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Archives of Disease in Childhood 2000;82:177-182; doi:10.1136/adc.82.2.177
Copyright © 2000 BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health.
Arch Dis Child 2000;82:177-182 ( February )

Guidelines

Guidelines for the ethical conduct of medical research involving children
Commentary

Guidelines for the ethical conduct of medical research involving children

Royal College of Paediatrics, Child Health: Ethics Advisory Committee

Correspondence to: Professor Neil McIntosh, Department of Child Life and Health, 20 Sylvan Place, Edinburgh EH9 1UW, UK

The first 150 words of the full text of this article appear below.

    Introduction

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 the Polkinghorne 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. . . . [Full text of this article]


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