Informed Consent No Longer Exists and it's Been Written out of the Law.
The U.S. Department of Health and Human Services, and The Food and Drug Administration have set the table for more lockdowns and bio-weapon shots.
HHS and the FDA have now added the so-called illnesses (real or fake) of Ebola and Marburg to their list of “illnesses” that would require their specified government and global countermeasures (i.e., reactions, plans and procedures), and they've removed informed consent from all IRB clinical trials. They made both of these official in January of 2024.
The HHS and the FDA have made declarations, and amendments to their declarations, while also writing themselves out of their own law regarding liability for what they have planned next. They want lockdowns. They want more poison shots to be distributed, and they are doing this openly as these government agencies are working directly to kill the citizens of America and those around the world. These government agencies have made this know within two recent documents.
Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Countermeasures Against Ebolavirus and/or Ebola Disease and Marburgvirus and/or Marburg Disease.
The first document is titled; Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Countermeasures Against Ebolavirus and/or Ebola Disease and Marburgvirus and/or Marburg Disease. Click HERE.
This document from HHS, amended on January 1st of 2024, states that Ebola and Marburg “viruses” are being added to the COVID protocols of the past. Therefore, if these so-called “illnesses,” either real, manufactured, or nonexistent, are mentioned to be a harm to citizens, then the same measures and further measures are going to be repeated and added by the government and all of their associated institutions. HHS has been in contact with the FDA, The National Institutes of Health, and The Department of Homeland Security, as they are all referenced within this declaration, along with the Department of Justice.
They know what they want to do, and they’re getting it down on paper and legalizing it before they do it. In fact, they may use the border invasion as a way to ensure that they get the lockdowns here that they want. The document linked above was registered on November 27th of 2023, and amended on January 1st of 2024.
Within this document, it states, among endless critical points;
“VI. Covered Countermeasures
42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 247d–6d(i)(1) and (7)
Covered Countermeasures are: (1) any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to diagnose, mitigate, prevent, treat, cure, or limit the harm EBOD, MARD, or the transmission of Ebolaviruses, Marburgviruses, or a virus mutating therefrom, any device used in the administration of any such product, and all components and constituent materials of any such product; (2) any product to diagnose, mitigate, prevent, treat, or cure a serious or life- threatening disease or condition caused by a product described in clause (1); or (3) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (1) or (2).
Covered Countermeasures must be ‘‘qualified pandemic or epidemic products,’’ or ‘‘security countermeasures,’’ or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.”
As I insist that this document be read by every single human on Earth, in summary, they’re stating that everyone will be legally required or highly pressured to follow every measure that the government lays out, as every institution and business is legally responsible for the safety of all of their participants, employees and inhabitants.
This won’t matter if what they say is happening is really happening or not (just like the COVID lie). If they say it’s happening, people will believe it, while others will not. This is your Civil War all over again. The second Civil War was the division that stemmed from the countermeasures employed in 2020 and the years after. This coming Civil War 2.0 will be this second go-around of the same thing from 2020 and the years after, but far worse in my humble opinion.
HHS and their fellow three-letter agencies, such as the DOJ, along with all of the institutions that are forced to comply with these measures, are now also free from liability, certainly through December of 2028. The document states;
“XI. Geographic Area
42 U.S.C. 247d–6d(a)(4), 247d– 6d(b)(2)(D)
Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.
Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.
XII. Effective Time Period 42 U.S.C. 247d–6d(b)(2)(B)
Liability immunity for Covered Countermeasures through means of distribution other than in accordance with the public health and medical response of the Authority Having Jurisdiction and extends through December 31, 2028.
Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a Declaration and lasts through (1) the final day the emergency Declaration is in effect, or (2) December 31, 2028, whichever occurs first.
XIII. Additional Time Period of Coverage
42 U.S.C. 247d–6d(b)(3)(B) and (C)
I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are
appropriate to limit the administration or use of the Covered Countermeasures.
Covered Countermeasures obtained for the Strategic National Stockpile (SNS) during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.
XIV. Countermeasures Injury Compensation Program
42 U.S.C 247d–6e
The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical, and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at the toll-free number 1–855– 266–2427 or http://www.hrsa.gov/cicp/.”
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.
As if the first document wasn’t bad enough, the second document is titled; Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations. Click HERE.
In summary, this document registered on December 21, 2023, and effective on January 22nd, of 2024, states the following;
“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.
I. Executive Summary
A. Purpose of the Final Rule
This final rule implements the statutory changes made to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Cures Act to allow for a waiver or alteration of 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 rule will permit an IRB to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain minimal risk clinical investigations.
B. Summary of the Major Provisions of the Final Rule
The final rule amends FDA’s regulations to allow IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations. For an IRB to approve a waiver or alteration of informed consent requirements for minimal risk clinical investigations, the rule requires an IRB to find and document five criteria that are consistent with the revised rule entitled ‘‘Federal Policy for the Protection of Human Subjects’’ (the revised Common Rule (January 19, 2017)). FDA believes the amendment provides appropriate safeguards to protect the rights, safety, and welfare of the human subjects participating in such clinical investigations. We are also making conforming amendments to FDA’s regulations.
C. Legal Authority
Sections 505(i)(4) and 520(g)(3) of the FD&C Act, as amended by the Cures Act, in conjunction with FDA’s general rulemaking authority in section 701(a) of the FD&C Act, serve as FDA’s principal legal authority for this rule. In addition, the Cures Act directs the Secretary of the Department of Health and Human Services (HHS) to ‘‘harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations,’’ to the extent practicable and consistent with other statutory provisions.
D. Costs and Benefits
This rule will help enable the conduct of certain minimal risk clinical investigations for which the requirement to obtain informed consent is waived or for which certain elements of informed consent are waived or altered.
In essence, HHS and the FDA have removed informed consent with regard to clinical trials, thereby speeding up the process of creating a so-called “cure,” or “preventive measure” via a “vaccine,” or other methods, and this will be cost effective to IRB boards (so they say) and safe (so they say), not to mention legally allowed to take place because the government deems the so-called “vaccine” or other methods of use, as being necessary, with little risk to the recipient, and for the ‘greater good of humanity.’
If you recall, they abandoned informed consent the last time with the COVID bio-weapon shots, both during the trials and with the widespread distribution under Emergency Use Authorization. Now, they have made their abandonment of informed consent, legal, in both avenues. If they don’t have to provide informed consent in the so-called “trials,” why do it with the general public if they manufacture a crisis and want to force the shots on people without question?
Ladies and gentlemen, I’m not one to stoke the flames of panic, but these two documents and the CLADE X scripted scenario linked below, scare the shit out of me. Our government wants to use these measures and declarations, not only to kill us off (“net zero”), but to also force us into financial ruin for non-compliance, only at an amplified level from what occurred previously with the COVID lie of 2020 and the years that followed.
If they didn’t want to do this, they wouldn't write it down first. By first writing down their maneuvers to end us, and acting them out within the Center for Health Security by Johns Hopkins and within their own CLADE X or Disease X roundtable, this is the premeditated murder of WE THE PEOPLE by our own government…again!
We have to tell as many people about the above information as we can, and tell them to prepare quickly and accordingly, get vocal, and NEVER COMPLY! This isn’t a matter of if, it’s only a matter of when.
BIO: Dr. Sean M. Brooks is the host of the podcast American Education FM and the author of several books including; The Unmasking of American Schools: The Sanctioned Abuse of Americas Teachers and Students. He’s also on Gab, Bitchute, Rumble and Truth.
This idea that government can simply remove your rights by some claimed statutory authority is pernicious in the extreme. Criminal behavior cannot be codified into law.
so the evil people sign some papers to make them immune from punishment? that's totally legit, and should totally be followed by us plebs, or else we're bad, bad law-breakers!