Gaps and Gains in Informed Consent for Surgery in a Non-Western Context: Beyond the Signatures of Iranian Patients

Informed consent is essential for protecting patients' rights and ensuring ethical medical practices. This study aimed to evaluate the quality and identify deficiencies in the informed consent forms of surgical patients at Shariati Hospital in Tehran. This descriptive cross-sectional study, conducted in 2022, reviewed the medical records of 288 surgical patients at Shariati Hospital from 2017 to 2021. A researcher-made checklist assessed demographic data, disease specifics, informed consent information, and completeness. Deficiencies in the forms and patients' understanding were evaluated using a Likert scale, with checklist validity confirmed by a pilot study (Cronbach's alpha = 0.75). Data analysis was performed using SPSS v.24. This study of 288 patient records found that while 93.4% had consent forms, only 2.2% were adequately informative and 4.5% understandable. Wound infection was the most discussed complication (89.6%), with no significant link to surgery type. Third-party consent was rare (2.8%), and 83% of forms had witnessed signatures. Residents obtained 98.5% of consents. This study identifies significant gaps in the informed consent process at a hospital, particularly in the disclosure and understanding of risks, benefits, and alternatives. While it does not assess voluntariness or decision-making capacity, it shows positive trends, such as increased healthcare team involvement and reduced third-party authorization, especially for female patients. The findings highlight a shift toward legal protections over ethical considerations, with implicit safeguards, like fingerprints and witness signatures, replacing explicit waivers.

The online version contains supplementary material available at 10.1007/s41649-025-00372-2.