Informed or Misinformed Consent?*

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The paperwork of clinical trials is probably not the most exciting part of a clinical researcher’s job, and drafting the informed consent document (ICD) is part of that paperwork. The European Medicines Agency defines informed consent as: “A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form” (1). The ICD is the contract between patient and researcher: the first gives permission to the principle investigator (PI) to be subjected to an experimental therapy, a comparison between two treatments, or to allow for the use of his data; the PI guarantees that he will do the study with all medical and legal precautions, according to "Good Clinical Practice.” As in every contract, both parties should clearly understand what they engage in. In clinical research, however, the patient is at the uneven side of information because in most cases, he or she lacks medical background knowledge and sometimes even a fundamental understanding of the basic principles of clinical research. In the ICU, the issue is further complicated because surrogate decision makers will often need to decide on participation on behalf of the (temporarily) noncapable patient. When it comes to drafting ICD’s, some general principles have to be abided to. ICD’s should be written in a language free of jargon, adapted to the intellectual level of the subjects. They should describe the state of the art and standard of care, objectives of the trial, and design of the experiment, together with practical information on duration, experimental procedures, diagnostic testing, follow-up, potential side effects, potential benefits, etc. Statements allowing the subject to decline participation or withdraw from the trial without any negative consequences are required. Short and concise ICD’s are preferred (2). Even when researchers have the best intentions, there are many issues with ICD’s in practice. For instance, not all patients read, let alone understand, what they have signed (3). Often, patients are not accurately informed of the study purpose, which raises the ethical question whether they were able to trade-off the benefit versus harm of participating in the trial (4). Such failure to correctly inform patients might lead to selection bias because patients who fail to understand the ICD might be more likely to decline participation (5).
In this issue of Critical Care Medicine, Atwere et al (6) present the result of a study in two phases. In the first phase, a systematic literature review was done, to define critical care–specific recommendations for ICD’s. From four consensus documents and six reviews, 18 recommendations could be distilled. Specific recommendations for the ICU include the timing and urgency of the informed consent decision or the role of the surrogate decision maker. In the second phase, they asked PI’s of recent trials in critically ill patients to submit their ICD’s for evaluation against 36 existing recommendations, identified in previous research by the same group (7, 8), and against the 18 critical care–specific recommendations identified in the first phase of the trial. The results were somehow striking, as most of the 18 critical care–specific recommendations have not been implemented in the ICD’s. Indeed, in more than half of the ICD’s, 10 of the 18 items were lacking. As for the 36 generic ICD guideline items, implementation varied from 7% 100% but was relatively high on average: 80% implementation rate for most of the 36 items.
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