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2021 AER Conference

Exhibitor Symposia

Research Involving Data and Biospecimens Track

AER21 Mid-day Break Sponsored Presentation by WCG IRB: Critical Considerations for Informed Consent in Cell and Gene Therapy Trials

Wednesday, November 17, 2021
1:00 PM – 1:45 PM ET
Location: Livestreamed

Sponsored By 
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Compared to other types of clinical research, the informed consent process in cell and gene therapy poses special challenges when it comes to ensuring that participants are fully informed about issues relating to investigational products and associated risks.

Learning Objectives:

  • Learn about the history of NIH guidance for review of informed consent forms in human gene transfer research
  • Review current best practices for IRBs and IBCs to work together on informed consent form review
  • Outline major categories of risk associated with cell and gene therapy clinical research
  • Share tips for clear communication regarding complex and novel gene transfer technologies