Clinical Trials Involving Minors: The Role of the Ethics Consultation in Avoiding Therapeutic Misconception

Abstract

"Therapeutic Misconception (TM) occurs when clinical trial participants believe that the central purpose of the trial is therapeutic and that they will personally benefit from participation. If individuals who are entitled to consent to participation in a specific clinical trial do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled may potentially benefit from the intervention under study, this false belief may motivate them to participate, and in extreme cases may disqualify their consent. TM is especially frequent in fields in which the patients are highly vulnerable, such as when they are children and require parental consent. The informed consent is an essential ethical prerequisite before enrolling each and every participant in research that should protect patients through a process of dialog about a planned course of action. We argue that Ethics Consultant’s competencies may be crucial in avoiding TM: The Ethics Consultant should be involved in neonatal and paediatric clinical trials in order to face the unique vulnerability of children as research subjects, and to ensure that parental consent procedures are rigorously managed, enhancing recruitment in research trials in the context of fully understood consent. "