SFASU Biosafety Manual
Visit the Biological Safety web page to download the Biosafety Manual.Biosafety in Microbiological and Biomedical Laboratories
Follow the link below for information on the CDC recommendations for laboratory safety that involves biosafety in microbiological and biomedical laboratories.
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
Information for Researchers
Biosafety Checklist for Researchers
PI Checklist for Work with Biohazards and Recombinant DNA
Stephen F. Austin State University Institutional Biosafety Committee
1. Stephen F. Austin State University Institutional Biosafety Committee (IBC) approval is needed for all research, teaching or testing activities conducted by a member of the faculty or staff of Stephen F. Austin State University prior to initiation of the following work with:
a) Recombinant DNA (and RNA) including the creation or use of transgenic plants and animals
i) Biological toxins
ii) Select Agents and Toxins, including strains and amounts exempted from the Select Agent Regulations
iii) Any material(s) requiring a CDC Import license or USDA permit.
b) Pathogens, potential pathogens or infectious agents of humans, animals, or plants
c) Materials potentially containing human pathogens (human blood, tissue, and cell lines; non-human primate blood, tissues, and cell lines)
2. Registration with the IBC
a) The initial step for approval to work with biohazards is to submit a complete IBC application to the IBC.
b) All applicable forms are available online http://www.sfasu.edu/researchcompliance. For instructions and assistance please contact Amanda Romig in the Office of Research and Graduate Studies. romigad@sfasu.edu.
3. IBC Training Requirements:
a) Principal Investigators (PI) conducting research involving recombinant DNA molecules must complete NIH Guidelines training. This training is offered online via the CITI training program at: http://www.sfasu.edu/researchcompliance/107.asp and must be completed once every three years.
b) All personnel who will be conducting research at a biosafety level two (BSL-2) must complete training before being permitted to work in the BSL-2 lab. BSL-2 Training is valid for three years and may be refreshed on-line via the CITI training program.
c) Bloodborne Pathogen (BBP) Training is required for all personnel at occupational risk of exposure to human and/or non-human primate blood, tissues, body fluids, and/or other potentially infectious materials. Annual retraining is mandatory. The Bloodborne Pathogens training is offered online via the CITI training program at: http://www.sfasu.edu/researchcompliance/107.asp and must be completed prior to initiating work with such agents.
4. Laboratory Inspection and Certification
a) As part of the IBC review and approval process, laboratories will be scheduled for inspection.
b) The IBC cannot approve any research project until all lab space has been inspected and certified for the appropriate biosafety level.
c) Example inspection checklists are available.
5. IBC Approval:
a) The IBC meets on an as needed basis. IBC meetings are open to the public. To view a full schedule of Committee Meetings refer to the compliance committee website: http://www.sfasu.edu/researchcompliance/.
b) IBC applications describing rDNA studies which are not exempt of the NIH Guidelines must be reviewed by the full committee during a regularly convened meeting. NOTE: An application must be submitted at least 10 business days before the meeting date in order to be considered for review during the upcoming meeting.
c) IBC applications describing non-recombinant work with biohazards, or recombinant work that is exempt of the NIH Guidelines, must still be registered with the IBC but can be approved by the IBC Chair on behalf of the IBC.
6. Commencement of Work
a) Once the approval memo, signed by the IBC Chair, is received by the PI, approved experiments may commence.
b) The IBC approval will detail the specific outline of the work permitted, including a list of approved agents, locations and assigned biosafety level(s).
c) IBC approval is valid for three years; annual renewals are required as described below.
d) A copy of the IBC approval letter will be provided to the PI, and the Department Head.
7. Annual Requirements:
a) If any changes will be made to the protocol review by the IBC chair and or committee will be needed.
b) Change in protocol forms will be available on the Research Compliance committee's website.
c) A laboratory inspection will be scheduled as part of the annual renewal.
8. Personnel training requirements will be reviewed annually to ensure that all personnel are current with respect to required trainings.
9. Amendments are required prior to implementing any changes to the existing IBC approval including changes in:
a) Personnel: Any deletion or addition of laboratory personnel to a BSL-2 research project
b) Funding: Any addition of funding must be submitted for review by the IBC.
c) Agents: Addition of agents, procedures, etc. must be submitted for review by the IBC
d) Locations: Any changes in locations must be submitted to the IBC.
i) The room being vacated must be decontaminated, chemical and biological agents properly disposed of (and/or secured for transport). The vacated lab will be inspected and decommissioned by Environmental Health, Safety, & Risk Management department.
ii) The new lab must be inspected and certified before work in the new space may commence.
10. Termination of IBC Permit
a) Termination will initiate the laboratory decommission process described in 8.d.i.
Other Research Activities:
Research involving animals must be registered separately with the Institutional Animal Care and Use Committee (IACUC). IBC approval does not convey IACUC approval.
Please see: http://www.sfasu.edu/researchcompliance/
Research involving human subjects must be reviewed by and may approval from the Institutional Review Board (IRB). IBC approval does not convey IRB approval. Please see: http://www.sfasu.edu/researchcompliance/
Research that may be subject to Export Control regulations must be in compliance with Federal guidelines. Please see: http://www.sfasu.edu/compliance/287.asp
Research activities involving the use of other hazards are not the scope or oversight responsibility of the Institutional Biosafety Committee. For questions regarding general lab safety, laser safety, and/or work with chemicals, radiation, etc., please contact the EHS&RM department: http://www.sfasu.edu/safety/.