MacCAT-CR: a way to legitimate the informed consent process in clinical research

Authors

Keywords:

Informed Consent, Clinical Trials, Research Ethics, Autonomy

Abstract

Informed consent is an essential ethical component of clinical trials, however, there are still many doubts about its proper realization nowadays. Consent is usually obtained formally, but there are doubts about the competence of participants in a clinical trial to decide whether to
participate. From there, a concern arises with the use of instruments capable of assessing the participants’ competence to express a decision. The MacArthur Competence Assessment Tool (MacCAT-CR) can be considered as an appropriate tool for assessing the informed consent process, as it can evaluate participants’ ability to express a decision about their participation
in each clinical trial. We review the application of MacCAT-CR in studies involving participants without cognitive impairment, representative of most individuals who generally participate in clinical trials. Our results demonstrate that few studies are evaluating the use of this tool to assess the competence of reasonable participants since most studies are focused on evaluating the consent process in individuals with limited autonomy. Here we discuss the ethical relevance of ensuring that the autonomy of research participants is manifested by assessing the effectiveness of the consent process, especially in developing countries.

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Author Biographies

Sergio Surugi de Siqueira, Pontifícia Universidade Católica do Paraná, Curitiba - PR, Brasil.

Sergio Surugi de Siqueira concluiu o doutorado em Ciências Biológicas com ênfase em Fisiologia na Pontifícia Universidade Católica de Chile em 2006. Pesquisador visitante no Pellegrino Center for Clinical Bioethics da Georgetown University em 2018. Atualmente é Professor Colaborador no Programa de Pós Graduação em Bioética da Escola de Ciências da Vida da Pontifícia Universidade Católica do Paraná . É Farmacêutico-Bioquímico formado pela Universidade Federal do Paraná em 1984. Recebeu 24 prêmios e/ou homenagens, entre as quais, recebeu o título de COMENDADOR DA ORDEM ESTADUAL DO PINHEIRO, honraria máxima do Governo do Estado do Paraná. Participou do Grupo de Trabalho desenvolvimento do conceito da Plataforma Brasil da Comissão Nacional de Ética em Pesquisa e do Grupo de Trabalho para o desenvolvimento do Sistema Proethos da Organização Panamericana de Saúde. É membro relator titular da Comissão Nacional de Ética em Pesquisa (CONEP)/Conselho Nacional de Saúde/Ministério da Saúde- Brasil.

Claudia Lucia Menegatti, Pontifícia Universidade Católica do Paraná, Curitiba - PR, Brasil.

Possui graduação em Psicologia pela Pontifícia Universidade Católica do Paraná (1992), Mestrado em Psicologia da Infância e da Adolescência pela Universidade Federal do Paraná (2002) e Doutorado em Saúde da Criança e do Adolescente pela UFPR (2015). Atua como Psicóloga Clínica e no Magistério Superior na Pontifícia Universidade Católica do Paraná, com ênfase em Psicologia da Saúde e Análise Aplicada do Comportamento.

Kleber Bez Birollo Candiotto, Pontifícia Universidade Católica do Paraná, Curitiba - PR, Brasil

Possui graduação em Filosofia pela Pontifícia Universidade Católica do Paraná (2000), Bacharelado em Direito pela PUCPR (2017), mestrado em Educação pela Pontifícia Universidade Católica do Paraná (2003) e doutorado em Filosofia pela Universidade Federal de São Carlos (2008). Professor do Programa de Pós-Graduação em Filosofia da PUCPR, na linha de pesquisa Ontologia e Epistemologia.

Renan Emilio Kintopp, Pontifícia Universidade Católica do Paraná, Curitiba - PR, Brasil.

Formado em Psicologia pela Pontifícia Universidade Católica do Paraná (PUCPR), bolsista Fundação Araucária do Projeto Institucional de Bolsas de Iniciação Científica (PIBIC). Formação inicial com ênfase em Análise do Comportamento, Qualidade de vida de idosos e Bioética. Mestrando no Programa de Bioética da Pontifícia Universidade Católica do Paraná.

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Published

2023-06-25

How to Cite

Siqueira, S. S. de, Menegatti, C. L., Candiotto, K. B. B., & Kintopp, R. E. (2023). MacCAT-CR: a way to legitimate the informed consent process in clinical research. Revista Brasileira De Bioética, 16, 1–14. Retrieved from https://www.periodicos.unb.br/index.php/rbb/article/view/33892

Issue

Vol. 16 (2020)

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Artigos Originais

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