Clinical Trials Administrative Start-Up Handbook

SECTION 8

The Review Process

Your study involves biohazards if you are administering potentially infectious agents, including work with blood and body fluids. This means that your work needs to be reviewed by the UW Institutional Biosafety Committee (IBC) or by staff at the Environmental Health and Safety (EH&S) Research and Biological Safety Office (RBSO).  The IBC's working definition of a biohazard is:

A potentially hazardous biological agent and its by-products including known agents (bacteria, rickettsia, fungi, viruses, protozoa, and other parasites); animals or materials which contain or may potentially contain known agents or yet unknown agents; human and non-human primate tissue, blood and body fluids and cell culture (primary or continuous) and other animal tissues and body fluids.

The purpose of the IRC's review is to ensure that potentially biohazardous materials are handled safely. The IBC/RBSO will review both your laboratory operation procedures and all staff training that is related to handling, storage, transportation, and disposal of potentially biohazardous materials.

Review is initiated by submitting a completed UW Research Project Hazard Assessment (RPHA) form to the IBC Coordinator, EH&S RBSO, at Box 357165 or FAX at 206-221-3068. Visit the EH&S Website for access to the RPHA form, including instructions for completing and submitting it. The RPHA form is used to identify potential biohazards, the regulations that apply, and the precautions that need to be implemented. Your RPHA form will be reviewed by the IBC and the EH&S RBSO staff.

When your protocol has been reviewed and approved, you'll receive a Biological Use Authorization (BUA) letter with a protocol reference number.

If the hazards associated with your study change during the approval period, contact the IBC Coordinator, EH&S RBSO, at 206-221-7770 to discuss what action you need to take.

Visit the Biological Safety Website for comprehensive information, including standards and guidelines, definitions, and work practices and procedures.

Best Practices for Expediting the Institutional Biosafety Committee Review

• Submit the completed RPHA form to the IBC concurrently with other administrative start-up submissions, such as the Human Subjects Committee application form and the GC-1 form.
• Be sure to attach to the completed RPHA form either a copy of the current GC-1 Form or an abstract of the study protocol.

Administrative Start-Up Checklist
Institutional Biosafety Committee

Click to Download Checklist in Word

Key Contact

IBC Coordinator

EH&S RBSO
Box 357165
Phone: 206-221-7770
FAX: 206-221-3068

Web Site:

Biological Safety

Timeline

UW IBC meetings will be held monthly beginning in July, 2009. You will be contacted within three days after your documents have been submitted. Allow 4-6 weeks for IBC/EH&S RBSO review.