Clinical trials directive takes shape:
This article was originally published in Clinica
The proposed EU directive on human clinical trials for medicines, which could set a precedent for medical device trials, has moved one step forward. The Council of Ministers has accepted amendments made by the European Parliament that include: risk/benefit judgments should be made by ethics committees; special protection should be given to individuals unable to give informed consent; and the principal investigator should always be a medical practitioner. Proposed amendments covering compensation for adverse effects or death from trials were not accepted.