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Research on Human Subjects (Paul Raymont)

The Kantian concern to avoid the instrumentalization of persons is evident in the ethicalprotocols 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 ofWorld 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 (andbefore 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 Japan Dr. Shiro Ishiiwas in charge ofUnit

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 Chineseprisoners, dissecting people while they were alive, spinning people in a centrifuge untilthey died, etc. After the war, some of Dr. Ishiis researchers were convicted of war crimesby the Soviet Union. Dr. Ishii himself was never brought to justice. Instead, the AmericanGeneral MacArthurgranted Ishii immunity in exchange for data from the Japaneseresearch. (The Japanese government finally acknowledged the existence ofUnit 731 in1998, although as the linked article indicates Japanese courts didnt acknowledge itsexistence until 2002.)

As a result of German and Japanese atrocities, theNuremberg Codewas instituted in1948. 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 it

will 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 notto 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 ofDr. Ewen Cameron, a prominent psychiatristwho treated patients in Montreal. He received funding from a CIA program called MK-ULTRA, the purpose of which was to develop mind-control techniques (brainwashing).Between 1950 and 1964, Cameron experimented with the methods that he called de-

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patterning and psychic driving, by means of which he attempted to erase large portionsof a patients personality and replace them with healthier character traits and attitudes.Camerons 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. In

1988, the CIA gave Camerons victims $67000 each in compensation for this abuse. In1994, the Canadian government (which knew of and also funded Camerons work) gave$100 000 to seventy-seven of Camerons victims. These people were deemed to havesuffered the most since Cameron had reduced them to a childlike state. (Ourgovernment denied compensation to more than 250 other patients of Camerons, althoughone,Janine Huard, who had been treated by Cameron for post-partum depression, wonan out-of-court settlement from the Canadian government in June, 2007.)

In the USA, there was the Tuskegee study. Between 1932 and 1972 a government agencyfunded the Tuskegee study of untreated syphilis in Alabama. In this research, 399 poor,rural, African-American men who had syphilis were not informed of their condition by

their physicians. Their physicians compared them with a control group of 204 men whowere receiving treatment for syphilis. The study continued even after 1947, whenpenicillin 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 1940s was quoted by James Jones as saying, Themens status did not warrant ethical debate. They were subjects, not patients; clinicalmaterial, not sick people.

In the Tuskegee case, the researchers claimed that they had done nothing unethical on thebasis that they hadnt actually harmed any of the men with syphilis. In short, went theirargument, 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 theprofessional obligation of healthcare professionals (including physicians) to help theirpatients 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 ones patients; in other words, one must notprovide 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 overconsiderations of the well-being of a human research subject;

and

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2. every patient (inc. those in a control group) should be assured of the bestproven diagnostic and therapeutic method.

In short, researchers must not compromise their human subjects care for the sake ofsome perceived greater good. Put this way, the Nuremberg and Helsinki codes seem to be

anti-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 cancerpatients, we still should not do so.

The duty of beneficence underlies an important ethical principle that applies specificallyto research on human subjects, the principle ofclinical 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 ifthere 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, then

it 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 ofbeneficence. 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 inferiortreatment).

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 itseasier 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 the extensive 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

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treatment to research subjects in a poor nation ifthe superior treatments are not generallyavailable in that poor nation and ifthe purpose of the research is to develop an effective,relatively cheap treatment that can be made reasonably available to the people in thatcountry.

This is relevant to the research into zidovudine as a means of reducing the likelihood oftransmission of HIV from an infected pregnant woman to the fetus. It was known that an$800 zidovudine treatment reduced maternal-fetal transmission by approximately two-thirds. Since this treatment is too expensive to be widely available in poor nations, theNational Institutes of Health (USA) and the UN wanted to see if a cheaper dose regimenwould also reduce the likelihood of transmission. The research was conducted inThailand, Dominican Republic and five African nations. Early in the study some of theresearchers expressed ethical misgivings about the research, since women in the controlgroup were not given any zidovudine they received only a placebo. Thus, these womenwere being given a known inferior treatment. Others disagreed, arguing that the purposeof the research was to help people in the poorer nations, and not to develop a treatment

that would then be used in richer nations (which were already using the $800 regimen).

In fact, in view of the CIOMS rules, this research was ethical in some of the participatingnations but not in others. This is because some of the countries (e.g., Thailand) pledgedbefore the study began that if the cheaper zidovudine treatment worked, it would be madewidely available to the people in that nation. However, the African governments did notmake this pledge. So, if we stick to the CIOMS guidelines, it looks like the research wasethical in Thailand but not in the African nations.

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