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Ethical Issues In Pediatric Psychiatric Clinical Trials

Robb A and Engle K

Abstract Background: Over the last decade, the number of research trials investigating psychiatric medications for children and adolescents has increased dramatically. However, this research brings to light ethical concerns regarding the doubly vulnerable population of children with psychiatric disorders. This article summarizes some of the practices established to reduce the risks this population may incur from participating in clinical trials research. Methods: A narrative synthesis was developed after a review of several summary articles focused on the issue of ethical issues in pediatric psychiatric clinical trials. Results: Federal regulations have been established to ensure that the rights and safety of children are protected during research participation, such as the four levels of risk to which every research protocol is assigned. This assignment is made based on all of the potential risks and benefits associated with participation. Safeguards exist to ensure that risks are minimized or eliminated whenever possible. The consent process and the requirement of assent (if applicable) is an opportunity to ensure that legal guardians and participants alike understand the meaning of their participation in the research and are not under a “therapeutic misconception” of benefit from research. All studies are required to receive approval from an Investigational Review Board before starting any study-related procedures, and some studies receive additional oversight from data safety and monitoring boards if they involve a highly vulnerable population, such as pediatric psychiatric clinical trials. Conclusions: Even with safeguards like these in place, many concerns still remain regarding the ethics surrounding this area of research. However, these obstacles should not discourage researchers from exploring the issues that need to be addressed in order to provide the best care possible for children and adolescents with psychiatric disorders.