Consent to research: Research involving children or young people

1. 14. When considering involving children or young people in research, you must follow the advice in 0-18 years: guidance for all doctors.⁷  It gives advice on the circumstances in which children or young people can be involved in research, effective communication with children and young people, and assessing capacity to consent. It also explains the different legal requirements across the UK for 16 and 17-year olds who lack capacity to consent.
2. Read out our advice on the circumstances in which children or young people can be involved in research.
3. 15. There are particular considerations in relation to seeking and acting on consent for children or young people to participate in research. As part of seeking approval for the project from a research ethics committee, you must clearly explain the arrangements for getting consent and seek advice if necessary.
4. 16. Before involving a child or young person in research you must get consent from a parent,⁸  but you should get consent from both parents, if possible, particularly if the research involves more than low or minimal risk of harm. If a parent is under 16 years of age, you must get consent from them if they have the capacity to make a decision about whether their child should take part in the research project. If a child or young person is able to consent for themselves, you should still consider involving their parents, depending on the nature of the research.
5. 17. You should aim to reach a consensus with parents about a child or young person’s participation in research. If disagreements arise it is usually possible to resolve them informally, and you should follow the advice in paragraphs 77-78 in Consent: patients and doctors making decisions together. If disagreements cannot be resolved informally, you should not involve the child or young person in research, unless the treatment can be accessed only as part of a research project and you assess that it is in their best interests. In these circumstances, if the decision about entering the child or young person in research has significant consequences for the child or young person, you should seek legal advice about whether you should apply to the appropriate court for an independent ruling.
6. 18. You should be familiar with the guidance on involving children or young people in research published by other relevant organisations,⁹  for example, the Medical Research Council, the Royal College of Paediatrics and Child Health, the Royal College of Physicians of London, and the British Medical Association. Annex B contains specific advice on some of the legal requirements for involving children or young people under 16 in clinical trials of investigational medicinal products.

Subsection:

• Emergency research (paragraphs 19-20)