Avaliação do processo de consentimento de participantes de pesquisa clínica

Abstract

Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual's willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn't know the type of study they participated in, 38,6% didn't know about the research they participated, 64,7% didn't receive information regarding other types of treatment, 62,7% didn't have information about compensation, 66,2% didn't read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population.

Estratégias para favorecer a compreensão do termo de consentimento pelos participantes de ensaios clínicos: revisão integrativa

“…Por sua vez, a fotonovela, que é caracterizada como uma sequência de fotografias com balões de textos semelhantes às histórias em quadrinhos, difere-se das estratégias pedagógicas tradicionais de educação em saúde. A fotonovela usa de um recurso estético que acessa o participante da pesquisa a partir da via subjetiva (46) . Contudo, o simples fato de ter sido utilizado um recurso artístico, não implicou, necessariamente, no comprometimento dos pesquisadores com o desenvolvimento da autonomia dos participantes da pesquisa.…”

Checklist para elaboração do termo de consentimento livre e esclarecidos para participantes de pesquisa clínica: estudo descritivo narrativo

“…Isso sugere a necessidade de um nível educacional mais elevado para compreensão adequada desses documentos. [BARROS, 2019;NASCIMENTO, 2018] Uma pesquisa constatou que a maior parte dos pacientes que não compreendeu o Termo de Consentimento Livre e Esclarecido (TCLE) (78,3%) pertencia a um grupo de indivíduos com nível educacional equivalente a analfabetismo ou ensino fundamental incompleto.…”