Biological Agents User Application Form
Biological Toxins or rDNA Encoding a Biological Toxin
Revised 10/15
Name:
Title:
Department:
Phone #:
Today’s Date:
Campus Address:
E-mail:
Project Title:
This Project is: new
IACUC / HIC Protocol # (if applicable):
Previously Approved by Biosafety Committee? yes
If yes, approval #:
If this is not an AIC or HIC protocol, list the funding source:
Do you, your spouse/domestic partner, or any dependent children have a potential conflict of interest* with the
sponsor of this project? no
WSU conflict of interest definition & policy: http://research.wayne.edu/coi/index.php
Research Location(s): Please list any containment facilities, biological safety cabinets, growth chambers, or other
special precautionary measures, and the most recent certification dates.
Building
Room #
Containment facilities
biosafety cabinets, etc. (specify)
Certification Date(s)
in vivo /in vitro
not applicable
not applicable
not applicable
Biosafety level of containment for proposed project (check one):
BSL1
BSL2
BSL3
Unsure of risk group/biosafety level assigned to your biological agent? www.absa.org/riskgroups/index.html
Overview of biosafety containment levels: www.oehs.wayne.edu/biosafety/containment-levels.php
Research Summary
Please provide a brief summary (no more than 1 page) of the biological work you will perform as
part of this project. Describe in your discussion the biological agent’s potential toxicity, routes of
exposure and the hazards/risks associated with this experiment (eg: needlesticks, handling of the
agent, any aerosolization that may occur, etc.):
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Biological Toxins or rDNA that will encode a Toxin
1. Are you using a CDC Select Agent or USDA High Consequence Livestock Pathogen or Toxin?
Yes
No
Unsure? See www.selectagents.gov, or call 577-1200.
2. What toxin (unfractionated mixture, purified conjugate, microbial culture capable of producing
toxin) will be used in this experiment, and where will you get it?
3. What is the LD50 of the toxin?
4. How will this toxin be applied and what is the target molecule?
5. Where (room / building) will the toxin be produced, stored, weighed, and in what amount? What
measures will be taken to assure containment and security of the toxin?
6. Does the experiment involve administration of toxin to animals?
Yes
No
7. Can toxin be released from animal into the environment?
No
Unsure
Yes
8. Approximately how long after administration could the toxin be shed?
* You must add this information in the AIC application, Animal Hazardous Agents Form Part II, if applicable
9. How will toxin-containing materials (urine, feces, blood, bedding, etc.) be inactivated?
10. Have all employees involved with the project received initial training and annual updates on
procedures?
Yes
No
11. Is an antidote available for persons exposed to the toxin?
Yes
No
If yes, do you have a supply stored in your laboratory?
Yes
No
12. Laboratory Biosafety Standard Operating Procedures (SOPs)
SOPs are a specific description of the potential biological exposure hazards and safety procedures that
will be employed to minimize the risk. The following issues should be addressed;
* Safe work practices
* Personal protective equipment
* Use of biological safety cabinet
* Sharps and other waste disposal
* Disinfection procedures
* Safe transport procedures from room to room/bldg. to bldg.
* Emergency response for exposures
* Emergency response for spills
If you already have written procedures that cover this information, you may attach that document, or
you may use this template: Invivo-SOP template or Invitro-SOP template
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Principal Investigator’s Agreement
I acknowledge responsibility for this project, and I agree to fully comply with all pertinent NIH, CDC and Wayne
State University guidelines and policies. I assure that all faculty, staff and students involved in this project will
be trained and qualified to carry out the research in a responsible manner in accordance with NIH, CDC and
University policies and procedures.
X
Date:
Principal Investigator Signature
Faculty Supervisor/ Sponsor (if applicable)
I have reviewed and approved the scientific and ethical aspects of this research project. I agree to supervise all
compliance aspects associated with it and adhere to all applicable CDC, NIH and WSU biosafety guidelines.
X
Date:
Faculty Sponsor Signature
Chair/Dean/Director:
In signing this description of the research project, the Department Chair or Institute/Center Director certifies that
appropriate scientific and ethical oversight has and will be provided.
X
Date:
Chair/Dean/Director Signature
Additional Personnel Signatures
All staff listed on this protocol should be aware of the hazards involved.
I have been informed of the hazards involved in this research and instructed on the appropriate
methods to carry out the research in a safe and responsible manner.
Name (please print or type)
Signature
Date
Submit Completed Form To Rob Moon, Biosafety Officer:
E-mail: rjpearson@wayne.edu
Fax:
313.993.4079
Mail: 5425 Woodward - Suite 300, Detroit, MI 48202
Phone: 313.577.1200
NOTE: You may e-mail a completed version of this form to the Biosafety Officer, but you must also print out this page,
sign it and submit the original through campus mail.
WSU Biosafety Committee Use Only
Approved
IBC Approval #
Not Approved
Approved with stipulations
Describe Stipulations:
AIC #
HIC #
Date of Lab Visit:
Signed:
Date:
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