Program Scope, Responsibilities and Regulatory Background

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A. Scope

This Manual is applicable to all laboratory, research, service and support activities that may involve exposure to biohazardous agents or materials and that come under the purview of the Institutional Biosafety Committee (IBC).
Research specifically addressed are those involving:
  • work with recombinant and synthetic nucleic acid molecules
  • microorganisms, including bacterial, fungal, and parasitic agents that could be harmful to humans, plants or animals
  • live viruses
  • experimentally infected research animals
  • human blood and tissues
  • receipt, handling, and disposal of biological materials

B. Regulatory Forces and Guidelines

Guidelines developed by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) form the basis for the biosafety practices included in this manual. These guidelines must be followed to ensure the continuation of grant funds from federal agencies.
  • mandate the establishment of an Institutional Biosafety Committee (IBC) for the review and oversight of biological research
  • outline roles and responsibilities for biosafety
  • establish the practices, procedures, and conditions under which  research with recombinant and synthetic nucleic acid molecules must be conducted.
Guidelines from CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories (BMBL) address the appropriate measures and facilities for work with all microbial agents, including bacterial, viral, fungal, parasitic, and rickettsial agents.
 
For work with human blood and some other body fluids and tissue, the requirements of the Occupational Exposure to Bloodborne Pathogens standard from the Occupational Safety and Health Administration (OSHA) apply. Special training, medical surveillance, procedures, and equipment that must be in place can be found in the Human-Derived Material section of the website.
The purchase, possession, use, or transfer of any select biological agent or toxin is strictly regulated by federal code and regulations. It requires federal permits and inspection as well as significant measures of lab security, personnel training, and accurate record keeping regarding the status of possessed materials. Further information on select agents and toxins is found in the Registration section of the Manual.
Handling and disposal of biohazardous waste is regulated and monitored by the NJ Department of Environmental Protection under the Regulated Medical Waste rules found in the NJ Administrative Code at 7:26-3A. The procedures for biological waste handling outlined comply with the requirements of these rules.

C. The Biological Safety Program at Princeton University

Princeton University is committed to providing a healthy and safe learning, teaching, research and work environment. Accordingly, the goals of the University's Biological Safety Program are to:
  • provide the resources necessary for research to be conducted in a manner that reduces the potential for exposure to potentially infectious materials and prevent laboratory-acquired infections.
  • prevent environmental contamination
  • secure experimental materials
  • comply with federal, state and local regulations.
This manual provides university-wide safety guidelines for working with biological hazards. It also outlines general policies and procedures for using and disposing of infectious and other potentially infectious material (OPIM). This manual is a guidance document and will be updated as needed to reflect changes in regulations and best biosafety practices. This manual may not address all hazards encountered by Princeton University faculty, students and staff.
Biological safety practices and procedures in all University laboratories must comply with those outlined in this manual. Principal Investigators must contact Environmental Health and Safety by phone (x5294) or via email, jw6@princeton.edu, if they have questions on how to categorize, handle, store, treat or discard any biologically derived material.
 
The roles and responsibilities of each are described below:

The Institutional Biosafety Committee (IBC):

  • The IBC has University-wide oversight, as mandated by the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) and is charged by the Dean for Research with review and approval of research projects and formulating policy and procedures related to the use of:
    • recombinant and synthetic nucelic acid molecules
    • microorganisms and viruses pathogenic to humans, plants or animals
    • biological material from human and non-human primates
    • animal tissues that pose zoonotic disease concerns
    • biological toxins
  • The Committee:
    • sets containment levels in accordance with NIH and the Centers for Disease Control and Prevention (CDC) guidelines
    • adopts emergency plans covering accidental spills and personnel contamination
    • investigates potential violations of the NIH Guidelines (Guidelines)
    • reports significant violations of the Guidelines and exposures, accidents or illnesses to the Institutional Official and the NIH OBA
    • makes recommendations for medical surveillance that may be required for staff, faculty and students to the Medical Director, University Health Services.
    • recommends sanctions to the Institutional Official (IO) on any individual whom the IBC determines has violated the terms of an approved protocol, has conducted projects subject to its authority without gaining appropiate IBC approval or has otherwise violated any provisions of applicable federal, state and local regulations or institutional policies regarding subjects under its purview.
  • The Dean for Research appoints members of the IBC.
The IBC membership includes representative faculty and administrators, the University Biosafety Officer, a University Physician, the Attending Veterinarian, and representatives from the local Princeton community.  The committee’s current membership and meeting schedule can be found on the Research Integrity and Assurance website.

Research Integrity and Assurance

  • Administers the IBC meetings and maintains all IBC records, including IBC registration forms, approval letters and meeting minutes
  • Oversees and coordinates the process for submittal and review and renewal of IBC registrations
  • Evaluates the IBC structure and organization to determine compliance with the Guidelines.
  • Responds to research community inquiries regarding IBC registration and approval process

Department Chairperson

  1. Department Chairs are responsible for the implementation of safe practices and procedures in their schools or departments.

Principal Investigator (PI)

  • Principal Investigator is responsible for registering the following research with the IBC: use of recombinant and synthetic nucleic acid molecules; organisms and viruses potentially pathogenic to humans, animals and plants, biological toxins; animal tissues that pose zoonotic disease concerns and human-derived materials.
  • PI must comply with the approval conditions specifed by the IBC.
  • PI must conduct a risk assessment to identify potentially hazardous procedures involving infectious agents, develop Standard Operating Procedures (SOPs), instruct and train all staff and students working in the lab on safe work practices. The PI must provide PPE to lab staff.
  • Report violations of the Guidelines, and research-related accidents and illnesses to the Biological Safety Officer.
  • Supervises lab staff to ensure that the required safety practices are employed.
  • Ensure that lab staff report all biohazard-related illnesses and injuries to University Health Services and seek prompt treatment in accordance with procedures established by Environmental Health and Safety.

Employees or Students

  • Laboratory staff and students must follow the PI's instructions for working in the laboratory.
  • All personnel working in Princeton laboratories with potentially infectious materials must attend Intro to Biosafety training and other training courses recommended by the BSO.
  • Lab staff and students must comply with the containment recommendations issued by the IBC.
  • Reports all accidents, spills, or contamination incidents to supervisor and seek prompt treatment through University Health Services for injuries and illnesses sustained while conducting research

Environmental Health and Safety (EHS) – Contact the Biosafety Officer at 609-258-1427:

  • Consults with researchers on issues of biosafety and the safe use of biological materials in the laboratory
  • Develops protocols and procedures to address issues of biosafety
  • Provides training in safe use and practices for those involved in work with potentially biohazardous materials and activities
  • Advises researchers on proper waste disposal methods based on federal and state regulations and established University practice
  • Provides oversight of the BBP program and manages the training program for those with potential exposure
  • Investigates exposure to potentially infectious materials, including animal bites and scratches and sends results of the investigation to the staff or student's supervisor/PI.
  • Conducts periodic inspection of labs using biological materials

University Health Services

  • advises on need for medical surveillance and/or immunization for those personnel exposed or potentially exposed to biological agents
  • provides medical review and medical surveillance, as appropriate for persons enrolled in the BBP program, animal worker medical surveillance or as recommended by the IBC.
  • provides medical treatment and follow-up for personnel who sustain injuries or illnesses while conducting research.

Other Committees (Institutional Animal Care and Use (IACUC)

  • Consults and coordinates with the IBC on any proposals under their purview which involves the use of potentially biohazardous materials or activities