Sense and Sensibility

Informed consent is rooted in the concept that individuals have the right to decide what shall or shall not happen to them (United States 1978). Thankfully, during the last century the ethical principles of autonomy and self-determination and the practical elements to support informed consent (information, comprehension and voluntariness) are regulated, and the process of informed consent is overseen by institutional review boards throughout the world. The research crimes of Nazi concentration camps and the Tuskegee experiment are reminders that laws and policies are needed. Yet the modern-day informed consent document, while meeting a legal standard, may not achieve its intended purpose—to support individuals in the decision-making process. While the informed consent document is a necessary component of informed consent, when poorly executed it may undermine important relationship-building between researchers and participants, induce stress and even discourage individuals from participating in research they might otherwise have consented to, had they felt more respected and supported. Simply put, the consent process is not designed around the informational, emotional or situational needs of the participant. In the clinical setting, for example, consent for medical procedures, even those that are elective, often takes place on the day of the procedure—in the preoperative waiting area, or while on the examination table just prior to the first dose of anesthesia (Habiba et al. 2004). The informed consent documents for clinical procedures tend to use generic templates referencing an informed consent discussion and often leave out critical procedure-specific information. Unfortunately, emphasis is placed on the signature. In the research setting, the opposite exists. In the spirit of transparency and full disclosure, informed consent documents have become incredibly lengthy, regardless of research type or setting, with important information about the study buried in a sea of detail and legal language that can make it hard to comprehend. In both scenarios, we have lost sense (good judgment) and sensibility (empathy) for the patient or their surrogate. In this issue of the American Journal of Bioethics, Dickert et al. (2020) systematically examine the informed consent documents of studies in patients with acute myocardial infarction and stroke through the lens of the patient and surrogate. The context is important. During an acute event, time is of essence and patients and surrogates may have limited concentration or tolerance for lengthy discussions about study protocols. Yet, research is essential and, overwhelmingly, data show that patients see the value of research and want to be part of the decision-making process, raising the question of how best this can be accomplished. Dickert et al. (2020) convened a collaborative team of ethicists, researchers, patients and surrogates to review the following informed consent elements: structure, content, tone and style. Their findings are not surprising but offer a different filter through which to view the sense and sensibility of our standard informed consent documents. With respect to structure, the length of the forms averaged nine pages. Moreover, the team felt that information was presented out of sequence, making it difficult to discern the main purpose of the study. They questioned the