JMIR Publications

ABSTRACT

Background:

Informed consent is a cornerstone of medical ethics, ensuring patients understand the risks, benefits, and alternatives of procedures before making healthcare decisions. However, challenges such as complex medical language, time constraints, and variable patient literacy often hinder comprehension. Recent advancements in artificial intelligence offer new opportunities to improve the informed consent process.

Objective:

This systematic review assesses AI’s effectiveness in enhancing patient understanding and decision-making.

Methods:

Following PRISMA guidelines, a comprehensive literature search was conducted in PubMed, Embase, and the Cochrane Library to identify studies published in the last five years on AI’s role in informed consent. Additionally, the reference lists of selected articles were manually reviewed to include any additional relevant studies. Descriptive and statistical analyses were conducted to evaluate AI’s effectiveness, along with tests for homogeneity to assess the feasibility of a meta-analysis.

Results:

A total of 33 studies met the inclusion criteria and were categorized by AI application: patient education, consent documentation, and direct AI-assisted consent acquisition. Overall, AI platforms provided accurate information, significantly enhancing patient comprehension across various specialties while also reducing anxiety and consultation times. However, concerns remained regarding AI’s lack of human empathy, potential inaccuracies, and ethical issues such as data privacy.

Conclusions:

AI has the potential to improve the informed consent process, but further research is needed to address ethical concerns and ensure its effective, patient-centered integration into clinical practice. Clinical Trial: The study protocol was registered on the International Prospective Register for Systematic Reviews (PROSPERO; #420250652460).