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Informed Consent

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When historians look back they will shake their heads in dismay, wondering aloud how a society could be so fooled by it’s profiteers. Lack of education is really the answer and now that the failure to censor information has become apex, mankind can look back at the atrocity of their times and understand how they were tricked, coerced, or chose the path which led society where it is today.

Informed consent according to the AMA,

“Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.” https://www.ama-assn.org/delivering-care/ethics/informed-consent

If your job is a patient service representative for a hospital system then you understand informed consent is a complete farce. Now the idea of it was simply to stave off litigation, of course we know this, but that’s not the point.

Any attorney on capitol hill can scan the data for ten minutes while sipping on coffee and come away with the fact a large percentage of patients, I won’t say how much, never read anything concerning their informed consent, nor are these rights explained, or gone over before getting that signature for the hospital to give physician care and get paid.

Now an army of litigators lined up from Santa Clara Valley to Mount Sinai hospital in New York would be quick to tell you “it’s all legal. It’s law.”

“People come into a hospital who are sick, hurting, dying, and need treatment for whatever reason. They don’t want to sit there and read paperwork. Of course they want to give consent that’s why they’re there.”

Everyone knows that once you sign in-patient consent form and disagree with the course of treatment and wish to leave the hospitlal the physician can disagree with you and release you under AMA (against medical advice) meaning the insurance company won’t pay the bill because you are leaving against medical advice.

A dozen lawyers could spin what I just said in oblivion circles and that’s the problem we find ourselves in.

Therein lay the problem. Informed consent is LAW, although for the majority of patients no one ever knows their rights, and what consent they are actually agreeing to. It’s never explained.

Now I am not explaining this truth for litigation, or discovery purpose. And attorneys who understand what I am saying have amassed great fortunes through litigation. I am merely communicating about catabolic systems. That’s my job for the next few weeks. I’ll continue to cover the topic of catabolism for both pathology and economic factors, but my work load will be focused on literary and publishing content for the foreseeable future.

Informed consent has become a global problem, similar to the hospital system. It’s a bunch of legal mumbo jumbo (never explained mind you) that entwines peoples lives, real estate, commodities and FX markets based off a ruling in 1957 Salgo v. Leland Stanford etc. Bd. Trustees. Salgo vs Leland pdf

“MEDICAL TREATMENT. U.S. courts first recognized the need for patients to give consent for medical treatment in Schloendorff v. Society of New York Hospital in 1914. It was not until Salgo v. Leland Stanford, Jr. University Board of Trustees in 1957, however, that the additional provision requiring physicians to give patients information relevant to their treatment decisions was established. This requirement for physician disclosure was expanded, developed, and solidified by Natanson v. Kline (1960), Mitchell v. Robinson (1960) and Canterbury v. Spence (1972). These precedents were then incorporated into statements by the Judicial Council of the American Medical Association (AMA) in 1981 and the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1982. The need to obtain patients’ informed consent has since been incorporated into the medical practice guidelines of numerous national and international organizations of medical professionals.” https://www.encyclopedia.com/medicine/divisions-diagnostics-and-procedures/medicine/informed-consent

Informed Consent states you are a human consenting to be experimented on as an international agreement,

“Advances in Medicine cannot be achieved without research involving human participants, but it is also of paramount importance that no harm is brought onto the research participants for the sake of research. Thus, it is required that the researchers obtain permission or approval from the participants to understand their willingness to undertake the risk onto oneself for the sake of benefit to the society which can be achieved by way of research.” Indian Dermatology Online Journal

History leading up to informed consent, HISTORY OF THE TERM INFORMED CONSENT by Robert D. Miller Honorary Fellow Medical History and Bioethics Department University of Wisconsin.

Informed consent for economics boils down to convincing people to sabotage their own critical infrastructure. This is how the abuse of law gets out of hand and lends to changes concerning terrorism, tort law, and the argument of personal ownership. If an entity can gain your consent to experiment on you or commit physician or medical service, without disclosing each and every step (not possible in a hospital) then suffice it to say when informed consent proved out to be one of the best insurance coverages since the 17th century, naturally this idea would float over to other law such as,

“Regulation of biological agents and toxins – 42 U.S.C.A. Sec. 262a and 7 U.S.C.A. Sec. 8401 regulate biological agents and toxins. If a person is involved with an organization that engages in domestic or international terrorism, he or she is not permitted to gain access to these regulated agents. Under the law, the Attorney General identifies individuals involved in “terrorism” to the Department of Agriculture. Once the person is listed, he or she cannot get access to any of the regulated agents or toxins. This provision will probably not impact most people, however, it might impact someone such as a scientist who might regularly use biological agents or toxins in their work.” https://www.aclu.org/other/how-usa-patriot-act-redefines-domestic-terrorism

Which gives us an understanding in the foot race to find out how companies are legally able to skirt the line of experimentation, through legality, which can then be used in Executive Orders. As noted by the American Bar Association,

“Executive orders are not legislation; they require no approval from Congress, and Congress cannot simply overturn them. Congress may pass legislation that might make it difficult, or even impossible, to carry out the order, such as removing funding. Only a sitting U.S. President may overturn an existing executive order by issuing another executive order to that effect.” https://www.americanbar.org/groups/public_education/publications/teaching-legal-docs/what-is-an-executive-order-/

Historical litigation concerning informed consent:

  1. The Duke of York’s laws (1665): Under this law, physicians and surgeons were required to obtain a patient’s consent prior to treatment. The law also said that as long as a treatment demonstrated no perceived risk or harm, physicians had the right to act without a patient’s consent. The precise definition of harm was left to the judgement of the treating physician/surgeon.
  2. The Case of Pratt vs. Davis (1905): A surgeon removed a woman’s uterus and ovaries, without her knowledge, to treat her epilepsy. The court ruled in favor of the patient, arguing that a “Physician or Surgeon, however skillful […] [cannot] violate without permission the bodily integrity of his patient.”
  3. The Case of Schloendorff vs. Society of New York Hospital (1914): Upon accidental discovery of an abdominal mass, by physicians, in a woman complaining of stomach discomfort, the patient insisted against removal of that mass/tumor. But the physicians went on to perform a hysterectomy, followed by gangrene of her left arm because of surgical complications and some of her fingers had to be amputated. Additional surgeries for that hand had to be performed also because of an embolism from the original surgery. The verdict clarified that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body […].”
  4. The Nuremberg Code (1949): During the World War II, concentration camp victims were tortured and killed in the name of scientific research. The Nazi physicians, responsible for these heinous crimes, were tried by a tribunal of three American judges. They stated that “The voluntary consent of the human subject is absolutely essential.” That research subjects “should be so situated as to able to exercise free power of choice,” and that they “should have sufficient knowledge and comprehension of the elements of subject matter.”
  5. Declaration of Helsinki (1964): Indirect influence of the Nuremberg code prompted the medical research community to frame its own guideline regarding behavior of researchers dealing with human subjects. These sets of guidelines by the World Medical Association has been the cornerstone of ethics in years to come and in its lifetime the “Declaration of Helsinki” has been revised many a times and has been constantly updated till October 2013. In most recent times, the area of ethical requirement in placebo-controlled trial and responsibilities of research participants at the end of study has been the focus of amendment.
  6. The case of Salgo vs. Leland Standford Jr. University Board of Trustees (1957): The patient awoke paralyzed after a routine aortography, which proved permanent. The patient was never informed by the physicians and surgeons that such a risk even existed. The patient sued the hospital and was awarded $250,000 in damages.
  7. Stanford Prison Experiment (1971): The researcher, Philip Zimbardo, at Stanford University indulged in an experiment, where a group of students were to act either as prisoners or guards in a makeshift penitentiary setting, leading to enduring psychological trauma for the participants.
  8. Tuskegee Syphilis Experiment (1931-72): In one of the most gruesome human experiments, effects of untreated syphilis were observed in poor African-American land workers for over 40 years by denying them an access to curative medicine. This monumental violation of human rights along with the Stanford prison experiment established groundwork for Federal policy for protection of human subjects, also known as the common rule.
  9. Belmont Report (1979): It defined the basic principles for oversight on research process, basic ethical parameters involving human subject research leading to creation of informed consent.
  10. HPV vaccine trial (2007): In India, HPV vaccine trial was initiated among tribal women (vulnerable population) under the pretence of “observational study” or “Demonstration project” without taking mandatory permission from Drug Controller General of India. The trial resulted in the death of seven girls and in 2010 the Indian parliament’s standing committee on health observed that “safety and rights of those children were highly compromised.”
  11. Regulatory requirement for conduct of clinical trials in India (2013): In the wake of public interest litigations, the Supreme Court of India recommended stringent control in the conduct of clinical trials to safeguard the rights of trial participants. Following the directions and observations of Supreme Court, the Central Drugs Standard Control Organization (CDSCO) introduced three steps to streamline the conduct of clinical trials. The institutions that are involved in reviewing and approving clinical trials were strengthened, the rights of clinical trial participants were protected, and measures were taken to reduce uncertainty and delay for clinical trial sponsors and investigators. https://journals.lww.com/idoj/Fulltext/2021/12040/Informed_Consent_in_Biomedical_Research__Scopes.5.aspx

Stay vigilant, you have bad guys to catch that hate America.