Biological research registration is required for any research involving hazardous biological material or recombinant or synthetic nucleic acid molecules. The IBC reviews and approves biological research registrations for research and teaching activities involving the following materials:
- Recombinant (rDNA) and synthetic nucleic acid molecules
- Infectious agents or microorganisms (bacteria, virus, fungi, yeast, parasites, prions) that can cause disease in healthy humans and/or significant environmental or agricultural impacts
- Human and non-human primate materials (blood, cells, tissues, fluids, and secretions that are potentially infectious)
- Select agents and toxins
- Genetically-modified animals or whole plants
- Other regulated biological materials such as federal, state, other permitted materials, or as designated by university
Research using these materials that fall under IBC purview cannot commence without IBC approval.
The IBC review process is as follows:
- Submission of Biological Research Registration on BioRAFT by Principal Investigator (PI).
- Types of Reviews: initial application, amendment, continuing review.
- Pre-review by Biosafety. Upon submission, Biosafety will pre-review the application to ensure completeness and consistency. Any identified issues will need to be updated or corrected by the PI prior to IBC meeting. Any outstanding safety trainings should be completed prior to completion of the pre-review process.
- Administrative review: research that meet specific exempt or IBC-designated criteria as outlined in the IBC charter may be eligible for IBC administrative review at the discretion of the Institutional Biosafety Officer (BSO).
- Institutional Biosafety Committee will review the proposed biological material, biological research activities, biosafety containment level (BSL), and safety procedures on after pre-review at the next IBC meeting. Adherence to submission deadlines, and any pre-review deadlines is critical to inclusion on the next meeting agenda. IBC will approve, conditionally approve (approve with contingencies), table (insufficient information for review) or disapprove application.
- Biosafety Inspection of research or teaching location(s), trainings, and approval of standard operating procedures are required prior to receiving full approval. A biosafety inspection must be completed at least annually. Biosafety will contact the PI and/or delegate to schedule.
- IBC Approval Letter with application summary, approved biological materials, biosafety level(s), approval period.
- Additional considerations: All personnel must be listed on the biological registration prior to beginning research activities with biological material(s). The PI and research personnel must have appropriate training, including safety training(s) and research-specific hands-on training, as well as demonstrate competency to the PI or delegate prior to beginning independent research activities. Undergraduates may be restricted and require direct supervision based on research activities outlined in biological registration. All personnel listed on the biological registration must be provided with and read the approved registration document as well as any subsequent amendments.
For more information about the biological research registration and review process or for new PI contact email@example.com.