Comprehension of informed consent in clinical research

Authors

  • Clarissa de Assumpção
  • Nínive da Silva Pinto
  • Luis Guillermo Coca Velarde
  • Osvaldo José Moreira do Nascimento
  • Beni Olej

Abstract

The informed consent form (ICF) is a document which explicitly confirms the consent of a participant in a research project, and should contain all necessary information clarifying the study in which the subject intends to participate. This study evaluates the level of comprehension of an ICF signed by 146 volunteers using a self-administered instrument. The average age of the sample was 47.29 years, and there was a prevalence of women (67.2%), incomplete primary education (53.4%) and no private health care (93.2%). The mean score of
correct answers of 146 respondents was 53.1%. There was no association between the percentage of correct answers and the variables of gender, age, education and time of response. There was a significant association
between taking the ICF home and the percentage of correct answers. The average value of correct answers found was not acceptable and educational measures must be implemented, seeking an increase in comprehension
and the safety of participants.

Keywords:

Informed consent. Comprehension. Human experimentation.
Vol. 24 No. 1 (2016): Rev. bioét. (Impr.). 2016; 24 (1)

Published:

2016-03-29

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How to Cite

1.
Assumpção C de, Pinto N da S, Velarde LGC, Nascimento OJM do, Olej B. Comprehension of informed consent in clinical research. Rev. bioét.(Impr.). [Internet]. 2016 Mar. 29 [cited 2024 May 21];24(1). Available from: http://revistabioetica.cfm.org.br/revista_bioetica/article/view/1062