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Research essentials The ethics of conducting research involving children

Geek speak Beneficence The application of evidence-based care that is generated from research and specific to children. Non-maleficence The need to avoid using harmful therapies taken directly from adult studies. Distributive justice The benefits of research being available to all populations. Respect for informed consent Developing autonomy for children who are considering participation in research. Respect for privacy and confidentiality Maintaining a child’s confidentiality within the law.

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IT IS ESSENTIAL that all research is carried out in a manner that is transparently in line with ethical thinking. This is even more important when the subjects or participants are children or young people. The Medical Research Council (2004) identified that children ‘require special protection because they are less likely than adults to be able to express their needs or defend their interests – they may not have the capacity to consent’. When involving children in research about matters affecting them, the first ethical imperative is to consider the following (United Nations International Children’s Emergency Fund 1989): ■■ The child is capable of forming his or her own views and has ‘the right to express those views freely in all matters’ affecting them. ■■ The views of the child are given ‘due weight in accordance with the age and maturity of the child’. Three main approaches to research can involve children (National Society for the Prevention of Cruelty to Children (NSPCC) 2013). These are: ■■ Children and young people’s attitudes and experiences can be directly sought or linked to parents’ or carers’ views about their children’s experiences. ■■ Direct observation of children and young people can be used to obtain information about how they behave in their natural environment or in response to specific stimuli. ■■ Researchers may wish to access records about children and young people. Ethical

(Adapted from Canadian Paediatric Society 2008)

and organisational agreement should be obtained beforehand. When children are to be involved in research, the Royal College of Paediatrics and Child Health (2000) recommends observing six principles (see panel below). The position of the Canadian Paediatric Society (2008) is that research in children is a ‘moral duty’ and should be based on ethical principles (see Geek speak).

Six principles for ethical conduct of research with children ■■ Research involving children is important for the benefit of all children and should be supported, encouraged and conducted in an ethical manner. ■■ Children are not small adults – they have an additional, unique set of interests. ■■ Research should be conducted on children only if comparable research on adults could not answer the same question. ■■ A research procedure that is not intended to benefit the child subject

directly is not necessarily either unethical or illegal. ■■ All proposals involving medical research on children should be submitted to an ethics committee. ■■ Legally valid consent should be obtained from the child, parent or guardian as appropriate. When parental consent is obtained, the agreement of school-age children who take part in research should also be requested by researchers.

(Adapted from Royal College of Paediatrics and Child Health 2000)

12 September 2014 | Volume 26 | Number 7

While there is no specific guidance on consent for research with those aged under 18 years, a strong argument can be made for applying the Fraser guidelines (NSPCC 2014), originally designed as guidance about seeking consent for medical treatment. Where a young person can demonstrate a sufficient level of understanding of what is to occur, their consent should be obtained directly. Where this is not the case, the consent of the parent or guardian should be sought. In cases when consent is gained from a child, the parent’s consent should also be gained, and vice versa, although this is not a legal requirement. Consent must be gained without coercion or inappropriate financial inducements, and participants should be given appropriate time to consider whether to take part. It must be made clear that, even after signing the consent form, subjects can withdraw at any time. Key messages ■■ Research should always ensure that it maintains the safety of those taking part. ■■ While there are particular ethical concerns with working with children, these are in addition to, not instead of, guidance in relation to research with adults. References Canadian Paediatric Society (2008) Ethical issues in health research in children. Paediatrics & Child Health. 13, 8, 707-712. Medical Research Council (2004) Medical Research Involving Children. tinyurl.com/mrc-res-children National Society for the Prevention of Cruelty to Children (2013) Conducting Safe and Ethical Research with Children. tinyurl.com/nspcc-res-children National Society for the Prevention of Cruelty to Children (2014) Gillick Competency and Fraser Guidelines. NSPCC Factsheet. NSPCC, London. Royal College of Paediatrics and Child Health (2000) Guidelines for the ethical conduct of medical research involving children. Archives of Disease in Childhood. 82, 2, 177-182. United Nations International Children’s Emergency Fund (1989) The United Nations Convention on the Rights of the Child. UNICEF, London.

Patric Devitt is senior lecturer in children’s nursing and Leyonie Higgins is lecturer in children’s nursing, University of Salford, on behalf of the RCN’s Research in Child Health Community NURSING CHILDREN AND YOUNG PEOPLE

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Research essentials.

IT IS ESSENTIAL that all research is carried out in a manner that is transparently in line with ethical thinking. This is even more important when the...
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