Clinical Research Education Series (CRES) | “Regulatory Updates: Changes Affecting Human Subject Research"

June 25, 2025

This presentation will provide a brief overview and education about recent changes and updates to regulatory guidance affecting human subject research. We will discuss and provide clarity on FDA expectations, highlight the responsibilities of IRBs, review changes to ICH E6 as well as other helpful information! 

Target Audience

Employees at Houston Methodist Hospital Research Institute 

Learning Objectives

Participant Learning Outcomes:

  • Provide an overview of recent changes to regulatory guidance affecting human subject research.

  • Clarify FDA expectations for protocol deviations. 

  • Discuss protocol deviation response process and responsibilities of the IRB and Investigators

  • Explain ethical considerations for biopsies in clinical trials 

  • Discuss revisions to ICH E6 

 

 

Course summary
Available credit: 
  • 1.00 Attendance
Course opens: 
05/29/2025
Course expires: 
06/29/2025
Event starts: 
06/25/2025 - 12:00pm CDT
Event ends: 
06/25/2025 - 1:00pm CDT
Add to calendar: 
Virtual Meeting
Houston, TX
United States

Virtual - ZOOM link with be provided to the registered participants.

Presenter(s) Info:

 Cindy Gates, JD, ADN, CIP 

1.00 Attendance

Available Credit

  • 1.00 Attendance
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