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:

(1)

Research involving children is important for the benefit of all children and should be supported, encouraged and conducted in an ethical manner

(2)

Children are not small adults; they have an additional, unique set of interests

(3)

Research should only be done on children if comparable research on adults could not answer the same question

(4)

A research procedure which is not intended directly to benefit the child subject is not necessarily either unethical or illegal

(5)

All proposals involving medical research on children should be submitted to a research ethics committee

(6)

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