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Registering Human Gene Transfer Studies

Clinical trials involving Human Gene Transfer (HGT) or gene therapy must obtain Institutional Biosafety Committee (IBC) approval as well as IRB approval in order to register MUSC as a study site. MUSC IBC applications are submitted online via the ERMA system. The following serves as a checklist for registering HGT studies. Depending on the needs of the HGT trial, the Investigator may need to refer to applicable Medical Center, Pharmacy and Infection Control policies as well as the applicable section of the MUSC IRB HRPP Program Guide (section HRPP 4.11, Human Gene Transfer Studies Policy and Procedures). Investigators and study coordinators must be aware of the general responsibilities assigned by NIH Guidelines to investigators conducting recombinant DNA research. Other useful information may be found in the NIH Office of Biotechnology Activities (OBA) Clinical Research Policy Analysis and Coordination page.

Please note: HGT trials originating at MUSC must be reviewed by the NIH Recombinant DNA Advisory Committee (NIH RAC) prior to IBC and IRB review at MUSC. NIH OBA also provides supplementary material that may assist investigators in applying relevant sections of NIH Guidelines' Appendix M to their HGT submission to the NIH RAC.

Facility Inspections

IBC approval will be contingent upon satisfactory completion of a facility inspection conducted by the Institutional Biosafety Officer. If utilizing facilities within the MUSC Medical Center, an Infection Control representative must also be present. The Principle Investigator or a study representative knowledgeable in all aspects of the use of the biological agent must be present during the inspection. The Principle Investigator must be present at the conclusion of the inspection to discuss any deficiencies and sign the necessary documentation.

All facilities where the agent is stored, manipulated (including dispensing and administering to patients) and inactivated must be inspected. The inspection will focus on the containment and safety practices described in the safety protocol as well as compliance with universal precautions and safety practices for work at the designated biosafety level. The following link may provide some assistance preparing for the inspection, however it was designed for biomedical research laboratories and may not be entirely applicable for all clinical settings: www.musc.edu/biosafety/BSL2 

If inspecting multiple facilities (e.g. Investigational Drug Service Pharmacy, clinic areas, operating rooms, etc.), the inspection can be divided in to separate appointments for each area in or order to accomodate the schedules of the necessary personnel. The inspection will be considered satisfactorily completed once all pertinent facilities have been inspected, deficiencies addressed and all necessary signatures have been obtained on the study's safety protocol. The final IBC approved safety protocol must be signed and dated by all study personnel who come in contact with or may manipulate the agent. A copy of the signed safety protocol must be provided to the Institutional Biosafety Officer.

Safety Protocols

Safety protocols must be submitted for IBC review along with the initial application. The Institutional Biosafety Officer can be contacted for assistance preparing the safety protocol and can review drafts prior to their submission to the IBC. The safety protocol details the risks associated with exposure to the agent utilized in the HGT study and details the containment and safety practices that should be utilized in order to work safely with the agent. The laboratory safety protocol should encompass the following:

Hazard Communication Statement: This statement details the risks associated with the agent. Likely symptoms of exposure as well as reasonable worst case scenarios can be included. Special warning should be provided for individuals who may be at greatest risk of severe complications from an exposure (e.g. immunocompromised, pregnant, etc.). A Material Safety Data Sheet (MSDS) for the agent utilized in the HGT study should accompany the safety protocol as supplementary material.

Personal Protective Equipment (PPE): The safety protocol should clearly state the type of personal protective equipment to be worn by study personnel at the various locations and types of manipulations involved with the agent.

Procedures / Safety Practices: The safety protocol should detail the pertinent safety practices that will be utilized throughout the various stages of storage, dispensing, transport, administration and inactivation of the agent. The standard microbiological practices or universal precautions to follow when manipulating the agent should be disclosed. If utilizing syringes to administer the agent, procedures for mitigating the risk of accidental parenteral inoculation should be disclosed. Any additional safety practices that will be required should also be disclosed. Examples may include offering vaccination to study personnel, the use of biological safety cabinets, N95 respirators, eye protection, secondary containment for transport of the agent, etc.

Decontamination: The means of decontaminating any items or surfaces that may have come in contact with the agent should be disclosed.

Spill Procedures: A procedure should be provided to address spills of the agent.

Post Exposure Protocol: A procedure should be provided to detail how personnel should respond in the event of exposure. The exposed area should be washed and if possible disinfected. Personnel should be instructed to seek immediate medical care. The exposure protocol should disclose any therapeutics that may be advisable for treating individuals exposed to the agent utilized in the study. Following the exposure, the Investigator must be notified and should report the incident to the IBC and the Institutional Biosafety Officer. The exposed individual should notify MUSC Employee Health Services by submitting an ACCORD form and if applicable, an Infectious Disease Exposure Questionnaire.

Attestation Statement: The attestation statement documents that employees have been notified of the risk of exposure and adequately trained to work with the agent. As sample attestation statement is shown below.

I have reviewed the procedures for proper use of the biological agent utilized in this clinical trial. I have had an opportunity to discuss any safety concerns I may have with my supervisor and feel I have been properly trained to safely fulfill my position's responsibilities associated with this agent.  I have reviewed the material safety data sheet for this agent and am aware of the of risk of exposure, means of preventing exposure and the procedure to follow in the event of exposure. 

The final IBC approved safety protocol must be signed and dated by all study personnel who come in contact with or may manipulate the agent. A copy of the signed safety protocol must be provided to the Institutional Biosafety Officer before the facility inspection can be considered satisfactorily completed.

 
 
 

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