Indiana University Biosafety Manual
Indiana University is actively committed to preserving the health and safety of its students, staff, and faculty, and to protecting the environment and the community. It is recognized that use of potentially pathogenic microorganisms, other biological materials, and organisms containing recombinant or synthetic nucleic acid molecules is necessary in many University research and teaching laboratories. To ensure the safe handling of these organisms, the University requires compliance with the NIH Guidelines and with the recommendations in BMBL. Compliance with other applicable federal, state, and local regulations is also required.
Authority and responsibility
- University Environmental Health and Safety
University Environmental Health and Safety for the respective campus will be responsible for:
- Preparing the Biosafety Manual and reviewing as needed or at least annually;
- Making available the Biosafety Manual to each faculty member who works with biological materials;
- Investigating accidents involving biological materials and toxins, infectious agents, and recombinant or synthetic nucleic acid molecules;
- Tracking the certification of Biological Safety Cabinets (BSC’s);
- Assisting and advising on the collection and disposal of biological waste when appropriate;
- Providing Bloodborne Pathogen (initial and annual) training as required by the Occupational Safety and Health Administration (OSHA), 29 CFR 1910.1030;
- Providing biosafety training and biological shipment training;
- Conducting laboratory inspections;
- Assisting investigators with risk assessments and risk mitigation including recommending or requiring safety equipment and PPE as necessary;
- Administering all elements of the biosafety program;
- Assist faculty with protocol submissions to the IBC and review IBC submissions; and
- Reporting any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illness to the appropriate institutional official and to the NIH Office of Biotechnology Activities (OBA) immediately and within 30 days, as required.
Departments shall be responsible for:
- Ensuring the compliance of the Principal Investigators; and
- Providing appropriate work space for the research being performed.
- Principal Investigators (PI)
For the purpose of this Manual, a Principal Investigator is defined as a person having ultimate responsibility for biological work being conducted and the oversight of personnel involved in said work at Indiana University. In addition to traditional Principal Investigators, this definition includes clinical laboratory directors, professors of teaching laboratories, and anyone else holding an equivalent position involved in biological work at Indiana University.
Principal Investigators shall be responsible for:
- Direct and primary responsibility for the safe operation of the laboratory;
- Assessing the risks of their experiments;
- Ensuring the safe operation of their laboratory;
- Notifying EHS Biosafety in the event of an injury or illness that occurs in the laboratory;
- Training laboratory personnel in safe lab-specific work practices;
- Ensuring they are providing necessary personal protective equipment;
- Complying with this Biosafety Manual as well as all applicable state and federal regulations and guidelines; and
- Registering the following experiments with the IBC :
- Experiments involving recombinant or synthetic nucleic acid molecules, including transgenic plants and animals;
- Work with infectious agents;
- Experiments involving the use of human blood or other potentially infectious materials, such as unfixed human tissues, human cell lines, and certain body fluids; and animal and plant pathogens; and
- Biological materials at BL2 or higher that are intended to be used as part of teaching laboratories.
- Institutional Biosafety Committee (IBC)
The IBC, as Administered by Office of Research Compliance (ORC) shall be responsible for:
- Reviewing recombinant or synthetic nucleic acid molecules research conducted at or sponsored by the University for compliance with the NIH Guidelines, and approve those research projects that are found to conform with the NIH Guidelines;
- Reviewing research involving infectious agents conducted at or sponsored by the University for compliance with the guidelines in Biosafety in Microbiological and Biomedical Laboratories (BMBL), and approving those research projects that are found to conform with the recommendations in BMBL;
- Notifying the PI of the results of the IBC’s review and approval;
- Reporting any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illness to the appropriate Institutional official and to the NIH Office of Biotechnology Activities (OBA) immediately and within 30 days, as required; and
- Following the guidelines for membership defined by NIH.
- Designated Medical Service Provider
The Designated Medical Service Provider for your respective campus shall:
- Provide medical evaluation, as required by the OSHA Bloodborne Pathogens Standard (CFR 1910.1030), and as recommended in the BMBL and NIH Guidelines; and
- Provide vaccinations, as recommended or required
- Laboratory Personnel
The Laboratory Personnel shall:
- Comply with safety recommendations for the work being performed;
- Complete all required training;
- Report all accidents or injuries to the PI; and
- When the following incidents occur, notify PI and EHS Biosafety for your respective campus:
- Experiments involving recombinant or synthetic nucleic acid molecules;
- Work with infectious agents; or
- Experiments involving the use of human blood or other potentially infectious materials, such as unfixed human tissues, human cell lines, and certain body fluids; and animal and plant pathogens.
Training and recordkeeping
Biological Safety Training
Biological safety training is required for personnel associated with work in biological laboratories, either for research or teaching purposes. The training ensures that personnel working in certain laboratories have been trained in basic biological safety principals before conducting work in laboratories at Indiana University.
This training is intended to promote a safe laboratory working environment and to help ensure compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the Biosafety in Microbiological and Biomedical Laboratories, 5th ed. Biological safety training pertains to all IBC protocols and research that fall under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, all Biological Safety Level 2 or higher protocols, and teaching laboratories at Biological Safety Level 2. Professors and assistants in teaching laboratories at BL2 need to complete the biological safety training. Students are not required to complete biological safety training but should receive classroom and topic specific training from the instructor.
Biological safety training may be completed either in class or online.
Biological safety training will be offered once a month as instructor led classroom training at the Bloomington and Indianapolis campuses unless the campus is closed the day of scheduled training. Training will be offered the same day and time each month. Classroom training will be available for scheduling outside of the regular monthly schedule for a group of 5 or more participants.
Biological safety training is available online through E Training via One.IU as an alternative to classroom training. The online training includes IUEHS Biosafety contact information for the respective campus in case of questions or if assistance is needed.
Biological safety training is required one time. Additional training may be required as a remediation step through the annual inspection process or by the IBC in response to certain laboratory incidences.
Bloodborne Pathogens Training
Bloodborne Pathogens Training is required for any employee that falls under the scope of the OSHA Bloodborne Pathogens Standard. For more information please refer to the Indiana University Bloodborne Pathogens Exposure Control Plan.
Laboratory Specific Training
Laboratory specific training is the responsibility of the PI or professor. Specific training must be conducted on special handling requirements and safety procedures of agents in the laboratory.
Biological Shipment Training
Any person shipping or receiving human or animal pathogens, non-exempt human material, or biologicals containing recombinant or synthetic DNA is required to complete DOT/IATA shipment training. This training is required every two (2) years. Training is available in person at the IUPUI campus or online through E Training. Training requirement is assessed during the annual biological safety laboratory inspection.
- Biosafety in Microbiological and Biomedical Laboratories (5th edition)
- CDC Permit to Import or Transport Etiologic Agents
- Export Administration Regulations Commerce Control list (15 CFR Part 774)
- Indiana University Bloodborne Pathogens Exposure Control Plan
- National Select Agent Program
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules(March 2013)
- NIH Office of Biotechnology Activities
- Selection, Installation, and Use of Biological Safety Cabinets (3rd edition)
- USDA/APHIS Permit to Import or Transport Livestock Pathogens
- Indiana University Laboratory Safety Policy
- IU Biosafety Manual
- Appendix A: HHS and USDA Select Agents & Toxins
- Appendix B: IUB and Regionals Specific Waste Handling Guidelines
- Appendix C-1: Indiana University Employee Vaccination Acceptance/Declination Form
- Appendix C-2: Indiana University Non-employee Vaccination Acknowledgement
- Appendix D: Spill Clean-up Sign
- Appendix E-1: Biosafety Level (BSL-1)
- Appendix E-2: Biosafety Level 2 (BSL-2)
- APPENDIX E-3: Biosafety Level 3 (BSL-3)