Registering Core Facilities with the IBC
Core facilities utilizing recombinant DNA, microorganisms or biological toxins are required to register with MUSC's Institutional Biosafety Committee (IBC) prior to using these agents. Registrations are submitted via the ERMA system. The IBC registration process for core facilities follows the general IBC registration process with some minor difference which are detailed below.
Section 3 of the IBC application requests a general description of services provided by the core which may involve recombinant DNA, microorganisms or biological toxins. The function of the core facility should be disclosed along with a brief narrative of the types of manipulations that will be performed. The narrative must state the core will comply with the following three conditions.
(1) The application will cover the functions of the core facility and will be entirely separate from the core personnel's research.
(2) The core will require a copy of the IBC approvals for all contracting Investigators prior to performing any work involving IBC registered agents.
(3) The core and it's records are subject to inspection by the Biosafety Officer to ensure compliance with NIH Guidelines for Research Involving Recombinant DNA and the CDC's biosafety guidelines, Biosafety in Microbiological and Biomedical Laboratories (BMBL).
Section 4 requires the disclosure of any procedures involving recombinant DNA manipulations performed by the core. Section 4e requires a listing of genes to be manipulated.The response to section 4e can indicate the genes will be covered by the registering Investigators' IBC registrations if the core is unable to predict the genetic modifications requested by its customers. Genetic manipulations requested of the core by contracting Investigators must be registered with the IBC via the Investigators' IBC application.
Applications and amendments including changes to the locations, agents or Investigators serving as Core Directors will require inspection of core facilities as conditions of approval. Core facility inspections are conducted by the Biosafety Officer and can be performed prior to discussion at the IBC meeting or following the meeting as a stipulation of approval. The following link details what inspections entail and provides guidance in preparing for a lab inspection.
In order for the inspection to be considered satisfactorily completed, a copy of the lab's safety protocol must be submitted to the Biosafety Officer. The safety protocol must cover each microbial agent being registered with the IBC and be signed and dated by all study personnel in order to document safety training. Template safety protocols are available for download.
Section 5 requires the disclosure of information specific to microorganisms that will be utilized by the core. Common examples of procedures which would require entries for both Section 4 (rDNA) as well as Section 5 (microbes) include:
- Propagation of plasmids or expression of recombinant proteins in E. coli or S. cerevisiae
- Production of recombinant viral vectors or use of such vectors