Ethical guidelines and regulations in conducting clinical research in children: A critical appraisal

Abstract

Conducting clinical research in children poses significant challenges with regard to several ethical issues, such as informed consent and protection from harm. Notwithstanding, children need to participate in research to address health issues that affect them but such research aims must be balanced with the safety and well-being of the participants. While being attentive to mitigating risks and providing the right support, researchers can ensure that children feel respected and can participate safely. The informed consent of parents or legal guardians should be obtained, preferably in writing, stating all the features of the research that may affect their willingness to allow the child to participate. Because of their vulnerabilities and the need to be protected from the risks associated with any kind of research, there has been increased global concern toward the involvement of children in research practice. As a general principle, although parents or guardians may be asked to consent on behalf of a child, depending on the child’s cognitive ability and the nature of the research, a refusal of assent or consent to participate should always over-rule the parent’s or guardian’s consent. To ensure proper ethical conduct of research in children, Institutional Review Boards (IRBs) or Research Ethics Committees (REC) will be required to provide ongoing monitoring of pediatric research, especially in the vulnerable population, since there may be a tendency for undue inducement or coercion, which could make parents/guardians consent to their children participating in a research and that exposes them to substantial risk. Similarly, it will be important to assess whether the approval of pediatric research, especially nonbeneficial research, should require a super majority, rather than the simple majority of IRB members required under current international regulation. This article provides an insight into the ethical guidelines and principles in conducting clinical research in children.