The Case for Pediatric Participation in Risky First-In-Human Clinical Trials

The purpose of a first-in-human (FIH) clinical trial is to gather safety, side effects, and (potential) dosage information, which is to say, information about how an intervention affects and interacts with the human body. Although participants in FIH trials may personally benefit, the primary goal is to obtain participant baseline human safety knowledge or knowledge of intervention efficacy. Some FIH clinical trials carry significant foreseeable risk to participants with little to no foreseeable participant benefit. As the potential risk is high and personal benefit unlikely, there is consensus that participants in risky FIH trials should consent to participate, which entails that children should not be included in a risky FIH trial that could enroll only adults. We take aim at this view and argue that risky FIH trials planned for adults should be open also to including children in some circumstances. Specifically, and focusing primarily on solid organ xenotransplant research, we argue that considerations of generalizability, fair inclusion, differential risk-benefit, parental authority, and children's interest are ethically salient, and that concerns of exploitation, instrumentalization, and upper-limits of harm can be effectively addressed.