Using Artificial Intelligence (AI) in Human Subjects Research

As artificial intelligence (AI) tools—especially generative AI—become more integrated into academic workflows, researchers must navigate new ethical, security, and regulatory considerations when designing studies that use these tools. Whether you’re using AI to help draft interview guides, transcribe data, analyze qualitative responses, or generate survey content, TC IRB requires researchers to proactively assess and disclose AI use in human subjects research.

Any AI-based software that interacts with human subjects data, whether directly or indirectly, may require both a TC Information Technology (TCIT) security assessment and IRB review prior to use in research. In such cases, it is the responsibility of the researcher to consult with both departments to obtain necessary approval.

Responsible and Secure AI Use in Research

Before using AI tools in your study, it's important to evaluate:

• Data security risks: including what data is being collected, especially if this involves identifiable sensitive data, and whether the software stores or shares sensitive data with third parties
• Ethical concerns: such as bias in AI-generated outputs or the lack of transparency in how decisions are made
• Compliance requirements: including software terms of use, consent disclosures, and institutional approval processes

Institutional Guidelines

We’ve developed a comprehensive guidance document to support researchers in navigating AI use in human subjects research: TC IRB Guidelines for Ethical and Secure Use of AI-Based Software in Research

This document includes:

• Step-by-step recommendations for consulting with TCIT
• Requirements for disclosing AI use in IRB applications
• Considerations for free vs. paid tools
• A researcher's checklist and FAQs

AI in Practice: Examples and Blog Posts

Looking for examples of how AI tools are being used—or misused—in research? Explore our blog series on AI ethics, IRB compliance, and practical tips for integrating AI responsibly into your research:

1. Understanding Artificial Intelligence with the IRB: Introduction
2. Understanding Artificial Intelligence with the IRB: Impacts in Research
3. Understanding Artificial Intelligence with the IRB: Recommendations from the Secretary's Advisory Committee on Human Research Protections
4. Understanding Artificial Intelligence with the IRB: Ethical Considerations and Advice for Responsible Research in the AI Era

Contact Us

Have questions about your use of AI in research?

• TC IRB
  Submit a ticket: AskIRB OR email: irb@tc.edu
  For questions about ethical use, IRB application disclosures, or compliance.
• TCIT Information Security
  Email: tcit@tc.edu
  For questions about software security assessments and technical reviews.

We strongly encourage early consultation with both offices before submitting your IRB application if your research involves AI-based software.