Country Report Portugal

The implementation of Directive 2001/20/EC changed considerably the legal regulation of clinical trials in Portugal. The rights of the participants in research, including minors and incompetent adults, are now more accurately described and the possibility of non-therapeutic research with minors was introduced. Moreover, the new administrative procedure and the role of ethics committees changed substantially, since the new National Ethics Committee for Clinical Research was given extensive power and the traditional local ethics committees have seen a decrease in their functions and activities.