Council of Europe Guideline for Ethics Commissions

In 2011 the Council of Europe published a guideline for ethics commissions which examine clinical studies prior to conduct. In Chapter 7.2 the authors explicitly refer to the involvement of children into clinical studies. They emphasize the obligatory approval of the parents, but also refer to the internationally varying legal provisions. Depending on their maturity, the committee points out that minors should be involved into the decision of participating in a research project as far as possible. Furthermore, those research projects are supposed to include individuals who are experienced in the health research with minors. The use of placebos should be tested carefully as well. In conclusion, the document also contains central questions for the members of the committee, by means of which the ethical justifiability of research with minors is to be established.

  • Is the research specifically related to children? Is there no analogy to adults?
  • Can the research help to understand the children’s development and does it directly affect the wellbeing of the child?
  • With respect to the pharmaceutical treatment: Is the involvement of children justifiable from the point of view of adults.
  • Can the research help to determine the requirements that are necessary to prevent a disease?
  • With respect to research in particularly sensitive matters (e.g. sexuality/ sexual abuse): Are there appropriate strategies to preserve the confidentiality? 

Bioethics at the Council of Europe Online Version

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