Ethics in Research Involving Children and Youths: Resources

• Regulatory Requirements for Research Involving Children, Department of Health & Human Services (U.S.)
• NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects (U.S.)
• Research Ethics @ Hospital for Sick Children, Toronto (Canada)

Ethics in Research Involving Children and Youths: Articles

• “Children as Research Subjects: Moral Disputes, Regulatory Guidance, and Recent Court Decisions”, Loretta M. Kopelman
• “An Exploration of Ethical Issues in Research in Children’s Health and the Environment”, Jerome A. Paulson
• “Ethics of Research in Children”, Australasian College of Physicians
• “Are Research Ethics Standards Satisfied in Pediatric Journal Publications?” Eric Weil, Robert M. Nelson, and Lainie Friedman Ross
• “Ethics of Research in Children” Royal Australasian College of Physicians
• “The Legal Ethics of Pediatric Research?”Doriane Lambelet Coleman

Ethics in Research Involving Children and Youths: Overview

Research involving children and youth raises unique ethical issues. These result primarily from related ideas of competence, autonomy and vulnerability. Children have traditionally been considered as more vulnerable than adults, because of their lack of competence to take part in decision-making around complex issues such as health care and inclusion in research. This vulnerability means that others (parents, legal guardians, health care professionals, educators) must be trusted to act in their best interests and make decisions for them. Moreover, this vulnerability has often meant that children have simply been excluded from research, out of well-intentioned but shortsighted attempts to protect them. The result of excluding children from research is that we fail to learn about them and thus, fail to develop new, better ways to approach, treat and protect them.

More recently, it has been accepted that children and youth have an evolving moral autonomy and by virtue of this developing sense of self, a concomitant evolving competence. In other words, competence and decision making abilities in children is now considered to be a much more gray area than in the past, when one could say that competence was a very black and white issue: Children could not provide consent and adults were the primary decision makers. Furthermore, it was noted that those most vulnerable, including children, should not be excluded from research simply because of their vulnerability.

Traditionally, children were not allowed to consent for themselves for medical procedures — even the simplest ones- and for inclusion into research, biomedical or otherwise. Now, there are three widely accepted models of consent for children and youth (minors). First, children who are considered competent, sometimes called “mature minors” may provide consent on their own. Second, some children may provide an assent with parental consent. Third, some children, due to their age or developmental stage, cannot provide consent and parental consent is sought. While this approach seems much more in keeping with accepted notions of the development of autonomy over the lifespan, it raises serious ongoing challenges for clinicians, researchers and REBs to grapple with. Some of these difficulties arise from the challenges of assessing competence, best interests and motivations, dealing with conflict between children and parents and or with children and youth who may be living on the street or in crisis, to name just a few.

These challenges alongside many others imply that REBs reviewing research which involves children have ongoing and emerging complex issues to consider. While the fundamental issues remain the same for ethical research involving children as well as adults — protection of dignity, respect for autonomy, beneficence, nonmaleficence, and the fairness and legitimacy of processes — there are other dynamic issues to attend to, when research involves children.