Young people consenting to medical research

• Published in: Archives of disease in childhood 2024-04, Vol.109 (4), p.349-350
• Main Authors: Davies, Felicity, Fisher, Harriet, Birchley, Giles
• Format: Article
• Language: English
• Subjects: Adolescent; adolescent health; Age; Behavioral Sciences; Biomedical Research; Case law; Committees; Consent; Decision making; Ethics; Ethics, Medical; Flow Charts; Guidance; Health sciences; Humans; Medical ethics; Medical research; Medical Services; Medical treatment; Older Adults; paediatrics; Parents; Parents & parenting; Pediatrics; Physicians; Research ethics; Researchers; Teenagers; Viewpoint; Young Adults
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/archdischild-2023-325692

Correspondence to Dr Felicity Davies, Bristol Medical School–Population Health Sciences, University of Bristol, Bristol, BS8 1QU, UK; [e-mail] ; Dr Giles Birchley, Bristol Medical School–Population Health Sciences, University of Bristol, Bristol, BS8 1QU, UK; [e-mail] Introduction: age-based consent for research The regulations and guidance regarding young people’s consent to participate in medical research are complex.1 Current regulations divide medical research into two types: research that involves the trial of a medication and research that does not (figure 1). The Health Research Authority (HRA) guidance for England, Wales and Northern Ireland suggests that competent young people, aged under 18 years, should be able to consent to research without additional input from their parents.3 Guidance from the Council for International Organisations of Medical Sciences states that parents should always be involved in the consent process.4 This more cautious stance has been adopted by Ireland, where it is a legal requirement to obtain parental consent for any research participant under the age of 18.5 Ethics committees in England may diverge in their adherence to national and international guidance, resulting in researchers receiving disparate advice for similar research studies. In such situations, a researcher who receives the consent of a Gillick-competent 15-year-old person to participate in a research study without the consent of their parent could theoretically be taken to court by that parent for battery.1 Given the lack of clarity regarding the legal position in this scenario, many research ethics committees stipulate that consent is obtained from parents. Researchers may not fully inform the young person about the research, and the young person may be less likely to engage with the information since they are not the decision-maker.13 Some ethicists have argued that assent is effectively meaningless, given that parents still retain the ability to consent.14 Joint consent Rather than assent, the legal framework in Australia solves these concerns by requiring consent for medical research from both a young person and their parents.15 In the event of a lack of consensus, the young person would not be enrolled in the research study.