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Office of Research Compliance

What Needs Review FAQ

1. Recombinant DNA or Synthetic Nucleic Acid Molecules (Including CRISPR-Cas9)

  • Clemson University 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. Clemson University 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.

  • If you plan at any time to introduce genetically engineered organisms into the environment, additional information must be filed (i.e. APHIS permit). 

  • If you will be part of a plant field trial involving genetically modified, REGULATED plant varieties/cultivars, a Regulated Plant Field Trial form is available.  An APHIS permit is required for submittal.

  • If you are involved in research involving genome editing technologies, a Gene Editing Notice of Intent is required.

2. Biological hazards

  • A biohazard is a potentially dangerous infectious or toxic agent or material (tissue, blood, cells, etc.) that could contain an infectious agent or whose hazard status is unknown. For Clemson University's purpose, a biohazard is considered any BSL2 agent or above. Human or non-human primate derived cell lines or similar are also considered biohazards (per OSHA). Infectious organisms include all agents (including prions) capable of causing disease in healthy humans or animals, whether these occur commonly in the environment or not.

  • Regardless of the source, if using human or non-human primate tissue, body fluid(s), or cells, 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.

3. Hazardous Chemicals with Vertebrates

Any chemicals in the below categories being used with vertebrates are considered hazardous:
  1. Investigational Drug where hazards are unknown and have not thoroughly been investigated
  2. Hazardous pharmaceuticals (e.g. chemotherapy, cardiovascular, etc.)
  3. Listed on SDS as one of the following:
    • Carcinogen
    • Mutagen
    • Reproductive Toxin
    • Highly Toxic by inhalation, ingestion or dermal absorption
    • Explosive

4. Nanomaterials

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.