Coordination of Approvals

Human Gene Therapy Research is defined by federal regulations as “any deliberate transfer of recombinant DNA, or DNA or RNA derived from DNA into human research subjects”. Specific provisions are necessary for conducting human gene transfer research at UCLA. Principal Investigators must complete a series of different reviews and approvals at the institutional level as well as the federal level (see NIH Guidelines for Research Involving Recombinant DNA). The approvals listed below are also required for the transfer of human cells (autologous or allothropic) transformed with recombinant DNA administered to human subjects