By definition (Federal Register 51 (88) page 16959 I-D-2), the Clemson University (CU) IBC reviews and oversees projects that deal with recombinant DNA technologies. While the most scrutinized protocols are those dealing with human gene therapy or 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 recombinant DNA molecules or organisms, although certain types of experiments will qualify as "Exempt from Full Committee Review". 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. See copy of the Guidelines for Research Involving Recombinant DNA Molecules. Non-exempt recombinant DNA work will receive Full Committee Review.
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).
A biohazard is a potentially dangerous infectious or toxic agent or material (tissue, blood, etc.) that is suspected to contain an infectious agent or whose hazard status is unknown. For Clemson University's purpose, a biohazard is any BSL2 agent or above, or human or animal blood, tissue, or waste specimen has the potential to harbor infections 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 include
The BMBL 5th edition (pdf) manual should be used in completing the Biohazards Protocol section.
Individuals working with human material, e.g. human blood, bodily fluids, unfixed human tissue, organs and including well established human cell lines must be enrolled in the CU-Medical Surveillance Program (MMSP), take Bloodborne Pathogens (BBP) training annually (OSHA requirement) and be offered the appropriate inoculations against any pathogen for any occupational health purposes. If inoculations are not accepted, a waiver must be signed. Regardless of the source, if using human or non-human primate tissue or body fluid(s), an IBC application is required and Clemson University considers the handling of these materials to be at the BSL-2 level regardless if the vendor indicates it is BSL-1 level.
Any chemical listed as highly toxic, carcinogenic (confirmed or suspected), mutagenic, teratogenic or explosive on its MSDS must be covered by an IBC approved protocol when used with vertebrate animals in research. If unqualified undergraduates are involved in the research then any chemical listed as toxic, highly toxic, carcinogenic (confirmed or suspected), teratogenic or explosive on its MSDS must be covered and the protocol. Unqualified undergraduates are those that lack at least a year of college level chemistry and biological science (e.g. general biology, microbiology, inorganic, organic biochemistry) or are under the age of 18. MSD sheets should be recent (within the last three years).
Members of the research team working with chemicals must take CU online Chemical Hygiene Training and Hazardous Waste Management Training.
Research and technology involving structures with at least one dimension less than 100 nanometers (nm), frequently with atomic/molecular precision and creating or using structure, devices, and systems that have unique properties and functions because of their nanometer scale dimension require the submission of an IBC application if used with recombinant DNA, biological hazards or chemical hazards used with vertebrate animals.