Environmental, Health and Safety Services

Human Subject Research

Recruitment and use of human volunteers for academic research is regulated by VT's Institutional Review Board (IRB). This oversight committee reviews and approves all aspects of research efforts that involve volunteers, such as recruitment practices, survey methods, recordkeeping practices, research procedures, security of volunteer information, etc. The IRB ensures that the rights and safety of human subjects/ volunteers are protected.

  • Examples of research areas where IRB oversight occurs:
    • Studies in sociology, psychology, human nutrition, transportation, etc.
    • Medical or clinical trials for pharmaceutics or other experimental treatments, imaging studies, genetic studies; etc.
    • When human specimen material is collected from volunteers for manipulations in research labs or teaching labs (see below).
  • Protocols for research projects of these types must be submitted to the IRB for review and approval, and for periodic renewal.
  • People must complete IRB-required training before beginning this type of research.

Human Biological Material (Blood/Tissues/Fluids, Human Cell Lines) Used in Research or Teaching

  • The Institutional Review Board oversees research involving human specimen material collected from volunteers for manipulations in research labs/ teaching labs.
    • Teaching labs that use human specimen material (blood from fingersticks, tissue from cheek swabs, saliva, etc.) from lab participants for exercises:
      • An application to the Institutional Review Board may not be needed, if the specimen material is self-collected and self-tested, and if test results are not shared in any way that identifies participants.
      • Contact the IRB to confirm whether your teaching exercises require IRB approval.
  • The Institutional Biosafety Committee (IBC):
    • Reviews research protocols and teaching lab protocols involving culturing and/or manipulation of biological material of human/non-human primate (NHP) origin, including the following:
      • Blood/ blood products/blood components
      • Unfixed tissue or organs from a human or NHP (living or dead)
      • Other potentially infectious materials of human/NHP origin, including sexual fluids, cerebrospinal fluid, organ fluids, joint fluids, amniotic fluid, saliva
      • Human or NHP cell cultures, including primary or established cell lines
    • These materials are considered biohazardous material due to the risk of exposure to bloodborne pathogens; the IBC has determined that any work with these agents must be conducted at BSL2.
    • Clinical diagnostic labs, service labs (such as for electron microscopy or flow cytometry), and some teaching labs using human materials receive a targeted review by the IBC as "Special Labs" rather than the broader review given to academic research labs.
    • OSHA requires that Bloodborne Pathogens training be taken by all lab personnel who have the potential for exposure to human blood or other potentially infectious materials (NHP is also included in this requirement).

See chart below for more details.

Lab SettingMaterial and ManipulationOversight Requirements
Research and Teaching LabsHuman blood, urine, saliva, etc. cultured and/or manipulated
  • Register with IBC
  • Perform risk assessment for BBP
  • Document training for personnel
  • Contact IRB
Clinical Research lab (e.g., VTCRI)Human blood, urine, etc. collected and/or minimally manipulated (ex: tested or shipped in closed containers)
  • Register with IBC as a Special Lab
  • Perform risk assessment for BBP
  • Document training for personnel
  • Contact IRB
Service Labs (e.g., Flow Cytometry)Manipulation or testing of tissues/ fluids/ cell suspensions of human, NHP, tumorogenic, transgenic, or infective material
  • Register with IBC as a Special Lab
  • Perform risk assessment for BBP
  • Document training for personnel
  • Contact IRB
Teaching LabsHuman saliva, cheek swabs, blood from fingersticks, etc.
  • No oversight needed IF:
    • Specimens are self-collected & self-tested.
    • Manipulations of specimens are minor, and/or take place in closed containers.
    • Results are not shared or are shared as de-identified information.
    IF ONE OR MORE CONDITIONS ARE NOT MET, CONTACT THE IRB.
Primary Hazards In Research Using Human/NHP Materials Safety Considerations In Research Using Human/NHP Materials
Exposure to bloodborne pathogens and/or other potentially infectious agents. Mitigate exposure risks by following OHSA Bloodborne Pathogen Standard criteria, and by adhering to specific work and containment practices as determined by risk assessment.

Guidance and Further Information:

IRB
IBC