Human Gene Therapy and Vaccine Trials

An IBC is required for institutions receiving support from the National Institutes of Health (NIH) for recombinant DNA research. The roles and responsibilities of the IBC and Principal Investigators (PIs) are spelled out in detail in the “NIH Guidelines For Research Involving Recombinant DNA Molecules (NIH Guidelines)”.

Human Gene Therapy Trials
The deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human research participants is defined by NIH as human gene transfer. PIs at UM must submit such work to the NIH Recombinant DNA Advisory Committee (RAC) for review and to the IBC for review and approval before research participants are enrolled. UM investigators participating in multi-center clinical trials of human gene transfer must obtain IBC approval before research participants are enrolled even though the project sponsor has obtained NIH RAC review and approval. The NIH requirements for protocol submission, review, and reporting of human gene transfer research are found in Appendix M of the NIH Guidelines.

Certain types of human gene transfer experiments, often referred to as vaccine trials, are exempt from the requirements for NIH RAC review and reporting. However, they are not exempt from IBC review. Specifically, this exemption applies to human studies in which induction or enhancement of an immune response to a vector-encoded microbial immunogen is the major goal, and such an immune response has been demonstrated in model systems, and the persistence of the vector-encoded immunogen is not expected. When all three criteria are met, investigators need only submit the information requested in Appendix M-II through M-V of the NIH Guidelines to the IBC.

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

Exempt from the NIH Guidelines:  IBC registration and review not required

IBC review and approval required

Subunit vaccines (such as the Hepatitis B and the HPV vaccines) where no recombinant DNA molecule is being delivered to a human, even though they were constructed using recombinant DNA technology.

DNA vaccines, sometimes called naked DNA vaccines.

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.

Live attenuated or inactivated vaccines made from recombinant or re-assorted organisms using recombinant DNA technology.  Example:  flu vaccine created by “reverse genetics.”

Research Involving Recombinant DNA and Infectious Agents
In addition to human gene transfer protocols, the IBC requires registration and review of all laboratory research with recombinant DNA molecules as defined by the NIH Guidelines.  Research conducted with non-recombinant microorganisms that are pathogenic to humans, plants, or animals as well as research using select agents also requires registration.

For more information on the NIH requirements for human gene transfer work, see the NIH FAQ web site. For more information on the IBC, contact Melissa Morland at 410-706-7845, or Steven Deck, Acting Director at 410-706-7055. Instructions for submission of research protocols for IBC review are found at this URL.