Structure and legibility of informed consent for clinical practice in Ecuador

Abstract

Introduction: Informed consent is an essential process in healthcare. It is a right endorsed by the Universal Declaration of Bioethics and Human Rights and allows people to make free and informed decisions about their health. The structure of the informed consent forms is evaluated in accordance with the regulations established in the Management Model for the Application of Informed Consent in Health Care in Ecuador.

Methods: A descriptive cross-sectional study was conducted. The assessment instruments were developed based on current national regulations. A total of 482 informed consent forms from 62 health institutions in the country were evaluated.

Results: Compliance with the structure established by national regulations is heterogeneous, ranging from 74.46% to 94.87%. Although these values suggest a relatively high level of adherence, they are insufficient to ensure fully informed decision-making that guarantees both patient autonomy and safety. Readability was 45.23%, which made it difficult to understand properly.

Conclusion: Informed consent in the Ecuadorian context presents deficiencies in compliance with its structure, which compromises its completeness, and a significant gap in its legibility, which compromises informed decision-making and limits the exercise of patient-centred medical practice.