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Research on Human Subjects
(Paul Raymont)The Kantian concern to avoid the instrumentalization of persons is evident in the ethical protocols for research involving human subjects. The upshot of these protocols is thateven in the context of a research program, healthcare professionals must continue to work  primarily for the benefit of the human subjects in the study and must not think of humanresearch subjects as if they were mere objects to be manipulated and used for somescientific purpose.Ethical guidelines for research involving human subjects were developed in the wake of World War II in response to the atrocities committed by the Nazis and by the ImperialJapanese. Both parties had conducted obviously unethical research during the war (and before it in the case of Japan) which involved deliberately producing illness in humansubjects and even killing people. Clearly, in these studies, researchers instrumentalizedthe human research subjects; that is, they treated these subjects as mere means to somedesired research outcome. For example, in JapanDr. Shiro Ishii was in charge of Unit 731, which committed atrocities while carrying out research on germ warfare andchemical weapons in China (which Japan had invaded before WWII). These atrocitiesincluded deliberately inducing the bubonic plague, cholera and anthrax in Chinese prisoners, dissecting people while they were alive, spinning people in a centrifuge untilthey died, etc. After the war, some of Dr. Ishii’s researchers were convicted of war crimes by the Soviet Union. Dr. Ishii himself was never brought to justice. Instead, the AmericanGeneral MacArthur  granted Ishii immunity in exchange for data from the Japaneseresearch. (The Japanese government finally acknowledged the existence of  Unit 731in 1998, although – as the linked article indicates – Japanese courts didn’t acknowledge itsexistence until 2002.)As a result of German and Japanese atrocities, the  Nuremberg Code was instituted in 1948. This code included such directives as the following for research on humans:1.voluntary, informed consent from the research subjects is required;2.avoid unnecessary physical and mental suffering;3.no experiment should be conducted where there is reason to expect death or disabling injury;4.scientists must terminate a study if they have probable cause to believe that itwill result in injury, disability or death.The emphasis in the Nuremberg Code is on the
duty of non-maleficence
. This is anegative duty – specifically, it is the general duty
not 
to harm people.Unfortunately, even after these guidelines were formulated many unethical studiesinvolving human subjects were carried out in various countries, including Canada and theUSA. For example, there was the case of Dr. Ewen Cameron, a prominent psychiatristwho treated patients in Montreal. He received funding from a CIA program calledMK-ULTRA, the purpose of which was to develop mind-control techniques (‘brainwashing’).Between 1950 and 1964,Cameron experimentedwith the methods that he called ‘de-1
 
 patterning’ and ‘psychic driving’, by means of which he attempted to erase large portionsof a patient’s personality and replace them with ‘healthier’ character traits and attitudes.Cameron’s methods included the use of sleep deprivation, sensory deprivation, massiveand repeated electric shock treatments (beyond what was then considered to be normal intreating depression), LSD and other experimental drugs, and drug-induced comas. In1988, theCIA gave Cameron’s victims $67000 eachin compensation for this abuse. In1994, the Canadian government (which knew of and also funded Cameron’s work) gave$100 000 to seventy-seven of Cameron’s victims. These people were deemed to havesuffered the most since Cameron had reduced them to a ‘childlike state’. (Our government denied compensation tomore than 250 other patientsof Cameron’s, althoughone, Janine Huard, who had been ‘treated’ by Cameron for post-partum depression, won an out-of-court settlement from the Canadian government in June, 2007.)In the USA, there wasthe Tuskegee study.Between 1932 and 1972 a government agency funded theTuskegeestudy of untreated syphilis in Alabama. In this research, 399 poor,rural, African-American men who had syphilis were not informed of their condition bytheir physicians. Their physicians compared them with a control group of 204 men whowere receiving treatment for syphilis. The study continued even after 1947, when penicillin had been adopted as the standard treatment for syphilis – the men were still notinformed of their diagnosis and so were not offered penicillin. Chillingly, one of theadministrators of the study in the 1940’s wasquoted by James Jonesas saying, “Themen’s status did not warrant ethical debate. They were subjects, not patients; clinicalmaterial, not sick people.”In theTuskegee case, the researchers claimed that they had done nothing unethical on the basis that they hadn’t actually harmed any of the men with syphilis. In short, went their argument, those men still would have suffered from syphilis even if the research trial hadnot been conducted.We can see why this response fails to exonerate the researchers when we consider the professional obligation of healthcare professionals (including physicians) to help their  patients as best they can. This brings us to another important duty, this time a positiveobligation called the
duty of beneficence
, which is the general duty to bring aid andassistance to those in need. In the context of healthcare, this becomes the duty to providethe best known treatments and care to one’s patients; in other words, one must not provide known inferior treatments.Beneficence is more prominent in a newer set of international guidelines for researchethics,the Declaration of Helsinki (1964). Among its guidelines are the following: 1.the interests of science and society should never take precedence over considerations of the well-being of a human research subject;and2
 
2.every patient (inc. those in a control group) should be assured of the best proven diagnostic and therapeutic method.In short, researchers must not compromise their human subjects’ care for the sake of some perceived greater good. Put this way, the Nuremberg and Helsinki codes seem to beanti-utilitarian, since they prohibit the sacrifice of human individuals for a (perceived)greater good such as a new cure for a disease. Thus, even if we could cure cancer byrunning research trials that involved harming (or at least not helping) some cancer  patients, we still should not do so.The duty of beneficence underlies an important ethical principle that applies specificallyto research on human subjects, the principle of 
clinical equipoise
. According toequipoise, we may give experimental treatment X to some patients and compare it totreatment Q (either a placebo or a currently accepted standard treatment)
only if 
there isno consensus in the relevant community of experts to the effect that one of thesetreatments is better than the other. If there were such a consensus favouring, say, X, thenit would be unethical to give Q to anybody in the research trial; for to give people Qwould be to give them a known inferior treatment, thereby failing to uphold the duty of  beneficence. Roughly, then, we can go ahead and give X and Q to various participants inthe study only if the experts are poised equidistant between X and Q (in the sense thatthey are neutral between the two treatments, seeing neither of them as being superior tothe other). New drugs are tested against either a placebo or the current standard treatment for theillness in question. The people in the ‘control group’ receive the placebo or (if there isone) the current standard treatment.It is because of beneficence that it is increasingly difficult to use a placebo in research inwealthy nations if the research is to meet the standards of ethics review boards. To wit,since we have developed treatments that are at least somewhat effective for a wide rangeof conditions, it would be unethical to give people in the control group a placebo insteadof one such effective treatment (since to do so would be to give a known inferior treatment).Given the difficulty of using placebos in wealthy nations, in which patients generallyhave access to whatever effective treatments have been developed, pharmaceuticalcompanies have tried to conduct more drug trials in poorer nations. The idea is that it’seasier to justify the use of a placebo in a nation where many people receive little, if any,medical attention, since the standard treatments that are available in richer countries areunlikely to be accessible to people in poorer nations.Guidelines for such studies were introduced in 1992 by the Council for InternationalOrganizations of Medical Sciences (CIOMS). Of theextensive CIOMS guidelines, Guideline 11 addresses exceptions to the rule that human research subjects should notgenerally be given known inferior treatments. In its discussion of Guideline 11, theCIOMS panel leaves it open that agencies from wealthy nations
may
give known inferior 3
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