Biosafety Program

Portland State University’s Biosafety Program and the Institutional Biosafety Committee (IBC) oversee research activities involving recombinant or synthetic nucleic acids (rsNA), Risk Group agents, biological toxins, select agents, controlled substances, and other biohazardous materials such as: animal or human biological specimens/tissues, wild type bacteria, viruses, fungi and protozoans, or plant pathogens, etc. The Biosafety Program assures compliance with federal and regulatory requirements and conformance to institutional policy and related best practices. The IBC is an ethics review committee required by the NIH and at PSU is responsible for reviewing and approving all related biosafety research. 

Biosafety Approval & Oversight

Protocol Submission

The PSU Biosafety Program uses Kuali Protocols to manage all biosafety protocol submissions for review. To submit a protocol application, or to amend, renew or close an existing approved protocol, please login to Kuali Protocols.

A complete submission includes a Kuali protocol application and a lab-specific Biosafety Manual. Review typically takes about 2 weeks and requires a lab assessment performed by the Biosafety Officer (BSO). Email ibc@pdx.edu with any questions about system access and submitting applications using Kuali Protocols. 

Kuali Protocols User Guide & Other Resources

For assistance accessing and navigating the system, refer to this User Guide. 

If you're unable to access the Kuali Protocols using your PSU Odin ID, please submit a Kuali Protocols User Access Request.

To provide Kuali Protocols user feedback, please submit our Kuali Feedback Form. 

Biosafety Manual Template 

• BSL-1 & BSL-2 BSM Template - open and download with MS Word before completing the template

Principal Investigator Policy

A faculty member is required to be identified as Principal Investigator (PI) for all biosafety submissions. All student-initiated research must list the faculty advisor in the PI role.

CITI Training & Kuali Integration 

• PSU faculty or employees: Kuali Protocols connects to the required CITI training records through PSU's single-sign on (SSO). In order for Kuali to reflect training for PSU-affiliated researchers, ensure the CITI account is linked using these CITI SSO instructions, under the Biosafety Training section.  

• PSU students: CITI training records are not connected to Kuali at this time. Please upload completion certificates in the Personnel table for each student. 

Office Hours

Biosafety Program staff offer the following drop-in Zoom office hours to help with navigating Kuali Protocols submissions (click the office hour link below to join the Zoom meeting at the scheduled day/time, please note that office hours are cancelled on University holidays): 

• Wednesdays, 11am to noon 

If this drop-in time does not work, please contact ibc@pdx.edu to schedule a 1:1 consultation.

Determining if Biosafety Review is Required

To help determine whether a proposed activity requires an application, please reference the following guidance: 

• Do I Need Review by the Biosafety Program? 

Biosafety review and/or protocol registration is required for the use of recombinant or synthetic nucleic acids (rsNA), Risk Group agents, biological toxins, select agents, controlled substances, and other biohazardous materials such as: animal or human biological specimens/tissues, wild type bacteria, viruses, fungi and protozoans, or plant pathogens, etc. 

Please note that an activity may be exempt of the NIH Regulations, however, it may still require oversight from the PSU IBC/Biosafety program. Please note:

• Biosafety levels 1 and 2 only are permitted at PSU.

• Risk Group 4 agents are not permitted for research at PSU.

Please note that investigators must check with the Biosafety Program prior to applying for external permits, licenses or authorizations to bring potentially biohazardous materials to campus. The Biosafety Program must be included on communications with external agencies and organizations concerning federal or state compliance oversight, please reach out to ibc@pdx.edu with questions.

Biosafety Training

Faculty, staff and students conducting regulated biosafety research are required to complete the following trainings:

• Biosafety training via the Collaborative Institutional Training Initiative (CITI). Visit our Training page for specific biosafety training login and completion instructions. - CITI training must be completed within the last three years

• Best Laboratory Practices & PSU Biosafety Information. - This training document must be read every three years

• Protocol-based Lab Trainings. The PI is responsible for ensuring all faculty, staff and students working on the study are properly trained on the specifics of the protocol. - This training must occur annually. 

• Applicable trainings by EHS depending on the specific work being performed: Working Safely in the Lab (annual), Working Safely in the Field (annual), Bloodborne Pathogen (annual), and Radiation Safety. Visit the EHS Training page for specific information and registration. 

Contact Us

For additional questions related to whether your study will require Biosafety oversight or regarding the use of recombinant or synthetic nucleic acids (rsNA), Risk Group agents, biological toxins, select agents, controlled substances, and other biohazardous materials such as: animal or human biological specimens/tissues, wild type bacteria, viruses, fungi and protozoans, or plant pathogens, etc., please contact the Biosafety Program at ibc@pdx.edu.