Rule Now Makes It So That “Informed Consent” Could Be Waived/Altered by IRB’s.

Comments that were submitted to the FDA opposing this change state:
1) Of the comments that oppose the proposed rule, two oppose it because they assert that waiving consent conflicts with existing ethical and international standards, such as the Belmont Report, the Nuremberg Code, the Declaration of Helsinki, and the International Covenant on Civil and Political Rights (ICCPR). Two other comments suggest that FDA withdraw the proposal because the underlying law and revised Common Rule are defective and “against the spirit” of human subject protection.
2) Several comments argue that waivers of informed consent weaken human subject protections and would allow IRBs to retreat from their human subject protection responsibilities.
3) Some comments suggest that conducting research without informed consent would violate the U.S. Constitution or weaken constitutionally guaranteed rights. One comment argues that “invasive procedures, interventions or intrusions” into a person's “body, cognition, or otherwise” without consent is a violation or a potential violation of the Fourth, Fifth, Eighth, and Fourteenth Amendments.
Links:
https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical#:~:text=For%20an%20IRB%20to%20approve,the%20revised%20Common%20Rule%20(January

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