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Description

With the transition to remote work due to the COVID-19 pandemic, research teams, Institutional Review Boards (IRBs), and others supporting human research have worked to develop alternate workflows for processes that would normally be done face-to-face.

This webinar explores the conduct of remote informed consent including components, process options, documentation requirements, and agency-specific regulatory requirements and flexibilities. The webinar discusses how to adapt face-to-face processes to remote, including options for electronic consent documentation. It includes real world examples in various research scenarios.

 

Learning Objectives

  • Consider requirements that apply to remote consent processes and documentation including HHS, HIPAA, and FDA regulated research.
  • Adapt informed consent components for a remote process including areas of regulatory flexibility afforded by agencies due to the pandemic.
  • Explore electronic consent solutions and challenges.
  • Review remote consent process examples in various research scenarios.

 

Audience

Research Administrators, Faculty, Students

 

Meet the Presenter

Belinda Smith, MS, RD, CCRC – University of Kentucky Office of Research integrity
Belinda Smith is a research education specialist with 34 years of experience, beginning in clinical research coordination and evolving into human subject protections. She currently oversees education and outreach for the University of Kentucky Human Research Protection Program and provides FDA consultation for the Office of Research Integrity and IRBs.