"What's Different About Cellular and Gene Transfer Trials? "

Pioneering trials such as gene therapy must undergo additional NIH DNA Recombinatorial Advisory Committee approval (DNA RAC) to ensure public safety and human subject research ethics.  The DNA RAC regulates the use of gene therapy on humans, animals and plants and allows for public input during the open meetings at NIH.  An Institutional BioSafety Committee (IBC) must also review gene transfer protocols with coordination and supervision of the DNA RAC.  IBC members consist of expert scientists whose focus is on the safety of gene transfer using infectious agents (viral gene vectors) and the risk of virulence (ability to infect others) to assure that biohazardous agents undergo biosafety containment.  Western IRB is also assisting the translation of cellular and gene therapy into clinical research trials by providing leadership and administrative services for developing a local IBC.  In addition to approval from the IRB, NIH DNA RAC, and IBC for both the principle investigator and the protocol, federal requirements for human gene transfer research must also have a facility inspection for site approval before they begin.