Emergency research in children: options for ethical recruitment

Abstract

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research.

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

“…The majority of parents in our sample were unfamiliar with deferred consent, yet responded positively to a general description of the method. When discussing deferred consent generally, parents questioned their capacity to provide an informed consent decision when their child was ill 4 45. They described how they trusted practitioners to make research-related decisions on their behalf and viewed deferred consent as an appropriate way to seek consent in emergency situations and thereby enable the future development of interventions to treat critically ill children 46.…”

“…Qualitative research has a potential role to inform this balance, particularly in challenging settings where some trials might otherwise be regarded as being too problematic to conduct. For example, in paediatric settings, there are relatively few clinical trials to inform the development of emergency care interventions to save the lives of children 4. Paediatric accident and emergency care trials are fraught with ethical and practical difficulties 5.…”

“…As children (<16 years) cannot legally provide consent for a trial of investigational medicinal products, informed consent in this setting refers to the ‘proxy’ consent that is sought from parents or legal guardians. Even when interventions in the emergency setting are not so time-critical, there are ethical concerns about the quality of parental informed consent, as their capacity to understand trial information is likely to be compromised by the stressful situation 4 10. In 2008, UK legislation was amended to address such issues by enabling consent to be deferred in children's clinical trials11 when the following conditions are met: (1) treatment is required urgently; (2) urgent action is required for the purposes of the trial; (3) it is not reasonably practicable to obtain consent prospectively and (4) an ethics committee has given approval to the procedure under which the action is taken.…”

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

“…11 Legislation introduced in the United Kingdom in 2008 allows the use of deferred consent for studies involving children provided that treatment is urgently needed, urgent action is needed for the purposes of the trial, it is not reasonably practicable to obtain consent prospectively, and an ethics committee has given approval to the procedure under which the action is taken. 12,13 However, there is a lack of evidence for the acceptability, design, and conduct of deferred consent in children, particularly relating to complex situations such as the death of a child.…”

Dilemmas in undertaking research in paediatric intensive care

“…Three possible solutions have been suggested: deferred consent, proxy consent by a third party and retrospective consent 22. Deferred consent is the most commonly advocated.…”