Compreensão do termo de consentimento em pesquisa clínica

Abstract

The informed consent form (ICF) is a document which explicitly confirms the consent of a participant in a research project, and should contain all necessary information clarifying the study in which the subject intends to participate. This study evaluates the level of comprehension of an ICF signed by 146 volunteers using a self-administered instrument. The average age of the sample was 47.29 years, and there was a prevalence of women (67.2%), incomplete primary education (53.4%) and no private health care (93.2%). The mean score of correct answers of 146 respondents was 53.1%. There was no association between the percentage of correct answers and the variables of gender, age, education and time of response. There was a significant association between taking the ICF home and the percentage of correct answers. The average value of correct answers found was not acceptable and educational measures must be implemented, seeking an increase in comprehension and the safety of participants. Keywords: Informed consent. Comprehension. Human experimentation. ResumoCompreensão do termo de consentimento em pesquisa clínica O termo de consentimento livre e esclarecido (TCLE) é documento onde se explicita o consentimento do participante, contendo todas as informações necessárias para que seja elucidada a pesquisa da qual se propõe participar. O objetivo deste trabalho foi avaliar o nível de compreensão do TCLE assinado por 146 voluntários, utilizando instrumento de coleta de dados autoaplicável. A média de idade foi 47,3 anos, com prevalência de participantes do gênero feminino (67,2%), ensino fundamental incompleto (53,4%) e sem assistência privada de saúde (93,2%). A média de acertos foi 53,1%. Não houve associação entre o percentual de acerto e as variáveis gênero, idade, escolaridade e tempo de resposta. Houve associação significativa entre levar a via do TCLE para casa e o percentual de acerto. O valor médio de acertos evidenciou a necessidade de novas medidas educativas, buscando aumentar a compreensão e a segurança dos participantes. Palavras-chave: Consentimento livre e esclarecido. Compreensão. Experimentação humana. Resumen Comprensión del consentimiento informado en la investigación clínicaEl consentimiento libre, previo e informado (CLPI) es un documento en el cual se explicita el consentimiento del participante, conteniendo toda la información necesaria para la elucidación sobre la investigación en la cual se propone participar. El objetivo de esta investigación fue evaluar el nivel de comprensión del consentimiento informado firmado por 146 voluntarios utilizando un instrumento auto-aplicable para la recolección de datos. La edad promedio fue de 47,3 años, con prevalencia de participantes de género femenino (67,2%); educación primaria incompleta (53,4%) y sin cobertura privada de salud (93,2%). El promedio de aciertos de los 146 entrevistados fue de 53,1%. No hubo asociación entre el porcentaje de respuestas correctas y las variables de género, edad, educación y tiempo de respuesta. Hubo una asociación si...

Termo de consentimento livre e esclarecido na assistência à saúde

“…A study on the ICF in research concluded that not all participants who signed the document really understood all the information, which impairs autonomous decisions 38 . The signature alone does not guarantee that the consent was free, autonomous and voluntary, and that the patient understood all the risks and benefits 39 . Factors such as stress, educational level, economic vulnerability and access to health services interfere in the process.…”

Ethical Conducts of Professors, Undergraduates and Graduate Students: The View of Dental School Patients

“…Therefore, research subjects should know their participation is voluntary and they must understand what health researchers will do and decide whether or not to give their consent to participate in a study (8,(12)(13)(14)(15)(16). Currently, many studies are conducted in educational institutions and the research subjects are patients who need the clinical services of those institutions.…”