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Instructions for Biosafety Application (Wright State University)

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RSP Biosafety Application (Version 1/1/09) Page –i–
Instructions for Biosafety Application
Research and Sponsored Programs
201J University Hall
Wright State University
Dayton, OH 45435
(937) 775-2425
Please use the attached application for requesting a review and approval of activities involving
biohazardous agents by the Wright State University Institutional Biosafety Committee (IBC).
This application should be used for all activities including research, teaching, and testing. The
IBC requests the information in accordance with its charge. This information is required by the
Occupational Safety and Health Administration's Occupational Exposure to Hazardous
Chemicals in Laboratories Standard, its Blood-Borne Pathogen Standard and/or the NIH
Guidelines for Research Involving Recombinant DNA (rDNA) Molecules.
The application rules and procedures are as follows:
Use the "Save As" function to save document on your disk.
Please be thorough and complete all sections - please type.
o Incomplete applications will be returned without review.
o Hand written applications will be returned without review.
If you need more space, attach additional sheets.
Obtain necessary signatures.
Allow the Biosafety Officer at least one week prior to the submission deadline for review
of application.
For procedures involving Class 1 biohazards, submit one (1) original application with
original signatures and two (2) copies.
For procedures involving Class 2 or higher biohazards, submit one (1) original
application with original signatures and eighteen (18) copies.
Submission deadlines will be strictly enforced. For a complete listing of these dates,
please refer to the Office of Research and Sponsored Program's Web site at
http://www.wright.edu/rsp/ or contact the IBC Facilitator as listed below.
Submit completed application(s) to
:
IBC Facilitator
Office of Research and Sponsored Programs
Room 201J, University Hall
Wright State University
Dayton, OH 45435
937-775-2425/3781 (voice/fax)
rsp@wright.edu
For additional information or assistance in completing this form, please contact the Department
of Environmental Health and Safety at 937-775-2215/3761 (voice/fax).
Note: The information provided may become publicly available under Ohio's Open
Records Act.
RSP Biosafety Application (Version 1/1/09) Page 1 of 8
Biosafety Application
Wright State University
Research and Sponsored Programs
This application contains proprietary/confidential information (Please attach a justification
statement and any relevant documentation).
Project Title (limit 81 characters, including spaces and punctuation):
Principal Investigator Section
PI Name/WSU username/Title:
Department: Address:
Phone/Fax: Email:
Statement of Responsibility: I accept responsibility for the safe conduct of work with the agents
described in this application. The information in this application is accurate and complete.
Date:
(Signature of Principal Investigator)
Laboratory Personnel Section (use additional sheet if necessary)
The undersigned individual(s) are involved in this project and have read this application. Please use
your WSU username (for example, w001xyz) in the appropriate section.
1. Name: username: Title:
Signature: Date: Contact:
2. Name: username: Title:
Signature: Date: Contact:
3. Name: username: Title:
Signature: Date: Contact:
4. Name: username: Title:
Signature: Date: Contact:
5. Name: username: Title:
Signature: Date: Contact:
Biosafety Officer Section
I have reviewed this application and found it be suitable for IBC review:
Name:
Date:
(Signature of Biosafety Officer)
For RSP use only:
Biosafety Protocol No.: __________
Date Received: _________________
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RSP Biosafety Application (Version 1/1/09) Page 2 of 9
PI Name:
1. Project Location(s) (Room/Bldg):
2. Animal Use? Yes No
AUP# Date:
3. Human Subjects? Yes No
HSP/SC# Date:
4. Select Agent Use? Yes No
If Yes, STOP here and contact the Institutional Biosafety Officer.
5. Which of the following biological agents will be used? (check all that apply)
Recombinant DNA (rDNA) Nonrecombinant DNA/RNA or Prions
Biological Toxins Tissue or Cell Culture
Human or Non-Human Primate Tissue Microorganisms
6. What level of biocontainment will be used?
BSL-1 BSL-2 BSL-2+ BSL-3
7. Recombinant DNA Section (Not Applicable , next section):
a. Are your activities exempt? Yes No
Refer to: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html (note exceptions)
If Yes, list exemption category:
If category is III-F-6, list system:
b. Will you express any drug or immunological resistance genes? Yes No
If Yes, list:
c. Will you express any oncogenic or pathogenic genes? Yes No
If Yes, list:
d. Will you express any toxins? Yes No
If Yes, list:
e. Will you express any microorganisms or prions?
Yes No
If Yes, list:
f. Please select the NIH category for your rDNA experiments.
Refer to: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html for complete details.
The descriptions in parentheses are provided only as a guide.
Section III-A (Transfer of drug resistance genes into microorganisms that are not
known to acquire the trait naturally)
Section III-B (Cloning of toxins with LD
50
< 100 ng/kg body weight)
Section III-C (Transfer of rDNA, DNA, or RNA derived from rDNA into human
subjects)
Section III-D (rDNA from Risk Group 2, 3, 4, or restricted agents as vector systems;
Infectious or defective DNA or RNA viruses; Whole animals and plants;
Large volumes)
Section III-E (rDNA involving < 2/3 of the genome of any eukaryotic virus in the
absence of helper virus or plasmids; Whole plants; Transgenic rodents)
Select
Select
RSP Biosafety Application (Version 1/1/09) Page 3 of 9
PI Name:
7. Recombinant DNA Section (continued):
g. Complete table below using one column per construct (deletion or mutation series of a gene
may be listed in one column; use additional sheet if necessary).
Construct 1 Construct 2 Construct 3 Construct 4 Construct 5 Example
Name and
Provider of Gene
Example:
green
fluorescent
protein from
Clontech
Gene Function
Example:
marker
Vector Name
Example:
pKH-WSU24
Vector Type /
Species and Strain
Example:
Viral /
Adenovirus
serotype 5
Expression
control elements
(promoters,
enhancers, etc)
Example:
CMV
promoter
Conc/titer of
rDNA (i.p./ml)
Example: 1 X
10
8
to 1
X10
12
infectious
particles/ml
Host and Strain, if
applicable
Example: E.
coli, Sure
TM
,
Mouse heart
cells, in vivo
Largest
Production
Volume of Host
Example:
1 liter
Host Range
(including any
genetic alterations
to host range)
Example:
amphotropic,
broad
mammalian
host range
Is recombinant
made in your lab?
If not, where?
Example:
Vanderbilt
Univ. Gene
Therapy
Center
If vector is a
genome, what %
has been deleted
or substituted?
Example:
10%
RSP Biosafety Application (Version 1/1/09) Page 4 of 9
PI Name:
8. Nonrecombinant or Synthetic DNA/RNA; Prions Section (Not Applicable , next section)
a. Are you handling DNA or RNA from pathogenic microorganisms? Yes No
If Yes, list:
b. Are you handling oncogenic DNA sequences?
Yes No
If Yes, list:
c. Are you handling DNA containing drug resistance genes?
Yes No
If Yes, list:
d. Are you working with any prions? Yes No
If Yes, complete the following table (use additional sheet if necessary):
Name of Prion
Pathogenic PrP
Isoform
Disease Natural Host
e. If Yes to ques. 8a-d, please list the provider(s) of the agents:
f. If Yes to ques. 8a-d, please explain what safety steps you will take to avoid percutaneous and
mucous membrane exposure of laboratory personnel and contamination of the environment
g. If Yes to ques. 8a-d, what types of sharps will be used and how will they be disposed of?
9. Toxins Section (Not Applicable
, next section):
a. Are you handling toxins of biological origin? Yes No
If Yes, list the name and provider of toxin(s):
b. In what form is the toxin(s) received?
c. Will you reconstitute the toxin(s)? Yes No
If Yes, describe:
d. What is the highest concentration with which you will work or possess?
e. What is the LD
50
expressed in ng per kg body weight?
f. Do you agree to comply with Appendix I of BMBL, which includes maintaining an inventory
system, secure storage, and proper use of primary and secondary containment? See:
http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm Yes No
RSP Biosafety Application (Version 1/1/09) Page 5 of 9
PI Name:
10. Tissue and Cell Culture Section (Not Applicable
, next section):
Tissues/Cells Provider
Catalog
Number Type
Infectious
Agents? (List) BSL
Use additional sheet, if necessary
11. Human or Non-human Primate Tissue Section (Not Applicable , next section):
a. Are you handling human or nonhuman primate tissue or fluids? Yes No
If Yes, list (include species):
b. What is the source and provider of the tissue(s)?
c. Are the tissues known or suspected to be infected?
Yes No
If Yes, describe:
d. Has your staff taken the blood borne pathogen program? Yes No
If Yes, list names and dates:
12. Microorganism Section (Not Applicable , next section):
a. Which category of microorganism is being used? (check all that apply)
Bacteria Fungi Protozoa
Archaea Unicellular Algae Parasitic Worms
Virus
Select
Select
Select
Select
Select
Select
Select
Select
Select
Select
Select
Select
Select
Select
Select
RSP Biosafety Application (Version 1/1/09) Page 6 of 9
PI Name:
12. Microorganism Section (Continued):
b. List each agent and its risk group, biosafety level, and provider (use additional sheet if
necessary). Refer to http://www.absa.org/resriskgroup.html for details.
Agent (genus, species, strain)
Risk
Group
BSL Provider
c. Are you producing or receiving vector virus? Yes No
If yes, please describe any safety features that prevent the generation of recombinant virus
and methods of safety testing that have been performed or will be conducted:
13. Safety Equipment Section
Sterilizer Available? Yes No
Type:
Location(s):
Hand washing sink available? Yes No
Location(s):
Biological Safety Cabinet(s)? Yes No
Cabinet #1 Type:
Location:
Certification Date:
Cabinet #2 Type:
Location:
Certification Date:
Cabinet #3 Type:
Location:
Certification Date:
Personal Protective Equipment Used (list):
RSP Biosafety Application (Version 1/1/09) Page 7 of 9
PI Name:
14. Safety Procedures Section
a. Will you work with biohazardous agents in any of the following aerosol-producing devices
or procedures?
Yes No (check all that apply)
Aspirators Intranasal Inoculation Pressurized Vessels
Blenders Large Volumes (10L) Shakers
Centrifuges Necropsy Sonicators
Homogenizers Pipetting Infectious Liquids Vortexers
Other, please list:
If Yes to any of the above, describe how you will contain the aerosol:
If using sonicator, how will you provide hearing protection to all workers in the area?
b. Do you concentrate the biohazardous agents? Yes No (check all that apply)
Centrifugation Filtration Precipitation
Other, please list:
If Yes, which agent is being concentrated?
c. Are you using a vacuum supply with the biohazardous agents? Yes No
If Yes, which agent is being used?
If Yes, select method for protecting the vacuum source:
d. At any time during the procedures, will biohazardous agents be moved from a higher safety
level to a lower one? Yes No
If Yes, provide a justification and describe method of inactivation for this step:
e. How do you generally inactivate the biohazardous agents described in this application?
f. How do you disinfect surfaces in the laboratory?
15. Waste Generation Section
a. Are you generating biological waste? Yes No
Refer to http://www.wright.edu/admin/ehs/documents/APPENDIXD.pdf
for
definitions.
If Yes, specify type:
b. Are you generating mixed waste? Yes No (check all that apply)
Biological and Chemical Hazard Biological and Radiological Hazard
Biological, Chemical, and Radiological Hazard
c. Have you notified the Department of Environmental Health and Safety?
Yes No
Select
RSP Biosafety Application (Version 1/1/09) Page 8 of 9
PI Name:
16. Transport and Transfer Section
a. Will you transport or transfer biohazardous agents? Yes No
[Transport refers to packaging and shipping these agents by air, land, or sea via airplanes,
motor vehicles, boats, or other means. Transfer refers to exchanging these agents between
laboratories, generally between rooms or buildings within a facility or institute.]
If Yes, describe agents and method of transport or transfer:
b. If transporting agents in my personal vehicle, I accept responsibility for the personal liability
I may incur in the event of an accident.
Yes No N/A
c. The transport and transfer of biological agents is governed by the Center for Disease
Control (CDC) and the Federal Government. Do you agree to comply with the CDC and
Federal regulations? Yes No N/A
Refer to http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm (BMBL Appendix C)
Refer to http://hazmat.dot.gov/
for Federal Hazardous Materials Transportation Law.
Refer to "Transporting Infectious Substances Safely" document.
17. Assurances Section. Please answer Yes or No.
Yes No
If required, Material Transfer Agreements (MTAs) will be secured for the above
described biohazardous agents transferred to or from Wright State University.
MTAs are administered through the Office of Technology Transfer and
Development.
Yes No The Principal Investigator is trained for the proposed studies.
Yes No
All personnel will receive the appropriate training in regard to safety practices and
protective equipment for this work.
Yes No Written experimental procedures will be maintained in the laboratory.
Yes No
Laboratory procedures will be in compliance with the University Chemical Hygiene
Plan, the Institutional Biosafety Manual, the OSHA Laboratory Safety Standard, other
appropriate OSHA Standards, and the Ohio Revised Code.
Yes No
Biological safety cabinets (BSCs) shall be maintained in sound working condition
at all times and shall be certified annually and after each move or maintenance
procedure. Laboratory personnel are aware of the operational limits of BSCs.
Yes No Chemical fume hoods shall never be used to contain biohazards.
Yes No
No employee or researcher will be asked to intentionally consume or otherwise be
exposed to a biological agent as part of a research protocol.
Yes No
All biological waste will be properly disposed in compliance with Infectious
Waste Management Guidelines established by the Department of Environmental
Health and Safety.
Yes No
As applicable, employees will be offered vaccination, banking of serum or
standard body material, and HIV testing. Banked material will be used for
detection of compounds or serum conversion in the event of exposure.
Yes No
Approval of this application is only for the biohazardous agents and procedures
described herein. Any changes to the protocol (e.g., change of organisms, vectors,
procedures, personnel, project location, etc.) must be approved by amendment
prior to use or implementation.
RSP Biosafety Application (Version 1/1/09) Page 9 of 9
PI Name:
18. Project Summary Section.
Please provide a brief overview of the proposed research containing sufficient information to
ensure adequate review of the protocol to determine compliance with Wright State University's
Biosafety Program and local, state, and federal regulations. DO NOT cut and past the specific
aims section from a grant application.
a. Purpose of research (brief);
b. Assessment of risk to personnel working with the biological agent;
c. An outline of the procedures and techniques employed;
d. Description of the safe practices, equipment, and facilities used to protect personnel;
e. Describe any specific methods of inactivation or disposal of the agent not mentioned above.
Attach additional sheets as necessary.
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