Recombinant DNA

 Human Gene Transfer Trials

The deliberate transfer of recombinant or synthetic nucleic acids, or DNA or RNA derived from recombinant or synthetic nucleic acids, into human research participants is defined by the NIH as "human gene transfer." PIs at UMB must submit such work to the IBC for review and approval before research participants are enrolled. The IBC is charged with reviewing the safety of the research staff. 

IBC approval is institution-specific, so PIs must submit for UMB IBC approval even if they are participating in multi-center clinical trials of human gene transfer and the IBCs of other institutions have granted approval.

FDA approval of a recombinant or synthetic nucleic acid product does not exempt a research study from the IBC approval requirement.

NIH has provided the IBC clarification on the applicability of the NIH Guidelines to Human Gene Transfer trials, as follows:

Exempt from the NIH Guidelines:

• Subunit vaccines (such as the Hepatitis B and the HPV vaccines) where no recombinant nucleic acid molecules are being delivered to a human, even though they were constructed using recombinant DNA technology.
• Live attenuated or inactivated vaccines made from recombinant or re-assorted organisms created by natural recombination.  Example:  flu vaccines constructed by natural re-assortment in eggs.
• Expanded Access, also referred to as “compassionate use.” Additional information on expanded access can be obtained from the FDA web site or by contacting the UMB Human Research Protections Office.