To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients.
After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term « informed consent » is provided.
Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed.
Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials.
Before concluding, areas for future research are discussed.
Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined.
Also, new directions for improvements and areas of further research can be outlined and discussed objectively.
The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. (...)
Mots-clés Pascal : Tumeur maligne, Anticancéreux, Essai clinique, Consentement éclairé, Ethique, Chimiothérapie, Traitement, Recherche fondamentale, Homme
Mots-clés Pascal anglais : Malignant tumor, Antineoplastic agent, Clinical trial, Informed consent, Ethics, Chemotherapy, Treatment, Fundamental research, Human
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0268269
Code Inist : 002B30A09. Création : 16/11/1999.