Tutorial - Ethics of children in clinical trials Aims

Aims and outcomes

By Pauline McCormack and Simon Woods, PEALS, Newcastle University


This tutorial aims to introduce the main ethical issues in relation to children’s participation in clinical trials.

Learning Outcomes

At the end of this tutorial you should:
Be able to recognise some fundamental ethical principles
Be able to identify the basic arguments for carrying out research on children
Be conversant with the discussion around reasons for including children in research
Have a working knowledge of the application of the Declaration of Helsinki in relation to children’s research
Be familiar with the ethical issues related to research on children with chronic illness


  • Aims and outcomes
  • What is ethics?
  • Children in clinical trials – introduction
  • Article – ‘Ethical concerns regarding guidelines for the conduct of clinical research on children’
  • Children in clinical trials – discussion
  • Rare disease and Duchenne muscular dystrophy
  • Introduction to ‘The World Medical Association (WMA) Declaration of Helsinki Ethical
    Principles for Medical Research Involving Human Subjects’
  • The Declaration of Helsinki
  • Clinical trials for children with rare diseases – empirical issues
  • Article – 'Ethical issues of clinical trials in children: a European perspective'
  • Conclusions
  • Further reading

Copyright: This tutorial is the copyright of Newcastle University and may not be reproduced or copied elsewhere.   It is freely available for non-profit educational use.

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12 Apr 2017