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The Evolving Landscape of Human Research with AI - Putting Ethics to Practice

Session II: Examining the Challenges of Applying the Belmont Principles and the Common Rule to Research Involving AI

Speakers


Moderator: Eric Mah, Ed.D., M.H.S.  
Associate Dean, Clinical and Translational Research, University of California, San Diego

Eric Mah

Eric Mah is Associate Dean at the University of California San Diego, where he leads the administrative operations of its central clinical research program. Prior to UC San Diego, he led the Ethics & Compliance Office for UC San Francisco and held leadership positions at the institutional review board (IRB) offices for UC Davis and UCLA. He has served on conference planning committees for Public Responsibility in Medicine and Research and as past-chair of its Diversity Advisory Group. More recently, he helped co-found the Consortium for Applied Research Ethics – Quality (CARE-Q.org), a joint effort between the University of California and Stanford University, to support quality improvement efforts across IRB programs nationally. He is currently serving a 4-year appointment on the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections.


Key Regulatory Terms and AI Tools in Human Subjects Research (HSR)

Iris Jenkins, Ph.D.
Director of Research Integrity and Consultation at Virginia Tech

Iris Jenkins

Iris L. Jenkins, Ph.D., serves as the Director of Research Integrity and Consultation at Virginia Tech. Dr. Jenkins has more than 14 years of research compliance experience, having also served in roles supporting the Institutional Animal Care and Use and Institutional Biosafety Committees.

Dr. Jenkins earned a B.A. in biological sciences from Mount Holyoke College and an M.S. in plant pathology from the University of Arizona. She conducted human subjects research while earning her Ph.D. from the University of Massachusetts Amherst in neuroscience and behavior. Her own research experience influences her work as an administrator. She is enthusiastic about helping researchers accomplish their goals while remaining in compliance with applicable regulations and policies.

How Does the Use of AI in Research Test the Notions of Personal Privacy and Identifiability of Data or Biospecimens?

Benjamin C. Silverman, M.D.
Senior IRB Chair, Human Research Affairs, Mass General Brigham; Director of Ethics, McLean Institute for Technology in Psychiatry, McLean Hospital; Instructor in Psychiatry and Faculty Member in the Center for Bioethics, Harvard Medical School, Mass General Brigham/McLean Hospital/Harvard Medical School

Benjamin C Silverman

Benjamin C. Silverman, M.D., is the Senior IRB Chair at Mass General Brigham, Human Research Affairs. Additionally, Dr. Silverman is currently the Chair of the Mass General Brigham Embryonic Stem Cell Research Oversight Committee, Director of Ethics for the Institute for Technology in Psychiatry at McLean Hospital, and at Harvard Medical School, serves as an Instructor in Psychiatry and a Faculty Member in the Center for Bioethics. Dr. Silverman received his medical degree from the Johns Hopkins University School of Medicine, completed his psychiatry residency at the MGH McLean Adult Psychiatry Residency Training program, and completed sub-specialty fellowship training in addiction psychiatry through Mass General Brigham.

Disclosing the Role and Use of AI in HSR

Sara Gerke, Dipl.-Jur. Univ.
Associate Professor of Law and Richard W. & Marie L. Corman Scholar, University of Illinois Urbana-Champaign College of Law

Sara Gerke

Sara Gerke is an associate professor of law and Richard W. & Marie L. Corman Scholar at the University of Illinois Urbana-Champaign College of Law. Her current research focuses on the ethical and legal challenges of artificial intelligence and big data for health care and health law in the United States and Europe. 

Professor Gerke has more than 60 publications in health law and bioethics, especially AI and digital health. Her work has appeared in leading law, medical, scientific, and bioethics journals, including JAMA, Science, and Nature Medicine.

Professor Gerke previously served as an assistant professor of law at Penn State Dickinson Law. Prior to that, she held the position of Research Fellow in Medicine, Artificial Intelligence, and Law at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed July 5, 2024
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