Moral reasoning in biomedical research protocols.
An analysis was performed of the ethics section in 134 biomedical research protocols submitted for review to a Danish Research Ethical Committee (REC) in 1990.
The statements made in the ethics sections were identified and classified.
It was found that 20% of the protocols lack an ethics section despite a specific requirement for such a section in the Helsinki-II declaration and the guidelines issued by the REC.
The ethics sections have a median length of 6 lines of text and contain a median of 3 ethically relevant statements, thereby comprising 1.13% of the total research protocol.
An analysis of the statements made show that 32% are purely formal and 30% are concerned with the area of information, consent and voluntariness.
Mots-clés Pascal : Ethique, Recherche scientifique, Science médicale, Organisme contrôle, Homme, Compte rendu, Danemark, Comité éthique, Europe
Mots-clés Pascal anglais : Ethics, Scientific research, Medical science, Supervisory institution, Human, Report, Denmark, Europe
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 94-0492780
Code Inist : 002B30A09. Création : 199501.