When Did the US Go Off the Rails on Informed Consent?

My analysis of the history of informed consent points to a familiar figure and his wife.

Good morning, Popular Rationalists. :)

Following the discovery of the harrowing atrocities of Joseph Mengele and his torturous experiments on children and the mentally handicapped in Nazi Germany, the world had enough. Part of Nuremberg led to the Nuremberg code, in which the rights of individual patients to certain protections were advanced. The right to voluntary informed consent was among them.

It wasn’t the first time the right to informed consent was conceived. In the early 1900s in the US, patients who suffered harm at the hands of surgeons who had taken it upon themselves to perform additional surgery without bothering to wake the patient from general anesthesia and review how the first surgery had progressed were sued, and decisions made in the Supreme Court began to set precedent for informed consent in the US.

In 1914, the rulings on a case known as Schloendorff v. Society of New York Hospitals gave the world the term “informed consent” a legal standing when the court gave a decision in favor of Mrs. Schloendorff, who had consented to abdominal examination under anesthesia. While she was under, the surgeon found and removed a tumor. The patient was not informed about the tumor, and the surgeon never informed her about the possible adverse outcome of the surgery.

The liability of the violation of failure to provide for the opportunity for informed consent was affirmed by SCOTUS, which restricted the liability to the physician and was not extended to the charitable hospital; the hospital was ruled immune from liability related to unauthorized surgery conducted by its resident physicians because the relation between the hospital and its physicians was not that of “master and servant”; in other words, physicians are independent actors with a relationship to hospitals more like that of an independent contractor.

This immunity from liability was struck down in 1957 via Bing vs. Thunig. While preparing the plaintiff for an operation, a hospital-employed nurse spilled a flammable antiseptic on his sheets. The plaintiff was seriously burned when the liquid was ignited by a cauterizing iron being used by the plaintiff's doctor. While the nurses' failure to remove the stained sheets was ruled a clear case of negligence, the act was considered “administrative” rather than “medical”, and the hospital was found to share liability with the physicians.

After WWII, the western world certainly said “Never Again” via the Nuremberg Code, but additional cases in the US clarified the more exacting modern concepts of informed concept.

A case in 1957 found that patients must be given sufficiently detailed information to have knowledge of the relevant risks and benefits of a medical procedure, and for physicians to deny this right is inappropriate. After translumbar aortography, the patient suffered permanent paralysis. Because the patient had not been informed of this known risk, the court rule in the patient’s favor.

The judge deciding this case drew a demarcation between informed consent and assent by stating,

“A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form [the] basis of an intelligent consent by [a] patient to a proposed treatment ….”.

The principles of medical research ethics and the ethical treatment of patients have also been asserted and ratified by

 Declaration of Helsinki

 The Belmont Report

 The Universal Declaration on Bioethics and Human Rights

And many other rulings, committee reports, resolutions.

Backed by prior and subsequent rulings from State and US SCOTUS on patients’ rights and affirmed by these additional reports and declarations, we now understand that informed consent itself must be

Free (Voluntary) – Being given of one’s own volition, explicitly without coercion.

Prior – BEFORE the medical procedure or treatment has been applied.

Informed – Provided with sufficiently detailed information on the risks and benefits of the specific action relative to inaction or relative to other possible actions.

How Informed Consent Should be Administered

Under the Council for International Organizations of Medical Sciences (CIOMS),

“(Informed) Consent (can only be) given by a competent individual who:

Has received the necessary information (verbally and in writing).

Has adequately understood the information.

After considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation.”

Further, this is considered to be a 4-step process:

Step 1: Information is provided

Step 2: Information is understood

Step 3: A decision is made

Step 4: Comprehension is monitored and maintained.

Given this history of informed consent, it is now understood that it is the physicians’ duty and responsibility to insure that the information they provide to patients on benefits and risks is clear and understandable and that the patient is not able to provide informed consent unless they understand the risks and benefit.

Informed Consent in the US is Off the Rails

When you check into a hospital, you are now sometimes given an electronic pad. There’s a form on the pad that you are asked to check. By checking this particular box, you are “assenting” to any and all medical procedures that any attending physician considers necessary for your health.

How We Got Here: Informed Consent Under Fauci and Grady

In1986, Christine Grady and Anthony Fauci argued that having an ethical physician in charge of decision-making was more important than informed consent, reversing 70 years of ethical standards first set forth for the Post-WWII era world by the Nuremberg Code. Christine Grady, Chief of the Department of Bioethics, is Fauci’s wife. (See: Grady & Fauci, "The Role of the Virtuous Investigator in Protecting Human Research Subjects" https://muse.jhu.edu/article/627988 (Paywalled).

Their position is that the world can trust people in white coats conducting medicine and human experimentation to be “virtuous” while, at the same time, writing their own rules and setting their own standards for “virtue” - and that physicians’ say over the disposition of patients in medical research is more important than the patients’ say because the physicians understand more.

In 1986, the National Childhood Vaccine Injury Act not only indemnified Pharmaceutical companies against claims of injury and death from vaccines; it created a permanent prospective (ongoing) human subjects research trial in which the long-term safety of vaccines is studied after they are administered to the public under the euphemism of “Pharmcovigilence”.

The Act also established pediatricians as “learned intermediaries” who petitioned to not have to describe all of the risks and benefits of vaccines to each parent every time and ensure the parent is sufficiently informed. Instead, they brokered a deal to shirk this responsibility, subtending informed consent activities to mere “Vaccine Information Sheets (VISs)” they only have to hand to patients in lieu of describing the risks and benefits.. In many cases, VISs are handed to parents after the child is vaccinated.

More recently, pediatricians have been encouraged to adopt a strategy of “presumed consent”, by telling parents “Ok, it’s time for Bobby’s MMR vaccine” or “Today, Susie’s going to have the chickenpox vaccine”… a far, far cry from the administrative requirements codified by prior supreme court rulings.

Under Fauci and Grady, and under the National Childhood Vaccine Injury Act, informed consent in the US is now only barely better than it was in Medieval times, when

“physicians considered themselves extensions of God and did not deign to confer with patients about their care.”

The courts in the US have ruled repeatedly and increasingly in favor of informed consent. Individual patient liberties and autonomy are fundamental rights. For years, Fauci, Grady, and much of allopathic medicine have acted in a manner outside that proscribed by SCOTUS rulings. We are now in a very bad way as a direct result of Fauci and Grady degrading the standards of ethics for clinical research and medical practice in the US - and they are dragging much of the rest of the West with them.

Some References

The CIOMS Guidelines (International Ethical Guidelines for Health-related research involving humans) https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

Kumar NK. Informed consent: Past and present. Perspect Clin Res. 2013 Jan;4(1):21-5. doi: 10.4103/2229-3485.106372. PMID: 23533975; PMCID: PMC3601698.

Osman H. History and development of the doctrine of informed consent. Int Electron J Health Educ. 2001;4:41–7.