Protocol Submission Guidelines
All proposed research involving the use of potentially biohazardous materials must be assessed for risk and all research involving biohazardous materials must be reviewed and approved by the SIUE Institutional Biosafety Committee (IBC).
STEP 1 Risk Assessment
If your planned activity type is covered by the SIUE Policy on Biohazardous Material Use and includes the use of biohazardous materials, then you must do a professional risk assessment and complete an IBC Risk Assessment form. Biohazardous material is defined as any biological material or organism which is covered by the NIH Guidelines, the Centers for Disease Control (CDC) List of Select Agents and Toxins, or is deemed by the IBC as a biohazardous material.
Biological material or organisms considered biohazardous include:
- is, or has significant probability of, becoming infectious AND pathogenic (bringing disease) to humans, animals, or plants, OR
- contains or produces recombinant DNA (see NIH Guidelines), OR
- contains or produces a toxin with an LD50<100ng/kg body weight, OR
- is a select biological agent or toxin as published in the CDC List of Select Agents and Toxins,
- is, or derives from, human or non-human primate, blood, body fluids, or unfixed tissues
- is a regulated plant pest as published in APHIS of the United States Department of Agriculture (USDA)
* Internet links to non-SIUE websites were current at the time of publishing of this document. However, it is the end users responsibility to ensure that they find and review the most current information available.
Note: The biological materials and organisms above are not an inclusive list. It may be useful to consult the ABSA Risk Group Database or the "Agent Summary Statements" in Section VIII of the Centers for Disease Control manual, "Biosafety in Microbiological and Biomedical Laboratories." While the database and agent summaries are useful, they are also not a complete listing of biohazardous materials, nor the definitive word on risk assessment for those biohazardous materials.
Please reach out to researchcompliance@siue.edu if you are unsure if a Risk Assessment is required for your activity type.
STEP 2 Training
Research activity classified as Biosafety Level 2 or higher requires all project personnel to complete the CITI Online Biosafety Training course titled "Group 2: BSL-2" and choose one elective from the four options that most closely aligns with the focus of the project. Elective options include "Animal Biosafety," "Recombinant DNA Research," "Dual Use Research of Concern (DURC)" and "OSHA Bloodborne Pathogens." (Please note: To fulfill the OSHA Bloodborne Pathogens Standard, all five modules must be completed within this elective.)
Biosafety training is also offered for those involved with projects at Biosafety Level 1. Personnel wanting to take this level of training should chose the course titled "Group 1: BSL-1."
STEP 3 Application for Biohazardous Material Use
After submission of the Risk Assessment form, the chair of the IBC will advise you as to whether you may proceed immediately, or whether you must submit a full Application for Biohazardous Material Use.
Note: The IBC meets on the second Tuesday of each month. The deadline to submit an IBC application to the IBC is always the 2 weeks before the second Tuesday of the month in which you would like for it to be considered. For more information, please contact researchcompliance@siue.edu.
For all activities with biohazardous materials, whether covered by the IBC or not, consult the SIUE Emergency Management & Safety Department for other requirements.
