Accessibility of the consent form in Brazilian clinical research

Authors

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.

Keywords:

Consentimento Informado, Termo de Consentimento Livre e Esclarecido, Pesquisa Clínica, Ética em Pesquisa

Author Biographies

Renan Emilio Kintopp, Pontificia Universidade Católica do Paraná

Mestre em Bioética pela PUCPR

Formado em Psicologia pela PUCPR

Sergio Surugi de Siqueira, Pontifícia Universidade Católica do Paraná

Professor do Curso de Farmácia da PUCPR
Professor Colaborador do Programa de Pós Graduação em Bioética da PUCPR

José Eduardo de Siqueira, Pontificia Universidade Católica do Paraná

Coordenador do Curso de Medicina da PUCPR (Campus Londrina)

Professor do Curso de Pós Graduação em Bioética da PUCPR

José Humberto Guerreiro Tavares Fregnani, Hospital A. C. Camargo Cancer Center

Superintendente de Ensino do A.C.Camargo Cancer Center. Pesquisador CNPq nível 2. Parecerista FAPESP, CNPq e DECIT.

How to Cite

1.
Kintopp RE, de Siqueira SS, de Siqueira JE, Fregnani JHGT. Accessibility of the consent form in Brazilian clinical research. Rev. bioét.(Impr.). [Internet]. 2023 Aug. 8 [cited 2024 May 19];31(1). Available from: http://revistabioetica.cfm.org.br/revista_bioetica/article/view/2967