tyb - We will succeed.
Donald J. Trump
Mark Levin: “We found a clip where Kamala Harris told us what her views are of Human Nature, and where she would take this Country. Now, either she is a rabid Marxist scholar who embraces it, or she's a blithering idiot.”
04:57
Jul 28, 2024, 11:15 PM
https://truthsocial.com/@realDonaldTrump/posts/112867601304035668
Donald J. Trump
Mark Levin: “Here she (Kamala Harris) is basically comparing U.S. Immigration and Customs Enforcement's (ICE), to the perception of the Ku Klux Klan…the combination of stupidity and arrogance is on full display, right here!”
04:35
Jul 28, 2024, 11:22 PM
https://truthsocial.com/@realDonaldTrump/posts/112867631363741470
Donald J. Trump
“Kamala Harris praising Defund Police Movement in resurfaced video…”
00:58
Jul 28, 2024, 11:24 PM
https://truthsocial.com/@realDonaldTrump/posts/112867637032435951
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
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. 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.
DATES:
This rule is effective January 22, 2024.
https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical
RFKjr ~ FDA and Congress "whittled down" The Nuremberg Code
Robert F. Kennedy Jr
The Nuremberg Code was established after World War 2 as the ethical and legal standard for conducting medical research in human subjects, worldwide.
But in the US it has been whittled down by the FDA and Congress to ease the legal constraints and financial costs for pharmaceutical companies conducting research in humans.
In January, the FDA issued a Final Rule that allows Institutional Review Boards hired by Pharma to determine that certain research constitutes only “minimal risk” (a definition with lots of wiggle room) and therefore does not require the informed consent of the subjects!
>Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
https://federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical
This is not acceptable. We need to return to the Nuremberg standard—which, by the way, would never have allowed experimental EUA vaccines to be given to anyone without fully informed consent, as was done during COVID. A clinical trial that poses any risk at all must have the informed consent of the subject.
My administration will work to amend existing legislation and FDA rules on Day 1, as the first step toward returning ethical medicine and ethical medical research to our nation.
11:51 PM · Jul 28, 2024·36K Views
https://x.com/RobertKennedyJr/status/1817769913475338641
Trump countersnipers' chilling text messages before assassination attempt reveal shocking truth: 'He knows you guys are up there'
A massive inquiry has started in the wake of the attempt, which Trump miraculously survived, with the resignation of Secret Service Director Kimberly Cheatle coming soon after the July 13 shooting. Now, it appears a group chat of those meant to protect Trump were aware that gunman Thomas Matthew Crooks , 20, was in their midst over 90 minutes before Trump was shot at, rather than 62 as the FBI had previously claimed.
https://www.dailymail.co.uk/news/article-13682279/Trump-countersnipers-chilling-text-messages-assassination-attempt-gunman-one-step.html