Perception of the informed consent form by participants in clinical trials

  • Silmara Meneguin RN, Ph.D. Professor, Universidade Estadual Paulista "Julio de Mesquita Filho" –UNESP-, Botucatu, Brazil. email: silmeneguin@fmb.unesp.br.
  • Jairo Aparecido Ayres RN, Ph.D. Professor UNESP, Botucatu, Brazil. email: ayres@fmb.unesp.br.
Keywords: Informed consent, understanding, clinical trial, bioethics.

Abstract

Objective. To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research.

Method. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis.

Results. Some of the participants were aware of the real objective of these studies while others had misperceptions. The reading of the informed consent is not always done and, when it is done, the patient does not understand it. The lack of understanding about the term “placebo” was mentioned by some participants. The motivation to participate was the personal benefit.

Conclusion. This study shows that obtaining the informed consent in CCTs is complex and that there is the need to adapt the structure and application of this document, in order to protect the participants and improve the quality of clinical trials performed in the country.

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Published
2014-02-21
How to Cite
Meneguin, S., & Aparecido Ayres, J. (2014). Perception of the informed consent form by participants in clinical trials. Investigación Y Educación En Enfermería, 32(1). Retrieved from https://revistas.udea.edu.co/index.php/iee/article/view/18574
Section
ORIGINAL ARTICLES / ARTÍCULOS ORIGINALES / ARTIGOS ORIGINAIS