Consent arrangements: Children

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Introduction

Research with children must normally only be carried out with the consent of a person with parental responsibility and/or child depending on the competence of the child. Good practice would suggest that a 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 Toolkit for more information.

Other than the Clinical Trial Regulations, the provision for children to consent is covered by common law, which differs slightly across 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, although young people between 16 and 18 are generally 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, common law provides the example of the Gillick case (with respect to consent for contraceptive treatment). This case determined that where a young person has sufficient understanding and intelligence to fully understand what is proposed, and can use and weigh this information in reaching a decision, s/he can give consent for treatment on their own behalf and that consent from a person with parental responsbility is not legally necessary (although their involvement should always be encouraged). This case has led to the term "Gillick competent" which describes a child who meets these criteria.

In the absence of any case law dealing specifically with research, the principle of Gillick competence has been generally applied to research, although the threshold for understanding will vary according to the complexity of the research.

Online guidance, developed by the HRA in partnership with the MRC Regulatory Support Centre, provides help with writing information sheets and consent forms that are applicable for children (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 to consent to medical procedures or treatment where they are considered to be competent. 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 they 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 be applied to research. At the same time, the threshold for understanding will vary according to the complexity of the research being undertaken.

Online guidance, developed by the HRA in partnership with the MRC Regulatory Support Centre, provides help with writing information sheets and consent forms that are applicable for children (2nd resource).

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

Resources