Core Facilities

IBC Guidance for Core Facilities

Core Facilities are labs that create products or provide services that involve work with potentially hazardous biological agents, including recombinant or synthetic DNA molecules, biological toxins, or infectious materials on behalf of Indiana University Investigators or a facility in which specialty equipment or services are offered in support of laboratory or clinical research and maintained under the responsibility of a specific PI or program.  

The IBC asks for protocols from Core Facilities 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, the Core Directors (i.e., the Core PI) are aware of incident reporting requirements, and the biosafety risks for the work are assessed and mitigated.  

Review the IU ORC Core Facility SOP for further guidance. 

For Core Facility users, all work being performed in a Core Facility on your behalf, or by your laboratory staff, should be thoroughly described on your own IBC protocol.

Examples of Core Facilities Subject to IBC Oversight 

  • IU Genome Editing Center (IUGEC) 
  • Flow Cytometry Core 
  • IU Simon Cancer Center Angio BioCore 

IBC Protocol Guide for Core Facility Submissions

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  • Principal Investigator (PI) – Generally, this should be the Core Director 
  • Department Name – This will populate automatically 
  • Title of the study – This should briefly and accurately describe the name of your Core and the services provided (e.g., “Bioprinting (3D)”) 

  • Protocol Type: Core Facility
  • Review Type:
    • Select Non-Exempt when a Core Facility handles materials or performs experiments that fall under the NIH Guidelines sections III-A – III-E.
    • Select Exempt when a Core Facility handles biological materials or performs experiments that are exempt from the NIH Guidelines (e.g., non-modified human samples)
  • Will rDNA or synthetic rDNA be used: If this Core Facility will use rDNA, check Yes.
  • Vector Systems: If this Core Facility will use any vector systems, check Yes.
    • Vector Type: Select all applicable vectors used in the Core Facility.
  • Will this research involve the deliberate transfer of rDNA or synthetic rDNA into humans: Generally, this answer is No.
  • Will animals be used: If this Core Facility will generate transgenic animals or use recombinant material with animals, check Yes.
  • Will plants be used: If this Core Facility will generate transgenic plants or use recombinant material with plants, check Yes.

  • Personnel List: List anyone who handles biological materials on behalf of the Core.

  • List any associated IRB or IACUC protocols.

  • Generally, Internal Funding can be checked.

  • List all Core locations where benchwork is performed or animals are used or housed.

  • The Research Description section should describe the activities performed in the Core Facility, being as complete as possible considering the different types of samples likely to be handled and manipulations commonly performed. Please also include a description of all specialized/service equipment (e.g., FACS, microscopes, etc.). Detail whether the equipment is used by Core staff and/or the investigator’s lab staff. Provide a description of the services provided by the core that involve biological hazards, rDNA, transgenic animals or transgenic plants.
  • Focus on safety practices of the Core, including a description of how staff are trained.
  • Detail Biosafety Information
    • Storage, handling, and disposal procedures
    • Decontamination protocols
    • Procedures for accidental exposure or spill response
    • Reporting timelines for safety concerns or protocol deviations
  • If using Vector Systems, you do not need to describe each system in detail, but provide an overview of the general systems used (e.g., Lentiviral Vectors, Lipid nanoparticles)

  • This section is highly dependent on the type of work being performed. The PI should make an attempt to complete this section, but RSCO and reviewers will assist in ensuring these are correct.

  • This section is highly dependent on the type of work being performed. Generally, you can complete one entry for each type of system used.

  • This section is dependent on the types of vectors you selected in the General Questionnaire.

  • Add an entry for each sample type handled in the Core (e.g., Human blood and/or blood derivatives, Mouse tissue)
  • Add an entry for each vector type being used (e.g., Lentiviral Vectors, whole plasmids)

Most of the time this will be dependent on the samples you will gather from the participants. However, there are some basics you can almost always check.

  • Select the highest containment level and animal containment level required for the biological materials the Core will handle.
  • General Practices:
    • Generally, you should always check all boxes except specialized spill procedures (unless indicated in the biological materials section), and that the lab will deviate from above practices.
  • Non-Animal Research PPE:
    • Generally, you can always check the following:
      • Closed toe shoes
      • Long pants or skirts that cover legs
      • Gloves
      • Laboratory Coat
      • Eye Protection
    • Other PPE may be required depending on the work being conducted.
  • Engineering Devices: Select all engineering devices that the Core uses.
  • Health Surveillance/Immunization: If human materials are being handled, check Hepatitis B vaccine offered. Other requirements will be dependent on the work being conducted.
  • Laboratory Practices:
    • Generally, you can always check the following:
      • Lab will transport materials outside of a laboratory
        • Transported in a closed, rigid, leakproof container with biohazard symbol (for the IP moving from pharmacy to administration location and or samples moving from clinical setting to lab)
        • Materials that are infectious to humans and/or animals will be shipped (for human samples being sent back to the sponsor)
      • Needles and syringes are not recapped or reused
      • Sharps containers are only 2/3 full before disposal
      • Vortexing/mixing/centrifugation performed in tightly capped tubes
      • Pipetting in Biosafety Cabinet for work requiring BSL-2 or higher containment
  • Laboratory Access
    • Generally, you can check the following:
      • Locked laboratories with limited public access
      • Limited to personnel trained for specific procedure
  • Lab and Surface Disinfectant
    • Generally, you can check 70% ethanol with 10 minutes contact time, but this may depend on the SOP of the trial location (e.g., IU Hospital SOP, CTL SOP)
  • Equipment Disinfectant:
    • This section is dependent on the types of equipment being used in the Core.
  • Solid Waste:
    • Generally, you can check the following:
      • Materials will be appropriately autoclaved
      • Puncture resistant container with biohazard symbol: autoclaved prior to disposal
  • Liquid Waste:
    • This section is dependent on the types of waste being generated in the Core.

  • Read and check

  • Attach any Core SOPs.