About This Video:

Gene transfer technology is playing an increasingly important role in the development of vaccines for COVID-19 and other infectious diseases, as well as therapies for a broad array of indications including cancer and rare inherited disease. In the oncology sector, several gene transfer products using CAR-T or oncolytic virus technology already have FDA approval, with hundreds of new products in development. Most clinical gene transfer research in the U.S. is subject to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines). That means that in addition to IRB review, these clinical trials must also be approved by an Institutional Biosafety Committee (IBC).

While IRBs are concerned with the ethical conduct of research and protection of study participants, IBCs are concerned with protecting staff, visitors, and the general public through safe handling of DNA, RNA, and genetically modified viruses and microbes. IBC approval at each site is a critical step in any gene transfer research subject to NIH Guidelines, and sites and investigators intending to conduct trials in this rapidly growing sector need to understand the requirements and best practices for IBC reviews.

What You’ll Learn:

  • Review what novel vaccines and therapies qualify as gene transfer products per NIH’s definition.
  • Understand when IBC review is required at clinical trial sites.
  • List major considerations for safe handling of genetically modified products or viral vectors.
  • Summarize recent changes in IBC and IRB review per amendments to NIH Guidelines.
  • Compare the process for local vs. central IBC administration in multicenter trials.