A. POLICIES AND PROCEDURES

The recommendations contained in the Centers for Disease Control (CDC) publication Biosafety In Microbiological and Biomedical Laboratories, 5th Edition, February, 2007, have been adopted by MUSC as the standard for working with infectious agents. This publication provides a description of the appropriate laboratory practices and physical containment associated with different classes of infectious agents. Investigators who use infectious agents in research and teaching must be familiar with current policies and practices for safe handling of hazardous organisms. Appendix II includes a listing of agents, classified on the basis of hazard, which should be consulted in assessing the level of biosafety required in the use of a particular agent.

These policies and procedures are designed to provide protection to laboratory personnel from possible exposure to the biological hazards involved in work with a particular organism. It is required that the responsible investigator in each laboratory advise all personnel on the hazards that will or may be encountered and those practices and procedures designed to minimize or eliminate risks associated with those hazards.

B. APPLICATION FOR APPROVAL OR REGISTRATION

All research programs at MUSC involving infectious agents require either approval by/registration with the Institutional Biosafety Committee (IBC). Approval/registration is required regardless of whether the research program is funded by an agency requiring such certification or not. All new, continuation, or renewal applications involving microorganisms which are submitted to the Office of Research and Sponsored Programs should be accompanied by the approval from the IBC. Approval from or notification of the IBC is also required whenever investigators initiate or significantly change research involving infectious agents under existing grants or contracts.

To comply with institutional policies for studies involving infectious agents, the Principal Investigator must submit to the Biosafety Committee an Infectious Agent Registration Document addressing the following points:

classification of the agent, biosafety level available in the laboratory;
whether or not laboratory animals will be infected with the agent;
if applicable, information on medical surveillance; and,
a signed statement that the Principal Investigator is familiar with the current NIH Guidelines and agrees to abide by their provisions, including a statement that the agents being used will not be transferred to other investigators or institutions unless their facilities and techniques have been assured to be adequate.

C. ROLES AND RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR

The principles stated here apply to all studies at MUSC involving infectious agents regardless of the source or type of funding. On behalf of MUSC, the Principal Investigator is responsible for complying fully with the MUSC Policy in conducting any research involving infectious agents.

1. General
The Principal Investigator shall assure that:
a.) No research involving infectious agents requiring registration with and/or approval by the IBC is initiated unless it has met all of the requirements contained in this document.
b.) Appendix A has been consulted for appropriate classification of the involved microorganism and has determined that the prescribed procedures for that class are being followed.
c.) He/she will report immediately to the IBC all significant violations of the policies and practices and all significant research-related accidents which result in overt or potential exposure to infectious materials.
d.) He/she is prepared to implement methods for dealing with accidental spills and personnel contamination.
e.) Appropriate permits required by the USDA and/or the USPHS for work with certain animal and plant pathogens are obtained.
f.) Appropriate importation and interstate shipment requirements for biological materials are followed. PIs must maintain accurate records (log-book type) of Class 3 microorganisms transferred to other research sites.
g.) All personnel have appropriate training and information relative to the agents used in the laboratory. Laboratories where Class 2 or 3 agents are being studied shall be directly supervised by the P.I. or his/her designee. Laboratory personnel working with Class 1 agents must have standard training in microbiological practices to insure proper handling of the agent. Personnel working with Class 2 & 3 agents must also have specific training in handing pathogenic microorganisms, and individuals who work with Class 3 agents must have specific training in handling potentially lethal agents. Procedures for handling Class 4 agents on the MUSC campus will be developed on a case-by-case basis.
h.) Competent medical advice has been sought before any person who is immunocompromised due to systemic corticosteroid therapy, chemotherapy for malignancies, radiation therapy, and/or certain diseases (e.g. lymphomas, leukemia, and AIDS) participates in research involving hazardous microorganisms. In addition, the P.I. is responsible for assessing any special risks to pregnant women working in the laboratory.

2. Prior to Initiating the Research the Principal Investigator shall:

a.) Register all Class 2 agents with the IBC at the time a new project is begun (see Registration Document).
b.) Obtain IBC approval for projects involving Class 3 or 4 agents.
c.) Determine in consultation with the IBC and the MUSC Employee Health Physician the usefulness of serological screening, requirements for medical surveillance, and the availability at vaccination for certain Class 2 and 3 agents. Inform laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested, such as vaccination or serum collection. MUSC has specific policies which apply to laboratories where procedures involve the concentration of HIV.
d.) Communicate to the IBC protocol changes which substantially modify the research procedure upon which approval was originally based.
e.) Provide the IBC, upon request, with a complete copy of the grant application or other pertinent material on which the IBC approval may be based.
f.) Assure that personnel working with infectious agents or biohazardous materials are appropriately trained so that they are aware of the hazards and are proficient in the practices and techniques required for safe handling of such materials.

3. During the Conduct of the Research the Principal Investigator shall:

a.) Supervise the performance of the staff to ensure that the required safety practices and techniques are employed.
b.) Investigate and report in writing to the IBC any significant biosafety problems pertaining to the pursuit of the research goals. The P.I. is responsible for correcting any conditions that might release biohazardous materials into the environment.
c.) Implement the procedures prescribed for dealing with laboratory accidents.
d.) Assess regularly the biological characteristics of the microorganisms used in experiments. Such assessment should include the purity and phenotype of the strain. Special restrictive characteristics such as attenuation require regular surveillance.
e.) Assure that biological safety cabinets, and other equipment used to prevent exposure to hazardous microorganisms, are properly serviced and functioning appropriately.