What research activities require Biosafety approval?
- Research, regardless of funding, and teaching labs using biohazards and non-exempt recombinant DNA is submitted to ORPC for review and approval by the Institutional Biosafety Committee. Note that certain types of biological research may require review under UMBC’s Export Control management program if there is a need to obtain a deemed export license under the Export Administration Regulations (EAR).
- Research, regardless of funding, and teaching labs involving human tissues, fluids and cell lines (bloodborne pathogens), and exempt recombinant is submitted to ORPC for registration with the IBC and biosafety approval; IRB approval will be required as well.
- Research, regardless of funding, and teaching labs involving animals, fluids and cell lines (including transgenic animals) is submitted to ORPC for registration with the IBC and biosafety approval; IACUC approval will be required as well.
My recombinant DNA research is exempt. Do I need to contact anyone?
Yes, exempt recombinant DNA research must be registered with the Institutional Biosafety Committee (IBC). The ORPC (firstname.lastname@example.org or 5-2737) will answer questions and provide assistance with form submissions.
What kinds of biohazards must be approved by the IBC?
Biohazards are infectious agents or hazardous biological materials that present a risk or potential risk to the health of humans, animals or the environment. These include disease-causing microorganisms, toxins, venom, human fluids, tissues, or cell lines, and animal tissues suspected to be infected with animal pathogens or zoonotic infectious agents.
Why must I take training?
It is important to be up to date on current topics related to biosafety and biosecurity to safe work with biohazardous materials. Modules covered in UMBC’s web-based courses provides details on the overall topic and biosafety training for researchers
My research or teaching needs Biosafety approval, who do I contact?
ORPC can answer questions, provide assistance, and register protocols with the IBC
Is there a policy for accidents or injuries in the lab?
Accidents and injuries involving biohazards or recombinant DNA must be reported to the Principal Investigator and Environmental Safety and Health (ESH). In the event of severe injury, call 911 or go immediately to the nearest emergency room. Details on the UMBC ESH process can be found at http://www.umbc.edu/safety/insuranceinjuries.html or call 5-2918.
I want to ship biological materials. What rules apply?
The Department of Transportation (DOT) and the International Air and Transport Association (IATA) regulate the labeling, packaging and shipping documentation for exempt human or animal specimens, non-pathogenic organisms, genetically modified organisms and pathogenic organisms. Please contact Environmental Safety and Health for information on controlled items.
The Office of Technology Development (5-3658) can answer questions about the shipment or transfer of materials from another investigator, institution or commercial vendor using a Material Transfer Agreement (MTA). Please consult the OTD process and forms page to initiate a MTA first; then contact the Office of Research Protections and Compliance to determine if Institutional Biosafety Committee’s (IBC) review and approval is required. Note that investigators may use the IBC’s Designated Review process for timely processing of:
- The purchase of commercially available materials (e.g. Addgene ) for a new faculty member “startup’ program, or
- The purchase of commercially available materials (e.g. Addgene ) for a faculty member wanting to explore a new research topic, or
- The processing through the Office of Technology Development of material transfer agreements to obtain materials from a collaborator/colleague for above two situations.
When is an import permit needed?
According to Code of the Federal Regulations Title 42 Part 71.54 Etiologic agents, hosts, and vectors. “(a) A person may not import into the United States, nor distribute after importation, any etiologic agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable of being a host or vector of human disease unless accompanied by a permit issued by the Director.” This includes microorganisms and human or animal tissues suspected to contain an infectious or etiologic agent.
I want to apply for an import permit. Is there someone I can contact for help?
Environmental Safety and Health can provide assistance with import permits.
What is my research has any potential biosafety security or health consequences?
Based on current understanding from the NIH, this type of research called Dual Use Research of Concern (DURC) , will require a higher level of review as the research can be reasonably provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety. While not anticipated at UMBC, investigators should be aware of issues and potential consequences. For more information, see the NIH OBA page on DURC or contact the ORPC.
NIH Frequently Asked Questions and links to information