To review the literature on comparisons between different methods of obtaining informed consent for clinical trials.
Eight hundred and twelve articles were traced, in the process of conducting a systematic review of the ethics of clinical trials, by searching a number of sources : bibliographic databases (Medline.
Psychlit and BIDS science and social science indices). hand searches, personal contacts, an original collection and a systematic follow-up of reference lists.
Fourteen research reports were found which provided comparative data on different methods of obtaining informed consent.
Eleven of these used a randomised design.
Studies were classified according to three outcome measures (anxiety, consent rate and understanding).
The results of the various studies suggest that giving people more information and more time to reflect tends to be associated with a lower consent rate.
There seems to be an optimal level of information about side-effects such that patients are not overburdened by detail, while grasping the most important risks.
More information in general is associated with greater awareness of the research nature of the trial, voluntariness of participation right to withdraw and (available) alternative treatments. (...)
Mots-clés Pascal : Consentement éclairé, Ethique, Méthodologie, Recrutement, Essai clinique, Randomisation, Homme, Attitude, Angoisse anxiété, Connaissance, Revue bibliographique, Article synthèse
Mots-clés Pascal anglais : Informed consent, Ethics, Methodology, Recruitment, Clinical trial, Randomization, Human, Attitude, Anxiety, Knowledge, Bibliographic review, Review
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0049863
Code Inist : 002B30A09. Création : 31/05/1999.