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Artificial Intelligence (AI)/Machine Learning (ML)/ Big Data IRB Collaborative Working Group

Our Goals

Artificial Intelligence (AI)/Machine Learning (ML)/Big Data IRB Collaborative Working Group aims to develop guidance for our respective HRPPs, with an emphasis on IRB review processes of AI Tool protocols, which will then be shared widely with other institutions. The Working Group includes subgroups to address various aspects of the challenges posed by research studies proposing to use, develop, validate, or implement an AI-based intervention.

Why We Formed

Recognizing a gap in HRPP/IRB guidance related to AI/ML/Big Data research, we formed a collaborative effort with 14 other institutions and PRIM&R.

Our Deliverables

  • Best practice guidance documents and checklists for the following subtopics led by subgroups:
  • IRB/HRPP Scope and Oversight
  • Ethics
  • Identifiability (meeting the OHRP definition of Human Subjects Research)
  • Data Quality
Our deliverables: The working group is developing deliverables such as general guidance recommendations and customizable checklists and tools. Identifiability (Meeting the OHRP definition of Human Subjects Research)
If you have any feedback on our deliverables or any recommendations for our group, please let us know here.
Dartmouth Health
Shannon Sewards, MA, CIP, Director of the HRPP
Emory University
Michelle Kalbeitzer, MSIOP, Research Protocol AnalystShara Karlebach, WHNP-BC, CIP Associate Director, QA/Education TeamBriana Rotterman, MS, MA, CIP Research Protocol Analyst, QA/Education TeamRebecca Rousselle, BA, CIP Assistant Vice President for the HRPP
Georgia Institute of Technology
Melanie Clark, CIP Associate Director of Research Integrity Assurance
Indiana University
Purna Garimella, MS, RAC, Director, HRPP
Johns Hopkins University School of Medicine
Megan Singleton, JD, MBE, CIP, Associate Dean for Human Research Protection and Director of the HRPP
Mass General Brigham
Donella Comeau, MD, Diagnostic Radiology, Radiology, Neuroradiology Martha Jones, MA, Vice President, Human Research Affairs Benjamin Silverman, MD, Senior IRB Chair, Director of Ethics at McLean Institute for Technology in Psychiatry, McLean Hospital; Instructor in Psychiatry, Harvard Medical School
Mayo Clinic
Tamiko Eto, MA, MS, CIP, Director, HRPP and IRB Research Operations Melissa Kuntz, Education Coordinator, IRB Kathleen McNaughton, JD, Administrator, Research Compliance
PRIM&R
Ivy Tillman, EdD, CCRC, CIP, PRIM&R Executive Director
Stanford University
Shana Stolarczyk, MEd, CIP, Senior HRPP Manager
The University of Texas at Austin
Kristen Crabtree, BA, CIP, Director, HRPP
University of California San Francisco
Edward Kuczynski, Director, HRPP
University of Florida
Ivana Simic, PhD, CIP, Associate Director, IRBs
University of Washington
Jason Malone, MPA Director, Human Subjects Division Maria Savage, Associate Director of Systems and Initiatives, Human Subjects Division
Vanderbilt University Medical Center
Don Mitchell, BA, CIP Operations Manager, HRPP Kyle Rybczyk, FNP-BC, CIM, CIP, Director, HRPP
Washington University in St. Louis
Jeanne Velders, JD, CIP, Executive Director, Human Research Protection Office