32 CFR 219.116(b)(8) states, “A statement that participation [in an investigational new drug] is voluntary” must be given to the service member.

We will ask the Armed Services Committee to clarify with JAG what laws they are using to justify the administration of INDs without the consent of service members. 

The only COVID-19 vaccines that have been made available to service members are labeled as investigational new drugs (INDs).

The federal government defines an IND as “A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration for testing in people. Also called an experimental drug, IND, investigational agent, and investigational new drug.”

32 CFR 219.116(b)(8)”refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.”

32 CFR 219.116(a)(1) “shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.”

“Respect for persons requires that subjects, to the degree, that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.”

“An agreement to participate in research constitutes a valid consent only if voluntarily given…this element of informed consent requires conditions free of coercion and undue influence.”

What nullifies legally effective informed consent?  “Sanctions,” “Coercion,” “Undue Influence.” “Unjustifiable pressures usually occur when persons in positions of authority or commanding influence — especially where possible sanctions are involved — urge a course of action for a subject.”

“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.”

What amazed Brian was that not one attorney he spoke to knew what a legally effective informed consent was.  Not one!  No member of Congress, state attorney general, or anyone else in the legal community could answer that question.  Brian discovered these 50-year-old laws buried under a mountain that was buried under another mountain.  America is about to be shocked to the core of her being.

Let’s be more clear about the question.  Can the military use both drugs to fulfill SECDEF’s August 24, 2021 “Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members” memo?

That depends on whether or not the president issued a waiver.  As of May 19, 2022, he has not.

We do not know what other laws senior pentagon leadership utilizes to justify the administration of an IND. However, we are asking the Armed Services Committee to clarify the answer to this question and the response should be priceless.

The administration of an investigational new drug requires the legally effective informed consent of the individual.  The individual cannot give that consent if they are under undue pressure.  Refusal to participate in an IND will involve no penalty or loss of benefits to which the subject is otherwise entitled.

These laws apply to all Americans, and what we do on behalf of our Armed Forces Service Members will benefit every American under a vaccine mandate.

Drug labels are laws, and Congress derived those laws. No public or private entity has the legal authority to ignore those laws or exempt themselves from them.

A medical provider may not legally administer an investigational new drug in the same manner as FDA-approved drugs. FDA-approved drugs are generally free from informed consent requirements, whereas INDs are not. INDs have laws attached to their labels that provide legal protections to the pharmaceutical company. Those protections operate under the guiding principle that recipients volunteer out of their free will. Mandates imply penalties, and penalties forfeit a legally effective informed consent.

Unfortunately, this legal fact has escaped the entire legal community in America.

However…. judgment cometh, and that right soon!

Yes, there is a ton more, but follow us on Twitter, and you will get the full download when a lawsuit is filed and Congress starts asking our questions.

Oh yeah, there are far more questions we will ask than the ones we’ve listed above.  How about committee members ask SECDEF Austin if he could provide the documentation he used to ensure that Armed Services members could comply with his vaccine mandate order.

On August 24, 2021 he ordered his commanders to start vaccinating soldiers with full-licensure COVID-19 drugs.  However, a day earlier, the FDA announced they were issuing another EUA because a licensed COVID-19 drug was not readily available to the American people. So what COVID-19 vaccine did SECDEF Austin intend to utilize when he gave that order?  Each EUA issued since that time has used the same reason for the need to issue an EUA. Therefore, could SECEF Austin please provide the committee with the names of the full-licensure COVID-19 drugs being used by service members to comply with his mandate?  Yes, simple questions are awesome.  We know…they will use FDA language that both drugs can be administered “as if” they were licensed.  But “as if” isn’t the same as “it is.”  Courts will find such legal misdirecting a travesty of justice.

Ok, one more since you asked.  How about the committee asks JAG if the DoD is allowed to appropriate funding for the administration of investigational new drugs if they do not acquire the legally effective informed consent of the service member in advance?