University of Wisconsin Oshkosh
Office of Grants and Faculty Development
Institutional Biosafety Committee
BIOLOGICAL AGENT REGISTRATION FORM
This form will be completed when the PI is conducting either 1). research activities or 2). a combination of
research and teaching activities
IBC Use Only
Registration Number:
Expiration Date:
Please submit one (1) hard copy of this form with required signatures to the Office of Grants and Faculty
Development, Dempsey Hall 214. You must also submit one (1) electronic copy to biosafety@uwosh.edu. ALL
individuals listed on this registration must provide a copy of their CITI completion report attached to this form.
Instructions for completing CITI training can be found at the end of this document. Your registration will not be
processed until the signed hard copies and CITI training documentation are received.
I. Cover Page: Project Identification, Personnel and Signatures
PROJECT TITLE:
Phone No:
PRINCIPAL INVESTIGATOR:
E-Mail:
COURSE NUMBER:
COURSE TITLE:
Campus Mailing Address:
Funding Agency:
New Submission
Grant Identification Number (if federally funded):
Renewal
Revision/Resubmission
Useful Resources:
Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
American Biological Safety Association (ABSA) Risk Group Database
American Type Culture Collection (ATCC)
Principal Investigator or Instructor Certification:
By signing below I am agreeing that all activities are conducted using biological safety practices described in the
CDC/NIH publication titled “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) and by
additional stipulations set forth by the University of Wisconsin Oshkosh Institutional Biosafety Committee (IBC). If
the IBC approves this Biological Agent Registration Form, I agree to execute these activities as described; notify
the IBC of modifications to this registration; comply with the guidelines set forth by the IBC, and be responsible for
the training, supervision and work of my staff. I realize that failure to adhere to the policies related to this research
may result in suspension or revocation of permission to perform this research at UWO facilities.
Signature of PI:
Date:
Signature of Department Chair:
Date:
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II. Class Determination
A. Check the appropriate section(s) below to determine which class the proposed work would fall under. Please
see definitions for each section under Appendix A: “Definitions for Class Determination”
III-A.
Experiments that Require IBC Approval, RAC review, and NIH Director Approval before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261560
Deliberate transfer of drug resistance strain to microorganism that are unknown to acquire the trait naturally,
if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary
medicine or agriculture.
III-B.
Experiments that require NIH/ORDA and IBC Approval before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261562
Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram
of Body Weight.
III-C.
Experiments that Require IBC and IRB Approvals and NIH/ORDA Registration Before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261564
Experiments Involving the Deliberate Transfer of Recombinant DNA or DNA or RNA Derived from rDNA into
one or more Human Subjects.
III-D.
Experiments that Require IBC Approval before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261566
Experiments Using Risk Group 2, Risk Group 3, Risk Group 4 or Restricted Agents as Host-Vector Systems
Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4 or Restricted Agents is Cloned
into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems.
Experiments Involving the Use of Infectious DNA or RNA viruses or Defective DNA or RNA Viruses in the
Presence of Helper Viruses in Tissue Culture Systems
Experiments Involving Whole Animals in Which the Animals Genome has been Altered by Stable
Introduction of rDNA into the Germ Line or Experiments Involving Viable rDNA-modified microorganisms
tested on Animals
Experiments involving More than 10 Liters of Culture
III-E.
Research Experiments that Require IBC Registration Simultaneous with Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261573
Experiments Involving the Formation of rDNA molecules Containing No More than Two-Thirds of the
Genome of Any Eukaryotic Virus.
Experiments Involving rDNA Modified Whole Plants and/or Experiments Involving rDNA Modified Organisms
Associated with Whole Plants.
Experiments Involving Transgenic Rodents (BSL1 containment only)
III-F.
Research Experiments that are Exempt from the NIH Guidelines.
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261577
Experiments that are not in organisms or viruses (e.g., DNA sequencing, PCR)
Experiments that consist entirely of DNA segments from a single nonchromosomal or viral DNA source.
Experiments that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses
when propagated only in the host or when transferred to another host by well-established physiological
means.
Experiments that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or
plasmids when propagated only in the host.
Experiments that consist entirely of DNA segments from different species that exchange DNA by known
physiological processes.
Experiments that don’t present a significant risk to health or the environment as determined by the NIH
Director.
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III.
Research Personnel
A. Identify research personnel conducting the experiments (including students working as research assistants).
Specify degree, applicable training (include CITI course(s) completed and dates, training from supervisor) and
experience (include duration), and project responsibilities.
Name
Degree
CITI Training Completion Date
Project Responsibilities
Attach a separate sheet if more space is required
B. Provide details on the type(s) of project-specific training all personnel listed in III.A. above have received. Include
hands-on training, training via supervisor, workshops, etc.
IV. Students and Teaching Activities
A. Attach a class roster for all students who are enrolled in the stated course(s) if the PI plans to conduct teaching
activities. An updated roster must be submitted prior to the start of each new semester. The updated roster can be
submitted through an IBC Modification Request form. All IBC forms can be found at
www.uwosh.edu/grants/forms. Students enrolled in the course must complete online training for Biosafety and
Biosecurity through the Collaborative Institutional Training Initiative (CITI), found at www.citiprogram.org
B. Provide a brief summary of the training provided to students who will be involved with the classroom activities.
Include any hands-on training, instructor-based training, or online learning.
V. Animal Use
Any use of animals for research, teaching or testing purposes must receive approval from the UW Oshkosh
Institutional Animal Care and Use Committee (IACUC) prior to Institutional Biosafety Committee (IBC) approval. The
IACUC requires that the researcher submit an IACUC Protocol Application for approval of animal use. Contact
iacuc@uwosh.edu for more information. IACUC forms can be found at www.uwosh.edu/grants/forms. Please note
that the IACUC holds 1-4 meetings per semester and requires the PI to submit protocol applications at minimum two
weeks before the next scheduled meeting. IACUC meeting dates can be found at: www.uwosh.edu/grants/iacucmeeting-dates
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A. Does the experiment involve the infection and/or use of animals?
Yes
No
If “Yes”, you must have an approved IACUC Protocol Application on file with the IACUC office prior to beginning work with
biological agents. Contact iacuc@uwosh.edu for more details
B. List animal specie(s) to be used in the proposed work and scientific justification for their use:
VI.
Project Summary*
A. Provide a brief description of the proposed research in such a way that a scientist in another field will understand
(layman’s terms). You must include the following: 1. Brief Introduction, 2. Goals/Purpose, 3. Experimental
Methods to Be Used, and 4. Outcomes to be Measured.
*If working with animals you must first receive prior approval from the Institutional Animal Care and Use Committee
(IACUC)
VII. Source
A. Explain how the biological agent will be acquired:
Laboratory Stock
Off-campus Collection
Off-campus Researcher
Directly from animal/plant tissues
Other (describe):
B. Provide further explanation of source, if needed:
VIII. Transportation
A. Will biological agents be transported between locations (i.e. between labs in the same building, between different
buildings on campus, between campus and satellite off-campus locations)?
No
Yes
B. If “Yes”, please explain transportation procedures:
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VIX. Storage and Security
A. Explain how the agent will be stored and maintained while at UW Oshkosh facilities. Include information on
security to ensure unauthorized people cannot access the toxin:
Lypholized
Chemical-fixation
Refrigerator (Provide location:
)
Freezer (Provide location:
)
Storage Cabinet (Provide location:
)
Incubator (Provide location:
)
In vivo (Also complete Appendix A)
Other (describe):
B. Provide further explanation of storage conditions, if needed:
C. Will storage space(s) be secured or locked? Provide explanation including who will have access to the agent(s):
X. Disposal
A. Explain how materials containing the biological agent are inactivated and disposed. If a chemical disinfectant is
used, state the kind and concentration. Explain how liquid waste and/or solid waste contaminated with toxin will be
inactivated and disposed of, as applicable. Reference: http://www.uwosh.edu/ehs/environmental
XI. Personal Protective Equipment
A. Select the personal protective equipment (PPE) to be worn for the procedures described on this form. Questions
regarding PPE requirements should be directed to biosafety@uwosh.edu
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Hand Protection
Examination gloves
Heat resistant gloves
Cold resistant gloves
Eye Protection
Safety glasses
Goggles
Face shield
Goggles + Face shield
Body
Laboratory coat (white)
Scrubs
Blue smock/coveralls
Tyvek body suit
Waterproof boots
Hair
Hair cover/hat
Respiratory
Guidance on respirator selection can be found at:
http://www.cdc.gov/niosh/docs/2005-100/pdfs/2005100.pdf
N-95 mask
Air purifying respirator (half mask/particulate)
Air-supplied respirator
Other (Explain):
B. Provide additional information, if needed, on PPE use for the proposed work:
XII. Safety Equipment
A. Select the safety equipment to be utilized for the procedures described on this form.
Biosafety Cabinet:
Autoclave:
Will your work require use of a biosafety cabinet?
Will your work require use of an autoclave?
Yes
No
Yes
No
Cabinet Class:
I
Model:
II
III
Autoclave Location:
Cabinet Location:
Certification Date**:
Other Equipment (Explain):
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** Biosafety cabinets under regular use must be certified on an annual basis by experienced personnel or through a
contracted and licensed company.
Class I cabinets are ventilated for personnel protection and have an inward flow of air away from operator. Exhaust
air is filtered through a HEPA filter. Class II cabinets are ventilated for personnel and product protection having an
open front with inward air flow for personnel protection, and HEPA filtered mass recirculated air flor for product
protection. Exhaust air is filtered through a HEPA filter. Class III cabinets are closed-front ventilated cabinets with
gas tight construction which provide the highest level of personnel protection. The cabinet is fitted with arm-length
rubber gloves and is operated under negative pressure. All supply air is filtered through HEPA filters. Exhaust air
is filtered through two HEPA filters or one HEPA filter and one incinerator.
Emergency Preparedness
This section requests a summary of all emergency response procedures that are in place for your laboratory or work
space.
XIII. Emergency Contact Information
A. Provide emergency contact information for the following:
i. PI and Research Staff
ii. Program Staff
iii. Student Health Center, personal physician or physician familiar with the pathogen(s), Environmental
Health and Safety, chemical disposal contact or company, etc.
XIV. Associated Health Risks
A. Describe the major health risks associated with the agent(s). Include information on available vaccines and their
recommended use for persons handling the agent(s)
XV. Potential Exposure Hazards
A. Identify potential exposure hazards (e.g., aerosol generation when transferring, mixing, or centrifuging, accidental
inoculation, ingestion, use of needles/sharps, etc.). If agents will be used in animals, be sure to specify additional
risks related to animal handling, husbandry practices, or animal by-products.
B. Explain the procedure for mitigation if an exposure were to occur. How will personnel health/safety be protected?
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XVI. Laboratory Acquired Infections
A. Identify potential hazards and risk for laboratory acquired infections (LAI).
XVII. Accidental Spill and Containment Breaches Response
A. Provide a spill response and/or containment breach procedure, as applicable, that will be utilized in the event of a
spill or breach. What steps will be taken to ensure the spill or breach is contained?
XVIII. Violations to Safety Protocol
A. Explain what steps will be taken if personnel are found to be performing work out of compliance with established
laboratory safety protocols or procedures.
Please note that any incidents such as exposures, personal injury (needle stick), accidental spills, or containment breaches
where biological agents are utilized must be reported to the Institutional Biosafety Committee within 24 hours by completing the
IBC Incident Report form and e-mailing to biosafety@uwosh.edu
FOR IBC USE ONLY:
Reviewer’s Recommendations:
Reviewer requests Full Committee Review
Reviewer Requests Further Information
Reviewer Requests Consultation from Ad Hoc Consultant
Additional Information (Explain below):
Chair Review Determination:
Approval Date:
Full Committee Review Determination:
Approval Date:
Instructions for CITI Training for Biosafety and Security Program (BSS):
1. Enter the training at www.citiprogram.org
a.
Select: New Users Register Here
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b.
c.
d.
e.
2.
3.
4.
5.
Create your profile and affiliate with University of Wisconsin Oshkosh.
You will be prompted by response driven questions that will determine what course and modules you will be
required to complete based on your role in the Biosafety and Security Program.
a.
Example: If you are a committee member and a faculty researcher on campus, answer the
questions according to both of your roles.
The program will provide you with a customized list of courses to complete. The course list will appear on
your Main Menu page.
You can enter the training by clicking on any of the courses listed in your Main Menu. Each course is
compiled of numerous modules. There is typically a short quiz after each module. You must complete the
quizzes to earn credit for the course.
Training may take 1-3 hours to complete depending on your role(s) in the program, so please plan
accordingly.
At the completion of the training, a completion report is issued verifying the curriculum completed. A hard
copy of the Training Certificate must be attached to the protocol application or registration form that you
submit to the IBC.
The CITI Program training is valid for three (3) years. A refresher course will be required at the time of
expiration for continuing projects.
For more information or questions about the CITI training requirement, please contact:
IBC Administration: biosafety@uwosh.edu
Appendix A: Definitions for Class Determination
III-A:
Definitions
Experiments that Require IBC Approval, RAC Review, and NIH Director Approval Prior to Initiation
(See page 16 of NIH Guidelines)
III-B:
Experiments that Require NIH/OBA and IBC Approval Prior to Initiation (See page 16 of NIH Guidelines)
Explanation: Experiments in this category cannot be initiated without submission of relevant information on the proposed
experiment to NIH/OBA. The containment conditions for such experiments will be determined by NIH/OBA in consultation with
ad hoc experts. Such experiments require IBC approval before initiation. Deliberate formation of recombinant or synthetic nucleic
acid molecules containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms
per kilogram body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae
neurotoxin). Specific approval has been given for the cloning in Escherichia coli K-12 of DNA containing genes coding for the
biosynthesis of toxic molecules which are lethal to vertebrates at 100 nanograms to 100 micrograms per kilogram body weight.
III-C:
Experiments that Require IBC and Institutional Review Board (IRB) Approvals and RAC Review
Before Research Participant Enrollment (See page 17 of NIH Guidelines)
Explanation: Human gene transfer is the deliberate transfer into human research participants of either:
1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules that meet any one of the following
criteria:
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome; or
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed
III-D:
Experiments that Require IBC Approval Before Initiation (See page 18 of NIH Guidelines)
Prior to the initiation of an experiment in this category, the PI must submit a registration document to the IBC which
contains the following information: (i) the source(s) of DNA; (ii) the nature of the inserted DNA sequences; (iii) the
host(s) and vector(s) to be used; (iv) if tan attempt will be made to obtain expression of a foreign gene, and if so, indicate
the protein that will be produced; and (v) the containment conditions that will be implemented as specified in the NIH
Guidelines. The Risk Group (RG1-4) of the work will define the containment level (BSL 1-4).
III-E:
Experiments that Require IBC Notice Simultaneous with Initiation (See page 22 of NIH Guidelines)
All such experiments not listed in the above categories are considered part of this class. All such experiments may be
conducted at BSL-1 containment. A registration document shall be dated and signed by the PI and filed with the
Institutional Biosafety Committee at the time the experiments is initiated. The IBC reviews and approves all such
proposals but IBC review and approval prior to initiation of the experiment is not required
III-F:
Exempt Experiments (See page 23 of NIH Guidelines)
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These experiments are exempt from the NIH Guidelines. A registration document must be completed by the PI and
submitted to the IBC office at the time the experiment is initiated. The IBC reviews and approves all such proposals but
approval prior to initiation of the experiment is not required
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