Compliance

Overview

Under the NIH Guidelines and its Policies and Procedures 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.

Concerns

Any concerns regarding biosafety issues involving the use of rDNA, microbes, and/or biotoxins may be directed to:

Dr. Michael Smith, IBC Administrator (843-792-6535, smitmic@musc.edu)

Dr. Caroline Westwater, Chair, IBC (843-792-7703, westwatc@musc.edu) 

Dr. John J. Woodward, Ph.D., Vice-Chair IBC (843-792-5225, woodward@musc.edu), or

relayed via the confidential Compliance Hotline at 800-296-0269.

In the event of accidental exposure, the Principal Investigator and Biosafety officer (843-792-6304) should be contacted immediately by phone. In addition, immediately a First Report of Injury or Illness form ACORD form should be filled out. In case of injury, immediately proceed to employee/student health or the Emergency Room if after hours.

Investigator Responsibilities

Never initiate or modify research that requires IBC approval

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. In summary, the PI is responsible for the following:

Before IBC Approval

  • Be adequately trained in good microbiological techniques
  • Perform an initial risk assessment
  • Develop laboratory specific Standard Operating Procedures (SOPs)
  • Inform personnel of the conditions of the registered project
  • Ensure personnel has received appropriate training
  • Schedule an inspection of all locations impacted by proposed work
  • Comply with additional stipulations required by the IBC for approval

Following IBC Approval

  • Provide supervision to ensure that all personnel follows procedures and precaution outlined in IBC registration and SOP
  • Provide proper surveillance of personnel, including changes in health status (i.e. pregnancy, altered immune status, etc.)
  • Report any significant problems, violations, or accidents (ensure personnel reports accidents immediately)
  • Have any biosafety cabinets (BSCs) in the registered facilities recertified yearly
  • Notify the IBC of any changes in the registered project (personnel, location, agents, procedures, etc.)
  • Comply with continuing reviews as well as three year renewals
  • Upon completion of the project, properly dispose of agent and submit a termination form to the IBC

Select Agents

Work involving Select Agents and Toxins (SAT Homepage) (complete SAT list), whether or not exceeding permissible amounts, need to be registered with the MUSC IBC page prior to shipping to MUSC.

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 Biosafety Officer Chris Voelkel-Johnson at 843-792-6304 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.

Animal Studies

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.

Facilities Inspection

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.