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Dr. Ewen Cameron “Psychic Driving” research http://www.royalcollege.ca/portal/page/portal/rc/ resources/bioethics/primers/research_ethics Dr. Ewan Cameron’s CIA-funded experiments at the Allan Memorial Institute in Montreal involved the administration of LSD, other medications and electroconvulsive therapy to subjects with minor psychiatric disorders. Dr. Cameron’s work, conducted in the 1950s and early 1960s, was part of the CIA’s mind-control research program, Project MKULTRA. The experiments were based on Cameron’s “psychic driving” theory that a damaged psyche could be rebuilt after erasing previous memories. In a paper published in the American Journal of Psychiatry entitled “Psychic Driving,” Dr. Cameron describes his brainwashing techniques and says, “Analogous to this is the breakdown of the individual under continuous interrogation.” Psychic driving was a procedure carried out in two stages; in the first stage, patients were depatterned, which meant they were reduced to a vegetable state through a combination of massive amounts of electroconvulsive shock, drug-induced sleep, and sensory isolation and deprivation. When fully depatterned, patients were incontinent of urine and feces, unable to feed themselves, and unable to state their name, age, location, or the current date. In the second stage, psychic driving was introduced. This consisted of hundreds of hours of tape loops being played to the patient through earphones, special helmets or speakers in the sensory isolation room. The tape loops repeated statements of supposed psychological significance… Dr. Cameron received a grant from Canada’s Department of Health and Welfare for $57,750.00 for the years of 1961 to 1964…Dr. Cameron’s brainwashing experiments stopped in 1964. Medical experimentation by the Department of Psychiatry at McGill resulted in death, psychosis, getable states, organic brain damage, and permanent loss of memory among other damages. It resulted in the creation of amnesia, identity disturbance, and depersonalization among other dissociative symptoms. Dr. Ewen Cameron was the main figure in these activities. (excerpted from “Dr. Ewen Cameron” by Colin A Ross in Biomedical Ethics: A Canadian Focus, 2nd ed., by Johnna Fisher (Oxford University Press, 2013); p.442-6) Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch Respiratory Distress Syndrome in Bolivian Infants A Placebo Controlled Trial Bolivia Located in central South America, Bolivia is…one of the least developed countries in South America. About 2/3 of the population lives below the poverty line, many as subsistence farmers…21% of the population is undernourished and 15% lack access to improved water sources…infant mortality remains relatively high at 53 per 1,000 live births. Respiratory distress syndrome, or RDS, is a common and potentially fatal disease in premature infants that is caused by insufficient surfactant in the lungs…Surfactant replacement therapy is the standard treatment for RDS in the Western world…but its high cost, about US $1,100-2,400 per child, precludes it as a viable option for most infants in Latin America. …A multicenter, double-blinded, randomized, two-arm, placebo-controlled trial was proposed to be conducted in Bolivia, and three other Latin American countries. The study population was to be 650 premature infants with RDS. The hospitals chosen for participation in the study generally did not have surfactant available for the treatment of RDS. Discovery Labs, a private US drug company, proposed to provide endotracheal tubes, ventilators, and antibiotics for all study participants. In participating research centers, parents of infants showing symptoms of RDS would be asked to give consent for their infants to participate in the study. With consent, a health care provider would intubate the infants with an endotracheal tube. After intubation, half the infants would receive air suffused with Surfaxin [the experimental drug] and half the infants would receive (“sham”) air without any drug. Endpoints for the proposed study were all-cause mortality by day 28, and mortality due to RDS (Excerpts from Rethinking the Ethics of Clinical Research: Widening the Lens, by Alan Wertheimer, p.194) Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch Halushka v University of Saskatchewan 1965 Mr. Halushka learned about a study at the University of Saskatchewan from the University’s employment office in late August 1961. During his initial visit with one of the researchers, he was told that the research involved a new drug that was “perfectly safe” and that “it had been conducted many times before,” that electrodes would be put into his limbs and head, than an incision would be made in his arm and a catheter inserted. For his research participation he would receive $50.00. Mr. Halushka agreed to take part in the research and signed a consent form that included a waiver of liability for the University and the research in the event of any “untoward effects or accidents.” Two days later, Mr. Halushka arrived at the hospital. Unbeknownst to him, the anesthetic drug to be used in the research had never been tested before. The researchers administered the fluoromar, and positioned the catheter inside Mr. Halushka’s heart chambers. Shortly thereafter, the level of the anesthetic became too deep and Mr. Halushka suffered a cardiac arrest. To resuscitate him, the researchers had to manually massage his heart after making a large incision in his chest. Mr. Halushka was unconscious for four days, and was discharged 10 days after waking up. At that point Dr. Wyant gave Mr. Halushka $50.00. When Mr. Halushka asked whether that was all he was going to get, given the adverse event he had suffered, Dr. Wyant offered to give him more in exchange for a complete release of legal liability from Mr. Halushka’s mother or older sister. Mr. Halushka did not accept this offer and ultimately sued for trespass on the person and negligence. (Halushka v University of Saskatchewan, (1965), 53 DLR (2d) 436, [1965] WWR 608 (Sask CA); summary prepared by Matthew Herder, in Health Care Ethics in Canada (3 rd ed) by F. Baylis et al. (Nelson, 2012)) In Court In Halushka v. The University of Saskatchewan has set the legal standard for disclosure of research risks in consent discussions. Mr. Halushka, a student at the University, experienced a cardiac arrest. He was successfully resuscitated, but suffered irreversible cognitive impairment. The judge ruled that researchers are bound by a higher standard of disclosure to research subjects than are physicians who obtain consent for medical treatment from patients. Justice Hall, in his ruling, states that researchers are required to disclose any and all information that a reasonable person would require to reach an informed decision about research participation. http://www.royalcollege.ca/portal/page/portal/rc/resources/bi oethics/primers/research_ethics Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch The Jewish Chronic Disease Hospital 1963 Summary provided by Jay Katz in Ethical Issues in Modern Medicine by B. Steinbock et al. (McGraw-Hill, 2003) p. 706 “In July 1963, three doctors, with approval from the director of medicine in the Jewish Chronic Disease Hospital in Brooklyn, New York, injected “live cancer cells” subcutaneously into twenty-two chronically ill and debilitated patients. The doctors did not inform the patients that live cancer cells were being used or that the experiment was designed to measure the patients’ ability to reject foreign cells—a test unrelated to their normal therapeutic program.” According to one study doctor, “The fact that these cells were tissue-cultured cancer cells did not measurably increase any risk inherent in the procedure because, being foreign to the recipient (the person injected), they bring about an immunologic reaction…that ultimately causes their destruction and elimination.” Cancer, vol. 19, November 1966, pp. 1743-1753 “[By] July 16, 1963 (the date on which the injections were made in Jewish Chronic Disease Hospital) approximately 600 persons had been studied by means of the techniques employed at JCDH, approximately 300 of whom were patients with cancer and 300 health, normal persons. In every health recipient of tissue-cultured cells, these foreign transplants were rejected with uniform promptness…” According to the physicians, “we have simply explained that the procedure was a test which had nothing to do with treatment, that it involved the injection of foreign material…and that its purpose was to determine the rate at which the expected nodules would develop and then regress… “to use the dreaded word “cancer” in connection with any clinical procedure on an ill person is potentially deleterious to that patient’s wellbeing…therefore to withhold such emotionally disturbing but medically nonpertinent details…is in the best tradition of responsible clinical practice.” This experiment had been partly funded by the American Cancer Society. Two years later, the Cancer Society elected the principal investigator (Dr. Emmanuel Southam) as their Vice-President. Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch Willowbrook State Mental Hospital for Children The Willowbrook Hepatitis Studies Staten Island, New York – mid 1950s http://www.museumofdisability.org/new york_timeline_1960s.asp Dr. Saul Krugman & Dr. Joan Giles were infectious disease specialists Their research was designed to determine the natural history of viral hepatitis – its mode of infection and the course of the disease; and to test the effectiveness of gamma globulin in developing an inoculation against hepatitis Krugman & Giles collected serum specimens before exposure to hepatitis, during the incubation period, and several times post-infection. As the institutional population skyrocketed, admissions were suspended unless parents agreed to place their child in the hepatitis ward. New children were deliberately infected with hepatitis to provide optimal control in the study. Willowbrook Hospital was overcrowded serving 6,055 patients though it was meant to handle just 4,000 - and understaffed. Dr. Saul Krugman opened a separate unit within Willowbrook. Children between the ages of 3 and 11 who could be enrolled into his hepatitis study were admitted to the school at a time when no new admissions were being accepted. Resources: https://philosophy.tamucc.edu/readings/ethics/willowbrookletters?destination=node%2F583; https://philosophy.tamucc.edu/readings/ethics/handouts/willowbrook “Therapeutic” Effect Parents were misled by exaggerations of the potential benefits of the study. The doctors claimed that the conditions were so unsanitary that the children would have developed hepatitis anyway. Drs. Krugman & Giles claimed that deliberately infecting the children was therapeutic because of their resulting immunity to hepatitis and that the hepatitis strain was mild. Further, the doctors pointed out that the school had optimum isolation facilities where there would be minimal exposure to other infectious diseases. Claiming that they had consent from parents, families were informed that they could withdraw consent before study was initiated in child. Study physicians maintained that there would be significant scientific progress resulting from the study. Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch Residential School Nutrition Experiments 1940s Experiments performed on malnourished Aboriginal children http://www.cbc.ca/news/canada/manitoba/hungry-aboriginal-people-used-inbureaucrats-experiments-1.1317051 Dr. Ian Mosby, Food Historian "In the 1940s, there were a lot of questions about what are human requirements for vitamins. Malnourished aboriginal people became viewed as possible means of testing these theories.“ “The first experiment began in 1942 on 300 Norway House Cree. Of that group, 125 were selected to receive vitamin supplements which were withheld from the rest. “At the time, researchers calculated the local people were living on less than 1,500 calories a day. Normal, healthy adults generally require at least 2,000. "The research team was well aware that these vitamin supplements only addressed a small part of the problem," Mosby writes. "The experiment seems to have been driven, at least in part, by the nutrition experts' desire to test their theories on a ready-made 'laboratory' populated with already malnourished human experimental subjects.“ http://www.cbc.ca/news/canada/manitoba/hungryaboriginal-people-used-in-bureaucrats-experiments-1.1317051 “The research spread. In 1947, plans were developed for research on about 1,000 hungry aboriginal children in six residential schools in Port Alberni, B.C., Kenora, Ont., Schubenacadie, N.S., and Lethbridge, Alta. “One school deliberately held milk rations for two years to less than half the recommended amount to get a 'baseline' reading for when the allowance was increased. At another, children were divided into one group that received vitamin, iron and iodine supplements and one that didn't. “One school depressed levels of vitamin B1 to create another baseline before levels were boosted. A special enriched flour that couldn't legally be sold elsewhere in Canada under food adulteration laws was used on children at another school. “And, so that all the results could be properly measured, one school was allowed none of those supplements.” “[The research] began with a 1942 visit by government researchers to a number of remote reserve communities in northern Manitoba…They found people who were hungry, beggared by a combination of the collapsing fur trade and declining government support. They also found a demoralized population marked by, in the words of the researchers, "shiftlessness, indolence, improvidence and inertia." “The researchers suggested those problems — "so long regarded as inherent or hereditary traits in the Indian race" — were in fact the results of malnutrition. "They knew from the beginning that the real problem and the cause of malnutrition was underfunding. That was established before the studies even started and when the studies were completed that was still the problem." Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch Syphilis Experimentation Guatemala syphilis experiment involved 1,300 people “An investigation by Guatemalan authorities has identified about 1,300 people who may have been involved in a 1940s U.S. syphilis experiment, a few of whom may still be living, Vice-President Rafael Espada says.” “Medical historian Susan Reverby of Wellesley College in Massachusetts uncovered the experiment. It apparently was conducted to test the effectiveness of penicillin, which was relatively new then, in treating sexually transmitted diseases.” “Records uncovered in the United States in 2010 suggested that researchers in the program in the 1940s attempted to infect about 700 prostitutes, prisoners and mental patients with syphilis. About 770 tests subjects, including soldiers, were exposed to gonorrhea.” “Patients were treated with penicillin. Among the goals of the research was to see how well differing dosages of penicillin worked against different venereal diseases.” "In addition to the penitentiary, the studies took place in an insane asylum and an army barracks," Reverby said in a release. "In total, 696 men and women were exposed to the disease and then offered penicillin. The studies went on until 1948 and the records suggest that despite intentions not everyone was probably cured." “The researchers induced the disease by allowing inmates in the central penitentiary to have sex with infected prostitutes [which was legal in Guatemala], or gave the disease to the prisoners by inoculating their arms, faces or penises with a solution of the bacteria that causes syphilis.” http://www.cbc.ca/news/world/guatemala-syphilis-experimentinvolved-1-300-1.1021108 http://www.cbc.ca/news/health/u-s-sued-over-syphilis-tests-inguatemala-1.981570 More from the Encyclopedia Britannica - http://www.britannica.com/event/Guatemala-syphilis-experiment “Approximately 1,308 soldiers, prisoners, sex workers, and psychiatric patients, ranging from age 10 to 72, were intentionally exposed to STDs during the study. Syphilis exposure occurred through inoculation of the cervix in sex workers; through injection or direct sexual contact with infected sex workers in prisoners; and through injection, inoculation (via abrasion) of the penis, cisternal puncture (the insertion of a needle below the occipital bone at the back of the skull to access cerebrospinal fluid), or oral ingestion in psychiatric patients. “Exposure to gonorrhea was carried out in sex workers through cervical inoculation and in Guatemalan soldiers through sexual contact with the sex workers and sometimes through urethral inoculation; psychiatric patients were infected through inoculation of the urethra, rectum, or eyes. Chancroid was transmitted to Guatemalan soldiers and psychiatric patients through abrasion and rubbing of inoculum into the skin on the arms or back.” Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch The Fernald School “Science Club” Walter E. Fernald State School, Massachusetts From 1946 to 1956 nineteen mentally retarded teenaged boys were fed radioactive iron and calcium in their breakfast cereal. The experiment took place at a state residential school in Fernald, Massachusetts. Parent's consent form contained no mention of radiation. The stated aim of the research was to gain information about metabolism. Beginning in 1949, the Quaker Oats Company, the National Institutes of Health, and the AEC fed minute doses of radioactive materials to boys at the Fernald School for the mentally retarded in Waltham, Massachusetts, to determine if chemicals used in breakfast cereal prevented the body from absorbing iron and calcium. The unwitting subjects were told that they were joining a science club. The consent form sent to the boys' parents made no mention of the radiation experiment. http://www.qcc.cuny.edu/SocialSciences/ppecorino/MEDICAL_ETHICS_TEXT/Chapter_ 7_Human_Experimentation/Case_Study_Radiation_Experiments.htm 44 Years Later, the Truth About the 'Science Club‘ http://www.nytimes.com/1993/12/31/us/44-years-later-the-truthabout-the-science-club.html Published: December, 1993 BOSTON, Dec. 30— A 53-year-old man who learned this week that he may have been among the boys who were fed radioactive milk in 1949 at the Walter E. Fernald State School in Waltham, Mass., expressed outrage at having been used as a "guinea pig." Some scientists, meanwhile, defended the experiments, saying the research, which began in 1946, had involved only low levels of radiation. State and Federal officials are examining old school records, correspondence and researchers' notes to try to determine what happened when scientists from Harvard University and the Massachusetts Institute of Technology fed the radioactive milk to a group of boys who had been led to believe that they were joining a "science club." Paper Says Experiment Exposed 19 Retarded Youths to Radiation Published: December 27, 1993 “The Massachusetts experiments, carried out from 1946 to 1956, were done on retarded boys at the Fernald State School in Waltham, Mass. Scientists from Harvard University and the Massachusetts Institute of Technology fed radioactive forms of iron and calcium to the boys, sometimes in their breakfast milk, to study the body's ability to digest minerals… “While one researcher said that the radiation levels to which the boys were exposed were not harmful, other experts said there was no such thing as a safe level of exposure. The experiment exposed the boys to radiation that was at least the equivalent of 50 chest X-rays”… The school sent a letter to parents but did not mention radiation. "We are considering the selection of a group of our brighter patients, including your son, to receive a special diet," said a portion of the letter printed in The Globe. The boys were told that they were part of a science club. http://www.nytimes.com/1993/12/27/us/paper-says-experimentexposed-19-retarded-youths-to-radiation.html Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch Real Knive, Fake Surgery Placebo surgery Monday, Feb. 22, 1999 Real Knife, Fake Surgery By Dick Thompson/Washington “George Doeschner had been suffering from Parkinson's disease for 12 years when his physician told him about an experimental surgery that might offer a cure. Researchers at the University of Colorado were taking cells from embryos and putting them in the brains of Parkinson's patients to replace cells killed by the disease. The 55year-old electrician applied to be a part of the experiment and flew to Denver. He was prepped for surgery and sedated. A hole was drilled through his skull. Then his surgeons sewed him up and sent him home-without giving him those embryonic cells. “Surgical error? Medicare fraud? No, …placebocontrolled surgical trials--are entering mainstream medical research. Double-blind placebo trials, of course, are standard procedure for drug developers, who know from long experience that 1 out of 3 test subjects feel better with only a sugar pill. Scientists sidestep the placebo effect in drug trials by dividing patients into two groups--giving one the real drug and the other a fake. It turns out that the placebo effect is especially powerful in Parkinson's disease. That's why Curt Freed at the University of Colorado and Stanley Fahn at Columbia University decided to create a control group whose members could be fooled into thinking they were getting the full surgical treatment. "When you have something as major as surgery," says Fahn, in defense of his experiment, "wouldn't it be best to know there was some benefit?" “[S]ome research administrators have concluded that the scientific knowledge that may be gained justifies the risk. They find reassurance in the fact that the dangers have been reduced by advances in minimally invasive surgery… “The biggest factor driving these experiments, however, may be that the easy questions--do patients survive or die with a new therapy?--have already been answered. Increasingly, scientists are looking for more subtle, and often more subjective benefits. Is there less pain? Is it easier to walk? These outcomes can be strongly influenced by wishful thinking. “Sorting the real benefits from the fake seemed a worthy goal to patient Doeschner. "I wanted to do something that would help everybody who has Parkinson's," he says. Besides, once the experiment was over, he came back for another operation. This time he got the real thing.” Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch HIV Positive Prison Inmates Prisoners as Subjects in AIDS Research Case Summary adapted from Cases for Analysis #3 in Ch. 6 of Healthcare Ethics in a Diverse Society by M.C.Brannigan & J.A.Boss (Mayfield, 2001) A disproportionate number of prison inmates are HIV positive. In 1990, more than 20% of men admitted to the New York State prison system were HIV positive. Others become infected while in prison, mainly as a result of intravenous drug use. In 1999, recently released prisoners accounted for 1/6th of AIDS cases in the United States. Because of the difficulty in recruiting enough human subjects to receive FDA approval for new drugs, the University Center for AIDS Research, in collaboration with the Apollo Pharmaceutical Company, approaches the State Department of Corrections with a research proposal. Dr. Kim, leader of the research team, opens the meeting by describing the experimental design. “Half of the group—500 inmates—will receive the new experimental drug,” she explains. “The others will receive AZT, an existing treatment.” Dr. Silva, the chief medical officer of the Department of Corrections, nods. “There’s no doubt that our prison medical facilities are overburdened. Allowing the research to be carried out here would provide a level of quality of medical care that we are currently unable to give to our prisoners who are HIV positive.” “That may be,” responds Ms. Digby…”But I think the solution is to improve the existing medical facilities…not to take advantage of prisoners as research subjects…How can a prisoner make a truly informed choice if it is his only option for getting proper medical care or escaping the boredom of prison life?” “Mr. Potter from the ACLU adds, “It’s a denial of a basic right to equal treatment to refuse prisoners access to experimental treatments because of their confinement or living conditions. To do so would be to add to their punishment in a way that is undeserved…it’s even more paternalistic to deny prisoners the right to give their consent to take part in research.” Mr. Potter adds, “Despite their limited options, it should be the prisoners themselves who make the final decision.” (adapted from a study in the Milbank Quarterly, Volume 67, Issue 2 (1989) (pages 171–207) by Nancy Neveloff Dubler & Victor W. Sidel, “On Research On HIV Infection and AIDS In Correctional Institutions”) Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch Baby Fae A Baboon Heart Transplant People, December 03, 1984 Vol. 22 No. 23 “Baby Fae: A Child Loved and Lost” by Howard Teresa (excerpts from the article) Born prematurely on Oct. 14 at 6:55 a.m., she was the daughter of a 23-year-old, unemployed, unmarried woman who had moved to California from her home in Kansas... Though she and Baby Fae's father had lived together for five years, they were separated at a critical moment—the baby's birth. Worse still, the 5.9-pound girl was born with a crippled heart. The left side of that organ was grossly underdeveloped and nearly useless. Doctors wrote the child off and sent her home to die. Within four days, as the pediatrician predicted, her color yellowed and her breathing became more difficult. It was just at this time that doctors from the Loma Linda University Medical Center called with the suggestion that she might be saved by a transplant of a baboon's heart. “Friday afternoon…Fae's pediatrician at Loma Linda called and mentioned a Dr. Bailey, who…specialized in transplants. He said something about the possibility of transplanting a baboon heart in Fae…He said if I was interested I'd have to bring the baby back to the hospital for them to keep her alive, since she could die at any time—any minute, any hour. He said Dr. Bailey would talk to us as soon as we could bring Fae to the hospital, and as soon as I could talk to Fae's father I called back the pediatrician and said yes, we were interested.” Dr. Leonard Bailey, a pediatric cardiac surgeon, inserted the walnut-size heart of a 7-month-old baboon into the infant's chest. The operation proved immensely controversial, sparking demonstrations by outraged animal lovers and vehement attacks by medical ethicists. Baby Fae lived for 20 days after the heart transplant and then died. Writing a commentary on the experimental procedure, George Annas quotes immunologist Dr. Sandra NehlsenCannarella: “Our hypothesis is that a newborn can, with a combination of its underdeveloped immune system and the aid of the anti-suppressive drug, cyclosporine, accept the heart of a baboon if we can find one with tissue of high enough comparability.” Annas notes that the experimental surgery “used” Baby Fae, a fragile and vulnerable person, to test out a research hypothesis. Annas concludes that the surgery constituted a “premature experiment on an impoverished, terminally ill newborn” and was “unjustified.” (“Baby Fae: The “Anything Goes” School of Human Experimentation” by George J. Annas in Ch.9 of Biomedical Ethics: A Canadian Focus (2nd ed), ed. By Johnna Fisher) Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch San Antonio Contraceptive Study Side Effects of Oral Contraceptives Goldzieher JW, Moses LE, Averkin E, Scheel C, Taber BZ. “A placebo-controlled double-blind crossover investigation of the side effects attributed to oral contraceptives.” Journal of Fertility and Sterility 1971 Sep; 22(9):609-23 In the early 1970s, Dr. Joseph Goldziher (of the Southwest Foundation for Research and Education) undertook research among women who came to a birth control clinic in San Antonio, Texas. Almost all of the women were indigent, poor, had no regular medical care and were Mexican-American. The research was funded by Syntex Labs (an oral contraceptive manufacturer) and the US Agency for International Development. The purpose of the experiment was to find out whether reported side effects of oral contraceptives were physiological or psychological in origin. Goldzieher used a double-blind placebo-controlled experimental design. In one group, 76 women were given placebo pills; in four other groups, women were given various hormonal contraceptives in various combinations and doses. The women were monitored for nausea, vomiting, headache, or breast discomfort, nervousness, or depression, weight loss or gain, and variations in blood pressure. These symptoms were recorded for each woman in a pretreatment cycle and at monthly visits. Each woman began with a pretreatment placebo cycle. - See more at: http://www.popline.org/node/482707#sthash.mDaUfpC5.dp uf In a second stage of the research, the placebo group women were switched to the hormonal contraceptives and the contraceptive groups of women received a placebo. All of the groups of women were also instructed to use a vaginal cream with limited contraceptive efficacy in addition to the daily pill. The women were not informed that they were part of a research study or that they would at some point be receiving an inactive, non-contraceptive pill instead of an active hormonal contraceptive pill. As reported in a presentation to the American Fertility Society conference, the women receiving placebo pills and the women receiving contraceptive pills had very similar side effects: nervousness, depression, breast tenderness and headaches. With one oral contraceptive (Oracon), women had increased nausea and vomiting. With another (Ovulen), women experienced more headaches. According to the researchers, the highest incidence of complaints regarding side effects occurred in the placebo cycle. The authors concluded that placebo controls are necessary in contraceptive trials, but the first cycle is not valid for comparison. Ten of the 76 women who received placebo pills became pregnant. Significant Research Codes of Ethics The Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html The Belmont Report, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/bel mont.html The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ; http://www.cirp.org/library/ethics/helsinki/ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ; Chapter 1: Ethics Framework, http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/ Additional Resources “Research Ethics,” by Andrew D. McRae, MD, FRCPC; Royal College of Physicians and Surgeons of Canada http://www.royalcollege.ca/portal/page/portal/rc/resou rces/bioethics/primers/research_ethics https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch