[Introduction of an accreditation system for hospital informed consent forms]

Area of Science:

• Medical Ethics
• Health Services Research
• Quality Improvement

Background:

• Informed consent forms (ICFs) are crucial for patient autonomy and ethical research.
• Assessing and improving ICF quality is essential for ensuring patient understanding and protection.
• Existing ICFs often have quality issues impacting their effectiveness.

Purpose of the Study:

• To describe the implementation of an accreditation system for ICFs in a tertiary hospital.
• To evaluate the effectiveness of this accreditation system in improving ICF quality.
• To assess the achieved improvements in ICF content, legibility, and readability.

Main Methods:

• An accreditation committee established ICF requirements and procedures following an external quality evaluation.
• Effectiveness was assessed by comparing two external evaluations (2011 and 2013) using 19 criteria and 60 ICFs per hospital.
• Accreditation required meeting 19 external criteria plus 5 specific criteria for legibility, readability, and validity.

Main Results:

• The accreditation system led to an 89% improvement in ICF quality, reducing defects from 8.2 to 0.9 per ICF.
• Significant improvements were observed in 18 out of 19 assessed criteria.
• The system established a validated review and approval process for ICFs, with a five-year validity period.

Conclusions:

• The accreditation system substantially improved ICF quality, guaranteeing content, legibility, and readability.
• The system's structural improvements do not ensure the overall consent procedure is conducted properly.
• Complementary strategies are necessary for measuring and improving the entire information and consent process.