Institutional Biosafety Committee
The University at Albany is committed to actively supporting biological research in our research and teaching labs. The Office of Environmental Health and Safety and the Institutional Biosafety Committee are equally committed to ensuring that researchers, their staffs, students and the community are not harmed or negatively impacted by that research.
To promote safe conditions in our labs, researchers are asked to fill out and submit a Biological Use Authorization form on-line.
When do I need approval from the Biosafety Committee?
In a nut shell - activities which involve microbiological agents (bacterial, viral, fungal, and certain multicellular parasites), biological toxins, recombinant DNA molecules, human or non-human primate blood or tissues, and cell cultures must have the approval of the Institutional Biosafety Committee (IBC), as required by the National Institute of Health Guidelines
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html. Prior approval may be required in some specific cases.
What type of research must be registered with the IBC?
Experiments involving the following must be registered with the IBC:
Pathogens affecting humans, animals, or plants;
- Materials potentially containing human pathogens (e.g. unfixed human specimens, human blood);
- Recombinant DNA molecules including viral vectors;
- All cell and organ cultures of human origin, including well established cell lines, human embryonic stem cells, and pluripotent cells and their derivatives
- De novo generation of transgenic animals (using recombinant DNA technology to add foreign DNA or subtract a portion of the animal's genome);
- Generation of de novo transgenic animals: Defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. Examples of recombinant DNA technology include (1) Direct microinjection of a chosen gene construct from another member of the same species or a different species into the pro-nucleus of a fertilized ovum; (2) Insertion of the desired DNA sequence by homologous recombination into an in vitro culture of embryonic stems and cells; (3) Use of a plasmid or virus to transfer the genetic material into germ cells. Breeding animals to generate transgenics need not be registered with the IBC. Those transgenics that already exist or which have been purchased are not subject to IBC registration.
- De novo generation of transgenic plants;
- Introduction of recombinant DNA (plasmids) or gene transfer vectors (including viral vectors) into human subjects;
If I am working only with biohazardous materials and not with recombinant DNA, do I need to register my protocol with the IBC?
Yes -The IBC reviews and approves all research involving biohazardous materials, (see below). IBC registration and approval of research involving these biohazards is required.
Naturally occurring or engineered micro-organisms or viruses capable of causing disease in humans and/or animals. These are Risk Group (RG) 2, 3 or 4 pathogens as defined by NIH (Note: this list is not all inclusive). Those agents not listed in RG 2, 3, and 4 are not automatically or implicitly classified as non-pathogens or in RG
- A risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed. Consult the following web sites for guidance.
- Human or mammalian cell lines (including embryonic & established), human tissue or blood.
- Toxins derived from plants, animals or micro-organisms that will have adverse effects in humans or animals.
- Plant pathogens or pests (arthropods, nematodes, weeds) that are regulated by state or federal policy or law. Consult the following web sites for up to date lists of regulated organisms.
- Select biological agents that may adversely affect public health, animal or plant health, or animal or plant products. Note: all possession and use of Select biological agents requires special registration through the Biological Safety Officer.
I work with mouse tissue culture and mouse gene transfections. Sometimes I use human tissue cultures. I have never registered with the IBC because I am exempt from the NIH Guidelines. Why do I have to fill out forms now and why am I considered to be doing BSL-2 research now?
The Institutional Biosafety Committee is charged with registering ALL recombinant DNA research. Whether this research has to have full IBC review and approval depends upon the genes being introduced into the host cell. The Biosafety Officer and/or the IBC Chair will make this determination. Any work with human cells or tissue cultures, even commercially derived (e.g. ATCC ), is considered to be "other potentially infectious material" (OPIM) unless the investigator or commercial source characterizes and documents the material to be free of contamination from human hepatitis viruses, human immunodeficiency viruses, and other recognized or latent bloodborne pathogens. This is the OSHA interpretation of the Bloodborne Pathogens Standard (29 CFR 1910.1030, http://www.osha-slc.gov/SLTC/bloodbornepathogens/ ).
For information on OSHA’s Bloodborne Pathogens Program contact the Biosafety Officer at 442-3425 or refer to UA’s Policy at http://www.albany.edu/ehs/pdf/BloodbornePathogensR2011.pdf
Am I exempt from registration if I work only with Risk Group 1 agents?
This depends upon what you are doing and the agent(s) with which you are doing it. The BSO or IBC Chair can determine whether you must register (which involves completing the form for review) or whether the IBC must review and approve your work. Contact the Biosafety Officer (2-3425 or firstname.lastname@example.org) to discuss what you are doing in your research, present documentation of the biosafety level for the agents, and determine whether full review and approval are required.
How do I know what I need for Biosafety Level 2 research?
The standards for research and clinical laboratories are published by the Centers for Disease Control, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), at http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
My research involves collecting saliva samples from patients in an outpatient clinic and then testing hormonal levels in the lab, do I really need an IBC review of my protocol?
No - you don’t have to register with the IBC . By not culturing the sample, the number of infectious particles are not increasing; therefore, there theoretically is no increased risk to staffers. The PI should consult the BSO to insure safe protocols for sample collection and sample storage are followed.
I am working with E. coli K12, plasmids, and Saccharomyces. Do I have to register with the IBC ?
Yes . Depending upon the types of genetic material being manipulated, this may be a simple registration with the Biosafety Officer or it may require full review and approval by the IBC . Please feel free to contact Michelle McConville (email@example.com) or Doug Conklin (Dconklin@albany.edu) with any questions.
I have an active IBC approval for recombinant work in my lab. Recently I submitted a new research proposal. Do I have to submit a new registration with the IBC or can I just modify the current protocol?
You will need to submit a new application with the IBC if the research project substantially differs from the currently approved protocol, or there is an increase in the biosafety containment level. A modification may be submitted for IBC review when changes are not considered to be substantial. The IBC reserves the right to request a full renewal or a new application for any submitted modifications that are deemed to be substantial in nature.