New Form: AI Systems Used in Human Subjects Research 9.8.2025

We’ve created a new form to support research projects that use artificial intelligence (AI) systems or tools in human subjects research. The AI Systems Used in Human Subjects Research Form is designed to capture key details about AI use so the IRB can review research more efficiently and ensure compliance with federal regulations and ethical frameworks relating to Human Subjects Research and Clinical investigations.

The new form does not change any expectations related to review, but is rather designed to set researchers up for success by ensuring the IRB has the right information at initial submission. For example, it prompts investigators to explain issues unique to AI such as risks related to bias or hallucinations and how participants will be informed about the AI use in the study.

Examples of when to use this form include:

• Using AI-assisted transcription or translation to analyze interview data
• Employing large language models (LLMs) or chatbots as part of an intervention
• Developing new AI algorithms to analyze human subjects data
• Creating AI-generated materials (e.g., images, text, or scenarios) for use in a study

Please submit this form along with your Exempt or Non-Exempt Protocol Application whenever your research involves AI systems or you are modifying existing studies to add AI systems. The new form is available now on our Forms page.

Note that we are piloting this form. If you have any recommendations for improvement, please send these along with your submission.