Institutional Biosafety Committee (IBC)

When activities are registered with the IBC, the IBC will review and maintain a record of your activity. This process may require changes to your project. Additionally, the IBC will also seek annual updates from you about the work.  

All registered or approved activities are subject to inspection by the IBC or other University officials to ensure all protocol and institutional standards are being carried out. 

The IBC is required to periodically review all biohazardous work at UAlbany. Review of biosafety protocols that require approval prior to initiation will occur at frequency appropriate to the work as determined by the IBC.  

It is the Principal Investigator’s responsibility to ensure that all approvals for the work are kept current. IBC oversight may only conclude after the last of any materials has been disposed of or exhausted. 

For registered research, you must annually confirm the activity is ongoing. The IBC is working to implement a system to support reminders for annual reviews and check-ins. 

When you submit a funding proposal to an external sponsor the involves previously registered or reviewed work, you will need to submit a new application with the IBC if activities will involve new procedures, the use of additional substances or other changes that may affect the risks of the activity.  

If the only change to the protocol is the addition of a project for which the activities will be undertaken, then a modification can be submitted.  

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. 

Recombinant or synthetic nucleic acid molecules (rDNA/sNA) work that are exempt from NIH guidelines and do not require registration with IBC 

Note: Other federal and state standards of biosafety may still apply to such research (for example, the Centers for Disease Control and Prevention (CDC)/NIH publication Biosafety in Microbiological and Biomedical Laboratories). 

• Synthetic nucleic acids that: 
  • can neither replicate nor generate nucleic acids that can replicate in any living cell, 
  • are not designed to integrate into DNA, and  
  • do not produce a toxin that is lethal for vertebrates at an LD50 < 100 ng per kg bw 
• rDNA/sNA molecules that are not in organisms or viruses, and not modified to penetrate cells 
• rDNA/sNA molecules that consist entirely of a single DNA segment from a single non-chromosomal or viral DNA source, though one or more may be a synthetic equivalent that exists in nature 
• rDNA/sNA molecules that consist entirely of DNA from a single prokaryotic host (including its plasmids or viruses) when propagated only in that host (or closely related strain) or when transferred to another host by well-established physiological means 
• rDNA/sNA molecules that consist entirely of DNA from a single eukaryotic host (including chloroplasts, mitochondria, or plasmids) when propagated only in that host (or closely related strain) 
• rDNA/sNA molecules that consist of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent 
• rDNA/sNA genomic DNA that has acquired a transposable element, provided the element does not contain rDNA/sNA 
• rDNA/sNA molecules that do not present a significant risk to health or the environment (see NIH Guidelines Appendix C) 

Whether activities involving only RG-1 materials are exempt 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 Institutional Biosafety Protocol Form for review) or the IBC must review and approve your work. 

Contact the IBC at [email protected] or 518-437-3850 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.   

rDNA/sNA work that is eligible to start simultaneously with IBC registration 

Experiments involving substances not in a risk group or in RG-1 and the following activities must be registered with the IBC; however, review and approval is not required prior to initiation. 

• Experiments involving the formation of rDNA molecules containing no more than two-thirds of the genome of any eukaryotic virus 
• Cloning in non-pathogenic prokaryotes and non-pathogenic lower eukaryotes 
• Generation by embryo injection of transgenic rodents requiring BSL-1 containment 
• Breeding two different transgenic strains of rodents to generate novel transgenic strains requiring only BSL-1 containment 
• Experiments involving recombinant or synthetic nucleic acid molecules in whole plants that require only BSL-1 or BSL-2 containment 

Registration requires the submission of Biosafety Protocol Evaluation Form (see above); work may begin once the form is submitted. The form is reviewed by the IBC and the IBC may require changes to the protocol to address identified risks 

Any changes to protocols involving the above substances or procedures must be reported to the IBC. 

rDNA/sNA work that requires IBC review and approval prior to initiation 

• Deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally if such acquisition could compromise the use of the drug to control disease or cloning of toxin genes with LD50 of less than 100 ng/kg body weight 
• Experiments involving the transfer of recombinant DNA or RNA derived from rDNA, into one or more human research participants 
• Experiments using Risk Group 2, 3, or 4 agents as host-vector systems 
• Experiments in which DNA from Risk Group 2, 3, or 4 agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems 
• Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems 
• Experiments involving the formation of rDNA molecules containing at least two-thirds of the genome of any eukaryotic virus 
• Cloning in pathogenic prokaryotes and pathogenic lower eukaryotes 
• Experiments involving recombinant or synthetic nucleic acid molecules in whole animals (with the exception of transgenic rodents requiring BSL-1 containment) or whole plants 
• Generation by embryo injection of transgenic rodents requiring BSL-2 or greater containment 
• Experiments involving more than 10 liters of culture 
• Experiments involving human influenza strains H2N2, 1918 H1N1, and/or highly pathogenic H5N1 

Any changes to protocols involving the above substances or procedures requires review and approval prior to initiation 

Other biohazardous work that is determined to present significant potential for human and environmental harms 

• The use of Select Agents or Toxins (Select Agents and Toxins List) that may adversely affect public health, animal or plant health, or animal or plant products. And any use of agents or toxins in Risk Group (RG) 2 or higher requires IBC approval prior to obtaining and using the substance. 
• RG-2 substances are associated with disease that can cause infection of varying severity; rarely lethal.  If you are unsure what risk group you the substance you are working with may be, please consult the ABSA Risk Group Database or Pathogen Safety Data Sheets. 
• Any activities or experiments requiring Biosafety Level (BSL) 3 or BSL-4 containment. The standards for research and clinical laboratories are published by the Centers for Disease Control in Biosafety in Microbiological and Biomedical Laboratories (BMBL).
  
  Currently UAlbany facilitates do not support greater than BSL-2 containment. If your research will require BSL-3 or greater containment, please contact the IBC at [email protected] or 518-437-3850. 
• IBC Review and approval is needed for the collection, storage or analysis of human or mammalian cell lines (including embryonic & established), unfixed human tissue or organ (other than intact skin), blood and any of the following human body fluids: 
  • semen 
  • vaginal secretions 
  • cerebrospinal fluid 
  • synovial fluid 
  • pleural fluid 
  • pericardial fluid 
  • peritoneal fluid 
  • amniotic fluid 
  • any body fluid that is visibly contaminated with blood 
  • all body fluids in situations where it is difficult or impossible to differentiate between body fluids, such as saliva from dental procedures
    
    Note: IBC review is not needed for the collection of saliva if it is not expected that samples will contain blood and if the samples are not cultured to increase infectious particles. By not culturing the sample, the number of infectious particles is not increasing; therefore, theoretically, there is no increased risk to laboratory staff. The PI should consult with EH&S to ensure safe protocols for sample collection and sample storage are followed.  
    
    Additionally, if the collection of samples from humans will be for research purposes, then review and approval will be needed by the Institutional Review Board (IRB) for human subjects protections.  
• The use of regulated plant pathogens or pests. (See U.S. Regulated Plant Pest List.) 
• The use of toxins derived from plants, animals or micro-organisms that will have adverse effects in humans or animals. 
• Any changes to protocols involving the above substances or procedures requires review and approval prior to initiation.