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?
A recent ruling (In July 2025, in Re S (Wardship: Removal to Ghana) [2025] EWCA Civ 1011) has clarified that the concept of Gillick competence, as established in Gillick v West Norfolk and Wisbech AHA [1986], is limited to the determination of whether a child under 16 has the capacity to give or withhold valid consent to medical treatment. The judgment did not say anything about its application within health and social care research.
Coverage of this has highlighted the lack of clarity over how children’s own decision-making ability should be considered in health and social care research. The long-standing assumption, reflected in existing HRA guidance, is that, in the absence of case law, a similar approach to the legal concept of ‘Gillick competence’ used in medical treatment may be valuable for a Research Ethics Committee (REC) in making its decision over what is ethical.
What is the HRA’s view?
We encourage you to continue to follow the HRA’s guidance on research involving children.
The judgment in Re S does not establish that the use of Gillick competence within research is unlawful or unethical. However, it does highlight the absence of case law to provide legal clarity.
Where consent is required by law there is no relevant statute or case law over who can legally give consent for research participation, particularly where the research does not itself provide individual care to the child or young person. In these cases, RECs use their established processes to apply careful and proportionate judgement on a case-by-case basis. Our staff support them through this decision making to ensure that there is consistency of approach.
Next steps
The questions raised following this ruling have highlighted an opportunity to provide greater clarity in this area to support a consistent approach across health and social care research involving children and young people that people can trust.
The HRA is engaging with partners across the health and social care research sector to inform our approach to support researchers and RECs to do this well going forward. As part of this we are engaging with our REC members.
The huge value of the research ethics review is that every application to do research involving NHS patients, their tissue or their data is reviewed by a group of people from a range of backgrounds independent from the research. This mix of expertise and different life experiences helps to ensure that the research is reviewed from a variety of perspectives and takes place in a way that people can trust. This ensures that, even in the absence of legal clarity, you can be confident that the participants best interests are at the heart of approved research.
We will continue to engage with you to provide greater clarity in this area. We will keep you updated as this work progresses.