- 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. 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.
- 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.
What needs to be reviewed
- Recombinant DNA or Synthetic Nucleic Acid Molecules (Including CRISPR-Cas9)
- 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.
- Hazardous Chemicals with Vertebrates
Any chemicals in the below categories being used with vertebrates:
- Investigational Drug where hazards are unknown and have not thoroughly been investigated
- Hazardous pharmaceuticals (e.g. chemotherapy, cardiovascular, etc.)
- Listed on SDS as one of the following:
- Reproductive Toxin
- Highly Toxic by inhalation, ingestion or dermal absorption
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.
Application Review Process
The IBC administrator conducts a pre-screen of the application when it is submitted to determine if the application is complete. Applications that need modification before they are sent to the IBC committee members are sent back to the PI with comments.
To expedite the review process the IBC utilizes three levels of review based on the nature of the hazard(s) involved — exempt, designated and full committee.
- Recombinant DNA
Protocols involving the use of recombinant DNA are either reviewed as exempt or are non-exempt and receive full IBC committee review. This determination is made by the IBC chair after the IBC application is submitted. Exempt protocols, as defined by NIH, are those that present only minor hazards with very low risk that may be addressed in an application that is formally reviewed by at least the IBC chair and the biosafety officer (BSO) to validate the exempt status. Nonetheless, all protocols with a recombinant DNA component are available for review by all members of the IBC. Exempt protocols may be validated immediately upon review by the BSO and IBC chair, but will still require an annual review and are approved for up to 3 years.
- Designated Review
Designated review is used for chemical and biological hazard protocols that present a moderate risk and require review by the BSO, IBC chair and usually at least one other IBC member with the appropriate expertise (designated by the IBC chair).
These protocols are sent to the members of the IBC for their comments as well. Protocols involving chemicals with vertebrate animals or protocols involving the use of hazardous biological agents may be reviewed as designated at the discretion of the chair and BSO. These protocols also require an annual review and are approved for up to 3 years.
- Full Committee Review
Full committee review is used for protocols that may present significant hazards to humans, animals or the environment. Examples of significant hazards would be work with biological agents requiring greater than BSL2 containment facilities or practices, or the release of genetically modified organisms. Non-exempt recombinant DNA protocols will receive full committee review. All members of the IBC participate in a full committee review. These applications are discussed at the convened IBC meeting. These protocols also require an annual review and are approved for up to 3 years.
Minor amendments and/or proposed changes in any protocol must be submitted and approved as an update prior to initiation using the minor amendment form. Changes of a more substantial nature require the submission of the appropriate section of the IBC application, e.g. Section B for biological agents, Section C for chemicals and Section D for recombinant DNA.
- Institutional Review Board
- Institutional Animal Care and Use Committee
- Institutional Biosafety Committee
- Responsible Conduct of Research
- Research Misconduct