HRA guidance on research involving children

A recent ruling over the scope of the legal concept of Gillick competence to give consent to medical treatment has shone a spotlight over how informed consent is approached when children are taking part in health and social care research. We explain what has happened and why you should continue to follow the HRA’s guidance on research involving children.

What is Gillick competence?

The HRA provides guidance on research involving children. The requirements for consent, where participants are children and or young people depend on the type of study and where in the UK it is taking place.

The clinical trials regulations prohibit children under the age of 16 from giving consent to take part in a Clinical Trial of an Investigational Medicinal Product (CTIMP). However, for other types of health and social care research there is no statute in England, Wales or Northern Ireland governing a child's right to consent to take part in research.

In England and Wales, under the Mental Capacity Act 2005, a person aged 16 or over is presumed to have capacity to consent for themselves, unless shown otherwise. This can include a decision about whether to take part in research, subject to any specific legal requirements that apply to the type of research.

For those aged under 16 in England, in the absence of statute, case law suggests that if a young person has sufficient understanding and intelligence to understand fully what is proposed and can use and weigh this information in reaching a decision (i.e. this is sometimes referred to as being 'Gillick competent' though this is not a formal, defined standard), he or she can give consent to treatment. This concept is a common law doctrine binding in England and Wales and generally persuasive in Northern Ireland. In the absence of law related specifically to consenting to take part in health and social care research, this approach can be a helpful guide to decision-making in this space.

There is no provision in Scottish Law governing a child’s right to consent to participate in research, other than in clinical trials involving an investigational medicinal product (CTIMP) (Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Clinical Trials Regulations”), as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. For all trials including those that do not involve an IMP, such as registries, treatments and non-drug interventions the overarching principles in Scottish Law must be applied including Children (Scotland) Act 1995, United Nations Conventions on the Rights of the Child 1989, Age of Legal Capacity Act 1991 amongst others listed below. Thereby ensuring that the rights of children and their welfare take precedent.

What has happened?