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

Silva, Juliana Carvalho Rocha Alves da; Capucho, Helaine Carneiro

doi:10.1590/1806-9282.20210621

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Revista da Associação Médica Brasileira

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Sumário

Original Article • Rev. Assoc. Med. Bras. 67 (11) • Nov 2021 • https://doi.org/10.1590/1806-9282.20210621 copy

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

Authorship SCIMAGO INSTITUTIONS RANKINGS

SUMMARY

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.

KEYWORDS:
Clinical trials as topic; Informed consent; Ethics committees; Research

Interview
Questions		Answer option	Type of analysis and generated data
Sample identification
	Initials of your name	Open response	Sample identification
	Date of birth	Date	Sample identification
Sociodemographic profile
	Sex	F; M; Not declared	Profile of research participants
	Education	Education; Literacy; Elementary School; High school; University education; Postgraduate lato sensu; Master’s degree; Doctorate degree; PhD	Profile of research participants
	Do you have health insurance?	Yes; No	Profile of research participants
	Do you have social networks?	Yes; No	Profile of research participants
	Have you participated in previous clinical research?	Yes; No	Profile of research participants
Questionnaire about the IC after reading and after video
	What do you remember as relevant in relation to the research procedures presented in the Electronic Informed Consent Form?	Open response	Assess the amount of information retained for each participant
	Can you say what the purpose of the survey was?	Open response	Assess the amount of information retained for each participant
	Can you explain to me who should not participate in the study?	Open response	Assess the amount of information retained for each participant
	Can you tell me what the risks are for this study?	Open response	Assess the amount of information retained for each participant
	Can you tell me what the benefits of this study are?	Open response	Assess the amount of information retained for each participant
	Can you tell me what assistance is offered at the end of the study?	Open response	Assess the amount of information retained for each participant

Interview
Questions		Answer option	Type of analysis and generated data
Sample identification
	Was Electronic Informed Consent Form relevant for a better understanding of the research?	Yes; No	Objective
	Do you think Informed Consent Form should be implemented in all surveys?	Yes; No	Objective
	Do you think the Informed Consent Form is enough for the understanding of the research or the face-to-face care with the doctor is essential?	e-IC is sufficient; I still need face-to-face medical service	Objective
	Do you think Informed Consent Form should be implemented in all surveys?	Yes; No	Objective
	On a scale of 1 to 5, how important did you think the Informed Consent Form was for understanding the research? Being 1, not relevant, and 5, fundamental for understanding	1; 2; 3; 4 e 5	Objective

Associação Médica Brasileira R. São Carlos do Pinhal, 324, 01333-903 São Paulo SP - Brazil, Tel: +55 11 3178-6800, Fax: +55 11 3178-6816 - São Paulo - SP - Brazil
E-mail: ramb@amb.org.br

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[1] *Corresponding author: juliana_alves13@msn.com