Regulation or Morality: The Problem of Legislation on Bioethics

Author(s): Didier Raoult, Philippe Brouqui

The COVID-19 health crisis has allowed a number of highly questionable practices in the field of international clinical research whose ethics are mainly based on the Declaration of Helsinki. This is based on the principle of benevolence, informing the patient about the expected risks and benefits, and agreeing to participate in research and transparency. Here we discuss these principles and their application during the crisis, taking as examples the vaccination campaign, information and consent of individuals and conflicts of interest. On the other hand, we discuss research regulations, which sometimes depart from the primary concepts of the Declaration of Helsinki, taking as an example on the one hand non-inferiority tests and on the other hand low-risk samples. In conclusion, it seems that bioethics has drifted from these objectives in favor of strict compliance with regulations.