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Developing medicines for vulnerable groups

Developing medicines for vulnerable groups A legal and ethical study on adequate consent procedures in relation to gaining or losing competence to consent to participation in research.

Subsidized by: ZonMw
Term: 2011 - 2015

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Description:
This research project focuses on the ethical review of protocols of clinical trials with children. Three ethical aspects are emphasized:

  1. The distinction between therapeutic and non-therapeutic research. Could we do more justice to subtle differences between protocols by using component analysis in review?
  2. The concepts of minimal risk and minimal burden.
  3. How to deal with dissenting behavior in children undergoing medical procedures in clinical trials?