LOS ANGELES - TelAve -- The World Medical Association (WMA) has unanimously approved new guidelines on informed consent in medical research aimed at enhancing human rights for research participants.[1] While acknowledging these advancements, the Citizens Commission on Human Rights, an international mental health industry watchdog, argues the declaration discriminates against individuals with mental health issues, permitting experiments on those deemed incapable of consenting. CCHR asserts that the WMA "Declaration of Helsinki" (DoH) is contrary to the global shift away from coercive psychiatric practices, including non-consensual research.

While the DoH asserts it respects "individual autonomy" through "[f]ree and informed consent" given voluntarily by the person participating in research, it allows consent to be obtained from a "legally authorized representative for participants who are 'incapable of giving free and informed consent.'" CCHR points to the October 2023 World Health Organization and United Nations Office of the High Commissioner for Human Rights Guidance on Mental Health, Human Rights and Legislation which recommends a ban on all coercive psychiatric practices, including research. It states: "Legislation should prohibit medical and scientific research, including all research studies and scientific experiments in the field of mental health (e.g. drug trials and clinical trials), without informed consent."[2]

The guidance reinforces that "clinical and experimental research without free and informed consent…can never be limited, even under conditions of national emergency." Additionally, "The Committee on Economic, Social and Cultural Rights has also stressed that freedom from non-consensual medical treatment and experimentation is part of the content of the right to health."

The DoH recognizes the right to health for all and that "individuals capable of giving informed consent may not be enrolled in research unless they freely agree."[3] However, Article 28 of the code dismisses such rights for those mentally incapable of consenting, by stating, "the physician or other qualified individual must seek informed consent from the legally authorized representative, considering preferences and values expressed by the potential participant." CCHR says the Code attempts to modify this by claiming individuals "must only be included if the research is likely to either personally benefit them or if it entails only minimal risk and minimal burden."

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CCHR says determining the benefit of psychiatric treatment is arbitrary and its value is open to abuse. Because of the numerous dangerous side effects of psychiatric treatments, the WHO/OHCHR opposes forced treatment, defining it as a potential form of torture.

The need for protections in medical and mental health research stems from the Nuremberg Code, established in 1947 after WWII to outlaw medical maltreatment in research, as conducted in the Nazi concentration camps, universities, and German psychiatric hospitals.[4] Leo T. Alexander, a Viennese-born psychiatrist and chief consultant to the prosecutors of the Nazi Nuremberg Doctors' Trials co-authored the Code with Andrew Ivy, a representative of the American Medical Association.[5]

Alexander's legacy is notorious because he excluded protections for individuals labeled "mentally ill" under the proposed Code. His entire professional life was committed to promoting his own role in the Nuremberg Code creation, according to Evelyne Shuster, Ph.D. However, the judges who approved the Code rejected Alexander's proposal to allow consent from next of kin for mentally ill subjects and chose instead to prohibit their inclusion in any research.[6]

Shuster wrote, "The judges at Nuremberg made no provisions for research with the mentally disabled, excluding them entirely as subjects in research. Alexander, on the other hand, included them under specific conditions because he wanted to make sure that fellow psychiatrists regain respect and gain leadership position." She believed "He knew quite well that psychiatrists had been discredited by their involvement in the Euthanasia, Sterilization and other deadly Nazi programs, and he continuously sought 'damage control' to their reputation." Playing down the reasons why the judges omitted the mentally disabled entirely from the Code "can only reinforce my belief that Alexander sought to promote the psychiatry profession," she added.[7]

Psychiatrists during the Nazi era sought to systematically exterminate their patients. "It has been acknowledged that the medical profession was profoundly involved in crimes against humanity during this period, with various publications describing this malevolent period of medical history. It is less known, however, that psychiatrists were among the worst transgressors," according to the article "Psychiatry during the Nazi era: ethical lessons for the modern professional," published in the Annals of General Psychiatry.[8] In the U.S., experiments were also conducted, including giving hepatitis to mental patients in Connecticut in the 1940s and again in the 1960s to children with mental retardation on Staten Island. "Many prominent researchers felt it was legitimate to experiment on people who did not have full rights in society—people like prisoners, mental patients, poor blacks. It was an attitude in some ways similar to that of Nazi doctors experimenting on Jews," as reported in "AP IMPACT: Ugly US medical experiments uncovered."[9]

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Judges in the Nuremberg Doctors Trial found that certain basic principles must be observed in order to satisfy moral, ethical, and legal concepts in medical research, such as: "During the course of the experiment the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible."[10]

For individuals deemed incapable of consenting, the inability to communicate their pain and suffering poses significant ethical concerns. Consequently, CCHR advocates for governments to ban psychiatric clinical drug trials and treatment experiments on mental health patients unable to provide informed consent and commit to a policy prohibiting all coercive psychiatric practices.

About CCHR: The group was established in 1969 by the Church of Scientology and professor of psychiatry, Dr. Thomas Szasz, and helped expose Nazi psychiatrists who went on to practice in prominent positions and as researchers following WWII.

References:

[1] Shannon Firth, "Informed Consent, Inclusion Prioritized in Revised Ethics for Human Trials — World Medical Association releases 'Declaration of Helsinki' principles for medical research," MedPage Today, 19 Oct. 2024, www.medpagetoday.com/publichealthpolicy/ethics/112478
[2] World Health Organization, United Nations Office of the High Commissioner for Human Rights, "Guidance on Mental Health, Human Rights and Legislation," 9 Oct. 2023, page 60, www.ohchr.org/sites/default/files/documents/publications/WHO-OHCHR-Mental-health-human-rights-and-legislation_web.pdf
[3] World Medical Association, "World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Participants," JAMA, 19 Oct., 2024, www.wma.net/policies-post/wma-declaration-of-helsinki/
[4] Gordon Thomas, Journey into Madness, The True Story of Secret CIA Mind Control and Medical Abuse, (New York: Bantam Books, 1989), p. 355
[5] Evelyne Shuster, Ph.D., "Medical Ethics at Nuremberg: The Nazi Doctors and The Hippocratic Oath," Draft Report, Prepared for the Annual Ethics Symposium: Fifty Years After The Nuremberg Medical Trial: 6 (Re) Forming Institutional Review Boards. Philadelphia Veterans Affairs Medical Center, 24 May 1996; Evelyne Shuster, Ph.D., "Fifty Years Later: The Significance of the Nuremberg Code," New England Journal of Medicine, 18 Jan 2021, www.transcend.org/tms/2021/01/fifty-years-later-the-significance-of-the-nuremberg-code/
[6] Evelyne Shuster, Ph.D., "Medical Ethics at Nuremberg"
[7] Evelyne Shuster, Ph.D., "Medical Ethics at Nuremberg"
[8] Rael D. Strous, "Psychiatry during the Nazi era: ethical lessons for the modern professional," Annals of General Psychiatry, 27 Feb. 2007, annals-general-psychiatry.biomedcentral.com/articles/10.1186/1744-859X-6-8
[9] "AP IMPACT: Ugly US medical experiments uncovered," CBS8, 27 Feb. 2011, www.cbs8.com/article/news/ap-impact-ugly-us-medical-experiments-uncovered/509-912b6260-6b15-48f3-9ffc-b775a5eda6de
[10] "Nazi Medical Experiments: Background & Overview," Jewish Virtual Library, www.jewishvirtuallibrary.org/background-and-overview-of-nazi-medical-experiments