The Institutional Biosafety Committee (IBC) is responsible for ensuring that recombinant DNA (rDNA) activities comply with The National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) . The principal investigator is required to submit a registration document for all recombinant DNA experiments that are not exempted from the NIH Guidelines. The rDNA registration document must be reviewed and approved by the IBC prior to the initiation of the research.
The UI IBC and Institutional Review Board (IRB) will not approve projects involving gene therapy until after the protocol has been registered with NIH. It is the responsibility of the initial study site to submit documentation from all oversight bodies involved in the review regarding their assessment of whether public Recombinant DNA Advisory Committee (RAC) review is warranted along with the submission from the Principal Investigator. The UI investigator should provide to the IBC and the IRB documentation of NIH protocol registration along with any correspondence from RAC, if applicable.
In October 2000, the NIH Recombinant DNA Advisory Committee (RAC) put new procedures in place regarding the timing of review of human gene transfer research protocols. The U of I IBC and Institutional Review Board (IRB) will not review projects involving gene therapy until after RAC review has occurred. The investigator should provide to the IBC and the IRB correspondence from RAC that indicates RAC has completed or waived its review of the protocol.
The IBC notifies the IRB of its approval of projects using recombinant DNA, but deliberations of the IBC are not shared with the IRB unless there are specific subject protection issues raised by the IBC. To prevent delays in the total review process, at its discretion, the UI IRB may allow concurrent review by the UI IRB and the IBC and defer release of the study contingent upon receipt of IBC approval.
Protocols requiring IBC review are retained for review by UI IRB-01 and are not sent to the Western Institutional Review Board (WIRB) regardless of industry sponsorship.
Direct questions to:
Interim Biological Safety Officer
Louis V. Kirchhoff