Regulatory aspects of Clinical Research

In every country, research on human subjects is governed by a legislative and regulatory framework of varying scope. This legislation is based on ethical considerations which aim to protect:

[image] those taking part in research, but also:
[image] their personal data;
[image] their samples (blood, tissue, etc.).

All Clinical Research projects must comply with the applicable regulations in the countries concerned. This is absolutely vital if the results of Clinical Research are to be published in the scientific press.

In France, the Public Health Code and Civil Code contain several obligations that must be adhered to, depending on the type of Clinical Research. To ensure compliance with this legislation, the French Government has set up various bodies responsible for authorizing research on human subjects. Regardless of the Clinical Research project, in accordance with article L. 1121-2 of the Public Health Code:

“The interests of those who take part in biomedical research
must always prevail over the interests of science and society.”

Act No. 2012-300 of March 5, 2012 (the Jardé Law) on research involving human subjects has amended the terminology, classification and regulatory procedures of research on humans. This Act will come into force once the implementing decrees are published in the French Official Journal. The information on this page will be updated when this happens.