WSU Institutional Biosafety Committee (IBC)

Biological Agents User Application – Protocol Amendment

This form must be submitted to the IBC in order to obtain approval for modifications to current IBC protocols. The original approval is valid for three (3) years from the initial review/approval process, and apply only to the lab originally inspected and the PI originally approved. After three years you must submit a new IBC Biological Agents User Application (BAUA) Form and accompanying documentation.

Please answer all of the questions below – do not leave any blank.

Principal Investigator: / Date:
Project Name: / IACUC Number (if applicable):
IBC Approval Number: / IBC Approval Date:

1)  Are you using a Risk Group 2 or higher biological agent or gene transfer vector that was not part of the initial IBC approved protocol?

If “Yes”, list agent(s) and complete a new BAUA form.

New Agents:

source: / source:
source: / source:

2)  Are you working with Risk Group 2 agents in a lab different from that listed in the initial IBC approval? If “Yes” please provide the following information:

Containment facilities

Building Room # biosafety cabinets, etc. (specify) Certification Date(s) in vivo /in vitro

not applicablein vivoin vitroin vivo & in vitro
not applicablein vivoin vitroin vivo & in vitro
not applicablein vivoin vitroin vivo & in vitro

Contact OEH&S at 7-1200 to schedule a biosafety inspection for an unapproved lab.

3)  If you are submitting an amendment to an approved protocol, are there any gene constructs being used that were not previously approved, or are there any changes in the procedure that may increase the risk of exposure (e.g., generation of aerosols, additional routes of exposure, higher concentration of agent, etc)?

Please describe changes to the protocol in detail below (for new gene constructs specify: the gene(s) to be expressed; their function; if it encodes a toxin lethal to vertebrates at an LD50 of less than 100 nanograms per kilogram body weight; if it encodes a protein involved in cell growth control (i.e., oncogenic); expected result of expression in the host, and; where you obtained the construct from):

The IBC will contact you if changes listed warrant a revision of your standard operating procedures (SOPs).

4)  Have you added new lab personnel since your initial IBC approval? If yes, please list:

New personnel listed on a protocol must:

a.  Take all required safety training Biosafety/Bloodborne Pathogens and Laboratory Safety.

b.  Read and sign off on original BAUA form.

c.  Read and sign off on lab specific biosafety standard operating procedures (SOPs).

Please send signed copies to the Biosafety Officer at OEH&S, 5425 Woodward Suite 300.

As Principal Investigator I certify the above information is accurate and complete. If I answered “Yes” to question #1, I understand that a new Biological Agents User Application Form (BAUA) must be submitted.

PI Signature Date 07/17