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Beyond consent: Reconstructing ethical justification in medical adaptive machine learning systems.
Keiichiro Yamamoto1, Makoto Udagawa2, Eisuke Nakazawa3
1Department of Clinical Research Management, Center for Clinical Sciences, Japan Institute for Health Security, Tokyo, Japan.
Global Health & Medicine
|June 29, 2026
Summary
Medical Adaptive Machine Learning Systems (MAMLS) continuously update using clinical data, challenging traditional research ethics. Current consent models face limitations, necessitating a shift towards public health ethics for MAMLS governance.
Area of Science:
- Medical Ethics
- Artificial Intelligence in Healthcare
- Machine Learning Governance
Background:
- Medical Adaptive Machine Learning Systems (MAMLS) continuously learn from clinical data, blurring lines between therapy and research.
- This necessitates re-evaluating their ethical classification and the applicability of informed consent requirements.
Purpose of the Study:
- To analyze the ethical challenges posed by MAMLS, particularly concerning informed consent.
- To explore the limitations of consent-centered ethics in the context of adaptive machine learning systems.
- To propose an alternative ethical framework for governing MAMLS.
Main Methods:
- Conceptual analysis of ethical frameworks for adaptive machine learning in clinical settings.
- Examination of the implications of irreversibility and data bias in MAMLS on consent and autonomy.
- Critique of traditional research ethics and proposal for a public health ethics approach.
Main Results:
- Informed consent faces structural limitations due to the irreversibility of deep learning models and the "autonomy dilemma" caused by data bias.
- Withdrawability, a key aspect of consent, is undermined, potentially transforming consent into institutional delegation.
- Individual consent can paradoxically harm collective autonomy when data is unrepresentative or biased.
Conclusions:
- Ethical justification for MAMLS requires moving beyond research ethics to a public health ethics framework.
- Transparency, accountability, and participatory governance are crucial for building public trust in MAMLS.
- Addressing MAMLS ethical challenges necessitates a broader societal approach beyond individual consent.
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