PLoS One. 2014 Oct 16;9(10):e110139. doi: 10.1371/journal.pone.0110139. eCollection 2014.
Informed Consent: How Much Awareness Is There?
Author information
- 1Department of Medical Ethics, Transilvania University, Brasov, Romania; Department of Clinical Research, Neomed Medical Center, Brasov, Romania.
- 2Department of Psychiatry and Human Behavior, University of California Irvine School of Medicine, Irvine, California, United States of America; University of California Irvine Neuropsychiatric Center, Orange, California, United States of America.
- 3Faculty of Psychology and Sciences of Education, Transilvania University, Brasov, Romania.
- 4Department of Medical and Surgical Specialties, Faculty of Medicine, Transilvania University, Brasov, Romania.
- 5Department of Fundamental Disciplines and Clinical Prevention, Faculty of Medicine, Transilvania University, Brasov, Romania.
Abstract
Improving the informed consent process in clinical research is of constant concern to regulatory authorities in the field and presents a challenge for both the specialists and patients involved. Informed consent is a process that should adequately match the complexity of clinical research. In analyzing the behaviour of 68 patients during the informed consent process related to the clinical research performed at Neomed Clinical Center in Brasov, we found that many patients do not ask any questions (35.3%). From those who do, part of the questions (20,6%) referred to general aspects (addressed the form but not the gist) of the clinical trial, some (72,8%) referred to specific aspects of the clinical trial they will attend and others (6,6%) unrelated to the clinical trial. These results suggest a lack of interest, awareness, and understanding of the information presented in the informed consent form. The possible underlying causes of this attitude and its bureaucratic, ethic, and legal implications are discussed.
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