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Hot Essays: Essay on Medical Research and Ethics

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Essay on Medical Research and Ethics; Essay …

The claim that the treatment of research subjects should be consistentwith the norms which govern clinical care has been applied mostprominently to the ethics of randomized clinical trials (Hellman &Hellman 1991). Randomized trials determine which treatment a givenresearch subject receives based on a random process, not based onclinical judgment of which treatment would be best for thatpatient. Lind assigned the different existing treatments for scurvy tothe sailors in his study based not on what he thought was best forthem, but based on what he thought would yield an effectivecomparative test. Lind did not give each intervention to the samenumber of sailors because he thought that all the interventions had anequal chance of being effective. To the contrary, he did this becausehe was confident that several of the interventions were harmful andthis design was the best way to prove it. Contemporary clinicalresearchers go even further, assigning subjects to treatments randomly. Because this aspect ofclinical research represents a clear departure from the practice ofclinical medicine it appears to sacrifice the interests of subjects inorder to collect valid data.

One of the most influential responses to this concern(Freedman 1987) argues that randomization isacceptable when the study in question satisfies what has come to beknown as ‘clinical equipoise.’ Clinical equipoise obtainswhen, for the population of patients from which subjects will beselected, the available clinical evidence does not favor one of thetreatments being used over the others. In addition, it must be thecase that there are no treatments available outside the trial that arebetter than those used in the trial. Satisfaction of these conditionsseems to imply that the interests of research subjects will not beundermined in the service of collecting scientific information. Ifthe available data do not favor any of the treatments being used,randomizing subjects seems as good a process as any other for choosingwhich treatment they receive.

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Several attempts have been made to justify exposing research subjectsto risks for the benefit of future patients. Lind’s experiments onscurvy exemplify the fact that clinical research is often conducted byclinicians and often is conducted on patients. Many commentators havethus assumed that the ethics of clinical research should be governedby the ethics of clinical care, and the methods of research should notdiverge from the methods that are acceptable in clinical care. Onthis approach, subjects should not be denied any beneficial treatmentsavailable in the clinical setting and they should not be exposed toany risks not present in the clinical setting.

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Clinicians, first trained as physicians taught to act in the bestinterests of the patient in front of them, often struggle with theprocess of exposing some patients to risky procedures for the benefitof others. It is one thing for philosophers to insist, no matter howaccurately, that research subjects are not patients and need not betreated according to the norms of clinical medicine. It is anotherthing for clinical researchers to regard research subjects who aresuffering from disease and illness as anything other thanpatients. These clinical instincts, while understandable and laudable,have the potential to obscure the true nature of clinical research, asinvestigators and subjects alike try to convince themselves thatclinical research involves nothing more than the provision of clinicalcare. One way to try to address this collective and often willfulconfusion would be to identify a justification for exposing researchsubjects to net risks for the benefit of others.

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The claim that clinical research should satisfy the norms of clinicalmedicine has this strong virtue: it provides a clear method toprotect individual research subjects and reassure the public that theyare being so protected. If research subjects must be treatedconsistent with their medical interests, we can be reasonablyconfident that improvements in clinical medicine will not be won atthe expense of exploiting them. Most accounts of the ethics ofclinical research now recognize the limitations of this approach andstruggle to find ways to ensure that research subjects are not exposedto excessive risks without assuming that the claims of clinicalmedicine apply to clinical researchers (Emanuel, Wendler, and Grady2000; CIOMS 2002). Dismissal of the distinction between therapeuticand non-therapeutic research thus yields an increase in bothconceptual clarity and concern regarding the potential forabuse of research subjects.

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Current research ethics does place significant weight on informedconsent and many regulations and guidelines devote much of theirlength to articulating the requirement for informed consent. Yet, asexemplified by the response to the Nuremberg Code, almost no oneregards informed consent as necessary and sufficient for ethicalresearch. Most regulations and guidelines, beginning with the Declaration of Helsinki, first adopted in 1964 (World Medical Organization 1996), allowinvestigators to conduct research on human subjects only when it hasbeen approved by an independent group charged with ensuring that thestudy is ethically acceptable. Most regulations further placelimitations on the types of research that independent ethicscommittees may approve. They must find that the research has importantsocial value and the risks have been minimized before approving it,thereby restricting the types of research to which even competentadults may consent. Are these requirements justified, or are theyinappropriate infringements on the free actions of competentindividuals? The importance of answering this question goes beyondits relevance to debates over Libertarianism. Presumably, therequirements placed on clinical research have the effect of reducingto some extent the number of research studies that get conducted. Thefact that at least some of the prohibited studies likely would haveimportant social value, helping to identify better ways to promotehealth and well-being, provides a normative reason to eliminate therestrictions, unless there is some compelling reason to retainthem.

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The libertarian claim that valid informed consent is necessary andsufficient to justify exposing research subjects to risks for thebenefit of others seems to imply, consistent with the first principleof the Nuremberg Code, that research with individuals who cannotconsent is unethical. This plausible and tempting claim commits one tothe view that research with children, research in many emergencysituations, and research with the demented elderly all are ethicallyimpermissible. One could consistently maintain such a view but thesocial costs of adopting it would be great. It is estimated, forexample, that approximately 70% of medications provided to childrenhave not been tested in children, even for basic safety and efficacy(Roberts, Rodriquez, Murphy, Crescenzi 2003; Field & Behrman 2004;Caldwell, Murphy, Butow, and Craig 2004). Absent clinical research withchildren, pediatricians will be forced to continue to providesometimes inappropriate treatment, leading to significant harms thatcould have been avoided by pursuing clinical research to identifybetter approaches.

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