Question:

I represent a clinical trial sponsor. Does my Human Gene Transfer (HGT) clinical trial require IBC approval at all sites?

Response:

Looking at this question from a sponsor perspective, points to consider include the following:

  • Does the Sponsor currently receive any direct NIH funding for research involving recombinant or synthetic DNA or RNA (for this or for other projects)? If so, all Human Gene Transfer (HGT) research conducted by Sponsor company requires IBC approval at each domestic clinical trial site.
  • Does the investigational product (IP) contain recombinant or synthetic DNA or RNA materials developed by the Sponsor using current or past NIH funding? If so, any clinical research using this IP requires IBC approval at each domestic clinical trial site.
  • Does the investigational product (IP) contain recombinant or synthetic DNA or RNA materials developed using NIH funds by some other business or institution, such as an academic research institution, and does that business or institution currently have contractual arrangements with the Sponsor? If so, any clinical research involving those materials requires IBC approval at each domestic clinical trial site.