Source: http://medicalwhistleblower.org/informed-consent
Timestamp: 2019-04-20 13:06:45+00:00

Document:
Rennie v. Klein, 476 F. Supp. 1294, 1313 (D.N.J. 1979).
Mills, 457 U.S. at 293 n.1, and “alter the chemical balance in a patient’s brain, leading to changes . . . in his or her cognitive processes.” Harper, 494 U.S. at 229.
"The makers of our constitution undertook to secure conditions favorable to the pursuit of happiness... They sought to protect Americans in their beliefs, their thoughts, their options and their sensations. They conferred, as against the government, the right to be let alone, the most comprehensive of the rights and the right most valued by civilized men."
Engaging in an informed-consent process between a clinical doctor and a patient should be an essential part of the standard of care in medicine. Informed consent is a process, not just a formality, and engaging in that process is of the essence of good medical care. Information must be provided to the patient in a timely manner and in accordance with the accepted standard of practice among members of the profession with similar training and experience. A health care professional may be legally liable if a patient does not give "informed consent" to a medical procedure and it results in harm to patient even if the procedure is properly performed. In a legal case Meador v. Stahler and Gheridian (Middlesex Superior Court C.A. No. 88-6450, Mass. 1993) a woman, Mary Meador, and her family were awarded approximately $1.5 million for damages resulting from a cesarean section which Meador claimed she neither wanted nor needed. As many patients do, Mary Meador signed a pro forma informed consent paperwork after being told that the cesarean section would only be done in case of an emergency. The minimal requirements of pro forma standard informed consent [i] are that the physician must obtain the patient's consent after informing the patient of the material risks of the proposed procedure. Meador's physicians did meet this minimal requirement. But the physicians in this case did not give Mary Meador the benefit of a dialogue to discuss the decision to have surgery rather than a vaginal birth and disregarded her wishes to give birth vaginally even when she was well into labor. Dr. Harold J. Bursztajn, Associate Clinical Professor and Co-Director, Program in Psychiatry and the Law, Harvard Medical School at the Massachusetts Mental Health Center, was the forensic psychiatrist providing testimony regarding the Post Traumatic Stress suffered by Mary Meador when the cesarean surgery was performed against her wishes and without the expedient circumstances of an emergency to justify the need for surgery. There were residual physical complications of the cesarean section as well as feeling of helplessness and horror that resulted from the sudden devastating loss of control the patient felt when the surgery was performed against her wishes. A thorough and ongoing informed-consent process must be one in which medical doctors engage in a positive process of discussion with patients and families, so that grief, misplaced blame, and feelings of helplessness, powerlessness, and abandonment do not lead to a bad outcome and precipitate a malpractice lawsuit. Adequate informed-consent process is not just a risk management process, it is good medical practice.
6) the risks and benefits of not receiving the treatment or procedure.
Informed consent should define risks and potential benefits, but also take into consideration alternative treatments. Informed consent is an agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved. A healthcare provider or facility may be held responsible for an injury caused by an undisclosed risk. Thus it is especially necessary to get prior informed consent for any invasive procedure or an experimental procedure that may involve human subjects. In many situations, the failure to obtain informed consent is a form of medical negligence, and may even give rise to a cause of action for battery. In any medical trials or experiments that receive federal funding, informed consent must be obtained from any human participant or subject obtaining informed consent is an absolute necessity.
The administrative duty of obtaining the signature on the consent form is not the same as obtaining the consent, which is actually done by the physician. The signature means that the nurse witnessed the patient sign but remember informed consent is NOT the form. True informed consent is explaining to the patient all their rights including their right to not have treatment as well as all pertinent information regarding the treatment or procedure. [iii] Often in legal cases brought to court there was a signed form but some important information was not shared with the patient that would have caused the patient to decline the treatment or undergoing the procedure.
Thus in clinical or research studies additional informed consent must be used to protect the human rights of the subjects. This is especially true if the human subject is going to undergo any evaluation, testing, treatment or procedure that is not part of standard medical care. When the human subject or patient involvement in the clinical or research study might in some way modify or impact the course of their care then they must be provided a study-specific informed consent. There are specific criteria defined by the Institutional Human Investigation Committees. A patient can choose to leave the study at any time for any reason and the patient does not have to give a reason. In addition it is imperative that their decision to withdraw will not impact their further medical care. These standards of informed consent are applicable even when "no standard of treatment" for their condition is even available.
The principle of Free, Prior and Informed Consent is an important human right which has been addressed in many international and domestic laws and practices. The U.S. is party to the Universal Declaration of Human Rights (UHDR), the International Covenant on Civil and Political Rights (ICCPR), the Convention against Torture (CAT), and the International Convention on the Elimination of Racial Discrimination (CERD), all of which must be applied without discrimination based on disability. The U.S. has signed but not yet ratified the Convention on the Rights of Persons with Disabilities (CRPD), as well as the Convention on the Rights of the Child (CRC) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). The human rights of patients are also delineated in the Universal Declaration on Bioethics and Human Rights [iv].
For those who are disabled the human right of informed consent has been repeatedly violated in the U.S. Despite the enactment of the Americans with Disabilities Act (ADA) which prohibits discrimination based on disability in employment, by state and local governments, and in public accommodations, and despite other enactments such as the Rehabilitation Act (of which Section 504 prohibits disability-based discrimination by federal agencies), the Fair Housing Act Amendments, and the Individuals with Disabilities Education Act (IDEA). Despite the policy of non-discrimination articulated by these laws, there are many aspects of federal and state law and policy that are contrary to the principles of the ADA but remain in force.
Often guardianship and the use of surrogate decision-makers is used to circumvent informed consent rather than making an honest attempt to discern the wishes of the person. [i] To refuse to recognize the individual patient's human right to informed consent is contrary to the recognition of the legal capacity of persons with disabilities on an equal basis with others, as required by CRPD Article 12 (to which the U.S. is a signatory) and constitutes discrimination based on disability under UDHR Articles 2 and 6, and ICCPR Article 26.
For reference I summarize the Principles of the Universal Declaration on Bioethics and Human Rights below.
3. In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual's informed consent.
(b) research should only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law, and if there is no research alternative of comparable effectiveness with research participants able to consent. Research which does not have potential direct health benefit should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and, if the research is expected to contribute to the health benefit of other persons in the same category, subject to the conditions prescribed by law and compatible with the protection of the individual's human rights. Refusal of such persons to take part in research should be respected.
(e) reduction of poverty and illiteracy.
(g) other forms of benefit consistent with the principles set out in this Declaration.
2. Benefits should not constitute improper inducements to participate in research.
[i] Guardianship keeps people in institutions and negates the right of people with disabilities to exercise legal capacity, an aspect of the right to recognition as persons before the law, in violation of UDHR Articles 2 and 6, and ICCPR Article 26, and in violation of CRPD Article 12.
[ii] United States ex rel Law Project for Psychiatric Rights v. Matsutani, et al. US District Court, District of Alaska, Case No. 3:09-cv-0080-TMB.
[iii] 67 N.Y.2d 485 (1986).
[iv] UDHR Articles 2, 3, 6 and 25, ICCPR Articles 7 and 26, CAT Articles 2 and 16, and CRPD Articles 12, 15, 17 and 25. CRPD Article 12 establishes that persons with disabilities have legal capacity on an equal basis with others in all aspects of life, including the right to make decisions about mental health treatment. See A/63/175, paragraphs 44 and 73-74.
[v] Civil commitment laws create a separate regime of detention and involuntary treatment applicable only to persons with psychosocial disabilities that is discriminatory in purpose and effect, contrary to U.S. obligations under UDHR Articles 2, 3 and 5, ICCPR Articles 2, 7 and 9, and CAT Articles 2 and 16, as well as CRPD Articles 14, 17 and 25.
[vi] Addington v. Texas, 441 U.S. 418 (1979) (civil commitment); U.S. v. Sell, Riggins v. Nevada, 504 U.S. 97 (1992).
[vii] See U.N. Doc. A/63/175 (2008), particularly paragraphs 40, 44, 47, 49, 50, 61-65, 73-74. This amounts to inadequate constitutional protection for persons with disabilities from practices that may constitute torture or ill-treatment, and violates U.S. obligations under UDHR Articles 2, 3 and 5, ICCPR Articles 2, 7 and 9, and CAT Articles 2 and 16, as well as CRPD Articles 4, 5, 15 and 17.
"Ordinary people, simply doing their jobs, and without any particular hostility on their part, can become agents in a terrible destructive process. Moreover, even when the destructive effects of their work become patently clear, and they are asked to carry out actions incompatible with fundamental standards of morality, relatively few people have the resources needed to resist authority"
In 1963 a Yale University psychologist Stanley Milgram published his work on a social psychology experiment which measured the willingness of the participants to obey an authority figure and to perform acts which conflicted with their personal conscience. This experiment was controversial and by some considered unethical or psychologically abusive. In this experiment the participants were asked to deliver a set of questions to the subject and if the subject answered incorrectly they were to deliver an electric shock. The level of electric shock increased with each incorrect answer. In reality the subjects were actors and the real experiment was whether the participants would deliver a lethal electric shock if so ordered by a person in authority. Prior to conducting the experiment, Milgram did a poll and most felt that only very small fraction of participants would be prepared to inflict the maximum voltage. However in the experiment Milgram found that 65 percent (26 of 40) of experiment participants administered the experiment's final massive 450-volt shock, though many were very uncomfortable doing so; at some point, every participant paused and questioned the experiment, but still delivered the shock. Stark authority was pitted against the participants strongest moral imperatives against hurting others, and even over the screams of the victim, authority won more often than not.
Milgram, Stanley (1963). "Behavioral Study of Obedience". Journal of Abnormal and Social Psychology 67 (4): 371–8. doi:10.1037/h0040525. PMID 14049516. as PDF.
Milgram, Stanley (1974). "The Perils of Obedience". Harper's Magazine. Abridged and adapted from Obedience to Authority.
Blass, Thomas (Mar/Apr 2002). "The Man Who Shocked the World". Psychology Today 35 (2).
The Stanford Prison Experiment (SPE), one of the most important psychology experiments in this country's history. In 1971 Stanford University Psychology Professor Philip Zimbardo, designed a research experiment to study how psychologically "normal" people would react to role playing as prisoners and guards while being immersed in a simulated prison environment for two weeks. Of the seventy-five people who applied, twenty-four males considered to be 100% fit and healthy (emotionally, physically, and psychologically) were selected to participate. Each of the participants was told that they would be going into a simulated prison environment for two weeks and that the roles of prisoner and guard would be assigned arbitrarily. Professor Zimbardo was to act as the Prison Warden and oversee the experiment. Twelve men each were randomly assigned to be a guard or a prisoner.
A mock prison, Stanford County Prison (SCP), was set-up in the basement of Stanford's psychology building. There were even bars put on windows, the cells were made of steel bars, there was a "yard" and "chow hall" area, and a windowless "hole." Through surveillance cameras Professor Zimbardo and his assistants to monitored the SCP 24 hours a day.
Once at the SCP the prisoners and guards dutifully played their roles. “Prisoners” were to be confined to the makeshift prison for the duration of the experiment, but guards were allowed to work eight-hour shift patters in teams of three. When not “working”, the guards were allowed to leave the site and resume their normal life. Wooden batons were given to the guards, although they were not supposed to be used to punish the prisoners. Prisoners were given ill-fitting garments, chains around their ankles, and assigned a number as part of a disorientation and depersonalization process. Prior to the experiment, the guards were told they were not allowed to physically punish the prisoners, but they could reinforce the sense of powerlessness prisoners would expect to feel in a real prison environment.
The first day of the experiment was uneventful, but by day two the situation inside the makeshift prison had begun to heat up. A riot broke out and some of the prisoners barricaded themselves inside their cell. The guards used fire extinguishers to break the riot and attempted to implement various psychological tactics as a way of regaining control. However, to the amazement of Professor Zimbardo and his assistants, within 24 hours an incredible transformation occurred: the "mock" prisoners became prisoners and the "mock" guards became guards. The SCP had morphed into being a prison. Some prisoners became passive while others became rebellious. The guards who did not participate in cruel punishments still did nothing to stop the guards that reveled in exercising their power over the prisoners. One guard was nicknamed "John Wayne" by the prisoners because he was so sadistic and changed Dr. Jekyll to the monstrous Mr. Hyde when he put on his guard's uniform. By the end of thirty-six hours, one of the prisoners was already experiencing a mental breakdown and was eventually released. As the days went by the guards as a whole flexed their power by increasing their aggressive, humiliating and dehumanizing tactics against the prisoners. More prisoners began to show signs of psychological stress and five more prisoners were released early. Finally on the sixth day the experiment was aborted after graduate student, voiced concerns as to the morality of the experiment. Christina Maslach, a graduate student and an outside observer, who saw the SCP for the first time after it had been operating for nearly six days was horrified to see that it had become indistinguishable from a real prison environment. She was able to convince Professor Zimbardo after a prolonged and impassioned argument that as administrators of the "prison" he and his assistants had become blind to the unconscionable activities happening in front of their eyes. The Standford Prison Experiment was a "controlled" experiment that had gone completely out of control. So after six days the SCP was abruptly shut down and the two-week experiment was terminated.
The Stanford Prison Experiment is frequently cited as an example of unethical research. The experiment could not be replicated by researchers today because it fails to meet the standards established by numerous ethical codes, including the Ethics Code of the American Psychological Association.
The SPE: What it was, where it came from, and what came out of it," Philip G. Zimbardo, Obedience to Authority: Current Perspectives on the Milgram Paradigm, edited by Thomas Blass, 2000, pp. 201-.
Criminal Injustice: Confronting the Prison Crisis, edited by Elihu Rosenblatt, South End Press, Boston, 1996, p. 83.

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