Work

Accessibility of the consent form in Brazilian clinical research

Year: 2023

Type: article

Abstract: 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.

Source: Revista Bioética

DOI: 10.1590/1983-803420232967en

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

Institutions: Pontifícia Universidade Católica do Paraná, AC Camargo Hospital

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Reduced inequalities

Open Access status: diamond

Funder: Universidade de São Paulo