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Randomised controlled trials in medical AI: ethical considerations.

Thomas Grote1

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Journal of Medical Ethics
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Summary

Artificial intelligence (AI) in medicine requires rigorous clinical trials, specifically randomized controlled trials (RCTs), to prove its benefit. Ethical considerations, including informed consent and fairness, must be addressed in AI RCTs.

Keywords:
clinical trialsinformed consentresearch ethicstechnology/risk assessment

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Area of Science:

  • Medical Informatics
  • Artificial Intelligence
  • Clinical Trials

Background:

  • Artificial intelligence (AI) shows promise for medical diagnosis and prognosis.
  • Current studies often lack evidence of clinical benefit for AI systems.
  • There is a growing consensus for AI's clinical utility to be validated through clinical trials.

Purpose of the Study:

  • To systematically examine the ethical considerations specific to conducting randomized controlled trials (RCTs) for AI in medicine.
  • To address the methodological adjustments and ethical challenges posed by AI RCTs compared to traditional drug RCTs.
  • To stimulate further discussion on the research ethics of medical AI.

Main Methods:

  • Focus on core ethical principles: clinical equipoise, informed consent, and fairness.
  • Analysis of ethical challenges unique to AI randomized controlled trials (RCTs).
  • Systematic account development for the ethics of AI RCTs.

Main Results:

  • AI RCTs necessitate distinct methodological adjustments compared to drug RCTs.
  • These adjustments introduce unique ethical challenges.
  • Key ethical principles require careful consideration in the context of AI clinical validation.

Conclusions:

  • The ethical landscape of AI clinical trials requires careful navigation.
  • Addressing informed consent, fairness, and clinical equipoise is crucial for ethical AI research.
  • Further discourse is needed to establish robust ethical guidelines for medical AI development and deployment.