A Researchers Guide to Biological Safety at UC Santa Cruz
Frequently Asked Questions
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)?
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 DNA (rDNA)
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 DNA Molecules”
Review and approve use of Risk Group 2 and 3 infectious agents or CDC/USDA Select Agents
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) and submit it to
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 to biosafety@ucsc.edu to initiate the review process.
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 according to the NIH Guidelines are available at:
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
A summary of PI responsibilities includes:
Full compliance with the NIH rDNA Guidelines
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?
No. 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.