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Related Concept Videos

Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
Clinical Trials01:16

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Nurses' Legal Responsibilities I

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Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Working with Human Tissues for Translational Cancer Research
07:48

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Published on: November 26, 2015

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
PubMed
Summary
This summary is machine-generated.

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.

Keywords:
AIartificial intelligencehealth literacyinformed consentpatient education

Related Experiment Videos

Last Updated: Jun 14, 2026

Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

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.