Informed consent for phase I studies : evaluation of quantity and quality of information provided to patients.
The process by which patients are informed and their consent is obtained in phase I trials has thus far been only marginally studied.
Since 1986 we have followed an oral procedure, consisting of three consecutive conversations in which the investigator responsible for phase I studies, the research nurse and the patients'relatives and/or friends also participate, followed by the patients signing of a written consent form.
It is required that six items of information considered essential by our staff be conveyed to patients by the responsible investigator.
Meerwein's model, which defines three main dimensions of the informing process, has been studied to ascertain whether it can be applied to evaluate the quality of the information proffered.
Thirty-two conversations were taped, transcribed and evaluated by one psychiatrist and one psychologist.
Complete information about the characteristics of the phase I drug and the modalities of the treatment and follow up was given to most 80% of the patients.
All but one of the items of the information dimension scored 3.5 or higher, with the one related to the assessment by the doctor of the patient's understanding at the end of the consultation scoring less than 3 in 53% of the patients.
The informed consent procedure applied was satisfactory from a quantitative point of view, and the main items of information were acceptable to the patients.
Mots-clés Pascal : Tumeur maligne, Essai clinique phase I, Consentement éclairé, Communication information, Malade, Epidémiologie, Homme
Mots-clés Pascal anglais : Malignant tumor, Phase I trial, Informed consent, Information communication, Patient, Epidemiology, Human
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0326630
Code Inist : 002B04B. Création : 01/03/1996.