Consent arrangements: Children

Introduction

Research with children must normally only be carried out with the consent of the person with parental responsibility and/or child depending on the competence of the child. Good practice would suggest that the person with parental responsibility and the child, if competent, both agree before the child participates in research.

There are specific requirements for involving children in Clinical Trials of Investigational Medicinal Products, under the Clinical Trials Regulations, please visit the Clinical Trials Tool Kit for more information.

Other than the Clinical Trial Regulations, the provision for children to consent is in Common Law, this differs slightly throughout the UK, and is summarised below (for more detailed information see the 1st resource below).

England, Wales and Northern Ireland
The law states that the age of majority is 18. Young people between 16 and 18 are presumed to be competent to give consent. No statute governs the rights of those under 16 to give consent for medical treatment or research.

However, case law provides the example of the Gillick case with respect to treatment. This case determined that where a young person has sufficient understanding and intelligence to understand fully what is proposed, and use and weigh this information in reaching a decision, he or she can give consent for treatment and consent from parents is not legally necessary – although parental involvement should always be encouraged. The child is described as “Gillick competent”.

In the absence of case law dealing specifically with research, the Gillick principles might reasonably be applied here, although the threshold for understanding will vary according to the complexity of the research.

Guidance from NRES provides help with writing information sheets and consent forms that are applicable for children of different ages (2nd resource).

The Human Tissue Act 2004 makes provision for the research use of samples from children and how appropriate consent can be obtained, a summary of these provisions in England, Wales and Northern Ireland is available in the 3rd resource (further information is available in the Human Tissue Authority Code of practice – 4th resource).


Scotland
Scottish statute makes legal provision for young people, where they are considered to be competent, to consent to medical procedures or treatment. Young people aged 16 and above are presumed to be competent to give consent until proven otherwise.

Young people under the age of 16 can also give legally binding consent to any surgical, medical or dental procedure or treatment as long as the are believed by the medical practitioner to be competent.

In the absence of law dealing specifically with research, the principles of Scottish law relating to consent procedures and treatment might reasonably applied. At the same time, the threshold for understanding will relate to the complexity of the research being undertaken.

Guidance from NRES provides help with writing information sheets and consent forms that are applicable for children of different ages (2nd resource).

Human Tissue legislation makes provision for the research use of samples from children and how appropriate consent can be obtained, a summary of these provisions in Scotland is available in the 5th resource.