The World Medical Assembly adopted the Declaration of Helsinki in 1964, to provide guidance for physicians in biomedical research with human subjects. It was most recently amended in 1996 and one section refers specifically to research with children and states "when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian." The ethical guidelines of many professional organisations reflect this principle.

At what age can children legally give their consent to participate in a research project? In law, judgements concerning children giving their consent have been in relation to medical treatment. A child aged 16 years can give their consent to surgical, medical or dental treatment as stated in the Family Law Reform Act 1969 ss.8 and 21. However, since 1985 'the Gillick principle' has meant that with certain provisos a child under 16 years can give their consent, without necessarily having their parent's. The case of Gillick v West Norfolk and Wisbech Area Health Authority (1985) established that "as a matter of law the parental right to determine whether or not their minor child below the age of 16 will have medical treatment terminates if and when the child achieves a sufficient understanding and intelligence to understand fully what is proposed" (Lord Scarman). A later court ruling also states that a child's refusal to consent to medical treatment can be overridden by someone with parental responsibility and by the court, even if the child has sufficient understanding. Therefore a child under the age of 16 years who has sufficient understanding and intelligence has the right to consent to treatment but not to refuse it. The legal situation is far from clear, developing as it has on a case-by-case principle. Caution on the part of the researcher is important and in most cases it is advisable to seek the consent of the responsible adult in addition to that of the child.

A further consideration is the possible impact of the research on the child, at the time and at a later date. As the National Children's Bureau guidelines state, "this is particularly important where the participant has been discussing painful or difficult experiences". Their advice to researchers, prior to interviewing, is to gather information on local sources of help and have them available, if required, and to recognise the limitations of their own expertise and resist giving advice and support beyond their area of competence.

Similarly, confidentiality anonymity and storage of data should be explained in a way that children can understand. It should also be made clear who will have access to the information and what will happen to it when the research is complete. Information can be given about how data will be used, in the same clear language as used about the research. It is recommended that written information should always be provided for the child and responsible adult, including a contact telephone number, should they wish to contact the researchers.

Consideration of informed consent, confidentiality and legal issues clearly must take place prior to negotiations to gain access to children. Due to their legal status as a minor and the implied vulnerability that this status confers, the researcher often has to negotiate access to children via gatekeepers, who through their relationship with the child are assumed to have a protective role. The gatekeepers will require information about the research, how consent will be obtained from the children and responsible adults and the extent of confidentiality, prior to approving access to children.

In other situations gatekeepers control physical access to children, such as in schools, where permission is needed simply to make the initial contact with parents. Again, in order to gain access to the children, researchers may be asked to make changes to their data collection instruments or to require parents to take positive action, i.e. elect for their child to 'opt in' to the research, which can cause methodological problems for the research design.

WEBLINKS

For more information, please visit

The Economic and Social Data Service: http://www.esds.ac.uk/aandp/create/guidelineschildren.asp

The National Children's Bureau guidelines

http://www.ncb.org.uk/Page.asp?originx1590ji_5806413122593j68i1627154244