Clinical Trials Administrative Start-Up Handbook

SECTION 8

The Review Process

Your trial involves biohazards if you are administering potentially infectious agents. This means that your work needs to be reviewed by the UW Institutional Biosafety Committee (IBC) or by IBC staff.  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.

Review is accomplished by submitting a completed Research Project Hazard Assessment (RPHA) form to the Biosafety Officer in the Environmental Health and Safety Department (EHS) at Box 354400. The RPHA form, including instructions for completing and submitting it, is available at https://www.ehs.washington.edu/rbsresplan/rpha.shtm

Review can be done in several ways:

1. By completing a "baseline" RPHA form that describes all of your ongoing, routine research. This will give the IBC an overview of the biohazards normally associated with your research and of the steps taken to minimize risks. Investigators doing multiple trials will want to use this option.
2. By checking with the Biosafety Officer to see if your existing, approved "baseline" RPHA form covers the work to be done in a specific trial. If so, you do not need to complete a new RPHA form for that trial. (Note: If your trial involves gene transfer, the "baseline" approach does not apply. All gene transfer trials require separate assessments.)
3. By completing a RPHA form for a specific trial:
   
   • if you are going to work with a new potential hazard (e.g., infectious agent, toxin) that is not covered by a baseline approval, or
   • if you do not have a baseline approval, or
   • if your sponsor requires an IBC approval letter for a specific protocol, or
   • if your trial involves pathogens requiring BL-3 containment.

The purpose of the IBC's review is to ensure that potentially hazardous materials are handled safely. The IBC will review the laboratory operation procedures and staff training related to handling, storage, transportation, and disposal of these hazardous materials.

Depending upon the nature of the work you are planning, your RPHA form will be reviewed either by the IBC or by the IBC staff. Examples of trials requiring full IBC review are those using newly identified human pathogens or those using viable microorganisms as therapy.

When your protocol has been reviewed and approved, you'll receive an approval letter and a protocol reference number.

If the hazards associated with your trial change during the approval period, call the Biosafety Officer at 206-543-7278 to discuss what action you need to take.

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.
• Submit a baseline application for routine protocols so that a baseline approval will be in place when you want to begin a specific protocol.

Administrative Start-Up Checklist
Institutional Biosafety Committee

Click to Download Checklist in Word

Key Contact

Bruce Whitney
Biosafety Officer
Box 357165
Phone: 206-221-7770
Fax: 206-221-3068

Glenn McLean
Biosafety Officer
Box 357165
Phone: 206-221-7770
Fax: 206-221-3068

Web Site:
https://www.ehs.washington.edu/rbsbiosafe/index.shtm

Timeline

The IBC meetings are held as needed. Applications are received and assigned continuously. Depending on the complexity of the protocol and the nature of the investigative reagent, turn-around time is similar to the UW Human Subjects Committees.