Informed consent: how much awareness is there?

Daniel Purcaru; Adrian Preda; Daniela Popa; Marius Alexandru Moga; Liliana Rogozea

doi:10.1371/journal.pone.0110139

Informed consent: how much awareness is there?

PLoS One. 2014 Oct 16;9(10):e110139. doi: 10.1371/journal.pone.0110139. eCollection 2014.

Authors

Daniel Purcaru¹, Adrian Preda², Daniela Popa³, Marius Alexandru Moga⁴, Liliana Rogozea⁵

Affiliations

¹ Department of Medical Ethics, Transilvania University, Brasov, Romania; Department of Clinical Research, Neomed Medical Center, Brasov, Romania.
² Department 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.
³ Faculty of Psychology and Sciences of Education, Transilvania University, Brasov, Romania.
⁴ Department of Medical and Surgical Specialties, Faculty of Medicine, Transilvania University, Brasov, Romania.
⁵ Department 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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biomedical Research*
Clinical Trials as Topic
Health Knowledge, Attitudes, Practice*
Humans
Informed Consent*

Grants and funding

This paper is supported by the Sectoral Operation Programme Human Resources Development (SOP HRD), ID76945 financed from the European Social Fund and by the Romanian Government. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The other authors received no specific funding for this work.