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Guidelines for the ethical conduct of medical research involving children
  1. Royal College of Paediatrics,
  2. Child Health: Ethics Advisory Committee
  1. Professor Neil McIntosh, Department of Child Life and Health, 20 Sylvan Place, Edinburgh EH9 1UW, UK

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These guidelines are written for everyone involved in the planning, review, and conduct of research with children. The Royal College of Paediatrics and Child Health's first guidelines (then the British Paediatric Association) were published in 1980. Since then, there has been significant progress in the understanding of children's interests, in legal requirements, and in the proper regulation of research. The revised guidelines take account of such developments. General guidelines relating to all medical research provide an essential background to this document on research with children.1-9 These guidelines are based on six principles:

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 only be done on children if comparable research on adults could not answer the same question
A research procedure which is not intended directly to benefit the child subject is not necessarily either unethical or illegal
All proposals involving medical research on children should be submitted to a research 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.

The special implications of fetal research are considered by thePolkinghorne Report.10

Value of ethical research with children

Medical research involving children is an important means of promoting child health and wellbeing. Such research includes systematic investigation into normal childhood development and the aetiology of disease, as well as careful scrutiny of the means of promoting health and of diagnosing, assessing, and treating disease. It is also important to validate in children the beneficial results of research conducted in adults.

Research with children is worthwhile if each project:

  • has an identifiable prospect of benefit to children

  • is well designed and well conducted

  • does not simply duplicate earlier work

  • is not undertaken primarily for financial or professional advantage

  • involves a statistically appropriate number of subjects

  • eventually is to be properly reported.

Comprehensive registers such as the National Perinatal Epidemiology Unit's register of perinatal research and the National Research Register help to promote high standards. They publicise worthwhile projects and good practice; they help to prevent unnecessary duplication; and by recording unpublished work they provide valuable information.

Children's interests

Children are unique as a research group for many reasons. They are the only people, in British law, on whose behalf other individuals may consent to medical procedures. Many children are vulnerable, easily bewildered and frightened, …

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