Webinar: IRB Review of Human Gene Transfer Protocols

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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.

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.


Charlotte ColeyCharlotte Coley, MACT, CIP is the education and training manager for the University of North Carolina Chapel Hill Office Human Research Ethics. She is a Certified IRB Professional (CIP) since 2003 and has over twenty years of experience working with both behavioral and clinical research IRBs. Prior positions have included IRB administrator, office director, and education director at both Battelle Memorial Institute and Duke University Health System IRB for Clinical Research. Charlotte's early career included working on environmental, public health and international education projects with several U.S. Departments and Agencies, including the EPA, NIEHS, AID, CDC, State and the United Nations Industrial Development Organization both at UNC Chapel Hill and with several consulting firms. She is an active member of PRIM&R and received the Distinguished Service Award in 2009. Charlotte is a frequent presenter at PRIM&R national and regional conferences and a faculty member of the At Your Doorstep Program. Charlotte is a nonscientist member of the UNC Chapel Hill and the Copernicus Group Independent IRB and serves as an AAHRPP Step 1 reviewer and site visitor. Charlotte has a Bachelor's degree in politics from St. Andrews Presbyterian College, a Master of Arts in College Teaching in political science from UNC Chapel Hill and is a graduate of two Disney Institute programs for which she was awarded a Mickey.

Joan RobbinsJoan Robbins, PhD is senior vice president of biosafety and gene therapy and has been with WCG Biosafety since March 2016. Prior to that, she was vice president of translational research at Tocagen, Inc., an immuno-gene therapy company focused on retroviral replicating vectors. She also served as chief scientific officer of ADVENTRX Pharmaceuticals, Inc., vice president of product development at Immusol, Inc., and is the co-founder of two virus and biologic specialty manufacturing companies. She has extensive experience in gene therapy clinical development, vector manufacturing, and regulatory interaction. She trained at the NIH NCI Laboratory of Tumor Immunology and Biology and received her B.S. in genetics from the University of California, Davis, and PhD in Genetics from the George Washington University, Washington D.C.

Background Reading

NIH RAC Revisions Factsheet, April 2016

Certificates of Attendance

Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext. 0.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP® recertification can be found here.

Contact Information

If you have additional questions about webinar archives, please contact us by phone (617.423.4112, ext. 1876) or via email.