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Emergency research in children: options for ethical recruitment
1Paediatric and Neonatal Intensive Care Unit, Great Ormond Street Hospital for Children NHS Trust, Great Ormond St, London, UK. brierj@gosh.nhs.uk
Insights
Children are often excluded from vital medical research due to ethical barriers in emergency situations. This paper examines alternative consent methods like proxy or deferred consent to improve pediatric emergency research.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Research Ethics
Background:
- Children are frequently excluded from clinical research, leading to a lack of evidence-based treatments, earning them the term 'therapeutic orphans'.
- Conducting research in emergency settings poses unique ethical challenges, particularly regarding informed consent for vulnerable pediatric populations.
- While UK organizations support pediatric research, balancing participant protection with research access remains critical.
Purpose of the Study:
- To explore ethical justifications and practical utility of alternative consent methods in pediatric emergency research.
- To address the challenge of obtaining informed consent in time-sensitive emergency situations.
- To safeguard vulnerable children and their families while advancing pediatric critical care research.
Main Methods:
- Literature review and ethical analysis of consent models.
- Exploration of proxy consent, deferred consent, and retrospective consent.
- Discussion of safeguarding measures for pediatric participants in emergency research.
Main Results:
- Traditional informed consent is often not feasible in true pediatric emergencies.
- Alternative consent models (proxy, deferred, retrospective) offer potential solutions.
- These methods require careful ethical consideration to protect participants.
Conclusions:
- Alternative consent strategies are necessary to improve evidence-based care for children in emergencies.
- Ethical frameworks must adapt to facilitate crucial pediatric research while ensuring robust participant protection.
- Further development and implementation of these consent models are vital for advancing pediatric emergency medicine.
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.
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