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Research with Hazardous Agents
Approval of Laboratory Procedures
The Principle Investigator, P.I or laboratory supervisor shall identify circumstances under which a particular laboratory operation, procedure or activity requires prior approval. All projects and activities involving regulated hazards at Clemson are subject to prior review by Environmental Health and Safety and the Institutional Biosafety Committee (IBC). Principle Investigators should complete the “Memorandum of Understanding and Agreement” and submit to the following committees as appropriate for the special hazards involved. These MOUs must be signed by the principal investigator and the department chair, then submitted to the Office of Research Compliance. The Institutional Biosafety Committee provides peer review of these protocols. The PI’s responsibility includes sufficient supervision of the students and technicians to assure their adherence to the approved protocol.
The IBC is divided into the following subcommittees:
Chemical Hazards Subcommittee
Any chemical listed as highly toxic, carcinogenic (confirmed or suspected), or explosive on its MSDS must be covered by an approved protocol; if undergraduates are involved in the research, any chemical listed as toxic, highly toxic, carcinogenic (confirmed or suspected), or explosive on its MSDS must be covered.
Highly toxic is defined as: 1) having an oral LD50 of <50 mg/kg body weight when administered orally to albino rats weighing between 200 and 300 g each. 2) LD50< 200mg/kg body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with bare skin of albino rabbits weighing between 2 and 3 kg each. 3) LC50 in air of 200ppm by volume or less of gas or vapor, or 2 mg/l or less of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within one hour) to albino rats weighing between 200 and 300 g each.
Toxic is defined as: 1) having an oral LD50 of more than 50mg/kg but not more than 500mg/kg 2) a contact LD50 of more than 200mg/kg but not more than 1000mg/kg for 24 hour exposure or 3) LC50 of more than200ppm but not more than 2000ppm by volume of gas or vapor, or more than 20 mg/l of mist, fume, or dust when administered by continuous inhalation for one hour exposure (or less if death occurs within one hour). If this information is not listed for rats (or rabbits for contact), and any test animal listed has LD50 lower than the amounts listed above; the chemical must be covered by an approved protocol. Also, chemicals having an LDLO for humans listed in amounts below those listed above must be covered by an approved protocol.
Biohazards Subcommittee
Any biological material (organism or tissue) with potential to cause disease, or which might contain such organisms is considered a biohazard. This includes all organisms with the potential for causing disease in healthy humans or animals, whether these occur commonly in the environment or not. Biomolecules with disease-causing potential (e.g. prions), Tissues which might contain these or tissues from organisms with transmissible disease of unknown etiology are also biohazards. Specifically, any substance categorized as CDC Biosafety Level 2 or higher is a biohazard requiring approval by the Clemson University Biosafety Committee. (If undergraduates are involved in the research, BSL 1 needs to be considered by the IBC.)
Recombinant DNA Subcommittee
By definition (Federal Register 51 (88) page 16959 I-D-2), the Institutional Biosafety Committee is the committee that reviews and oversees projects which deal with recombinant DNA (rDNA) technologies. Clemson must have such a committee, made of faculty, staff, and people from the community, for review of protocols and compliance in matters dealing with rDNA. While the most scrutinized protocols are those dealing with environmental release of genetically engineered organisms, all protocols including those using only laboratory-contained experiments are closely examined. While certain types of experiments are considered exempt, Clemson University has the policy of requesting that all investigators file a protocol when using rDNA organisms.
