Research Project Review and Approval Process

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Research and Biological Safety Office
Environmental Health and Safety
221-7770
 Our mandate from APS 12.3
• evaluate existing and potentially biohazardous
conditions at the University, establish safety standards
• provide staff support to the Institutional Biosafety
Committee (IBC).
 We are also responsible for the administration of the
Bloodborne Pathogen Standard.
 We are responsible for the Occupational Health Program
for Animal Use.
The following rules, regulations, and guidelines govern the use of biohazards
and recombinant DNA molecules at the University:
University of Washington Biosafety Manual.
National Institutes of Health Guidelines for Research Involving Recombinant
DNA Molecules.
Center for Disease Control and National Institutes of Health—Biosafety in
Microbiological and Biomedical Laboratories.
Washington State Occupational Exposure to Bloodborne Pathogens (Chapter
296–823 WAC).
Washington Industrial Safety and Health Act (Chapter 49.17 RCW).
Seattle-King County Biomedical Waste Regulations (including sharps).
• Biosafety Officers—the “legs” of the IBC.
· They validate lab facilities appropriate to planned research.
· Assess microbiological practices and biosafety practices are
appropriate to planned research/containment level.
· If facilities and practices are not in compliance , they work
with the PI to achieve this. A Biological Use Authorization
(BUA) cannot be issued until completed or substantially so.
• IBC Coordinator/Occupational Hygienist-works with
researcher working with hazardous chemicals, nanoparticles
• Occupational Health Nurses -review animal research
projects for Occ Health hazards.
There will be 2 primary tracts
I) IBC tract
 Must be reviewed and approved by the IBC PRIOR to initiation
of the project. All IBC members must have RHPAs available for
review.
 IBC meetings will monthly, the third Wednesday.
 Cutoff for IBC review will be 2 weeks prior to the meeting.
 Longest turn around time will be 6 weeks (also dependent on
PI responsiveness).
 Biosafety Officers will still need to perform their work with PI
and lab
 Once approved by the IBC notification will be sent to the PI via
email with 1-3 business days.
II) Biosafety Officer approval or administrative approval
 As is currently being done. The Biosafety Officer works
with the PI to validate lab and biocontainment practices.
 Biological Use Authorization (BUA) letter is issued. The PI
can begin work right away.
 Approvals given by the Biosafety Officer are reviewed in
the IBC monthly meeting.
 A revised Research Project Hazard Assessment (RPHA) form
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has been developed to increase capturing all the pertinent
information straight away.
An RPHA will not be submitted to the IBC unless complete (PI
dependent).
Biosafety Officers will continue to work as they have beforevalidating lab space and biocontainment procedures.
If Biosafety Officer work completed by the IBC meeting,
approval obtained. If not, once completed approval given.
Assistance and cooperation by the PI will facilitate the IBC
approval process.
 During new role out if there are any urgent situations,
concerns, issues or problems that are encountered,
please contact:
JoAnn Kauffman
Manager
616-5514
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