[Assessment of Informed Consent by Ethics Committees in Portugal: Procedures and Constraints in an Observational Study].

Abstract

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.