An IBC is an oversight body that assesses the risks to research staff, participants, facilities, and communities that handle, store, manipulate, transport, and dispose of investigational products containing engineered genetic materials. IBCs help ensure compliance with NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, first published in July 1994 and most recently updated in April 2019.
What Types of Research Require IBC Review?
IBC review involves the deliberate transfer of engineered genetic materials to human research subjects, including the following types of studies:
- Gene therapy
- Gene editing
- Vaccines containing engineered genetic material
- E.g., virus-based vaccines, genetic vaccines, mRNA based vaccines
- Genetically modified cellular therapy and immunotherapy
- E.g., CAR T cells, engineered T cell receptor
- Genetically modified microorganisms
- Regenerative medicine
Learn how Advarra can assist with the registration process and completing IBC reviews.