DOI: 10.1097/01.ccx.0000144768.11590.96

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Issn Print: 1070-5295

Publication Date: 2004/12/01


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Ethics of ICU research

François Lemaire

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The first ICUs appeared in the mid-1950s in the wake of a dramatic worldwide polio epidemic. For the next 30 years, progress in mechanical ventilation, hemodialysis, management of multiple trauma, shock states, and/or metabolic disorders was steady and spectacular. Obviously such an improvement in clinical skills was closely linked to frantic research developments. Indeed, the decades of the 1970s and 1980s were the golden age of clinical research, with practically no legal or ethical constraints and minimal oversight [1]. During this era before randomized, controlled trials (RCTs), most of ICU research was physiologically oriented, with small cohort studies. Research and care were closely intertwined, the patients conveniently unconscious and their families kept out of the ICU. Multicenter controlled trials were not implemented until the 1990s. Since then, large and expensive RCTs have become the cornerstone of knowledge, reinforced by the overwhelming wave of the newly discovered evidence-based medicine (EBM).
However, the uncontrolled freedom of clinicians/investigators came to an end, and the golden age was over when a series of scandals and abuses were exposed, first in the United States. After Beecher, in a famous article in the New England Journal of Medicine [2], denounced unethical research, the highly questionable Tuskegee Syphilis Study was suddenly revealed. The resulting public outcry prompted the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which produced in 1979 the famous Belmont report and the first comprehensive set of regulations for clinical research in the United States. Twenty years later, some tragic accidents during clinical trials again drew the attention of the media, watchdogs, and federal agencies to some loopholes in the organization and oversight of human experimentation. It is certainly no surprise that, in such a context, the ARDS Network controversy [4,5] was so intensely debated. Silverman and Natanson et al. (pp. 560-564) give us the lessons from this important scientific, legal, and ethical discussion. There is no doubt that the methodology of trials, especially the design of control groups, will be different in the future.
In Europe, the pace of implementation of regulations for human research was certainly slower, with a great reluctance in some legislation to separate research from patient care. Lemaire [5] explains why the concept of research with “direct individual benefit” is so powerful in Europe, at odds with U.S. regulations. The national laws governing clinical research all over Europe have been so far extraordinarily heterogeneous. In 2001, the European Commission and Council passed a directive intended to harmonize all member state legislation on drug research. This went into effect in April 2004 in most of European Union countries. To share common regulations is certainly most welcome. However, the implementation of the directive also created some problems, especially for intensive care physicians. Druml (pp. 570-573) evokes the unsettled issue of research on patients who cannot consent, either due to the alteration of their cognitive function or to emergency. Lawmakers in all European countries have been struggling with the difficult concept of a “legal representative” for an incapacitated patient who would provide consent for the patient [6]. Many researchers have expressed the fear that the implementation of the directive could actually put emergency, intensive care, and, more globally, academic research on hold [7-10].
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