- What is the submission process?
- Who can register?
- What needs to be registered?
- Special instructions for Clinical Trials
- When do I need to be registered?
Prior to starting work with recombinant and synthetic nucleic acid molecules, microorganisms, and/or biotoxins, the Principal Investigator will electronically submit an application to register the agents.
Use eProtocol, our electronic application system for IACUC/DLAR/IBC, to submit an IBC application.
Active use of recombinant or synthetic nucleic acid molecules, microorganisms, and/or biological toxins:
Your IBC application will be reviewed at the next monthly IBC meeting (submission deadlines).
As part of the IBC review process, the investigator will also require to:
- Take biosafety training (all personnel on the protocol also have to take this training)
- Have a lab inspection of all the facilities used for the project. Call the BSO at 843-792-3125 to schedule.
- Prepare a safety protocol for the agent(s) being registered
Storage of microorganisms and/or biological toxins:
All microorganisms (including viral vectors, bacteria etc), irrespective of risk group, that are not actively used in research but held in storage, need to be registered with the IBC. Biological toxins also need to be registered.
For eRMA, please follow the abbreviated process for registering stored-only agents. This registration will serve to keep inventory of stored-only agents, which will be reviewed administratively only.
For eProtocol, please follow instructions for IBC submission through eProtocol (DOC).
A 'storage-only' registration will need to be updated if agents become actively used or if agents are disposed of.
Only MUSC faculty are eligible to submit IBC applications. Post-doctoral fellows, graduate students, and visiting faculty must have the faculty member with whom they are working submit applications covering their work. The faculty member must be registered in the Provost’s Office Faculty Database to be able to submit on the Electronic Research Management applications System (ERMA).
MUSC IBC approval must be obtained to use the following for research:
- Recombinant DNA (rDNA)
- Microbes [Risk group (RG) 1-4] (including agents on the Select Agents list)
- All biological toxins (including toxins on the Select Agents list)
The IBC requires registration of research involving the isolation, culture, or manipulation of known bloodborne pathogens (e.g. in blood, tissues, or cells). It is expected that investigators follow the Office of Risk Management's Blood Borne Pathogen Exposure Control Plan (PDF) for all other work involving human biological materials.
For research involving administration of these products to human subjects, special instructions apply for submission through eProtocol to the IBC.
Applications must be submitted prior to the initiation of work with the agent(s) being registered. The IBC meets monthly and submission deadlines are three weeks before the meeting. Submissions should be done in a timely manner as needed to permit:
- Submission of grant proposals
- Release of funds for approved proposals
- Achievement of a satisfactory laboratory inspection conducted by the Institutional Biosafety Officer (BSO) as required for IBC approval. Call 792-6521 to schedule
- Release of approvals from other regulatory committees (IACUC and IRB) requiring IBC approval for their applications involving use of agents registered by the IBC.
- Approved protocols in eProtocol are active for three years and require annual continuing review. After the 3rd year, the PI will need to submit a new IBC application in eProtocol. The IBC may determine that the research risk is of significant magnitude meriting review more frequently than on an annual basis. Prior to a registration’s expiration date, the IBC staff will send the Principal Investigator a timely reminder of approval expiration.
Amendments to registrations must be submitted prior to making a change in personnel, agents, procedures/practices, and facilities.