It Happened Here!
Informed Consent Thrown Under the Bus By the FDA
Never has such blasphemy emanated so foully as this new rule made in the height of seasonal goodwill on December 21st, 2023, and became effective on January 23, 2024, by the United States Food and Drug Administration.
After the defeat of NAZI Germany, trials were held in Nuremberg, Germany. With extensive evidence of medical atrocities and death to millions emerged the Nuremberg Code of 1947. The very first point was the requirement of medical informed consent. This was defined as no agreement or permission can be given by a patient to anyone else to perform a medical procedure upon the person unless that person has first been given complete and accurate information about all possible effects of or results from the procedure or medicine.
In other words informed consent requires the disclosure of all relevant information, ensuring understanding, capacity to comprehend, and alternatives that leads ultimately to the Individual patient's agreement or refusal. There are also Common Law principles to be considered including negligence, battery and fiduciary duty.
This has not stopped the Food and Drug Administration (FDA) from placing a rule in its administration that it will not follow Informed Consent. Here is the direct quote from the document - Certified Government Publishing Office 88228:
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.
What worthless nonsense to circumvent an inalienable right and obligation of the government to protect the Individual. How can you include appropriate safeguards to protect the rights of human subjects by denying those rights to those subjects? This is absurd language and purposefully misleading. The FDA claims this right over the Individual because it has determined the FDA clinical investigation poses no more than a minimal risk. Where is the problem that this is in any way necessary to deny informed consent? The problem does not exist, and the new FDA rule is wrong and the Rule needs to be stricken.
A further abuse is the broad terms of denial permitting an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent. That is complete denial. Then the FDA adds It will be under limited conditions which is vague and that it will be FDA regulated in experiments with minimal risk. If there is minimal risk, then why hide behind denying informed consent?
What is the nature of these clinical trials? Is the FDA already doing actions that we know nothing about and are unaware of? Well, yes, the so-called vaccination program was one that created a complete denial of informed consent! Also earlier reported in 2022, the FDA adopted a "Future Framework" that allowed manufacturers to reformulate and release new COVID-19 injections without clinical trials.
This new FDA rule thwarts responsibility and protects the Government’s alliance with on-going mandated military sponsored “countermeasures” which was used to validate the (Modified) mRNA injections. It is completely illegal and cannot be upheld in a court of law, but will that stop malfeasance?
This rule is an anathema upon freedom, rights, and protection of society from government attack, overreach and despotic behavior. The right of informed consent should NEVER be side-stepped for any reason. In this case there is no reason and no logical, ethical, or moral reason for it to do so here and now. This is fascism and intolerable.
It is URGENT that everyone recognizes the importance and passage of the Medical Freedom Amendment to protect informed consent along with other inalienable rights of medical freedom and medical choice and medical privacy. It is a requirement in the present dangerous state of our times.
Here is the Medical Freedom Amendment, the proposed 28th Amendment to the United States Constitution. Let infinite justice move forward and protect us all from harm. Our government has become a stairway to the gallows.
Nevertheless, it is OUR government and long may it remain OUR government. Become informed and active.
Act now to pass the Medical Freedom Amendment.
"All people have the Right to secure their Health in the manner they choose. Congress, the President, State Legislatures and Executives, Governmental Agencies or Departments shall make no law, rule, regulation, countermeasure, executive, or emergency order that impedes the Individual's rights to informed consent nor right to medical choice nor freedom of medical choice. Nor shall the President, Congress, State Legislatures and Executives, Governmental Agencies or Departments make any law, rule, regulation, countermeasure, executive, or emergency order that impedes the Individual's right to medical privacy and freedom without individual and specific judicial warrant supported by Oath and affirmation of necessary cause to protect Society from Harm describing the Individual's condition and danger it presents."
Bring the Questionnaire to the Representative’s office and personally demand an answer, and email [email protected] your petitions and Questionnaire results. Or you can snail mail to the National Health Federation at P.O. Box 288 Mossyrock, WA, 98564, US
Letter to Your Representative with the MFA Questionnaire
Petition to circulate with all contacts.
The National Health Federation (NHF) is the first organization to endorse and support the Medical Freedom Amendment. Hopefully, other organizations will soon follow in NHF's footsteps. This comports with NHF's nearly seven-decades-long tradition of promoting and defending health freedom as well as its long history of consumer and individual health protection on local and global levels, including its unique position of participation in the Codex Alimentarius process.
The NHF Medical Freedom Amendment Campaign
-Michael LeVesque-
After the defeat of NAZI Germany, trials were held in Nuremberg, Germany. With extensive evidence of medical atrocities and death to millions emerged the Nuremberg Code of 1947. The very first point was the requirement of medical informed consent. This was defined as no agreement or permission can be given by a patient to anyone else to perform a medical procedure upon the person unless that person has first been given complete and accurate information about all possible effects of or results from the procedure or medicine.
In other words informed consent requires the disclosure of all relevant information, ensuring understanding, capacity to comprehend, and alternatives that leads ultimately to the Individual patient's agreement or refusal. There are also Common Law principles to be considered including negligence, battery and fiduciary duty.
This has not stopped the Food and Drug Administration (FDA) from placing a rule in its administration that it will not follow Informed Consent. Here is the direct quote from the document - Certified Government Publishing Office 88228:
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.
What worthless nonsense to circumvent an inalienable right and obligation of the government to protect the Individual. How can you include appropriate safeguards to protect the rights of human subjects by denying those rights to those subjects? This is absurd language and purposefully misleading. The FDA claims this right over the Individual because it has determined the FDA clinical investigation poses no more than a minimal risk. Where is the problem that this is in any way necessary to deny informed consent? The problem does not exist, and the new FDA rule is wrong and the Rule needs to be stricken.
A further abuse is the broad terms of denial permitting an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent. That is complete denial. Then the FDA adds It will be under limited conditions which is vague and that it will be FDA regulated in experiments with minimal risk. If there is minimal risk, then why hide behind denying informed consent?
What is the nature of these clinical trials? Is the FDA already doing actions that we know nothing about and are unaware of? Well, yes, the so-called vaccination program was one that created a complete denial of informed consent! Also earlier reported in 2022, the FDA adopted a "Future Framework" that allowed manufacturers to reformulate and release new COVID-19 injections without clinical trials.
This new FDA rule thwarts responsibility and protects the Government’s alliance with on-going mandated military sponsored “countermeasures” which was used to validate the (Modified) mRNA injections. It is completely illegal and cannot be upheld in a court of law, but will that stop malfeasance?
This rule is an anathema upon freedom, rights, and protection of society from government attack, overreach and despotic behavior. The right of informed consent should NEVER be side-stepped for any reason. In this case there is no reason and no logical, ethical, or moral reason for it to do so here and now. This is fascism and intolerable.
It is URGENT that everyone recognizes the importance and passage of the Medical Freedom Amendment to protect informed consent along with other inalienable rights of medical freedom and medical choice and medical privacy. It is a requirement in the present dangerous state of our times.
Here is the Medical Freedom Amendment, the proposed 28th Amendment to the United States Constitution. Let infinite justice move forward and protect us all from harm. Our government has become a stairway to the gallows.
Nevertheless, it is OUR government and long may it remain OUR government. Become informed and active.
Act now to pass the Medical Freedom Amendment.
"All people have the Right to secure their Health in the manner they choose. Congress, the President, State Legislatures and Executives, Governmental Agencies or Departments shall make no law, rule, regulation, countermeasure, executive, or emergency order that impedes the Individual's rights to informed consent nor right to medical choice nor freedom of medical choice. Nor shall the President, Congress, State Legislatures and Executives, Governmental Agencies or Departments make any law, rule, regulation, countermeasure, executive, or emergency order that impedes the Individual's right to medical privacy and freedom without individual and specific judicial warrant supported by Oath and affirmation of necessary cause to protect Society from Harm describing the Individual's condition and danger it presents."
Bring the Questionnaire to the Representative’s office and personally demand an answer, and email [email protected] your petitions and Questionnaire results. Or you can snail mail to the National Health Federation at P.O. Box 288 Mossyrock, WA, 98564, US
Letter to Your Representative with the MFA Questionnaire
Petition to circulate with all contacts.
The National Health Federation (NHF) is the first organization to endorse and support the Medical Freedom Amendment. Hopefully, other organizations will soon follow in NHF's footsteps. This comports with NHF's nearly seven-decades-long tradition of promoting and defending health freedom as well as its long history of consumer and individual health protection on local and global levels, including its unique position of participation in the Codex Alimentarius process.
The NHF Medical Freedom Amendment Campaign
-Michael LeVesque-
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