Research Project Review and Approval Process

1. Research Project Review and Approval Process Research and Biological Safety Office Environmental Health and Safety 221-7770

2. Research and Biological Safety Office • 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.

3. APS 12.3 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).

4. Research and Biological Safety Office • 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-workswith researcher working with hazardous chemicals, nanoparticles • Occupational Health Nurses -review animal research projects for Occ Health hazards.

5. Research Project Review and Approval Process 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.

6. Research Project Review and Approval Process 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.

7. What does the new process mean to you? • A revised Research Project Hazard Assessment (RPHA) form 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 before-validating 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.

8. Research Project Review and 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