Accessibility of the consent form in Brazilian clinical research

Kintopp, Renan Emilio; Siqueira, Sergio Surugi de; Siqueira, José Eduardo de; Fregnani, José Humberto Guerreiro Tavares

doi:10.1590/1983-803420232967PT

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Table of contents

Research • Rev. Bioét. 31 • 2023 • https://doi.org/10.1590/1983-803420232967EN linkcopy

Accessibility of the consent form in Brazilian clinical research

Authorship SCIMAGO INSTITUTIONS RANKINGS

The informed consent form informs clinical research patients about the nature of the research and their rights, formalizing their decision to participate; however, studies show that this document is written in a complex manner, compromising patient autonomy. Two consent forms from the same hypothetical research were developed with different writing styles and analyzed by the Coh-Metrix Port tool, which evaluates linguistic metrics and textual accessibility. Results showed that both texts were complex and required high schooling level to be understood. These findings reinforce the perception that consent forms may have their real function compromised and point to the importance of changing its elaboration.

Informed consent; Clinical protocols; Ethics, research; Consent forms

Information block	Corresponding items, as per CNS Resolution 466/2012
Basic information for the participant	a.Justification b.Objectives
Procedures that will be used in the research	c.Methods
Information about risks and benefits	d.Risks e.Benefits
Rights of the participant	f.Right to assistance g.Freedom to choose whether or not to participate in the research h.Confidentiality and privacy during all phases of the research i.Guarantee that the participant will receive a copy of the ICF j.Reimbursement guarantee if there are expenses related to the research k.Indemnity in case of damages arising from the research

Part of the text analyzed	Number of metrics in which the modified form showed improvement in relation to the representative form	Number of metrics in which both forms showed no difference	Number of metrics in which the modified form became worse in relation to the representative form
Full text	43	3	37
Basic information for the participant	27	7	49
Procedures that will be used in the research	47	4	32
Information about risks and benefits	41	3	39
Rights of the participant	37	5	41

Parameter	Basic information for the participant	Procedures that will be used in the research	Information about risks and benefits	Rights of the participant	Full text
Proportion of content words with familiarity values between 1 and 2.5 (from 0 to 4 years of age)
Proportion of content words with familiarity values between 2.5 and 4 (from 5 to 7 years of age)
Proportion of words with familiarity values between 4 and 5.5 (from 8 to 10 years of age)
Proportion of words with familiarity values between 5.5 and 7 (from 11 years of age)
Average familiarity values of text content words (the lower the overall average, the simpler the words)
Proportion of text content words with acquisition age between 1 and 2.5 (from 0 to 4 years of age)
Proportion of text content words with acquisition age values between 2.5 and 4 (from 5 to 7 years of age)
Proportion of words with acquisition age values between 4 and 5.5 (from 8 to 10 years of age)
Proportion of words with acquisition age values between 5.5 and 7 (from 11 years of age)
Average acquisition age values of text content words (the lower the overall average, the simpler the words)
Proportion of text content words with imageability between 1 and 2.5 (from 0 to 4 years of age)
Proportion of text content words with imageability between 2.5 and 4 (from 5 to 7 years of age)
Proportion of words with imageability values between 4 and 5.5 (from 8 to 10 years of age)
Proportion of words with high imageability value, from 5.5 to 7 (from 11 years of age)
Average imageability values of text content words (the lower the overall average, the simpler the words)
Number of times each form had a higher result or they obtained the same result	RF=8 MF=5 Equals=2	RF=10 MF=4 Equals=1	RF=10 MF=4 Equals=1	RF=8 MF=6 Equals=1	RF=10 MF=4 Equals=1

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Conselho Federal de Medicina SGAS 616, Conjunto D, Lote 115, L2 Sul, CEP: 70200-760, Tel: (61) 3445-5932 - Brasília - DF - Brazil
E-mail: bioetica@portalmedico.org.br

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[TFN1001] ICF: informed consent form; RF: representative form; MF: modified form; blank cells: equal results; green cells: RF higher than MF; yellow cells: MF higher than RF