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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). Trials of medications are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004,2 whereas other forms of medical research operate without statutory guidance. The statute states that anyone aged 16 years or older can consent to participate in a clinical trial. Those under the age of 16 cannot consent, and consent must be provided by a parent or guardian. This age-based approach is in keeping with other legislation surrounding a young person’s decision-making, such as age limits on learning to drive or buying a lottery ticket. This approach is pragmatic, as it is straightforward to identify which young people can consent for themselves.
Competence-based consent for research
Rather than using age, research not involving trials of medications identifies which young people are able to consent based on an assessment of their competence. 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 …
Funding GB’s research was funded in whole, or in part, by the Wellcome Trust (grant no 209841/Z/17/Z). For the purpose of Open Access, the authors have applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. FD is an academic foundation doctor with research time funded by the Health Education Authority.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.