Artificial intelligence (AI) is redefining how clinical trials identify and engage potential participants. AI-driven recruitment platforms can analyze large datasets, identify eligible candidates, and automate outreach in ways that were not possible just a few years ago. While these technologies hold tremendous promise, they also introduce new ethical, regulatory, and operational considerations for sponsors, CROs, and research institutions.
This guide outlines Univo IRB’s approach to the review and oversight of artificial AI tools used in the recruitment and prescreening of research participants. It provides clarity for sponsors, investigators, and digital vendors regarding the ethical and regulatory expectations for AI-driven recruitment systems based in emerging FDA, OHRP, and international guidances.
Download it now to learn:
- How IRBs evaluate AI-driven recruitment platforms during protocol review
- Key regulatory frameworks that apply to AI-enabled research tools
- Critical oversight considerations, including algorithm transparency, bias mitigation, data security, and participant communications
- Expectations for human oversight, system validation, and ongoing monitoring of AI performance
- Practical recommendations for submitting AI-supported recruitment strategies for IRB review
