Éthique dans les essais cliniques : Principes fondateurs, lignes directrices internationales, rôles et responsabilités des comités d’éthique

Abstract

La protection et le bien-être des participants à la recherche reposent sur des principes de respect de la personne humaine, bienfaisance, justice, égalité, et de rigueur scientifique. En découlent des règles (consentement préalable, confidentialité, équilibre bénéfices/risques, équité, publication des résultats…) reprises dans des textes de loi et dans des normes de Bonnes Pratiques Cliniques appliquées par les acteurs de la recherche (promoteurs, comités d’éthique, investigateurs…)

Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.