The Gene Transfer Safety Assessment Board conclusions also would need to be disseminated to these parties in a timely manner. A subject identifier is a major benefit of these forms. This enables the Gene Transfer Safety Assessment Board and the public to determine if SAEs are in one or more subjects. It is understood that the information collected in each form is destined for different uses. The identification in applications of all IBCs, IRBs, and the proposed clinical sites that are required in Appendix M of the guidelines does not always occur.
Some studies involve multiple clinical investigators at more than one hospital or university.
It must be an absolute requirement to identify these investigators and locations in applications. The sponsor needs to train the PI, or provide PIs with information related to the gene therapy agent. The Gene Transfer Safety Assessment Board Working Group should include an epidemiologist and a pathologist. The basic science molecular biologists often bring to the discussion less well known aspects of molecular mechanisms associated with gene transfer. The perspective of a biological safety professional is not only beneficial, but ultimately necessary for this Working Group to address all aspects of health and safety.