Research And Evaluation Of Informed Consent In Artificial Intelligence Related Cinical Trial - Info and Reading Options
By Hankun Su and Hok San Chau
“Research And Evaluation Of Informed Consent In Artificial Intelligence Related Cinical Trial” Metadata:
- Title: ➤ Research And Evaluation Of Informed Consent In Artificial Intelligence Related Cinical Trial
- Authors: Hankun SuHok San Chau
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- Internet Archive ID: osf-registrations-cfjgw-v1
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This study investigates the current state of informed consent practices in clinical trials that integrate artificial intelligence (AI), with a focus on identifying ethical gaps and advancing patient-centered transparency. As AI technologies become increasingly embedded in clinical research—ranging from diagnostic support to data analysis—the adequacy of informed consent documents in communicating AI-specific risks and processes remains critically underexamined. Despite growing ethical concerns around algorithmic bias, data privacy, and patient autonomy, there is a lack of large-scale, empirical assessment of how these issues are addressed in real-world consent procedures. The purpose of this research is to evaluate the transparency, comprehensibility, and ethical rigor of informed consent documents across AI-integrated clinical trials globally. Using a systematic review methodology and a hybrid analytical framework grounded in established ethical models, the study assesses how well these documents disclose AI functionality, associated risks, data governance practices, and participant agency. Special attention is given to the influence of regional regulatory environments and risk stratification in shaping consent quality. The expected outcome of this work is the development of a new framework to standardize and enhance informed consent in AI-driven research. Additionally, the project advocates for the adoption of dynamic digital consent platforms that support ongoing participant engagement, granular data control, and adaptive communication as AI systems evolve. By promoting regulatory harmonization, clinician education, and algorithmic accountability, this research aims to transform informed consent from a static procedural requirement into a living, ethically robust process that upholds patient trust and autonomy in the age of artificial intelligence.
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- Added Date: 2025-09-10 19:01:16
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