Innovative therapies: general aspects and ethical criteria for evaluating protocols.

There are many ways of interpreting the notion of "innovation" with reference to therapeutics. The term is generally given a wide meaning, encompassing anything that brings something new. From the ethical point of view the definition of "innovation" is of key importance, for example when dealing with a major problem such as the evaluation of protocols that propose "innovative" therapies. There is currently debate as to whether this should be accomplished using the same procedures typically applied to experimental research protocols, or by following quite different procedures when "innovation" is involved. The present article offers an overview of the notion of "innovation" in the context of biomedical research, together with some considerations and proposals for evaluating it from the ethical viewpoint.