Chapter 1. The Declaration of Helsinki revised: a new context, new challenges for biomedical research

Abstract

The new Declaration of Helsinki, as the recent texts which have been drawn up in the area of biomedical research place this in a new context, a new significant stage in the place acquired by this practice which is as much social as scientific.
The double logic of recognising the development of activities of research on human beings and the need for a vigilant respect for the rights of the individual leads to no longer being satisfied with principles which are proclaimed and not applied but to seeking a balance between universal values and diverse changing realities. The political meaning of the new Declaration of Helsinki is precisely that it makes us note that biomedical research is part of a structured system of organisation of clinical trials and at the same time forces us to make effective the principles of ethics that it proclaims.
Consequently there is a procedural necessity: to guarantee transparency, conduct dialogue, insert each sensitive situation into a logic of examination, even of control and if necessary sanction. That is the price to pay if the efficiency sought by industrial logic is to preserve its credibility in the eyes of citizens.