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IBC Submission Process

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What is the Submission Process?

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.

A-tune's tick@lab is the protocol and research management system used for MUSC's Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), and the Division of Laboratory Animal Resources (DLAR).

Instructions for tick@lab system.

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 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.

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 to the eProtocol platform.

What?

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

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.

Clinical Trials

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

Clinical Trials & Human Research Applications

Initial Instructions for MUSC IBC Applications Involving Human Gene Transfer Studies

All human gene transfer clinical trials occurring at or sponsored by institutions receiving NIH funds for recombinant DNA research must be submitted to the NIH Office of Biotechnology Activities (OBA) for review by the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC). NExTRAC review occurs before final IBC approval in order to inform that committee of the NExTRAC's recommendations before the IBC makes its final determination.

If MUSC is added as a site in a multi-center trial and MUSC is not the lead-site, then most likely the lead-site or the sponsor will submit a package to the NExTRAC for review. The investigator at MUSC should request from the lead-site or sponsor copies of most of the documents listed below.

OBA has developed many tools to help you in your preparation of a submission to NExTRAC, including a list of frequently asked questions on their website.

The investigator at MUSC should submit an IBC application through eProtocol. At minimum the uploads listed below need to be attached. It may not be possible to provide all uploads with the initial application, but if they are not available, they should be provided as soon as possible so as not to delay IBC processing.

  • A document that contains responses to Appendices M-II through M-V of the NIH Guidelines as submitted to the NIH OBA Recombinant DNA Advisory Committee (RAC)
  • Any correspondence sent by NExTRAC to the submitting investigator regarding its review of the protocol
  • Any correspondence sent by the submitting investigator to NExTRAC in response to its review of the protocol
  • The Clinical Trial Protocol
  • The Investigators' Brochure for the clinical trial
  • Informed Consent document submitted to the MUSC IRB
  • Safety protocol covering the work described in the MUSC IBC application and specific to MUSC. [template] (DOCX)
  • Biosafety training materials to be used with personnel at MUSC who may be exposed to the IBC registered agents
  • Documentation from the Investigational Drug Services (IDS) Pharmacy regarding its role in handling the IBC registered agents
  • "Cards" to be given to study participants and/or their caregivers with information relative to aftercare such as disposal of bandages or information for health care workers that the study participant may see
  • If MUSC is not the lead-site, a document detailing the delegation (if any) of reporting responsibilities as described in section M of the NIH Guidelines. [Template] (DOCX)
    Other information requested in the IBC application form.

In addition, please note that some uploads, in particular the safety protocol, will most likely undergo multiple revisions so that during the course of processing uploads will need to be replaced with the most current versions. Each version should be dated and numbered. It is most useful if changes in versions are indicated e.g. by highlighting them.

When preparing materials, applicable Medical Center, Pharmacy, and Infection Control Policies should be referred to. HRPP 4.11, Human Gene Transfer Studies Policy and Procedures, in the MUSC's IRB HRPP Program Guide should be consulted also. See Resources for links.

Furthermore, the IBC should be contacted (smitmic@musc.edu, 843-792-6535) as soon as possible for assistance with preparation of the safety protocol and the facilities inspection. The inspection which must be conducted of all areas in which the agents being registered are received, stored, processed, and administered and those in which the study participants will be until the time of discharge. Initial instructions on preparation of a safety protocol and the facilities inspection may be accessed here.

Reporting Requirements for MUSC IBC Applications Involving Human Gene Transfer Studies

For details, please read Section 8.5 of the IBC Policies and Procedures.

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. 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.

Periodic Reviews

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

Amendments to registrations must be submitted prior to making a change in personnel, agents, procedures/practices, and facilities.

Inventory of Stored Agents

Registration Instructions

Actively Used, Unregistered Microorganisms &/or Biological Toxins

Please follow these instructions for registering agents with the IBC. There are detailed instructions for the IBC electronic registration system eProtocol. Your IBC application will be reviewed at the next monthly IBC meeting (submission deadlines). Work with the unregistered agents HAS TO CEASE while the application is pending.

Stored-Only, Unregistered Microorganisms &/or Biological Toxins

All investigators (with or without previously approved IBC protocols) should file a new application for registering agents not actively used in research but held in storage. This application will serve to keep inventory of stored-only agents, which will be reviewed administratively only. This 'storage' registration will need to be updated if agents become actively used or if agents are disposed of.

Note:

  • When registering stored-only viral vectors, there is no need to list the individual genes cloned into each vector.
  • Unless encoding a toxin, stored plasmids, cDNA, oligos etc. do not need to be registered with the IBC.

However, once you plan to actively use these, you will have to submit an (or amend your existing) IBC registration to obtain approval prior to starting experiments in accordance with the NIH Guidelines.

Instructions for registering agents held in storage only:

  • Prepare an Excel file (optional template (XLS) and upload it to the Attachment section of the eProtocol indicating:
    • PI Name
    • Storage location(s): Building and room number.
    • A list of names for each microorganism being registered (including strain if applicable)
    • A list of names for each biological toxin that you are registering.
      • Notes:
        • For each agent on the Select Agent list, please also provide the quantity held in storage. Keep in mind that certain toxins have to be at or below a Permissible Toxin amount to avoid Select Agent registration with the USDA/CDC.
        • There is no need to register endotoxin/LPS
          Note: Please store the file with the .xls extension (not .xlsx)

Contact Us

Office of Research Integrity
843-792-4148

1 South Park Circle
Building 1, Suite 401
Charleston, SC 29407