Children, Ethics, and Modern Medicine

11. Ethical Issues in Pediatric Research

THERAPEUTIC ORPHANS Inoted in the last chapter that one function of an ethics committee is to educate hospital staff about moral and legal standards in biomedicine— to function as a school of sorts—especially in response to new developments in science, culture, and technology. To that end, Baylin’s Ethics Advisory Committee (EAC) convenes a retreat each spring to orient new members, to thank members who are rotating off their three-year term, and to present educational materials for discussion and review. The daylong meeting occurs at a large retreat center, away from the rhythms and routines of the hospital, and offers a precious commodity for busy medical professionals: time to reflect about the moral challenges of their work. Typically , members of the EAC’s core group—Sharon Johnston, Michael DeVries , Robert Hamilton, and Christopher Martin—give presentations and guide discussion on a select topic. One spring, while I was completing a draft of this book, the EAC convened a special retreat to discuss the ethics of pediatric research. The goal of that meeting was to bring together members of the hospital’s Institutional Review Board (IRB) and members of the hospital’s ethics committee to disELEVEN Ethical Issues in Pediatric Research I do consider children vulnerable. We have to limit the amount of risk that we expose children to.1 —Marilyn Waters, Director of Research Compliance, Baylin’s Institutional Review Board There is a moral imperative to formally study drugs in children so that they can enjoy equal access to existing as well as new therapeutic agents.2 —American Academy of Pediatrics Ethical Issues in Pediatric Research | 239 cuss federal regulations, moral arguments, and concrete cases regarding the use of children in scientific research. Baylin’s IRB (like all IRBs) is responsible for screening research proposals involving human subjects to ensure soundness of research design and proper protection of individuals who are enlisted in investigative studies. The EAC has little direct influence over the workings of the IRB; they are two relatively independent groups. The general feeling at Baylin was that matters were becoming more complex because the IRB was being presented with an increasing number of research protocols that posed risks to patients and offered financial incentives to researchers and families. In Johnston’s mind, “It was important to bring together people who knew something about ethics with people who new something about research.”3 A retreat that generated discussion between members of the EAC and members of the IRB, it was hoped, would enable each group to educate the other. In a research hospital such as Baylin, the tensions between medicine and science are not insignificant—aspects of which we have already considered in the cases of Billy Richardson and pediatric autopsies. Here, as before, we are reminded that in biomedicine ethical norms and virtues are often mediated by different groups in institutional settings. Given the complexity of issues in medicine and research, moreover, bioethics sometimes requires a division of labor. Retreat participants included members of Baylin’s EAC and IRB, workers at a local extended care center, employees of the drug industry, and myself . All of those who attended were provided a folder of reading materials in advance of the retreat to help focus the day’s discussions. Among those readings were the following real-life cases, drafted by Marilyn Waters, the Director of Research Compliance on Baylin’s IRB. •An investigator is looking at the relationship between a pediatric urological condition and fertility. If the condition threatens fertility, early surgery might prevent problems later in life. The investigator would like to collect semen samples from adolescent boys age thirteen and up. Who should be approached first, the adolescent or the parent? • An investigator proposes to conduct a focus group of adolescent girls with Down syndrome and their mothers to explore the special needs of these girls as they start menstruating. Two focus groups are proposed, one with the mothers and the one with the girls. Many of these adolescents are capable of providing some level of assent. Are there special considerations for enrolling these subjects onto the trial? How should the investigator recruit participants and obtain permission/assent? •An investigator is testing the hypothesis that in patients with attention deficit hyperactivity disorder (ADHD), behavior can be modulated by a special diet. The study involves a total of two days on a general clinical research unit—two one-day visits at least one day apart. While in [18.119.132.223] Project MUSE (2024-04-19...