Office of Research

Application Review Process

Clemson University aims to provide a safe and healthy work environment for employees, students and visitors. The intent is to minimize, to the extent practicable, all recognizable hazards and to comply with all federal and State laws and regulations. In accordance with federal regulations, the Institutional Biosafety Committee (IBC) was established to provide review of all protocols that involve the use of hazardous or potentially hazardous agents.  The Biosafety Officer must be consulted regarding any proposed use of potentially hazardous agents. RS is responsible for the maintenance of a biosafe environment at Clemson, and they work with the principal investigator (PI) who is directly responsible for adherence to biosafety regulations in his/her laboratory. This includes the actions of all students and technicians. Upon request, the BSO will assist investigators in developing protocols. The BSO can be reached at (864) 710-2933.

A typical IBC protocol directly parallels a research project overseen by the PI. Thus it addresses all potential hazards (biological, chemical when vertibrate animals are needed and recombinant DNA) associated with that research project. Therefore, any given protocol may have a combination of “exempt” and “non-exempt” components. In addition, the lifespan of an approved protocol is three (3) years. Just as a PI may have more than one active research grant, the PI may have more than one approved IBC protocol. Furthermore, these protocols may have much in common with respect to hazardous agents used.

The IBC Administrator in the Office of Research Compliance is available for assistance in completing the application and can be reached at smith@clemson.edu, (864) 656-0118 or 223 Brackett Hall.

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” (work may begin upon submission of the IBC application) 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 (or portions thereof), 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 for the three-year approval period.

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 that are highly toxic, carcinogenic, mutagenic or teratogenic and utilizes vertebrate animals or protocols involving the use of hazardous biological agents may be reviewed as designated at the discretion of the chair and BSO. Designated review usually requires 10 working days and approval may be granted once concerns, if any, have been adequately addressed by the PI. These protocols also require an annual 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, which may require up to 20 working days depending on the complexity of the proposed work. These applications are usually discussed at the convened IBC meeting. Protocols requiring full committee review may be approved as soon as all the concerns have been adequately addressed by the PI. These protocols when approved require an annual review or more frequently, if indicated.

Amendment(s). 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.

The IBC application should be completed and signed by the principal investigator and his/her department chair or institute director. Please submit the original signature page and Hazard Acknowledgement Signature sheet to the Office of Research Compliance and retain a copy for your files. An application will not be considered complete until all of the items have been addressed (requested information that is not available should be noted). Please note specific instructions for each type of biohazard (biological, chemical and recombinant DNA). Incomplete forms will not be approved. Should you have any questions, please do not hesitate to contact the Office of Research Compliance.

Keep in mind that research work with one hazardous agent may simultaneously require the use of another agent that may be hazardous as well. Although a PI may start out to submit an Exempt or Non-Exempt recombinant DNA protocol, he/she may need to submit the sections appropriate for a “non-exempt” chemical hazard(s) being used.

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