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IRB NextGen Teams

redesign projectThe IRB NextGen Project is a cross-campus collaborative effort to design and construct the next version of U-M's IRB application and IRB review processes with a focus on increase the quality and efficiency of data, right-sizing buren among the study team and the IRB, and improving the overall process for researchers, IRB memebers, and IRB staff.  

Steering Committee

The Steering Committee provides leadership and institutional perspective for the project.  Members of the steering committee represent U-M's Human Research Protection Program (HRPP), the U-M IRBs, and our ITS eResearch partners.  

Judy Birk, HRPP Associate Director, IRB Executive Director
Lori Deromedi, UMOR Research Ethics & Compliance Change Management
Kevin Ferrell, IRBMED Manager
Lana Gevorkyan, IRBMED Assistant Director
Cathy Handyside, ITS eResearch Director
Mary Locey, ITS Product Manager
Lindsey Mitchell, UMOR Project Senior Manager
Mary Ramirez, IRB-HSBS Assitant Director
Kathy Rogers, UMOR Research Ethics & Compliance, Project Administration
Kate Sasamoto, ORCR, Senior Research Compliance Associate
Sana Shakour, HRPP Associate Director, HRPP Operations 
Cindy Shindledecker, IRB-HSBS Director
Lark-Aeryn Speyer, IRBMED Coordinator
Pat Ward, Director of Regulatory Affairs
Corey Zolondek, IRBMED Assistant Director, Operations

Contact the Steering Committee at:  NextGenIRBSteering@umich.edu

Project Management Team (PMT)

The Project Management Team (PMT) organizes the project working groups and runs the project activities and reports up to the Steering Committee.  

Kevin Ferrell, IRBMED Manager
Mary Locey, ITS Product Manager
Lindsey Mitchell, UMOR Project Senior Manager
Mary Ramirez, IRB-HSBS Assitant Director
Kate Sasamoto, ORCR, Senior Research Compliance Associate
Lark-Aeryn Speyer, IRBMED Coordinator

Contact PMT at:  Next.Gen.PMT@umich.edu

Working Groups

Multi-phase workThe IRB NextGen Project working groups are comprised of volunteers from across the U-M campuses and health system who are regulary involved with biomedical and social/behavioral human subjects research at U-M.  These volunteer researchers, coordinators, and administrators provide key input into the redesign efforts from the study team and IRB staff perspective.  Multiple working groups will be established for work throughout phase 1 and 2 of the project.

Standard Application Working Group (SAW)

The SAW group is charged with evaluating and designing the core section of the IRB application, which gives the IRB Office and Boards the key information to review the study.  SAW members represent various study team roles, including: 

  • Principal Investigators
  • Research Staff
  • Study Coordinators / Project Managers
  • Survey Specialists
  • Research Compliance Specialists
  • Research Administrators
  • IRB Staff
If you wish to volunteer for an IRB NextGen Working Group, contact Next.Gen.PMT@umich.edu

Drugs & Devices

This working group will evaluate and design the IRB application questions related to the use and/or development of FDA regulated drugs and devices in human subjects research.  

Special & Vulnerable Population Details

This working group will review and design the IRB application questions that provide additional detail to the IRB Board for their evaluation of the participation of certain groups (e.g., children) in the research.

Study Team Details

This working group will reconsider how U-M identifies members of the study team on the IRB application and the study team requirements by team role.