UCSB Institutional Biosafety Committee
What is the Institutional Biosafety Committee?
An Institutional Biosafety Committee (IBC) is required at any institution
that conducts research involving recombinant DNA or moderate risk human
pathogens. The requirement stems from the National Institutes of Health,
and must be met in order to receive NIH research funding. The UCSB IBC
is composed of UCSB researchers knowledgeable in pertinent research topics,
a human health specialist, an animal specialist, and a plant specialist.
The IBC must have at least two members who are unaffiliated with the University.
The institution must also have a campus biosafety officer to ensure compliance
with IBC requirements.
The IBC will consider research requests from UCSB principal investigators,
or researchers from other institutions who wish to perform work at a UCSB
facility. Approved biosafety authorizations are effective for 3 years from
the date of approval. The biosafety officer will perform periodic lab surveys
to ensure conformity with the terms of the authorization.
Who needs a Biosafety Authorization?
Any researcher who wishes to perform work involving the following
must first obtain an authorization from the IBC:
-
Microorganisms that are pathogenic to humans (bacteria, fungi,
prions, rickettsial organisms, viruses)
- Any substance from a human body (blood, cell lines, tissue,
organs, or any fluids)
- Any recombinant DNA technique requiring IBC approval as described
by the NIH Guidelines: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
- Field researchers who trap and handle wild mammals
To download the UCSB request form, please visit:
http://www.ehs.ucsb.edu/units/biosafety/biorsc/biorequestforms.htm
The biosafety officer works with researchers to determine who will need
to obtain an authorization. The first step is to determine the risk level
of the work to be performed. The risk assessment begins with the infectious
nature of the organism to be used. True risk to researchers and the public
is then determined by evaluating how the material will be manipulated in
the lab or in the field. Once the biosafety officer establishes the risk
level, the IBC will consider the safety controls proposed by the researcher.
The following sites may serve as a starting point in determining risk
for known pathogens:
http://www.absa.org/XriskgroupsX/index.html
http://www.phac-aspc.gc.ca/msds-ftss/index.html#menu?
For microorganisms obtained from commercial sources, the vendor
may provide an opinion of an appropriate risk level.
How soon can I begin work?
After submittal of a completed request form to the campus biosafety officer
(BSO), they will perform an initial evaluation of the proposal. This may
take a week to complete. If the request needs significant changes in terms
of risk assessment or biosafety controls, they will contact the PI for
needed changes. If the request meets most accepted criteria, the BSO will
forward the form to the IBC for consideration. The IBC meets quarterly.
If an expedited review is needed, contact the BSO for assistance (893-8894).
What if I need to work with a high risk pathogen?
If a risk assessment for your research indicates that biosafety level
3 is appropriate, the work can only take place in a BSL-3 compliant
laboratory. BSL-3 lab availability is extremely scarce on the UCSB campus.
Additionally,
if the organism of interest appears on the following list:
http://www.cdc.gov/od/sap/, your research will be subject to the requirements
of the Select Agent Rule under 42 CFR, Part 73. Research
with these organisms includes requirements for an FBI security risk
assessment for individual
researchers as well as independent approval by the Centers
for Disease Control or US Department of Agriculture, and will take at
least 4 months
for the approval process.
Any work involving a risk level of biosafety level 4 is prohibited at
UCSB.
Exemptions
If the BSO determines that the proposed work poses no risk to humans or
the environment (BSL-1 or Risk Group 1), your work will be registered,
but is not subject to an approval by the IBC. If the nature of your work
changes after your exemption, resulting in increased risk, you must contact
the BSO to determine if there are new requirements.
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