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Informed Consent Disclosures and Minimum Requirements in AI Clinical Trials: Cross-Sectional Analysis
Hankun Su1,2, Fen Xiao1,2, Hoksan Chau1,2
1Department of Reproductive Medicine, Xiangya Hospital Central South University, Changsha, Hunan, China.
Journal of Medical Internet Research
|June 12, 2026
Summary
Informed consent documents for AI clinical trials often lack transparency and clarity, failing to adequately inform participants about AI usage and risks. Standardized, participant-centered consent practices are needed to improve ethical robustness.
Area of Science:
- Clinical Research
- Artificial Intelligence
- Bioethics
Background:
- Artificial intelligence (AI) integration in clinical research complicates traditional informed consent (IC) due to its complexity and opacity.
- Existing ethical guidelines lack specificity for AI in healthcare, and AI representation in trial registries' IC documents is unassessed.
Purpose of the Study:
- To evaluate the prevalence, clarity, and completeness of AI-related disclosures in clinical trial IC documents.
- To propose a framework for enhancing patient digital literacy and ethical robustness in AI clinical trials.
Main Methods:
- Cross-sectional content analysis of 114 AI-involved clinical trials registered on ClinicalTrials.gov.
- Assessment of AI disclosures, readability (SMOG index), document length, visual aids, and data governance against WHO/NIH standards.
- Refinement of an AI risk framework and scoring of trials based on autonomy, deviation from standard care, patient interaction, and clinical risk.
Main Results:
- 55% of ICs failed to disclose AI type/usage; 16.4% omitted risks.
- Significant discrepancies noted between registry and IC reporting of AI methods.
- Only 14% of ICs met brevity and readability criteria; higher-risk trials lacked improved readability.
- Data handling post-withdrawal was inconsistent, with most ICs offering no participant choice.
Conclusions:
- Current IC practices in AI clinical trials exhibit significant deficits in transparency, readability, and participant data control.
- There is a critical need for standardized, participant-centered consent processes for AI in clinical research.
- The proposed Minimum Requirements for Informed Consent in AI-Related Clinical Trials (MRIC-AI) framework aims to enhance consent quality.
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