Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

Abstract

Treatments and interventions used to care for children in emergencies should be based on strong evidence. Well-designed clinical trials investigating these interventions for children are therefore indispensable. Parental informed consent is a key ethical requirement for the enrollment of children in such studies. However, if time is limited because of an urgent need for intervention, there are additional ethical challenges to adequately support the informed consent process. The acute situation and associated psychological impact may compromise the ability of parents to give informed consent. Little evidence exists to guide the process of consent seeking for a child’s research participation when time is limited. It is also unclear in what circumstances alternatives to prospective informed consent could be applied. This article describes possible options to manage the informed consent process in an appropriate, practical, and, we believe, ethical way when time is limited.

Ethical Challenges in Pediatrics from the Viewpoints of Iranian Pediatric Residents

“…Considering children's rights as research and educational subjects in the field of pediatrics, prevention of ethical challenges in this regard was another finding of the present research; findings of other studies have also confirmed this issue (31,32).…”

Focus on paediatrics

“…However, these parents would be concerned about not seeking prior consent in trials involving either "new" drug interventions or other potentially significant changes in clinical practice. Last, a report from a European group of pediatric clinical researchers described a new framework for informed consent processes under different time constraints [13], which will be applicable to PICU studies.…”

Ethical Issues in Perinatal Clinical Research

“…Ensuring that parents are fully informed and can actively give permission for infants to participate in research is mandatory, but there is uncertainty and debate about how to best integrate these processes in pragmatic studies [7, 8]. For non-urgent interventions, parents may be approached at a time that suits them and be given sufficient opportunity and support to process information about the study aims, design, requirements, and possible benefits and risks.…”