The first thing that shocked me about the pediatric CVICU was how calm it was. Amid the bright decorations and soft beeping of machines, medical teams worked efficiently from patient to patient, quietly discussing each patient’s status so the newborns wouldn’t wake. Their complex and unique cases made it abundantly clear how different these patients are from the typical adults in a standard ICU. However, during our journal club meeting and subsequent discussion on pediatric research, it became apparent that developing improved treatments for these patients is not just an issue of clinical complexity but ethical ambiguity. In 1973, the United States Department of Health, Education and Welfare published its first proposals to developing regulations around children as vulnerable populations that had “limited capacities to consent” [1]. Since this time, ethicists have fought long and hard on the details, but the question remains: What ethical considerations must be taken into account when undergoing pediatric research?
The fundamental ethical problem in pediatric research is fairly straightforward: as opposed to adults, pediatric patients do not have the ability to provide their own consent. Instead, permission to enroll in a clinical trial must come from parental consent and from a concept called assent [2]. However, each of these has its own controversies.
Many medical procedures already require parental consent. However, the emotional connection between parents and their children compounded with the inherent complication of medical trials may make them less than rational actors. In multiple scientific studies, patients and caregivers with emotional connections tend to hyperinflate the possible benefits and undermine risks, giving them notoriously low risk comprehension. They also demonstrate a very low correlation between actual risk and self-perceived ability to understand risk [3]. Given these biases, are we able to say that parents have appropriate decision-making capability? If we are able to satisfy this requirement and obtain parental consent, then we must receive assent from the pediatric patient.
William Bartholome defined four fundamental elements of child assent: (1) a developmentally appropriate understanding of the nature of the condition, (2) disclosure of the nature of the proposed intervention and what it will involve, (3) an assessment of the child’s understanding of the information provided and the influences that impact on the child’s evaluation of the situation, and (4) a solicitation of the child’s expression on willingness to accept the intervention [2]. However, these guidelines do have flaws, the first of which is the understanding of his condition and understanding of the information provided. Many adult patients have difficulty understanding their conditions. What reasoning can we provide to show that a child could truly understand their condition and make a rational decision when the capacity for adult-level decision-making is still in question? This is further convoluted by childhood perception of medicine. Anyone who has worked in a pediatric setting has faced the bitter resistance of children who do not want to take medication or receive a shot. Despite their resistance, the medical team provides their services because they understand that the benefits of their intervention greatly outweigh the temporary discomfort that may be caused. With that in mind, how can we determine that not giving assent is just an overblown fear of the treatment?
Despite these ethical dilemmas, there is a great need for additional pediatric research. Before quality pediatric testing, tens of thousands of children were harmed by therapies that were assumed in the absence of research to be safe and effective [4]. As pediatric research has increased, so has our understanding of pediatric pathophysiology and treatment, leading to better outcomes. By understanding the ethics behind pediatric research, we can continue these trends and improve quality of care for our colleagues, patients, and children.
Samuel Timm is a student at The University of Arizona College of Medicine – Phoenix, class of 2019, and is a native of Arizona. He graduated from The University of Arizona in 2013 with a Bachelor in Science in psychology. His academic interests include medical ethics and medical advocacy in legislation and policy. In his spare time, Sam enjoys swimming, playing guitar, traveling, and hiking. If you have any questions or comments, please feel free to contact him at samuelt[at]email.arizona.edu.