• Purpose: The purpose of this policy is to provide the requirements for training to all personnel involved with a COMS registered protocol.
  • Applicability and Minimum Guidelines
    • All personnel (PI, staff, students) handling CRM must meet all institution-mandated training requirements.
    • All PIs registered with COMS must complete NIH Guidelines training prior to initiation of recombinant or synthetic nucleic acid molecules work and not less frequently than once every three years thereafter.
    • Initial awareness-level training on the NIH Guidelines must be provided to PIs that do not work with recombinant or synthetic nucleic acid molecules.
    • All personnel handling CRM must be provided registration and agent-specific biosafety training appropriate to the job activity.  This training may be performed by the PI or by a knowledgeable designee.  The training must be provided prior to initiation of work, when novel biohazards are added to the work, and as per institutional requirements, but not less frequently than once every three years.
  • Record Keeping Requirement: Each institution or their designee maintains documentation of training for laboratories under COMS purview.
  • Implementation procedures
    • Monitoring Compliance and Sanctions for Non-compliance:
      • Each institution shall verify at the time of laboratory inspections.
      • At the time of COMS registration renewal the PI or his designee will verify the PI and their laboratory members have taken the required biosafety training.
      • Untrained individuals will be prohibited from working on the registered biological research.
      • COMS registration will be suspended if training non-compliance is not corrected.  
    • COMS Responsibilities:
      • Establishes minimum guidelines for required training at participating institutions.
      • Ensures appropriate training for the Committee Chair and members.
      • Provides materials/resources for institutions to meet training requirement.
      • Notifies Institutional BSOs about new regulations related to training, changes in COMS processes, training modifications.
      • Provides training to IACUC/IRB/Grants management personnel on COMS procedures.
    • Institutional Responsibilities:
      • Delivers and documents, through methods determined by the institution, annual biosafety training.
      • Distributes or makes available training resources/references such as Biosafety Manual, Lab Inspection Checklist, autoclave validation process, spill kits, etc.
      • Provides resources to laboratories to enable them to perform laboratory and registration-specific biosafety training upon request.
  • Policy Authority: The Committee on Microbiological Safety shall enforce this policy.