Biological Agents User Application Form
Native or Recombinant Mammalian Viruses (Non-Exempt rDNA)
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. Focus your discussion on the biological agents to be used and the
hazards/risks associated with the experiment (eg: needlesticks, handling of the agent, any
aerosolization that may occur, etc.):
1
Native or Recombinant Mammalian Viruses
1. For each viral construct to be used, specify:
a) viral vector (e.g., adenovirus, lentivirus, etc.)
b) gene to be expressed (no abbreviations, indicate source species, wild-type or mutant; if mutant, how?)
c) function of the wild-type gene product
2. Do any of the genes to be expressed encode a toxin lethal to vertebrates at an LD50 of less than
100 nanograms per kilogram of body weight:
Yes
No If yes, indicate which:
If yes, please also complete the Biological Toxins Form
3. Are any of the genes to be expressed oncogenes, or might their expression result in tumor
induction? If yes, explain.
4. From where (name of company or institution) did you obtain the construct(s)? Will you be
expanding any of them in your lab?
5. For each viral vector you will use, is the virus replication-deficient or attenuated? If so, explain how:
6. Host(s) used to propagate recombinant DNA(s):
7. Host(s) to receive/express recombinant DNA(s):
8. Will any of the experiment involve the infection of animals?
Yes
No
If yes, can infected animal(s) release microorganism into the environment? Not Applicable
9. Will any of the experiment involve the infection of humans?
Yes
No
If yes, can infected patient(s) release microorganism into the environment? Not Applicable
10. Approximately how long after administration could the microorganism be shed?
11. For each viral construct to be used, describe the expected result of expression in the host:
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
2
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 WSU 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:
3