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Children

Research Involving Children

Research involving children exists within both a legal framework and a more traditional context. The following guidance seeks to facilitate research involving children within a legal environment whilst respecting and taking into consideration the traditional and sometimes more formal guidance/procedures many settings may have.

Parents (and others with parental responsibility) may agree to their children taking part in research, but where a child is able to understand sufficiently to give informed consent, their consent should be obtained. Where the child consents to participate the parent's consent is not required, but there are often good reasons for informing parents about planned research; parents’ agreement will be necessary if children are to be seen at the parents' home or elsewhere if it is not a place where the child can be expected to go without parental agreement.

It is the researcher's responsibility to assess whether the child has sufficient understanding to consent to the research. Children’s capacity to consent to research depends on their understanding of the research to be undertaken. The leading case on children's capacity to consent is Gillick W Norfolk and Wisbech A.H.A decided in 1985. It was held that a child with sufficient understanding could consent to medical treatment, and that a parent of such a child would not be able to override this consent. This decision is taken to apply to decisions about research participation except in the case of “clinical trials” [see below] Where information about the research and study can be given clearly and simply, it is possible for quite young children to consent to take part in research.

For a child to give valid consent they would need to understand the nature of the engagement with the researcher and understand that it is different to other interactions with those who may seek information from the child. Particularly, the child must be able to understand that the researcher is not able to make decisions about their life, and will use the information the child provides, but not in a way which would allow others to identify the child.

Where a researcher wishes to include children in a study whom he/she considers is not mature enough to decide about participation he/she must obtain the agreement of at least one person who has parental responsibility for the child before engaging them in any research activity,

Where children are considered competent by a researcher to participate they should be accorded the confidentiality as would an adult, There are however two areas of concern where the same level of confidentially cannot be promised to a child, where a child discloses that they are being seriously harmed or ill treated, or where the researcher discovers a condition about which the parents could take action to benefit the child. In these instances researchers could be seen to have a duty of care to disclose such information to relevant third parties.

In the case of research in educational settings, any special school policies or procedures must be followed and efforts made to fully inform those responsible for children in these settings of the purpose and benefits of any proposed research with children.

The Medicines for Human Use (Clinical Trials) Regulations 2004 impose additional safeguards in relation to clinical research on children. This can only be undertaken where research has already been conducted without involving children, where it is essential to involve minors and where the patients concerned will derive a benefit. The interests of the child must prevail and inducements must not be offered to secure participation. In England Wales or Northern Ireland the informed consent of someone with parental responsibility must be obtained if a minor is to be involved in clinical trial.

*A valuable source used in creating the above guidance on research involving children, Doing Research with Children and Young People, S Fraser et al, 2004, London: Sage, can be consulted for further information on this area.