Instruction for Form Submission

The IBC Protocol Application should be completed and signed by the Principal Investigator and Department Chair. Please submit an original signature page and Hazard Acknowledgment Signature Sheet to the Office of Research Compliance,223A Brackett Hall, the complete protocol is to be submitted electronically to ventura@clemson.edu. This form will not be considered complete until all of the items have been addressed.  Please note specific instructions for each type of biohazard (biological, chemical, and recombinant DNA). Incomplete forms will not be accepted. Should you have any questions, please do not hesitate to contact the Office of Research Compliance at 864-656-0118.

PART A: General Information:

General information about the agents being used, where they will be used and who will be working with them. This information will be expanded in the next three sections.

PART B: Biological Hazards:

A biohazard is a potentially dangerous infectious agent or material (tissue, blood, etc.) that is suspected to contain an infectious agent or whose hazard status is unknown. For our purposes, a biohazard is any BSL2 agent or above, or human or animal blood, tissue, or waste specimen known to harbor infectious agents or whose biohazard status is unknown; human or non-human primate derived cell lines or similar are also considered biohazards (per OSHA definition). Infectious organisms includes all agents (including prions) capable of causing disease in healthy humans or animals, whether these occur commonly in the environment or not.

The Center for Disease Control-NIH Biosafety in Microbiological and Biomedical Laboratories manual should be used for guidelines in completing the Biohazards Protocol section. It is a requirement that all personnel be offered appropriate inoculations against any pathogenic for any occupational health purposes before any lab work can be done. If inoculations are not received, a waiver must be signed. Regardless of the source, if using human or non-human primate tissue or body fluid(s), a protocol will be required.

If appropriate contact EHS for assistance in completing an Exposure Plan Checklist and/or a Lab Exposure Control Plan.

PART C: Chemical Hazards:

Any chemical listed as highly toxic, carcinogenic (confirmed or suspected), mutagenic, teratogenic, or explosive on its MSDS must be covered by an approved protocol; if undergraduates are involved in the research, any chemical listed as toxic, carcinogenic (confirmed or suspected), teratogenic, or explosive on its MSDS must be covered and the protocol will not qualify as Exempt.

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 of 200 mg/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 200 ppm 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 (500 mg/kg) 2) a contact LD50 of 1000 mg/kg for 24 hour exposure or 3) LC50 of 2000 ppm with one hour exposure. If this information is not listed for rats (or rabbits for contact), and any test animal listed has an LD50 lower than the amounts listed above, the chemical must be covered by an approved protocol. Also, chemicals having an LD50 for humans listed at amounts below those listed above must be covered by an approved protocol.

PART D: Recombinant DNA:

By definition (Federal Register 51 (88) page 16959 I-D-2), the CU IBC reviews and oversees projects which deal with recombinant DNA (rDNA) technologies. Clemson University must have such a committee made up of faculty, staff, and community members, for review of protocols and compliance in rDNA matters. While the most scrutinized protocols are those dealing with the environmental release of genetically engineered organisms, all protocols including those using only laboratory contained experiments are closely examined. CU has a policy of requesting that all investigators file a protocol when using rDNA molecules or organisms, although certain types of experiments will qualify as "Exempt". This process guarantees our compliance with Federal regulations and allows us to assure the public that we are safeguarding the public interest.

If you work with recombinant DNA, (see Section I-B of the NIH Guidelines: Definition of Recombinant DNA Molecules), a component of the protocol form will require you to identify the section(s) and appendices of the NIH Guidelines appropriate for your experiments. A copy of the Guidelines for Research Involving Recombinant DNA Molecules is available on the Internet at http://www.nih.gov/od/oba/. A hard copy is available in the Office of Research Compliance.

If you plan at any time to introduce genetically engineered organisms into the environment, additional information must be filed. For this component, you will need to complete Steps 1-4 in Part D of the protocol. You also will need to reference the USDA publication entitled Guidelines for Research Involving Planned Introduction into the Environment of Genetically Modified Organisms (December 3-4, 1991 or most current version).

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