Hmmm a thought experiment: Using all the DNA date sent to places like Ancestry.com, could AI also read these and generate personalised/racialized gene therapies for prophylaxis, kill or cure treatments?
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@MarkSean Perish the thought! AI Clinical Investigations will certainly prevent that from happening. FDA has us covered.
Federal Register / Vol. 88, No. 244
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
SUMMARY:
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."
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Yep, feeling much better about that now.
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