Does Human Gene Transfer research at my site require IBC approval?

Question:

I represent a clinical trial site. Does Human Gene Transfer (HGT) research at my site require IBC approval?

Response:

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

• Does my site belong to an institution or business that currently receives any direct NIH funding for research involving recombinant or synthetic DNA or RNA? If so, then all HGT clinical trials conducted at this site require IBC approval.
• Does a specific HGT clinical trial involve funding at the product or sponsor level as defined above? If so, then that specific clinical trial requires IBC approval.
• Our subject matter experts are happy to answer questions from Sponsors, CROs, and sites about specific applications of the NIH Guidelines and expectations for IBC review. Please address any questions to our online form. When we receive your question, a member of our team will personally follow up within the same business day.