Artificial Intelligence in Human Participant Research: Ethical Risks and Institutional Policy Considerations

Area of Science:

• Bioethics
• Artificial Intelligence
• Research Governance

Background:

• The integration of artificial intelligence (AI) into human research introduces novel ethical and governance challenges.
• Existing ethical frameworks offer insufficient guidance for AI-specific risks, including informed consent, transparency, data privacy, and fairness.

Purpose of the Study:

• To synthesize key ethical concerns of AI-enabled research.
• To examine implications for institutional policy development and research ethics review processes.
• To identify governance and procedural gaps in AI oversight.

Main Methods:

• Commentary synthesizing ethical concerns and policy implications.
• Examination of governance and procedural gaps in AI oversight.
• Illustrative example demonstrating policy ambiguity.

Main Results:

• AI integration in research creates significant ethical and governance gaps.
• Existing frameworks inadequately address AI-specific risks in human research.
• Lack of clear institutional policies leads to ambiguity in research ethics review.

Conclusions:

• Institutions require updated, AI-specific policies for responsible research ethics review.
• Emphasis on institution-level policy development is crucial for consistent AI oversight.
• International research ethics review systems (IRBs, RECs, ERCs) must adapt to AI advancements.