A plea for pragmatism in clinical research ethics

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.     

An apology for Socratic bioethics

Bioethics is a hybrid discipline. As a theoretical enterprise it stands for untrammeled inquiry and argument. Yet it aims to influence medical practice and policy. In this article we explore tensions between these two dimensions of bioethics and examine the merits and perils of a "Socratic" approach to bioethics that challenges "the conventional wisdom."     

The fair transaction model of informed consent: an alternative to autonomous authorization

The doctrine of informed consent in bioethics has relied on the view that consent is valid when it represents a patient or research subject's autonomous authorization. In this article we challenge this reigning conception of the validity of informed consent in clinical research, focusing in particular on the problem of the therapeutic misconception. We argue that the autonomous authorization model of informed consent suffers from four defects: (1) it fails to do justice to the relevance of risk-benefit considerations in shaping the criteria for the validity of consent, (2) it compromises the interests of subjects by preventing them from consenting to research participation with less than substantial understanding when doing so would likely be consistent with their preferences and beneficial to them or at least be unlikely to cause them harm, (3) it jeopardizes the interests of investigators by denying them fair notice regarding when the consent of research subjects can be considered valid and thus make it permissible for them to be enrolled in research, and (4) it threatens the reasonable limits on the responsibility of investigators to assure the adequacy of subjects' understanding of what research participation involves. In place of the autonomous authorization model, we present and defend a fair transaction model of informed consent, which better reflects the values served by consent.     

Therapist Behavior During Exposure Tasks Predicts Habituation and Clinical Outcome in Three Randomized Controlled Trials for Pediatric OCD

This study measured therapist behaviors in relation to subsequent habituation within exposure tasks, and also tested their direct and indirect relationships (via habituation) with clinical outcomes of exposure therapy. We observed 459 videotaped exposure tasks with 111 participants in three clinical trials for pediatric obsessive-compulsive disorder (POTS trials). Within exposure tasks, therapist behaviors and patient fear were coded continuously. Outcomes were habituation and posttreatment change in symptom severity, global improvement, and treatment response. More therapist behaviors that encourage approach—and less use of accommodation, unrelated talk, and externalizing language—predicted greater subsequent habituation during individual exposure tasks (exposure-level), and also predicted improved patient clinical outcomes via higher “total dose” of habituation across treatment (patient-level indirect effect). For six of seven therapist behaviors analyzed, the relationship with subsequent habituation within exposure differed by patient fear (low, moderate, or high) at the time the behavior was used. Two therapist behaviors had direct effects in the opposite direction expected; more unrelated talk and less intensifying were associated with greater patient symptom reduction. Results shed light on the “black box” of in-session exposure activities and point to specific therapist behaviors that may be important for clinical outcomes. These behaviors might be best understood in the context of changing patient fear during exposure tasks. Future studies should test whether therapist behaviors can be experimentally manipulated to produce improvement in clinical outcomes.     

A Qualitative Exploration of Sleep Habits and Intervention Needs Among Youth with Cystic Fibrosis

Evidence suggests that individuals with Cystic Fibrosis (CF) experience difficulties with sleep architecture and hygiene, although research is limited. There are currently no behavioral sleep interventions for youth with CF. The current study used qualitative methods to understand sleep needs and concerns among youth with CF, as well as to obtain feedback about potentially useful behavioral sleep intervention strategies. Semi-structured interviews were conducted with youth with CF between the ages of 11–17 and their parents. Themes were extracted from the data and will be used to inform the development of a brief behavioral sleep intervention for youth with CF. Youth and their parents described several CF-specific sleep concerns, often related to respiratory symptoms, and a number of strategies used to manage these concerns. They also described concerns that apply to the general population, including pervasive use of technology around bedtime. Many evidence-based behavioral sleep intervention strategies are acceptable to youth with CF, although modifications are appropriate to reduce time burden and address CF-specific needs. Youth with CF experience a number of disease-specific and more generalized sleep concerns which are likely amenable to behavioral intervention. Results from this study will be used to inform the development of a brief behavioral sleep intervention for youth with CF.

     

Benjamin Franklin and shock-induced amnesia

Shock-induced amnesia received considerable attention after Cerletti popularized electroconvulsive shock therapy in the late 1930s. Yet, often overlooked is the fact that Benjamin Franklin recognized that passing electricity through the head could affect memory for the traumatic event. Franklin described his findings on himself and others in several letters from the mid-1700s, 2 of which were published in his lifetime. What he observed was confirmed in 1783 by physician Jan Ingenhousz, who was one of his correspondents. Although Ingenhousz had lost his memory for his electrical accident and was confused immediately afterward, he felt strangely elated and unusually sharp the next morning. Hence, he called for clinical trials with patients with melancholia who were not responding to more conventional therapies. After Franklin received Ingenhousz's letter, he also called for clinical trials. Neither man, however, tied the possible new cure for melancholia to the memory loss--nor did the operators that began to treat some patients with melancholia successfully with cranial shocks. Only much later would the amnesia be thought to be associated with the cure.