What Needs IBC Approval?
In order to maintain safe conditions and regulatory compliance in research and teaching areas, work done with any of the following biological materials must be registered with the IBC for review and authorization:
- Recombinant/synthetic nucleic acid molecules, as covered by the NIH Guidelines
- Infectious agents (viruses, bacteria, fungi, parasites, prions, etc.) that can cause disease in healthy humans and/or significant environmental or agricultural impacts, as covered by the BMBL
- Select agents and select toxins, as covered by the CDC DSAT regulations
- Human materials (including all fluids, tissues, excretions, secretions, or cell lines), as covered by the Cal/OSHA Bloodborne Pathogens Standard
- Nonhuman primate materials (including live animals, all fluids, tissues, excretions, secretions, or cell lines), as covered by the BMBL and Cal/OSHA Bloodborne Pathogen Standard
- Genetically-modified animals and whole plants, as covered by the NIH Guidelines
- Certain animals or animal specimens known to be reservoirs/vectors of zoonotic diseases. EXEMPT: Most animals from UCLA DLAM approved vendors. (See http://publichealth.lacounty.gov/vet/guides/vetzooman.htm for list of zoonotic animals)
Who Needs IBC Approval?
It is the responsibility of the Principal Investigator to (a) seek IBC approval for the safe handling, transport, use and disposal of hazardous biological materials and recombinant/synthetic nucleic acids and (b) maintain an approved IBC protocol during the time period these materials are used. PIs are responsible for updating their IBC protocol(s) to include any modifications to personnel, locations, materials, procedures, etc.
The University is responsible for ensuring that, irrespective of funding source, all research and teaching laboratories involving hazardous biological materials and/or recombinant/synthetic nucleic acids are fully compliant with regulatory guidelines and policy. Willful or negligent violation of UCLA’s established biosafety practices and procedures may result in suspension, limitation, or termination of research activities involving biohazardous materials.
Registration Review and Approval
All applications (Biological Use Authorizations) must be submitted using SafetyNet. The IBC no longer accepts paper applications.
When reviewing Biological Use Authorizations (BUAs), the IBC is evaluating whether the activities can be conducted in a manner that will ensure protection of personnel, the general public, and the environment. Specifically, the IBC considers the following items when reviewing a research or teaching project:
- Does the PI have sufficient expertise to oversee the safe conduct of the research?
- Is the proposed Biosafety Level appropriate for the work?
- Does the proposed location(s) meet the requirements for the assigned Biosafety Level?
- Will the work be conducted using appropriate biological safety practices and equipment?
- Is there a potential for environmental release or public exposure? If so, how is this risk mitigated?
- Are there Standard Operating Procedures (SOPs) in place outlining procedures for waste disposal, decontamination, spill response, exposure response, transport of materials, etc.?
- Are personnel properly trained, including general EH&S trainings and lab-specific training?
- Is hazard communication provided to all personnel who are at reasonable risk of exposure to hazardous biological or r/sNA materials?
- Have occupational health considerations been addressed, including vaccinations and medical surveillance, when appropriate?
All approvals are contingent upon meeting facility inspection requirements, applicable training requirements, additional federal, state, and local requirements and obtaining other institutional committee approvals.
BUAs are valid for three years from the date of approval. If work will continue beyond that time, a renewal application must be submitted.
IBC Meeting Calendar and Applicable Submission Deadlines
The IBC meets twice each month to review those submissions requiring full Committee review. Deadline dates were created to allow adequate time for pre-review and for reviewers to assess submitted research project registrations.
Submission deadlines for the corresponding IBC meeting dates can be viewed at: IBC Meeting Calendar. In compliance with NIH Guidelines Section IV-B-2-a-(6), when possible and consistent with protection of privacy and proprietary interests, the IBC opens its meetings to the public. To ensure that privacy, proprietary and security interests are appropriately addressed, visitors must contact the IBC Manager firstname.lastname@example.org prior to the meetings.
During the three year approval period, any modifications to the approved BUA must be made using SafetyNet. The amendment request should include a brief summary of the changes that are being requested as well as updates made directly to the BUA form. For BUAs that were originally submitted and approved using the paper forms, you will need to complete the entire SafetyNet form, including all experiments/materials that were previously approved as well as the newly added information/modifications.
Questions or Assistance
If you have any questions or need assistance, please email email@example.com or call the IBC help desk at (310) 794-0262.