Percepção dos doentes incluídos em ensaios clínicos relativamente ao processo de consentimento informado
DOI:
https://doi.org/10.31877/on.2012.20.05Palavras-chave:
princípios éticos, consentimento informado, informação, ensaios clínicos, percepção, tomada de decisãoResumo
Os ensaios clínicos são a fonte para o desenvolvimento de novas estratégias de tratamento. O consentimento informado constitui uma salvaguarda ética para os doentes candidatos a ensaios clínicos, na medida em que reconhece a autonomia nas decisões e o direito à informação adequada. Contudo é necessário garantir que a informação transmitida é devidamente percepcionada, pelo
que devem ser consideradas as variáveis idade, nível educacional e estado de saúde, na medida em que influem no processo de percepção do consentimento informado. Outros factores parecem influir na percepção do consentimento informado, tais como: estrutura e linguagem utilizada nos formulários; outros materiais informativos; ambiente envolvente; tempo dado para a tomada de decisão e a relação de confiança entre investigador – médico e sujeito – doente. É essencial que os profissionais de saúde encontrem estratégias ao nível da informação e comunicação que promovam a compreensão em doentes idosos, iletrados e oriundos de minorias étnicas. Para tal, é fundamental considerar os factores supracitados e conhecer as motivações, expectativas e barreiras quanto à participação dos doentes em ensaios clínicos. Este artigo proporciona uma revisão bibliográfica acerca do processo de consentimento informado.
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