FDA, EUA, Informed Consent and You

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WIV

No Experiments Without Your Consent

According to FDA rules of engagement, as stated in their document titled, “Emergency Use Authorization of Medical Products” the recipient has the right to reject or accept the procedure without coercion (1, pg. 28). In addition, full disclosure of potential benefits and risks associated with the product or alternative needs stated and shared with participant.

The FDA continues with the recommendation of a fact sheet shown with all essential information in terms as simple as possible. (ibid, pg. 29)

Title 21

In Title 21 USC 360bbb-3 section e-1-A-ii it declares a person must be informed about the emergency product with knowledge of adverse reactions, risks and benefits. It iterates the fact the person has the option to accept or refuse without consequence or coercion. (2)

They Cannot Force or Manipulate You

Lastly, as stated in section 46.116 of title 45 in the code of federal regulation, it makes it clear on the requirements for informed consent. (3)

Federal law requires participants to give full consent of medical experiment without manipulation or force. If a subject cannot answer for themselves, their legal representative answer on their behalf. The researcher (vaccines representative) cannot inject without it.

Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.

In addition, as stated above, the person who moves forward with the trial must have the opportunity to ask questions about the experiment without the possibility of coercion or undue influence — no media manipulation, no threats of no vax no mask. Side note, the mask also classifies as a medical experiment which falls under these guidelines.

(2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.

Furthermore, all information about the medical treatment needs written in easy-to-understand language.

(3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.

If the experiment causes more than minimal risk, which the covid injection does, they’re required to explain if any compensation or medical treatment is available if injury occurs.

(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

And one last point, if the person refuses to take part in the experiment, they cannot be subject to any kind of penalty.

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and

Yet federal and local governments use strong-arm tactics to force individuals into Big Pharma compliance without explaining the risks or the adverse reactions we see across the world and here in the United States.

Cites

  1. FDA. 2017. “Emergency Use Authorization of Medical Products,” January, 49.
  2. United States. n.d.a. “21 U.S. Code § 360bbb–3 – Authorization for Medical Products for Use in Emergencies.” LII / Legal Information Institute. Accessed March 15, 2021. https://www.law.cornell.edu/uscode/text/21/360bbb-3.
  3. ———. n.d.b. “45 CFR § 46.116 – General Requirements for Informed Consent.” LII / Legal Information Institute. Accessed May 13, 2021. https://www.law.cornell.edu/cfr/text/45/46.116.

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