Virtual consent and the use of electronic informed consent form in clinical research in Brazil

Rev Assoc Med Bras (1992). 2021 Nov;67(11):1570-1574. doi: 10.1590/1806-9282.20210621.

Abstract

Objective: In view of the need to apply term free and informed consent (IC) in clinical research involving humans, in accordance with the Brazilian ethical standards (CNS Resolution No. 466/2012), it is necessary to assess whether this practice is being effective and can be improved. The aim of this study was to evaluate the use of the IC in electronic format (e-IC), regarding its feasibility and suitability, as a complement to the written/physical consent form.

Methods: Quantitative-qualitative research with a questionnaire instrument.

Results: Greater retention of information and fewer wrong answers were observed after the application of the e-IC.

Conclusions: The use of e-IC is of great value to research participants in Brazil.

MeSH terms

  • Brazil
  • Consent Forms*
  • Electronics
  • Humans
  • Informed Consent*
  • Surveys and Questionnaires