Office of Research Integrity
Under the NIH Guidelines and its MUSC Charter the MUSC IBC oversees research using recombinant DNA [rDNA], microbes [of all risk groups, RG 1-4], and biotoxins. Work with all Select Agents is included.
Initial applications and amendments requiring or recommended for full committee review are considered at monthly scheduled MUSC IBC meetings. Prior to the meeting they have been reviewed administratively and by members of and consultants to the Committee. Continuing reviews are filed each year by the Principal Investigators to inform the MUSC IBC of research status, reports to the NIH, and changes in the research as described in the approved application/registration. Indicated changes must be followed up with amendments to the current registration.
What are Select Agents? A current list of select agents and other updates may be found at the CDC Office of the Director Select Agent Program website.
Please contact Dan Eisenman (Biosafety Officer) if you have any questions regarding select agent registration with University Risk Management, security, shipping or transfer of select agents.
Gene Transfer Studies
IBC approval of human gene transfer studies is required before the IRB can release their approval. Experiments utilizing live and/or attenuated microorganisms, whether or not recombinant, for the purposes of human vaccination and that have not been approved by the Food and Drug Administration, must also be approved by the MUSC IBC. Special instructions apply for submission of human research to the IBC.
IBC approval is required for protocols involving the injection or other exposure of animals to recombinant DNA, microbes, and/or biotoxins. The IACUC will need the IBC approval before it can release their approval.
Approval by the IBC requires a current, satisfactory laboratory inspection of the rooms and spaces to be used that has been conducted by the Institutional Biosafety Officer (BSO). A satisfactory inspection requires submission of a satisfactory safety protocol covering the work described in the approved IBC registration(s) of the principal investigator and signed by the personnel working with or possibly exposed to the registered agents. Reinspections are conducted every two years, and when: new agents are added, there is a change in laboratory space, and there is a change in the investigator. Guidance on Facilities Inspections.
Responsibilities of the Principal Investigator are detailed in Section IV-B-7-a of the NIH Guidelines and, in addition, in Appendix M of the same document for human gene transfer studies. Section 7 of the MUSC IBC application contains responsibilities that the investigator must acknowledge and provide assurance of when submitting an application.
Any concerns regarding biosafety issues involving the use of rDNA, microbes, and/or biotoxins may be directed to:
Dr. Yashmin Karten, IBC Administrator, (792-6521)
Dr. Michael Schmidt, Chair, IBC (792-6235)
Dr. Daniel Eisenman, Biosafety Officer (792-4304), or
relayed via the confidential Compliance Hotline at 1-800-296-0269.
INCIDENT REPORTING: In the event of accidental exposure, the Principal Investigator should be contacted immediately at by phone. In addition, the Biosafety Officer, Dr. Eisenman should be contacted at either 843.792.4304 or 843.792.0590/12883. A First Report of Injury or Illness form ACORD form should be filled out.