[The Committee for the Protection of Human Subjects in biomedical research, crossroads of misunderstandings].

The conditions for carrying out clinical experiments involved numerous and serious breaches of Hippocratic morality and of the rights of people subjected to research situations. The World Medical Association has recommended the prior intervention of an independent committee "for advice and guidance" to the medical researcher. This recommendation has been taken into consideration by the competent authorities of industrially developed countries, which have incorporated structures of this type into their legislation, each having their own dispositions in this domain.

[Legal aspects of consent in children (Part 1)].

In pediatric research, the patient is legally a minor and therefore protected by law. Research can only be conducted after parental consent and patient assent have been obtained. In this context, this review discusses the historical events and documents related to all ethical precautions and obligations.

[Consent in children: Practical situations (part 2)].

Ethical and regulatory documents frame informed consent in pediatric research; their application is obligatory but may be complex. In this specific context, pediatric investigators have a central ethical role to play to ensure the strict respect of regulatory and ethical requirements adapted to the French legal, social, and cultural context as well as good clinical practices. This article attempts to shed light on the considerations that can allow researchers to come to terms with industrial and institutional demands while responding to the needs of patients, particularly in the domain of pediatric research.

How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?

The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies).