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UTEP IBC Handbook

Introduction
Statement of Purpose
UTEP IBC Composition
Roles and Responsibilities
IBC Policies and Procedures
Submission Types
Review Types, Processes, and Timeline
Protocol Termination
Protocol Deviations and Allegations of Non-Compliance

Roles and Responsibilities

 

Institutional Official (IO)

The IO, appointed by the UTEP President, represents the IBC to federal and regulatory agencies.  Their role includes assigning members to the IBC and ensuring the committee adheres to the NIH Guidelines .  Additionally, they manage all incoming and outgoing biosafety communications and distribute messages accordingly.  

IBC

The IBC's primary role is to provide local review and oversight of research involving rDNA or SNAMs as specified in Section III of the NIH Guidelines .  In addition, the UTEP IBC will review protocols involving RG2 and RG3 infectious agents, select agents, toxins, human/non-human primate derived materials, biological samples known/suspected to be contaminated with RG2 or RG3 agents, and arthropods.  The IBC must ensure that these research projects conducted at or sponsored by the institution comply with the NIH Guidelines .  The review of the protocols shall include ( i ) an independent assessment of the containment levels required by the NIH Guidelines for the proposed research; ( ii ) an assessment of the facilities, procedures, practices, and training and expertise of personnel involved in research with rDNA or SNAMs, RG2/RG3 agents, toxins, select agents, human-derived, animal derived, plant derived, primate and non-primate materials, and arthropods.  

More specifically, as per the NIH Guidelines ( see Section IV-B-2 ), the IBC’s responsibilities include, but are not limited to:  

  • Notifying the Principal Investigator of the IBC's review and approval results.  
  • Assessing the proposed reduction of containment levels for specific experiments mentioned in Section III-D-2-a. These experiments focus on cloning DNA from Risk Groups 2, 3, or 4 and Restricted Agents into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.      
  • Setting containment levels as specified in Sections III-D-4-b, Experiments Involving Whole Animals .  
  • Periodically reviewing the institution's rDNA or SNAM research to ensure compliance with the NIH Guidelines .  
  • Adopting emergency plans covering accidental spills and personnel contamination from rDNA or SNAM research.  This includes reviewing and approving facility biosafety manuals ( e.g., BSL-2 and BSL-3 manuals), general biosafety policies, and SOPs.  

The IO has granted the IBC the authority to enforce these guidelines and ensure that investigators and laboratory personnel follow approved protocols.  The IBC evaluates each project's risk level, and only those that meet safety and compliance standards are approved. Any significant incidents, violations, or research-related accidents and illnesses involving rDNA or SNAMs must be reported to the NIH Office of Science Policy (NIH OSP) by email (NIHGuidelines@od.nih.gov) through the IO, per the NIH Guidelines .   

IBC Chair

The IBC Chair is a member appointed by the VPR. The Chair works closely with the IBC members, IBC analyst, and PIs to ensure the safe conduct of activities involving biohazardous materials. The IBC Chair’s duties include:  

  • Conducting monthly meetings and calling for additional meetings as necessary.  
  • Assigning reviewers for Full-Committee Review (FCR) and Designated Member Review (DMR).  
  • Reviewing policies and biosafety manuals.  
  • Signing official IBC documentation as needed.  
  • Ensuring that all IBC members are appropriately trained as described in the NIH Guidelines Section IV-B-1   
  • Submitting an annual report on the IBC's activities to the IO.    

BSO

A BSO must be appointed and be a permanent member of the IBC if UTEP conducts research involving the use of rDNA SNAMs for either large-scale research or production (>10 L), in the BSL-3 containment or gene drive-modified organisms ( ref. Section IV-B-3-a, b, and c ). As per the NIH Guidelines (ref. Section IV-B-3-d ), the BSO's duties include:  

  • Provide training, conduct facility inspections, and communicate related regulatory requirements to assist laboratories in conforming to regulatory and IBC Handbook guidelines.  
  • Conduct regular inspections to ensure that laboratory standards are strictly adhered to.  
  • Report any significant problems, violations of the NIH Guidelines , and any significant research-related accidents or illnesses to the IBC and IO unless the BSO determines that the PI has already filed a report.  
  • Develop emergency plans for handling accidental spills and personnel contamination and investigate any laboratory accidents associated with the research of rDNA or SNAMs.  
  • Provide advice on laboratory security.  
  • Provide technical advice to PIs and the IBC on research safety procedures.  

Principal Investigator

The PI is the faculty member who conducts research, whether funded or not.  The PI must comply with UTEP's biosafety policies, practices, and procedures.  This responsibility extends to all individuals who enter or work in the PI's laboratory or collaborate in carrying out the PI's research.  Although the PI may assign some aspects of the Biosafety Program in their laboratory to other personnel like laboratory directors, supervisors, or faculty, the PI is still accountable for all activities happening in their laboratory.  Documenting training and compliance with appropriate biosafety practices and procedures is crucial.  The PI is responsible for ensuring proper employee safety training and correcting errors and unsafe working conditions. As part of their general responsibilities, the PI shall:  

  • Never initiate or modify research involving biological materials that require IBC review and approval until the IBC has approved that research or proposed modification.  
  • Inform laboratory personnel, maintenance personnel, and visitors about the potential risks of exposure to biohazardous agents and the necessary safety measures to minimize them. Educating everyone about the hazards and appropriate safety practices before entering or working under such threats is essential.  
  • Be adequately trained in microbiological techniques and ensure that laboratory staff is adequately trained to ensure safety and the procedures for dealing with accidents.  
  • Notify the BSO of significant issues, accidents, or policy violations.  
  • Ensure that all individuals covered under their research protocol are up-to-date with mandatory training ( e.g., Laboratory Safety triennially and Biosafety/Bloodborne Pathogens annually) and be enrolled in the UTEP Occupational Health Program (OHP), if applicable.  
  • Work with the BSO to create emergency protocols that address accidental spills and personnel contamination.  
  • Establish a laboratory environment that promotes open communication regarding biosafety concerns, incidents, and violations.  The PI shall not penalize or reprimand individuals who report such issues to the appropriate authorities, such as the IBC, BSO, Risk Management, or State or Federal agencies.  
  • Ensure lab personnel comply with shipping regulations for biohazardous and/or select agents. The BSO provides shipping training to ensure compliance.  Before shipping microbiological cultures, tissues (human or animal), body fluids, or dangerous goods, the PI must contact the BSO to verify that all applicable transportation safety regulations have been met.