Young people consenting to medical research

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...
Source: Archives of Disease in Childhood - Category: Pediatrics Authors: Tags: Viewpoint Source Type: research