There is a strain within the clinical and bioethics community that takes a minimal view of informed consent: investigators are supposed to provide requisite information to volunteers; if research subjects fail to comprehend this information, pity for them. This view brings to mind a memorable exchange between Inspector Clouseau and a hotel clerk (Clouseau: "does your dog bite?" Clerk: "No." Clouseau then extends a hand; the dog lunges at him. "I thought you said your dog doesn't bite." Clerk: "Zat is not my dog.")The ISSCR guidelines take a bold stand on informed consent. "Investigators involved in clinical research must carefully assess whether participants understand the essential aspects of the study." The guidelines go on to state "ideally, the subject's comprehension of information should be assessed through a written test or an oral quiz during the time of obtaining consent." Once again, ISSCR shows vision here in going well beyond the legalistic conception of informed consent described above.
The ISSCR guidelines also urge researchers to:
• explain possible irreversibility of some toxicities
• describe the sources of stem cells
• inform patients that researchers "do not know whether they will work as hoped"
These laudable recommendations aside, I might have hoped for more guarded language about the therapeutic value of early phase studies. For one, the guidelines use mostly "therapeutic" language, for example, using the aspirational term "cell therapy" instead of the neutral term "cell transfer." Second, the third item above logically means that the probability of benefit is less than 100%; experience tells us, however, that when interventions are highly novel, major therapeutic benefits for early phase trials are very improbable. (photo credit: Helen K, Stems, 2008)
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