Informed Consent – Losing Ground in America

informed consent

by Dani Lasher, Vaxxter Contributor

Merriam-Webster dictionary defines informed consent as consent to surgery by a patient or to participation in a medical experiment by a subject after achieving an understanding of what is involved.”

Informed consent is the foundation for any medical procedure performed in the United States. Unfortunately, the government is intent on dismantling it. Years have gone by, where medications and vaccines have harmed patients. And with that, billions have been paid by big pharma for conveniently leaving critical health warnings off product inserts. This has become a hard lesson learned for Americans. 

Informed Assent is the New Informed Consent

The European Journal of Pediatrics (EJP) states,

“Informed assent” means a child’s agreement to medical procedures in circumstances where he or she is not legally authorized or lacks sufficient understanding for giving consent competently.” In other words, informed consent occurs when a person accepts a procedure after fully understanding it; inform assent occurs when a person accepts a procedure without comprehending it. The government uses this terminology to disguise their intent to perform medical procedures when a patient does not understand the risks.

This terminology undermines the principles of informed consent. Currently, there is a growing trend to introduce legislation that targets teens and uses the slippery change – from informed consent to informed assent – to undermine current protections in our society. This change sends a message to millennials and young teens that:

  • Informed consent is unnecessary their own behalf, and unnecessary to offer someone else
  • Parental beliefs, wishes, and authority do not matter
  • The government comes first, before parents, and before the child in question

The EJP also notes, “Doctors should carefully listen to the opinion and wishes of children who are not able to give full consent and should strive to obtain their assent. Doctors have the responsibility to determine the ability and competence of the child for giving his or her consent or assent.”

If a doctor infers a child’s assent and vaccinates them without parental consent, should the doctor be liable for injuries?

Legislators don’t think so. Maryland’s current cross-filed SB135 and HB87 state:

A healthcare provider “is not liable for an adverse reaction related to an immunization of the minor resulting from factual errors in the health history or information given by the person to the health care provider” and “not liable for damages arising from an immunization administered to a minor…”

Are Providers Even Capable of Informing Patients?

Cornell Law defines informed consent as:

An agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved or any available alternatives.”

A 2011 study published in the Royal Society of Medicine notes physicians are years behind on research. In fact, the study goes even further and says this: 

“For example, Balas and Bohen calculate an average of 17 years from original research to practice formed from adding together a number of single studies of different phases including one that estimates a lag of 6–13 years. Accounting for various changes their estimate of the time lag between journal submission to use in practice from between 17 years to 23 years.”

Can physicians possibly convey risks to patients if they aren’t up to date on the science, the research, and current data?

The Absence of Informed Consent

Informed consent comes from the idea that patients, not doctors, should be in charge of their own healthcare. Stanford University states that informed consent:

“Replaced a medical ethos founded on trust in physicians’ decisions, often on the assumption that ‘doctor knows best,’ with an ethos that sought to put patients in charge of their own care.

“When a sufficiently capacitated adult does not give sufficiently informed and voluntary consent to an intervention in her body or her private sphere, then, at least when the intervention is substantial, not trivial, and absent severe jeopardy for third parties, the intervention is impermissible—even when it seeks to assist her, physicians recommend it, third parties would benefit from it, and the patient herself had repeatedly consented to it before expressing a change of mind.

The publication goes on to describe that a lack of informed consent can be used in court as a precedent for negligence, battery, and assault.

The Fallacy of Presumed Consent

Presumed consent concerns a patient who may not be able to give or refuse consent. The most notable example would be such for someone who is unconscious. Doctors may utilize presumed consent to harvest organs or administer vaccines, but is it ethical, or even legal?

Agreement implies consent and therefore disagreement implies there is no consent. However, if someone cannot render either, should the absence of refusal equal consent? Do we presume consent in the case of intercourse with an unconscious party? No, that’s sexual assault.

It may be ethical for a physician to administer life-saving methods to an unconscious party, but experts only claim vaccines are life-saving in terms of prevention. There is no last-minute, now-or-never situation in which a vaccines are needed to prevent imminent death. Thus, there is no ethical reason to vaccinate anyone without their consent.

Here Comes Implied Consent

The World Health Organization supports informed consent and informed assent. They also support implied consent. The WHO states,

An implied consent process by which parents are informed of imminent vaccination through social mobilization and communication, sometimes including letters directly addressed to the parents. Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent. This practice is based on the opt-out principle. Parents who do not consent to vaccinate are expected implicitly to take steps to ensure that their child or adolescent does not participate in the vaccination session. This may include not letting the child or adolescent attend school on a vaccination day, if vaccine delivery occurs through schools.”

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Support for Informed Consent

The Nuremberg Code notes,

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

This latter element requires that before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.”

Clinical researchers must adhere to strict FDA rules when using minors as research subjects. Title 21, Volume 1 of the Code of Federal Regulations asserts age, maturity level, and psychological state must be assessed in determining whether a subject is capable of informed assent.

Adhering to Standards

Should we not hold the same standards for medical procedures performed on children? Can a healthcare provider who has no contact with the parent and no hard copy data on a child’s health history be allowed to affirmatively assess the maturity level and psychological state of a child in merely a few minutes upon meeting him/her?

The FDA also reports, even if a subject is capable of informed assent, the need for it can be waived if:

  • The research bears only minimal risk to the minor subject
  • Waiving the requirement for informed assent will not negatively impact the rights or welfare of the minor

Considering there are hundreds of potential adverse reactions to vaccinations, including death, no waiver to informed consent or informed assent should be allowed.

Can a child give informed consent? The answer is no, and the government knows this.

That’s why we now have variable forms of consent that are acceptable by our government and healthcare industry. These have been created to circumvent the need to inform the patient, and worse, to take control of the child away from the parent. 

What’s Next?

Several active bills are underway to undermine parental rights across the U.S. If signed into law, these bills would allow minors of a certain age to be vaccinated. This would occur even if it against their parents’ expressed wishes:

Some states already allow minors access to abortions and birth control without parental consent. Many states want to implement screening for developmental disorders in daycares and for mental illness in middle and high schools. Maryland’s HB396 calls for screening for developmental disorders for children under three at statewide childcare facilities. North Carolina’s HB75 was signed into law in September 2019, making it official that a school mental health crisis response program will be developed. Federal bill HR1109 was introduced last year; it calls for the implementation of mental health screening and treatment in schools.

A current Virginia amendment proposes allowing individuals deemed mentally incompetent to vote. This sheds light on just how little legislators are concerned with a person’s mental competency. Which shows how little their interest in in understanding the choices they’re making.

State governments are encroaching upon parental authority regarding what a minor can do with their body. What lies ahead? What happens when a child seeks chemical castration or gender reassignment treatments and the parent doesn’t agree? Current minor consent bills for vaccination set a slippery slope for a case for precedence the likes of which this nation has never seen. Be vigilant. Be in your legislator’s office. And be sure to register and vote out those who are working to take your children away from you.

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Dani Lasher is a writer, motherhood coach, and health advocate living just outside of Washington, DC. While passionate about informed consent and women’s birthing choices, she’s also slightly obsessed with city living and cooking. You can catch up with Dani at her site, BumpMama.

Photocredit: ID 143570181 © Sergeyacros | Dreamstime.com



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