Biosafety Program

Biosafety Research Oversight

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. 

Please reach out to ibc@pdx.edu with questions.

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

• animal or human biological specimens/tissues

• wild type bacteria 

• viruses

• fungi and protozoans

• plant pathogens

Important Notices

• Biosafety Levels 1 and 2 only permitted at PSU

• Risk Group 4 agents are not permitted

• An activity may be exempt of the NIH Regulations, however, it may still require oversight from the PSU IBC/Biosafety program. 

• Investigators must consult 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. 

• For questions, contact ibc@pdx.edu.

Biosafety Protocol Management

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.

Protocol Submission

The PSU Biosafety Program uses Kuali Protocols to manage all biosafety protocol submissions for review.

How to Submit

1. Login to Kuali Protocols

2. Select New Protocol and choose IBC.

3. Complete Basic Biosafety Information.

   • A faculty member must be listed as Principal Investigator (PI).

   • Student-initiated research must list a faculty advisor as PI.

4. Select Next and complete General Information.

   • Responses regarding human participants or vertebrate animals may trigger Ancillary Review.

   • The IBC Administrator will notify you if additional committee approval is required.

5. Continue through the remaining sections.

   • The application will adjust based on your responses.

6. If PSU personnel cannot be added using an Odin ID search, submit a Kuali System User Access Request.

7. When complete, select Submit.

   • If the protocol creator is not the PI, select Notify PI to Submit.

   • The PI must review and submit for formal review.

What a Complete Submission Includes

• Kuali protocol application.

• Lab-specific Biosafety Manual. 

• Lab assessment performed by the Biosafety Officer (BSO)

• Review typically takes about 2 weeks 

See Office Hours for a 1:1 consultation if needed.

Kuali Protocol Resources

• Kuali Protocols User Guide

• Kuali Protocols User Access Request

• Kuali Feedback Form

• Biosafety Manual Template

- Note: BSL-1 & BSL-2 BSM Template (open and download with MS Word before completing)

Institutional Biosafety Committee Meetings 

• The Institutional Biosafety Committee meets as-needed. Meetings are subject to holidays, university closures, and quorum availability. Meetings are currently hosted virtually.

• Agendas are posted at least one week in advance of scheduled meetings.

• Next meeting: TBD

Contact ibc@pdx.edu to confirm meeting details.

Contact Us

For additional questions related to whether your study will require Biosafety oversight or regarding regulated biological materials, please contact the Biosafety Program at: ibc@pdx.edu.