<< The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations. >>️
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations. A Rule by the Food and Drug Administration on 12/21/2023. federalregister.gov
FonT: 'Minimal Risk Clinical Investigations (MRCI)': here are intriguing both (i) the scientific formalization of the operational methods decided (case by case) by the FDA about MRCI and (ii) the possible strategies - if at least one exists - for avoiding the 'multitude of unaware' from this type of interception.
Also: Are you ready for all this?, in https://www.inkgmr.net/kwrds.html
Also: evitare (avoid), in Notes (quasi-stochastic poetry) https://inkpi.blogspot.com/search?q=evitare
Also: avoid, in FonT https://flashontrack.blogspot.com/search?q=avoid
Also: Robert F. Kennedy's opinion on the issue https://twitter.com/RobertKennedyJr/status/1752126207821271080
Keywords: life, FDA, informed consent, risk, minimal risk, minimal risk clinical investigations, avoidance, 1or2achoos, are you ready
