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eResearch NextGen Teams

Steering Committee

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

Project Management Team (PMT)

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

Judith Birk, IRB Executive Director and HRPP Associate Director
Mary Locey, ITS Product Manager, Regulatory Management system
Lark-Aeryn Speyer, IRBMED Coordinator, Regulatory Lead
Delaney Brewer, HRPP Business Process Analyst
Terri Ridenour, HRPP Project Manager
Lori Deromedi, HRPP Change Management Consultant

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

Working Groups

The eResearch NextGen working groups are composed of representatives from U-M study teams, IRB staff and board members, and ancillary units (as applicable) who are regularly involved with biomedical and social/behavioral human research at U-M.  These volunteer researchers, coordinators, and administrators provide key input into the redesign efforts from the study team and IRB perspective.

Phase I

STANDARD INTERACTION/INTERVENTION APPLICATION

The Standard Application working group is charged with evaluating and designing the intervention/interaction, non-exempt human research application. 

Project deliverable:  Model for the intervention/interaction human research application for non-exempt research in eResearch Regulatory Management, including the core question set and organization.

Status:  Complete

PROTOCOL

The Protocol working group will evaluate various protocol templates to develop guidance to assist U-M study teams in selecting the appropriate protocol for their research. 

Project deliverables:

  • Protocol checklist outlining the key information to include in a study protocol.
  • U-M protocol template(s) for specific study designs that may be used in cases where a sponsor template (e.g., NIH, industry) is not applicable.

Status:  In progress

DRUGS & DEVICES

The Drugs & Devices working group will focus on the human research application questions related to the use and/or development of FDA regulated drugs and devices in human research.

Project deliverables:

  • Validation and design of the question set required for the IRB review of FDA-regulated studies.
  • Identification of data needed for the MICHR IND/IDE Investigator Assistance Program (MIAP) ancillary review.

Status:  Complete

REVIEWER TOOLS:  METHODS and MANAGEMENT

The IRB-focused Reviewer Tools working group will evaluate the design and functionality of the system tools and processes IRB staff and board members use to review and make determinations on human research applications.

Project deliverable:  IRB staff reviewer checklist, IRB (board member) reviewer checklist.

Status:  Complete

STUDY TEAM

The Study Team working group will consider the U-M study team roles, responsibilities, and requirements, and evaluate the design of the study team questions in the human research application

Project deliverables:  Study team roles and definitions and the study team question set for the human research application.

Status:  In Progress 

DOCUMENT MANAGEMENT

The Document Management working group is responsible for developing business processes and guidelines to manage the supporting documents uploaded in the human research application.  

Project deliverables:  Evaluation of, and recommendations for, the Uploads & Links section of the human research application, document categories and naming conventions, watermarking requirements.

Status:  In Progress

Phase II

EXEMPT and NOT REGULATED APPLICATION

The Exempt and Not Regulated Application working group is charged with evaluating and designing the exempt and secondary use (exempt and regulated) application questions, and the not regulated application considerations.  This working working group will collaborate with the Protocol and Reviewer Tools working groups to make recommendations regarding protocol requirements and IRB staff and board member reviewer checklist.

Project deliverables:  Exempt, secondary use, and not regulated application questions and design.

Status:  In Progress

MULTI-SITE APPLICATION

The Multi-site Application working group will examine the business processes and information required for IRB oversight of multi-site/collaborative research to streamline and reduce redundancy.

Project deliverables:  Multi-site and ceding application questions and design.

Status:  In Progress

Questions?

Have questions about the eResearch NextGen: Human Research Application project?  Email the Project Management Team at Next.Gen.PMT@umich.edu