Biosafety - Frequently Asked Questions
A Researcher's Guide to Biological Safety at UC Santa Cruz
- What type of research activities are covered by the UCSC Biological Safety program?
- What type of research activities does the Institutional Biosafety Committee (IBC) review?
- How do I initiate IBC review of my planned research (rDNAexperiments, Risk Group 2 or 3 infectious agents, or CDC/USDA Select Agent)?
- Do each of the listed research activities (rDNA, RG 2/3 infectious agents, select agents) in the IBC charge require full committee review and approval?
- As a Principal Investigator, what are my responsibilities according to the NIH rDNA Guidelines?
- What is required to work with human blood, human cell lines or OPIM?
- Does work with human blood, human cell lines or OPIM require authorization from the IBC?
1. What type of research activities are covered by the UCSC Biological Safety program?
All research involving:
- Recombinant and/or Synthetic Nucleic Acid Molecules
- Human, Animal, or Plant Pathogens
- CDC / USDA Select Agents
- Human blood, human cell lines, or other potentially infectious materials (OPIM)
2. What type of research activities does the Institutional Biosafety Committee (IBC) review?
The IBC establishes policy and provides oversight for designated uses of biological materials. The Committee is delegated authority and responsibility from the Vice Chancellor of Research as follows:
- Review and approve recombinant DNA research according to criteria listed in “NIH Guidelines for Research Involving Recombinant and Synthetic DNA Molecules”(April 2019).
- Review and approve use of Risk Group 2 and 3 infectious agents or CDC/USDA Select Agents and Toxins.
3. How do I initiate IBC review of my planned research (rDNA experiments, Risk Group 2 or 3 infectious agents, or CDC/USDA Select Agent)?
Complete a Biological Use Authorization (BUA) by logging into the Risk and Safety Solutions (RSS) Platform and selecting "Begin a Biological Use Authorization" link. The Pricipal Investigator must begin the process and certify and submit the BUA, but a selected delegate may fill out the body of the form. The submitted BUA will be reviewed by the Biosafety Officer before it is sent to the IBC for review.
For questions, contact biosafety@ucsc.edu.
4. Do each of the listed research activities (rDNA, RG 2/3 infectious agents, select agents) in the IBC charge require full committee review and approval?
Recombinant DNA
No, not all research activities require full IBC review. Current procedures allow the Campus Biological Safety Officer (BSO) to review and possibly approve designated rDNA research activities based on the NIH rDNA Guidelines as follows:
The BSO is delegated authority to review and determine whether rDNA research is exempt, requires notice only to the IBC, or whether a full committee review is required. To make this determination, a BUA must be completed in enough detail for the BSO to evaluate the proposed research in context of the NIH rDNA Guidelines.
Note: The rDNA NIH Guidelines are complex. The BUA is an essential tool in determining what sections of the NIH Guidelines apply to your research. Please submit requests for assistance to biosafety@ucsc.edu.
Infectious Agents
All research activities proposing use of RG 2 or 3 infectious agents require full IBC review. A BUA must be completed and submitted via the Risk and Safety Solutions Platform to initiate the review process. For questions or assistance, please contact biosafety@ucsc.edu
Select Agents
UCSC is NOT currently registered or licensed to use CDC / USDA Select Agents. All proposed research activities with CDC / USDA Select Agents or Select Agent Toxins must be authorized by the IBC. To inquire about the use of Select Agents or exempt quantities of Select Agent Toxins, contact biosafety@ucsc.edu.
5. As a Principal Investigator, what are my responsibilities according to the NIH rDNA Guidelines?
A complete list of PI responsibilities is listed in the NIH Guidelines Section IV-B-7.
A summary of PI responsibilities includes:
- Full compliance with the NIH Guidelines for Recombinant or Synthetic Nucleic Acid Molecules
- Determine whether experiments are covered by the NIH Guidelines and require NIH or IBC approval
- Report any significant problems, violations of NIH Guidelines or research related accidents or illnesses to the appropriate individual(s)
- Be adequately trained in good microbiological technique
- Adhere to approved plans for handling spills or personnel contamination
- Comply with shipping requirements
- Supervise the safety performance of laboratory staff
- Instruct and train laboratory staff in safe research work practices
- Correct work errors and conditions that may result in release of rDNA
- Ensure integrity of physical and biological containment
6. What is required to work with human blood, human cell lines or OPIM?
Research with these materials requires compliance with the Cal-OSHA Bloodborne Pathogen Standard (CCR Title 8 Section 5193). Laboratory research groups must complete a written Exposure Control Template specific to their operations.
7. Does work with human blood, human cell lines or OPIM require authorization from the IBC?
This work will require a Biological Use Authorization (BUA) as described above in Section 4. The campus Biosafety Officer can determine if the project requires notification to or approval from the IBC. The BSO and EH&S is delegated authority for administering the Campus Bloodborne Pathogen Program. Submit requests to biosafety@ucsc.edu for assistance establishing a lab specific Exposure Control Plan.
