Responsibilities
Principal Investigator
- Establish, follow, enforce rules, procedures and methods for the proper control of potentially hazardous biological agents
- Ensure staff and students are adequately trained in in-lab safety practices and online training requirements
- Prepare a safety plan for any research or teaching under their direction
- Correct work errors, identify defective work conditions, and emphasize accident prevention
- Inform staff and students of the potential risks posed by agents used in research or teaching labs
- Obtain IBC approval for teaching and research activities that require IBC review before initiation
Biosafety and Occupational Health Department (BOHD)
The Biosafety Program of BOHD performs activities and offers a number of services to support continuous biosafety improvement in the University community. Please contact our office (612) 626-6002 for more information on any of the following:
- Biosafety, biocontainment, and biosecurity consultation
- Administration of and training for UMN Select Agent Program
- Biological incident investigation
- Lab safety audits
- IBC contributing member
- BSL-3 Advisory Committee (BAC) contributing member
- Certification/annual recertification of BSL-3 labs and vivaria
- IACUC consultations
- Written guidelines and tools (fact sheets, standard operating procedure templates, biological spill clean-up, biohazardous waste plan)
- Training resource development
- Lab construction/retrofit consultation for labs that will work with or store biological agents and/or research animals
The Occupational Health Program of BOHD performs activities and offers a number of services to support health and safety in the University community. Please contact our office (612) 626-5008 for assistance with any of the following:
- Compliance tracking and reporting for supervisors of employees that have occupational health requirements
- Referral to location-specific (University system-wide) occupational health clinics for work-related immunizations, tests, and exams
- Referral to occupational health physicians for consultation on the effects of specific work hazards on pregnant or immuno-compromised individuals
- Referral to occupational health physicians after exposures to work-related hazards
- Facilitating on-site medical services and respirator fit testing for groups of employees
- IBC protocol and IACUC Field Study medical review (through contracted occupational health services provider)
- Technical assistance for the UMN Occupational Health Portal
Institutional Biosafety Committee (IBC)
The IBC has the University system-wide responsibility of establishing, monitoring, and enforcing policies and procedures in compliance with applicable guidelines or best practices for potentially hazardous biological agents. The IBC is responsible for the review and approval for the use of potentially hazardous biological agents by University faculty, staff, and students, or by non-University employees when the activities occur at University property.
- IBC Oversight
- IBC Committee
- IBC Policies
- IBC Application Process
- Applications for Core Facilities
- Applications for Teaching Laboratories
- Meeting & Submission Deadlines
- IBC Application Sections
IBC Risk Assessment and Approval
- Assess the containment levels required
- Assess the facilities, procedures, practices, and training and expertise of personnel involved in the activities
- Assess biosafety issues for UMN personnel involved in human clinical trials subject to IBC oversight
- Approve activities found to conform with the NIH Guidelines and the BMBL.
Common Stipulations to IBC Approval
- Required training not complete or not current
- Lab inspection required
- Biosafety cabinet certification date expired
- Not enough information for IBC risk assessment
- Inconsistent information in application
Office of Biotechnology Activities Oversight (OBAO)
The OBAO provides administrative support to the IBC and has biosafety experts to support the University community by providing risk assessments, biosafety guidance, technical guidance, and assistance for IBC applications. The OBAO also has University system-wide responsibilities in (i) the interpretation of federal, state, and University guidelines, policies, and regulations; (ii) fulfilling the NIH Guidelines reporting responsibilities for the IBC and Institutional Official; (iii) working with other University research compliance units on their responsibilities for shared activities; and (iv) carrying out directed activities from the IBC and assisting the IBC in fulfilling its responsibility to Board of Regents Policy.
Starting or Maintaining Your Biological Research / Teaching
Research Oversight Requirements
The Office of Biotechnology Activities Oversight (OBAO) reports through OVPR and provides administrative support to the University community for the IBC and the Institutional Review Entity (IRE). The OBAO: (i) assists the University community and the IBC in the interpretation of federal, state, and University guidelines, policies, and regulations; (ii) fulfills the NIH Guidelines reporting responsibilities for the IBC and the Institutional Official (IO); (iii) provides biosafety guidance, technical guidance, and assistance for IBC applications; (iv) works with other University research compliance units (e.g., the Institutional Animal Care and Use Committee (IACUC), the Institutional Review Board (IRB), the Institutional Review Entity (IRE)) to ensure that the IBC and the IO fulfill their responsibilities to the NIH Guidelines; and (v) carries out directed activities from the IBC and assists the IBC in fulfilling its responsibility to Board of Regents Policy: Activities Involving Recombinant and Synthetic Nucleic Acid Molecules or Other Potentially Hazardous Biological Agents.
Applying for IBC Approval
Who Needs IBC Approval?
To learn more about which teaching and research activities need IBC approval, click the button below.
If you have questions about IBC approval, please contact [email protected].
Biohazardous and Infectious Waste
Biological Materials and Toxins
- Potentially Hazardous Biological Agents in IBC Oversight (OBAO)
- Biologically-Derived Toxins
- Biologically-Derived Toxins (BOHD)
- Biologically-Derived Toxins (IBC)
- Bloodborne Pathogens Exposure Program (BOHD)
- Human and Non-Human Primate Cells, Tissue, and Bodily Fluids (BOHD)
- Infectious Agents
- Prions and Prion-like Proteins
- Recombinant DNA or Synthetic Nucleic Acid Molecules (r/sNA)
- Select Agents and Toxins
Biosafety Policies and Procedures
- Biosafety and Biosecurity Policy
- Infectious Agents (not generally to humans)
- Institutional Biosafety Committee Policies
- Prions and Prion-like Proteins
- University Regents Policy on Activities Involving Potentially Hazardous Biological Agents
- University Administrative Policy on Activities Involving Potentially Hazardous Biological Agents
- University Procedure for Activities Involving Potentially Hazardous Biological Agents
- University Policy on Clinical Research Using Drugs
- University Procedure on Dual Use Research of Concern
- University Procedure for Storing and Using Select Agents
Dual Use Research of Concern
Fact Sheets and Reference Materials
- BOHD Fact Sheets and Templates
- Biosafety in Microbiological and Biomedical Laboratories (6th Ed) (BMBL)
- NIH Guidelines - National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Office of Science Policy
- Office of the Vice President for Research (OVPR) Resources
- OSHA Bloodborne Pathogens Standard
- Pathogen Safety Data Sheets (PSDS)
- U.S. Department of Agriculture/ Animal & Plant Health Inspection Service (USDA/APHIS)
- HUGO Gene Nomenclature Committee (HGNC)
- German Collection of Microorganisms and Cell Cultures (DSMZ)
- Writing an SOP
Other Research Oversight and Safety Requirements
Research Support Services
Risk Assessment
Preparing a Risk Assessment
- Biological Risk Assessments (BOHD)
- IBC Process for Risk Assessment and Biological Safety Levels (OBAO)
- Biological Risk Groups (BOHD)
- Biosafety Levels (BOHD)
- Writing an SOP (BOHD)
Risk Group Resources
- ePATHogen - Risk Group Database - note that this site classifies agents with risk groups for both humans and animals.
- Pathogen Safety Data Sheets (PSDS)
- ABSA International-The Association for Biosafety and Biosecurity
- German Collection of Microorganisms and Cell Cultures (DSMZ)
- NIH Guidelines - National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Biosafety in Microbiological and Biomedical Laboratories 6th Ed. (BMBL)
Training
Training Resources
- BOHD Required Training
- Occupational Health Programs and Instructions
- IBC Required Training
- Dual Use Research of Concern Training
Note: You may be required to take additional training based on the type of research of materials used for instruction. See the Other Research Oversight Requirements section to identify additional requirements.
Training Records and Documentation