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Introdução: As comissões de ética (CE) desempenham um papel central na supervisão ética e na proteção dos participantes em investigação. Porém, os dados sobre a sua composição e atividade em Portugal permanecem limitados. Este estudo teve como objetivos caracterizar os membros das CE, avaliar a sua atividade e constrangimentos percecionados, e explorar as suas perspetivas sobre a avaliação do consentimento informado (CI) na investigação.Métodos: Foi realizado um estudo entre março e junho de 2025, com recurso a um questionário anónimo online distribuído a CE em instituições de saúde, ensino superior e centros de investigação. O questionário recolheu dados sociodemográficos, informação sobre a composição e o funcionamento das CE e perceções relativas aos documentos de CI.Resultados: Foram obtidas 81 respostas. A maioria dos inquiridos era do sexo feminino (63,0%), tinha 51 - 60 anos (33,3%) ou ≥ 61 anos (30,9%) e mais de cinco anos de experiência em CE (49,4%). As CE que responderam pertenciam sobretudo a instituições de saúde (50,6%) ou ensino superior (42,0%). Os principais constrangimentos identificados foram a falta de formação (87,7%) e a ausência de tempo de trabalho dedicado (79,0%), sendo frequente a ausência de formação em bioética (56,8%) e em proteção de dados (47,0%). A maioria referiu utilização de modelo padrão de CI (74,1%), mas os pedidos de revisão por linguagem pouco clara foram frequentes (91,4%). Vinte e um por cento classificaram os CI como fracos ou medianos, atribuindo-o à falta de formação dos investigadores. Quanto à revogação do CI, 35,8% consideraram-na dependente de formalidades e 5,0% não souberam responder. Além disso, 45,7% indicaram não ter experiência pessoal na obtenção de CI. Verificou-se variabilidade na importância atribuída a componentes como condições do estudo e procedimentos para novas informações, formato de conservação dos dados e contactos da CE e do encarregado da proteção de dados.Conclusão: O CI é reconhecido como central, mas as respostas revelam heterogeneidade na avaliação de alguns componentes, a par de constrangimentos estruturais relacionados com a formação e o tempo dedicado no horário de trabalho. O reforço da formação, a harmonização de orientações e maior apoio institucional poderão aumentar a consistência e o valor pedagógico da revisão ética.
Introduction: Ethics committees (ECs) play a central role in ethical oversight and in protecting research participants. However, empirical evidence on their composition and practices in Portugal remains limited. The aim of this study was to characterize members of ECs, assess their activity and main constraints, and explore their views on the assessment of informed consent (IC) in research. Methods: A cross-sectional observational study was conducted between March and June 2025 using an anonymous online questionnaire distributed to ECs in healthcare institutions, higher education institutions and research centers. The survey collected sociodemographic data, information on EC composition and functioning, and perceptions regarding IC documents. Results: Eighty-one EC members participated. Most respondents were women (63.0%), aged 51 - 60 years (33.3%) or 61 years and older (30.9%), and nearly half had more than five years of EC experience (49.4%). The ECs represented were mainly based in healthcare institutions (50.6%) and higher education institutions (42.0%). The most frequently reported constraints were lack of training (87.7%) and insufficient time allocated to EC work (79.0%). Respondents reported no previous training in bioethics (56.8%) or data protection (47.0%). However, requests for revisions to the consent form were frequent, primarily due to unclear language (91.4%). Twenty-one percent rated the IC as poor or average, identifying lack of investigator training as the main reason. Regarding withdrawal of consent, 35.8% stated that it would depend on compliance with certain formalities, whereas 5,0% reported not knowing. In addition, nearly half of the respondents (45.7%) indicated that they had no personal experience in obtaining IC. Variability emerged regarding the importance attributed to certain consent components, particularly study conditions and procedures related to the communication of new information, the format of data retention, and contact details for the EC and the data protection officer. Conclusion: Portuguese EC members recognize informed consent as a central ethical safeguard, but their responses reveal heterogeneity in the assessment of some informational components, together with structural constraints related to training and time allocated to EC activities. Strengthening training, harmonizing guidance and improving institutional support may enhance the consistency and pedagogical value of EC review.
Introduction: Ethics committees (ECs) play a central role in ethical oversight and in protecting research participants. However, empirical evidence on their composition and practices in Portugal remains limited. The aim of this study was to characterize members of ECs, assess their activity and main constraints, and explore their views on the assessment of informed consent (IC) in research. Methods: A cross-sectional observational study was conducted between March and June 2025 using an anonymous online questionnaire distributed to ECs in healthcare institutions, higher education institutions and research centers. The survey collected sociodemographic data, information on EC composition and functioning, and perceptions regarding IC documents. Results: Eighty-one EC members participated. Most respondents were women (63.0%), aged 51 - 60 years (33.3%) or 61 years and older (30.9%), and nearly half had more than five years of EC experience (49.4%). The ECs represented were mainly based in healthcare institutions (50.6%) and higher education institutions (42.0%). The most frequently reported constraints were lack of training (87.7%) and insufficient time allocated to EC work (79.0%). Respondents reported no previous training in bioethics (56.8%) or data protection (47.0%). However, requests for revisions to the consent form were frequent, primarily due to unclear language (91.4%). Twenty-one percent rated the IC as poor or average, identifying lack of investigator training as the main reason. Regarding withdrawal of consent, 35.8% stated that it would depend on compliance with certain formalities, whereas 5,0% reported not knowing. In addition, nearly half of the respondents (45.7%) indicated that they had no personal experience in obtaining IC. Variability emerged regarding the importance attributed to certain consent components, particularly study conditions and procedures related to the communication of new information, the format of data retention, and contact details for the EC and the data protection officer. Conclusion: Portuguese EC members recognize informed consent as a central ethical safeguard, but their responses reveal heterogeneity in the assessment of some informational components, together with structural constraints related to training and time allocated to EC activities. Strengthening training, harmonizing guidance and improving institutional support may enhance the consistency and pedagogical value of EC review.
Descrição
Palavras-chave
Ethics Committees Research Informed Consent Portugal
Contexto Educativo
Citação
Editora
Ordem dos Medicos