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

Who Are We

Who Are We

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

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 goals:
The 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.

Our planned deliverables:

Our planned 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. Please check back in late 2024 for additional information.

Members

 

Dartmouth Health

 Shannon Sewards, MA, CIP, Director of the HRPP

Emory University

Michelle Kalbeitzer, MSIOP, Research Protocol Analyst
Shara Karlebach, WHNP-BC, CIP Associate Director, QA/Education Team
Briana Rotterman, MS, MA, CIP Research Protocol Analyst, QA/Education Team
Rebecca 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, Instructor in Psychiatry 
 

Mayo Clinic

Tamiko Eto, MA, MS, CIP, Director, HRPP and IRB Research Operations 
Melissa Kuntz, Education Coordinator, IRB 
Kathleen McNaughton, JD, Administrator, Research Compliance 

URL: https://www.mayo.edu/research/institutional-review-board/overview

PRIM&R

 Ivy Tillman, EdD, CCRC, CIP, PRIM&R Executive Director 

Stanford University

Shana Stolarczyk, MEd, CIP, Senior HRPP Manager 

URL: https://researchcompliance.stanford.edu/panels/hs  
 

The University of Texas at Austin

 Kristen Crabtree, BA, CIP, Director, HRPP 

University of California San Francisco

Edward Kuczynski, Director, HRPP 

https://irb.ucsf.edu/ 
 

University of Florida

 Ivana Simic, PhD, CIP, Associate Director, IRBs 
 

Indiana University

 Purna Garimella, MS, RAC, Director, HRPP

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, Executive Director, Human Research Protection Office