Getting Started

Any research or testing activity that involves the use of potentially hazardous agents (biological, chemical or rDNA) or the construction or use of genetically engineered organisms requires review by the Institutional Biosafety Committee (IBC) before beginning the project.

In order to obtain the approval for your study, please follow these basic instructions…

1. Although we attempt to complete reviews in two to three weeks, it can take as long as six weeks to complete the IBC approval process.
2. Download and complete the IBC Protocol Application "Research Involving Hazardous Agents" as per our guidelines. The form must be typed, and it is available to download and fill out electronically. 
3. Carefully read all instructions in the packet.  Important and helpful information for completing the form is contained throughout the packet.
4. The Director of Environmental Health and Safety (EHS) is responsible for the maintenance of a biosafe environment at Clemson, and the EHS office works with the principal investigator (PI or instructor) who is directly responsible for adherence to biosafety regulations in his/her laboratory (or classroom). Upon request, the Director of EHS (864-656-1806) will assist investigators in developing protocols.
5. Once you have completed the paperwork, Electronically submit the document to the IBC Coordinator at ventura@clemson.edu as an attachment (MS Word format, please) along with any other documents you feel would assist the reviewers. Print off and submit the signature page with the original signatures of the PI and the Department chair as well as the Hazard Acknowledgment Sheet.
6. You may be required to enroll in the Medical Surveillance Program, attend training sessions (Blood Borne Pathogens, etc.) or obtain necessary vaccinations (tetanus, hepatitis, etc.). Please allow for this in your research budget and timetable.
7. If you are using human source material (human blood, blood products, body fluids, organs, tissues, or cell lines of human origin) you need to complete initial training for blood borne pathogens and an annual update available on-line at EHS or show certification that the material is pathogen free.  Laboratory personnel working with human source material are advised to treat all human blood, blood products, body fluids or tissues as if they are potentially infectious and handle them accordingly.
8. If your IBC protocol involves the use of human subjects, you are required to submit an IRB application and gain IRB approval prior to initiation of the study. Human subject’s research involves, but is not limited to, human source materials e.g. human blood, blood components, blood products, fluids, organs, pathological specimens, diagnostic specimens, organs, tissues, or cell lines of human origin.
   If a cell line is obtained through intervention or through interactions with a living individual or if the cell line can be linked to identifiable private information pertaining to a living individual, then review by the Clemson University IRB is necessary.
   If you need assistance determining if IRB approval is necessary, please contact the Office of Research Compliance at 656-6460.
9. When biohazardous material is used in with animals, and AUP (Animal Use Protocol) must be submitted to the Animal Research Committee.  Investigators are required to work under the containment conditions appropriate for the specific agent.  Investigators are expected to understand the risks associated with a proposed agent and to use practice and procedures appropriate for the activity to be conducted based on biosafety containment criteria described in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th edition and Clemson University Biological Safety Manual.  Investigators must provide information on appropriate safeguards such as personal protective equipment (PPE), proper handling of contaminated bedding, cages, water bottles, carcasses, and proper labeling of cages and facilities.
10. Investigators should consult the Clemson University Chemical Hygiene Plan for handling procedures when using potentially hazardous chemicals.

The Review Process

During the review process, the Director of Environmental Health and Safety (EHS) will be consulted. EHS works with the principal investigator (PI) who is directly responsible for adherence to safety regulations in his/her laboratory. This includes the actions of all students and technicians. The PI's responsibility includes sufficient supervision of students and technicians to assure their adherence to the approved protocol. All documents submitted for review are routed to the appropriate reviewer(s). After questions are resolved between the reviewer(s) and the principal investigator, the protocol is recommended for approval to the IBC Chairperson.

Once approval is granted, the PI can proceed with the study. Any proposed changes in the protocol for the use of hazardous agents, including changes in participants, must be submitted and approved as an update prior to initiation. A continuing review of hazardous agents use must be completed and approved at least every twelve (12) months for the study to continue.

For additional information and instructions, please contact Marlene Ventura, EdD at 864-656-0118.

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