Human Biospecimens - IBC Safety Guidelines

Research Involving Human Specimens With Potentially Infectious Materials and Bloodborne Pathogens 

Human tissues, such as tissues and fluids may contain disease causing agents that are potentially hazardous. Blood, saliva, sputum, nasal, cheek and throat swabs are examples of human specimens that may be collected for research activities. Sweat does not typically carry agents of concern, and is not considered biohazardous. 

Even though the OSHA (BBP) Standard exempts urine, feces, vomit, sweat, tears and saliva if no visible blood is present, BBP training emphasizes aseptic (sterile) and exposure control techniques that will significantly reduce the risk of exposure to any agent  found in human fluids.  

CMU requires Bloodborne Pathogen (BBP) training when working with human derived tissues or fluids, even if not visibly contaminated with blood (see EHS Policy).  

Before Conducting Research Involving Human Specimens

  • Principal Investigators may need to submit an IBC Registration Form to the Institutional Biosafety Committee for review before starting a new project.
    Contact the IBC Office at IBC@cmich.edu for more information.
      
    • All personnel must complete CITI "Basic Introduction to Biosafety Training" 
    • All personnel must complete a "Bloodborne Pathogen Training" through EHS or comparable training (e.g., Office of Laboratory and Field Safety and/or Health Professions BBP training)

  •  The PI is responsible for communicating with either the Office of Laboratory and Field Safety (OLFS) or the Biosafety Officer (BSO) based on what is advised during their lab risk assessment evaluation. OLFS and/or the BSO may need to perform an additional risk assessment which could include a lab inspection. 

Recommendations:  Collection of Saliva and Cheek/Mouth Swabs

Sample collection of saliva should be performed by the study participants with instruction in proper use of a collection tube or kit supplied by the researchers. Participants should also be supplied with disinfecting wipes to wipe the outside surfaces of the tube after sample collection and sealing. The sample tube should be labeled and placed in a secondary containment vessel for transport to the lab.

Research involving the collection of human saliva and mouth swabs, which can be considered potentially infectious materials, should be conducted using the same biosafety practices for collecting other human specimens.

 Saliva may contain various infectious agents including, but are not limited to:

  • SARS-CoV-2
  • Herpes viruses (i.e. Simplex, Cytomegalovirus, Epstein-Barr virus)
  • Hepatitis A virus
  • Human T-Lymphotropic virus (HTLV)
  • Influenza viruses (including H1N1)
  • Staphylococcus aureus
  • Streptococcus (ssp.)
  • Mycobacterium tuberculosis
  • Rhinovirus (and other common cold agents)

If saliva or cheek/mouth swabs are being collected for research on a known infectious agent, an IBC registration is required prior to initiation of the study (e.g., COVID swabs of positive individuals).



4/27/2021