The number and variety of clinical trials involving Human Gene Transfer (HGT) is expanding at a rapid pace. While there is a comfort level with some HGT agents after years of clinical experience, new agents are continuously being developed. Even previously tested agents occasionally show unexpected serious adverse events. For example, a recent phase 2 study testing CAR T-cells was briefly halted after the deaths of three subjects. (Presented on October 19, 2016)
HGT studies present unique challenges for IRB review, as many IRBs lack the expertise to evaluate these protocols. The recent NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, released on April 27, 2016, details a new system in which IRBs are responsible for assessing whether review by the NIH Recombinant DNA Advisory Committee (RAC) is warranted. With the IRB's role in this research increasing, how can the efficient and timely review of HGT studies be facilitated while continuing to protect human subjects?
In this intermediate-level webinar, a biosafety and gene therapy expert and a nonscientist IRB member will cover the following topics as they relate to reviewing HGT protocols:
- Gene Therapy 101: a primer on HGT, its defining characteristics, and how to recognize it
- Coordination between the IRB, Institutional Biosafety Committee (IBC), and RAC in accordance with the new NIH guidelines
- Informed consent elements
- Assessing risks and benefits
What will I learn?
After attending this webinar, attendees will be able to:
- Recognize the defining characteristics of human gene transfer (HGT) studies
- Determine when RAC review is required under the new NIH guidelines
- Understand special considerations for informed consent and risk assessment
Who should attend?
This intermediate-level webinar will benefit IRB and IBC professionals, members who review protocols involving HGT or who may review this type of research in the future, and those responsible for oversight of their institution's HRPP. This webinar will be beneficial for both scientist and non-scientist IRB members.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
Access to purchased content will be available for 90 days after the date of purchase. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. Content purchased prior to January 1, 2021 will remain available indefinitely. After access has expired, users can purchase an additional 90 days of access.
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