Guidelines on the practice of ethics committees in medical research with human participants

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The most widely quoted set of guidelines from a professional body is now in its fourth edition (published September 2007).

The guidelines provide a comprehensive, concise, accessible and practical guide to research ethics. This edition contains a summary of research practice, sections on legal background and ethical principles, and guidance on a wide range of specific areas such as research on human tissues, placebo, complementary medicine, the terminally ill and finance.

The main recommendations from Research on healthy volunteers and Research involving patients, previously published by the RCP as separate reports, have been updated and incorporated here. A detailed index and a glossary will assist both professional and lay readers, as will the extensive references to published material from other bodies, including online resources.

The guidelines will provide essential reading and guidance for all those involved in research, research governance, the ethical review of research, and for students of research ethics. Policymakers will find the concise guidance to current organisation and thinking invaluable.

Although primarily concerned with ethical review in the UK, the guidelines are likely to be of value to those in other countries concerned with the ethical review of research.


  • Background
  • Research, its benefits and the responsibilities of investigators
  • Medical research
  • The legal background
  • Ethical considerations
  • The use of placebo in research
  • Research involving use of human tissues or records and research presenting no material ethical issues
  • Research in special groups of participants
  • Special classes of research
  • Financial considerations

This guideline is available to download as a pdf.

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