IBC Guidance for Core Facilities

Core facilities that create products or provide services that involve work with potentially hazardous biological agents including r/sNA molecules, biological toxins, or infectious agents should have an IBC application in place to account for their use by University faculty, staff, and students, or by non-University employees when the activities occur at University property. University faculty, staff, and students using potentially hazardous biological agents in a Core Facility are expected to perform these activities in ways that eliminate or reduce potential exposure to personnel, students, animals, and the environment. The IBC asks for applications from Core Facilities in order to develop processes and procedures so that the Core’s staff are aware of the risks they are exposed to, the IBC is aware of the work performed at the Core, Core Directors are aware of incident reporting requirements, and so that biosafety risks for the work are assessed and mitigated. After the initial IBC application’s approval, the Core Director should ensure that the application remains active and in compliance by submitting the appropriate renewal or continuing review form before the expiration date to prevent any interruption to the Core’s work.
 

Examples of Core Facilities Subject to IBC Oversight

• create genetically modified (GM) cells or animals
• create viral vectors
• produce proteins using recombinant techniques
• collect/maintain/distribute genetically modified strains of D. melanogaster or C. elegans
   

eProtocol Application Guidance for Core Facilities

1. At the Personnel Section, add the lab staff associated with the Core Facility that will be performing procedures subject to IBC oversight. Please take note of the application editing capabilities based on the eProtocol role assigned.
   1. End users of the products produced by the Core Facility or those who receive services by the Core Facility should have their own separate IBC application.
      1. If the client or end user provides material (e.g., plasmids) to the Core then the cloning and/or maintenance of the plasmid in E. coli should be accounted for in the client’s IBC application.
2. In the Activities Include section, select the appropriate boxes to cover the work performed.
3. In the Study Objectives section,
   1. Create an Official Project Title that clarifies that the application is intended to cover work performed by a Core Facility.
   2. Within part (1a and 1b), include a description of the Core and describe the procedures that will be performed up to the point when the product is provided to the client or the agent/material containing r/sNA molecules, biological toxins, infectious agents is decontaminated, destroyed, or inactivated.
4. Complete sections 2-4 corresponding to the r/sNA section, biological toxins section, and infectious agents section as appropriate. 
   1. The application can be generalized if the Core Facility is producing products/agents after a client request is made.
      1. Specific client requests are typically tracked through the use of a shared Google sheet between the Core Facility and the IBC Admin so that repeated amendments do not need to be submitted and to ensure compliance by the end users with IBC requirements.
   2. A risk assessment should be performed to determine whether modifications to SOPs are needed to account for potentially higher risk services requested by a client (typically relevant for Core Facilities creating viral vectors).
5. Complete the Safety section (7) of the application.
6. In the Attachments section, 
   1. Include SOPs that describe the procedures that will be performed by the Core Facility.
      1. If applicable, include SOPs to address low risk vs high risk requests to distinguish how the containment and PPE might differ. This is generally applicable to Core Facilities that create viral vectors.
   2. Include a Biological Decontamination and Spill Clean-up Plan and a Biological Waste Disposal Plan. 
   3. Include vector maps including any relevant packaging system maps if applicable. 
7. The Core Director (P.I.) should read and complete the assurance page of the application.