Committee on Clinical Investigation of the Johns Hopkins Medical Institutions 
prior to final institutional approval of this study. 
13.2. NIH - Recombinant DNA Advisory Committee 
In addition to FDA approval, this phase I trial will be reviewed by the 
NIH Recombinant DNA Advisory Committee (RAC) . This is in conformance with all 
US human trials of gene therapy. The NIH RAC review will evaluate scientific 
merit and potential biosafety issues involved in the use of recombinant DNA 
and retroviral vectors in human subjects. Only upon written NIH RAC approval 
will this trial proceed. Full documentation of NIH RAC proceedings and 
documented approval of this trial will be filed with the Joint Committee on 
Clinical Investigation. 
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