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Office of Research Integrity

IBC Submission Process

•  What is the submission process
•  Who can register?
•  What needs to be registered? 
             - Special instructions for Clinical Trials
•  When needs to be registered?
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What is the submission process?

The IBC registration process is conducted on the Electronic Research Management applications System (ERMA) accessible at https://erma.musc.edu/. A NetID is required to login.  

Registering use of recombinant or synthetic nucleic acid molecules, microorganisms and/or biological toxins:

Detailed instructions for the IBC electronic registration system (eRMA)

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:

  1. take biosafety training (all personnel on the protocol also have to take this training)
  2. have a lab inspection of all the facilities used for the project 
  3. prepare a safety protocol for the agent(s) being registered 

Registering 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.

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. 

This 'storage-only' registration will need to be updated if agents become actively used or if agents are disposed of.

Eligibility

 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).


What?

MUSC IBC approval must be obtained to use the following for research:

For keeping microorganisms and/or biological toxins in storage only (not actively in use) an abbreviated registration process can be followed. Once agents are utilized in research, they have to be registered following the normal route. 

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 (BBP) Exposure Control Plan for all other work involving human biological materials.

Clinical Trials
For research involving administration of these products to human subjects, special instructions apply for submission to the IBC.

When?

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
  • release of approvals from other regulatory committees (IACUC and IRB) requiring IBC approval for their applications involving use of agents registered by the IBC.

Periodic Reviews
Unless renewed by Continuing Review, an approved initial application is active for one year. For all approved applications (registrations), 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
Amendments to registrations must be submitted prior to making a change in personnel, agents, procedures/practices, and facilities.