IBC Requirements and Procedures

The IBC oversees compliance with university, local, state, and federal regulations governing biological safety and security, in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules.

Principal Investigators (PIs) planning to carry out research or teaching which involve any of the following biological hazards must submit a written Project Registration form to the IBC for review:

  • Recombinant DNA
  • Agents that are potentially infectious for humans, animals or plants
  • Toxins
  • Human blood, body fluids, or unfixed tissue
  • Tissues, organ or cell cultures of human origin
  • Human gene therapy
  • Old World primates or sheep

Procedures for Reviewing IBC Project Registrations

  1. Projects involving either DNA recombinant research or the use of biological materials has been assessed to require a level of containment of Biosafety Level 1 (BSL1) or its equivalent (Group I, Class 1, or Low Risk), the project may be approved by the IBC Executive Committee (IBC Chair and at least one other voting member).
    • Any member of the IBC Executive Committee who reviews the Project Registration may request review by the full committee
    • Projects reviewed and approved under these provisions will be reported in the activity report to the IBC at its next convened meeting. Copies of Project Registrations will be available to all IBC members 
  2. Projects that require containment procedures at or above Biosafety Level 2 are reviewed by the full IBC at a scheduled meeting.

Procedures for Continuing Review of Project Registrations.

  1. The IBC Office will inform the Principal Investigator that the current Project Registration is about to expire and that an renewal or modification is required. Each registration is approved for a maximum of three years.
  2. Prior to expiration, the PI must submit a new Project Registration form for review.

Procedures for Amending an MUA

  1. Minor modifications to the approved project - such as disinfectant changes, use of same agent in a different form, or changes in vector or host organisms that do not alter classification of the experiment or safety of the protocol require that an Amendment be submitted to the IBC for review.
    • The amendment may be approved by the IBC Executive Committee.
    • Approved amendments will be reported to the IBC at the next regular scheduled meeting.
  2. Major modiications to the approved project - such as changes in PI, changes/additions to chemical or biological agents, changes in animal model, or use of vector or host organisms that change classification of the experiment require completion of an Amendment and review by the IBC at a scheduled meeting. In some cases, the IBC may require a new Project Registration

Training

  1. Recommended CITI Training
    • Introduction to Biosafety
    • Initial Biosafety
    • OSHA Personal Protective Equipment 
    • Other Biosafety and Biosecurity modules relevant to your specific research focus