Connecticut

SOCRA Connecticut Chapter Meeting

AI Technology in Human Research: Whose Job Is it to Review?

Date:                     Tuesday, December 9, 2025

Time:                    12:00 – 1:00 PM EST via ZOOM

Session: As artificial intelligence (AI) becomes increasingly embedded in clinical and behavioral research,
institutional review boards (IRBs) are being asked to assume responsibilities they were never designed or staffed to
handle. From algorithmic bias and data provenance to model drift and cybersecurity, the technical dimensions of AI fall well beyond traditional human participants' protection expertise. In this session, Dr. Klote asserts that expecting IRBs to assess AI systems is both inefficient and risky. Instead, institutions should establish (or formally rely upon) a specialized AI Review Committee (AIRC), a body of technical, ethical, and legal experts capable of evaluating AI systems using standardized criteria before IRB review. Drawing from emerging frameworks such as SPIRIT-AI and CONSORT-AI, Dr. Klote will outline how a two-tiered review structure can protect research participants, preserve IRB integrity, and accelerate responsible innovation. Participants will gain a clear understanding of how to implement practical governance models that integrate technical AI validation with ethical oversight and then look at the responsibilities of the IRB once the technical review has been completed.

Learning Objectives: By the end of this session, attendees will be able to:

1. Differentiate between the ethical oversight responsibilities of Institutional Review Boards (IRBs) and the
   technical validation functions appropriate to an AI Review Committee (AIRC) or equivalent expert body.
2. Identify and apply the core domains of AI system evaluation: data quality, model validation, fairness,
   transparency, and security; and understand why these areas fall outside the IRB’s primary scope of expertise.
3. Integrate best practices from frameworks such as SPIRIT-AI and CONSORT-AI into institutional processes to
   promote transparent, auditable, and compliant AI oversight.
4. Design and evaluate a tiered institutional review workflow that incorporates AIRC technical review with IRB
   ethical oversight, including IRB responsibilities after technical review, such as informed consent, risk–benefit
   analysis, equity, and data governance.

Speaker:
Molly Klote, MD
President & CEO
Klote Medical Research Advisors, LLC

Cost:      Free Admission

Credit:   SOCRA Members may claim 1 CE towards SOCRA Recertification. 

Only SOCRA members will receive a certificate of attendance.

Location:             The meeting will be held remotely via ZOOM.                         

  Please share this announcement with your colleagues.

Members and Non-members welcome!

Chapter Locations and Site Contacts

More Information: Alyssa Gateman, MPH, CCRP, Chapter Chairperson, at alyssa.gateman@yale.edu