Ethics in Pharmacologic Research in the Child with a Disability

Abstract

This article reviews the unique ethical concerns that face clinicians, researchers, and family members in the realm of research involving children and youth with childhood-onset disabilities. Presented are the contemporary legal and regulatory environments in which we work and a synopsis of relevant articles on bioethics in this sector of the scientific literature. The most important ethical themes that emerged for children with disabilities include justice in research, consent and assent, child-centered communication, child- and family-centered decision making, participation in multiple studies, and therapeutic misconception. Two publicly recorded clinical studies are profiled to illustrate common considerations and concerns that arise during our ethical review of drug studies involving children with disabilities. It is concluded that the balance of access to current research and treatments must be weighed against risk for all involved. Collaborative planning amongst those involved in the development, review, approval, conduct, and oversight of drug study protocols can lead to effective scientific inquiry within the context of core ethical principles and child- and family-centered care.

Researchers’, Regulators’, and Sponsors’ Views on Pediatric Clinical Trials: A Multinational Study

“…1 Trials in children are complex and can be challenging due to the unique requirements of this population, safety concerns, stringent ethical requirements, and the lack of commercial interest. 6,7 In lowand middle-income countries (LMICs), there are additional challenges related to poverty, fear of exploitation, and mistrust. 8,9 The pharmaceutical industry is perceived as reluctant to conduct trials in children, whereas pediatricians' concerns regarding risks are seen as barriers.…”

The challenges of research participation by children

“…Fathers, parents with lower education levels, and those with minority status have been reported to perceive lesser degrees of voluntariness associated with research decisions for their children (5). There is often a degree of protectionism around the involvement of children with disabilities in research, leading some to argue that this leads to unequal access to the potential benefits of research (6).…”

Creating a New Ethical Climate for Drug Research in Children and Pregnant Women

“…The theme issue also addresses the specific ethical considerations encountered when conducting research in different pediatric subpopulations, from the fetus [4] and newborns [5] to the adolescent [6], the developmentally challenged child [7], and the child with cancer [8]. Certain clinical situations are particularly challenging from a research ethics perspective and are covered in detail in this issue, including intensive care [9], the emergency department [10], and low-income countries [11].…”