Educational Resources
This page features educational resources developed by the Regulatory Program’s Emerging Technologies, Ethics, and Research Data (ETech) Subcommittee to support Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) as they navigate the growing role of AI in human participant research and in IRB/HRPP operations. These materials are designed to provide practical and accessible guidance on:
- Foundational AI concepts
- Common misconceptions
- Ethical and regulatory considerations
- Historical context
- Strategies for incorporating AI expertise into review and administrative processes
Together, they are intended to help IRBs/HRPPs build informed and thoughtful approaches to both the oversight of AI-related studies and the responsible internal use of AI tools.
A Guide for Understanding AI: Myth vs. Reality
This document aims to clarify common myths and misconceptions about AI by contrasting them with current realities, helping IRB/HRPP professionals better understand how AI actually functions in research contexts. By separating hype from fact, it supports more informed, practical, and ethically grounded review of studies involving AI, particularly as these technologies continue to evolve and be integrated into human participant research.
Authors: Regulatory Program ETech Subcommittee
A Guide to Recruiting an AI Specialist to an IRB/HRPP
The growing use of AI in research presents novel ethical, legal, technical, and regulatory considerations for IRBs/HRPPs. Many IRBs/HRPPs may benefit from adding a member with a specialization in AI to their roster (depending on their research portfolio). Alternatively, IRBs/HRPPS may opt to consult with an outside/external AI expert to help evaluate protocols that involve such technologies. This guide outlines the qualifications, recruitment strategies, evaluation questions, and best practices for onboarding the right expert.
Authors: Regulatory Program ETech Subcommittee
Historical Roadmap: AI & Human Participant Research
This document provides a high-level historical overview of the evolution of AI alongside key developments in human participant research and research ethics. By tracing major milestones in technology, regulation, and ethical frameworks, it helps IRB/HRPP professionals contextualize current challenges and better anticipate emerging considerations as AI continues to shape the design, conduct, and oversight of research involving human participants.
Authors: Regulatory Program ETech Subcommittee
Onboarding an AI Expert to the IRB/HRPP
AI experts can help IRBs/HRPPs evaluate issues such as algorithmic bias, model interpretability, synthetic data development and usage, and AI-assisted decision-making. They may also advise the IRB/HRPP on whether, when, and how AI tools should be used to support IRB/HRPP operations (e.g., administrative triage, pre-review screening, or workflow support). This guide offers a framework for incorporating this specialized knowledge into IRB processes.
Authors: Regulatory Program ETech Subcommittee