Help with IBC Applications
All research involving recombinant DNA, microorganisms or biological toxins must be registered with the MUSC Institutional Biosafety Committee (IBC). IBC applications are submitted electronically via the ERMA system.
|The IBC meets the first Thursday of each month. Registration documents must be received by the IBC no later than three weeks prior to the meeting where they will be reviewed.|
Overview of the MUSC IBC Review Process
IBC applications undergo three stages of review.
- Initial review by the IBC Administrator upon submission
- Pre-review by the IBC
- Review and discussion at the monthly IBC meeting
Applications may be returned to the Investigator following any stage of review along with feedback and requests for revisions. Please note, IBC reviewers are unable to review applications once they have been returned to the Investigator for revision. Failure to resubmit applications in time for the IBC meeting will prevent the IBC from reviewing the application at that month's meeting and will result in the application being delayed until the following month's meeting. A PowerPoint presentation is available to provide more information about the structure of the IBC forms and the associated review process.
Investigators are welcome to contact the IBC Administrator to request to be present at the IBC meeting to participate in the discussion of their application. The Investigator will not be allowed to remain at the meeting during the voting process for their application or for review of applications submitted by other Investigators.
Investigators are welcome to contact the IBC Administrator or the Biosafety Officer for assistance at any point during the IBC registration process. The IBC administrator can assist with any technical issues involving the online software. The Biosafety Officer can be contacted for assistance involving risk assessments, containment, safety practices and lab inspections. Contact the IBC Administrator or Biosafety Officer
All new applications and amendments including changes to Investigators, locations or agents will require lab inspections as conditions of approval. Lab 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.
Research in which IBC registered agents will be administered to animals will require both IBC and IACUC approval. The IACUC Biological Materials Appendix (BMA) must be submitted to the Biosafety Officer to review. The Biological Materials Appendix will be approved once IBC approval has been granted. The IACUC will review applications independent of IBC review and can grant approval pending approval of the BMA form by the Biosafety Officer.
Human gene trasfer (HGT) studies require both IRB and IBC approval and typically require a minimum of 2-3 IBC monthly review cycles in order to obtain IBC approval. Please note, failure to provide the necessary documentation or delays in submitting requested revisions will delay the IBC review process. A safety protocol detailing the necessary containment and safety practices for use of the agent will undergo thorough IBC review. The IBC will provide feedback and request revisions in order to finalize the safety protocol prior to the facility inspection taking place. The facility inspection will focus largely on the containment and safety practices detailed in the safety protocol. The following provides instructions in drafting safety protocols for HGT studies.
- Guidance to the IBC forms
- Help with recombinant DNA classification categories
- Help registering laboratory strains of E. coli
- Help writing amendments to add viral vectors
- Help registering core facilities
- Frequently asked questions (FAQ) page
- IBC Project Termination Form
- Contact the IBC Administrator or Biosafety Officer
- Introduction to Retroviral Vectors
- Introduction to Adenoviral Vectors
- Adeno-Associated virus (AAV) Safety Protocol
- Biosafety Training Modules
- Biosafety Training Modules on iTunes
- NIH Guidelines for Research Involving Recombinant DNA
- Biosafety in Microbiological and Biomedical Laboratories, ed. 5