# Structure and legibility of informed consent for clinical practice in Ecuador

## TL;DR

This study evaluates the structure and readability of informed consent forms in Ecuador, finding significant gaps that hinder patient understanding and decision-making.

## Contribution

The study provides a national assessment of informed consent forms in Ecuador, highlighting structural and readability issues impacting patient autonomy.

## Key findings

- Compliance with informed consent structure ranges from 74.46% to 94.87% across institutions.
- Only 45.23% of forms are readable, making them difficult for patients to understand.
- Deficiencies in structure and legibility compromise informed decision-making and patient-centered care.

## Abstract

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.

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.

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.

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.