Registration Document For Biohazards
All applicants are required to complete the following sections:
Principal Investigator Information
Location of Study
Section A: General Administrative Information
Section B: Material Use Checklist
Section H: Transport
Section I: Dual Use Research of Concern
Section J: Protocol Specific Laboratory Safety
In addition to the sections above, please complete the appropriate protocol-specific sections:
Section C: Exempt Recombinant DNA Experiments
Section D: Non-Exempt Recombinant DNA Experiments
Section E: Research with Potentially Infectious Biological Agents
Section F: Human and Non-human Primate Blood, Body Fluids, Cell Lines, and Tissue Explants
Section G: Toxins of Biological Origin
P.I Information
Name:
Title:
Department:
Email:
Phone Number:
Location of Study
Building:
Room #’s:
Are the facilities shared:
Yes No
If yes, with what group:
Date of study:
Section A: General/Administrative Information
Protocol Title:
PI’s Anticipated Biosafety Level:
Brief Description of Protocol (please describe experimental protocol including how the biological material will
be utilized in the laboratory, attach additional sheet if necessary):
Protocol #:
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Section B. Material Use Checklist
Please check the materials that are used in your lab then complete the specified section for each material
1) Recombinant DNA: Genetic manipulation of microorganisms including inserting or deleting genes, use of viral vectors,
development of human gene therapy, experiments involving siRNA, development of synthetic DNA constructs, etc.
2) Microorganisms/Potentially Infectious Agents:
Bacteria
3) Human/Non-Human Primate Derived Materials, Blood, Body Fluids, and Cell Lines:
4) Other:
Human Subjects - Embryonic Stem Cells
5) Risk Assessment: Please describe the risk assessment process and how the appropriate biosafety precautions
were determined for this protocol; please include database searched, search terms, other reference material
consulted, previous experience, etc.
Describe risk assessment process:
PubMed Search, Search Terms:
CDC-NIH Guidelines
rDNA Guidelines
NJIT Safety Literature
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Section B. Material Use Checklist (Continued)
Please check the materials that are used in your lab then complete the specified section for each material
6) Protocol Specific Laboratory Safety: Please complete Section J for all protocols submitted to the Biosafety Committee
for consideration.
Principal Investigator Acknowledgement:
By signing below, the Principal Investigator acknowledges that the laboratory workers (including students,
faculty, staff or visitors) under his or her direction have received appropriate training required to manipulate,
store, and disinfect the microorganisms, human-derived materials, recombinant or other materials proposed for
use in the following protocol. Further, laboratory workers have been instructed on emergency procedures
involving potentially infectious materials as outlined in the NJIT Biological Safety Guide.
Principal Investigator: __________________________________ Date: ________________
Biosafety Committee Action:
This protocol was reviewed by the NJIT Institutional Biosafety Committee on:_____________
The following IBC action was taken:
Protocol Approved
Protocol Withdrawn
Protocol Conditionally Approved
Protocol Tabled Until Next Meeting
Protocol Not Approved
Protocol Approved By:
Assigned Biosafety Level:
Signature:
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Section C: Exempt Recombinant DNA Experiments
(please check those sections of the NIH Guidelines under which your experiments are exempt)
Section III-F-1. Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that can
replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of
replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to
integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms
per kilogram body weight. If a synthetic nucleic acid is deliberately transferred into one or more human research
participants and meets the criteria of Section III-C, it is not exempt under this Section.
Section III-F-2. Those that are not in organisms, cells, or viruses and that have not been modified or manipulated
(e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.
Section III-F-3. Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single
source that exists contemporaneously in nature.
Section III-F-4. Those that consist entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids
or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to
another
Section III-F-5. Those that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts,
mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the
same species).
Section III-F-6. Those that consist entirely of DNA segments from different species that exchange DNA by known
physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers
will be prepared and periodically revised by the NIH Director with advice of the RAC after appropriate notice and
opportunity for public comment (see Section IV-C-1-b-(1)-(c), Major Actions). See Appendices A-I through A-VI,
Exemptions under Section III-F-6--Sublists of Natural Exchangers, for a list of natural exchangers that are exempt
from the NIH Guidelines.
Section III-F-7. Those genomic DNA molecules that have acquired a transposable element, provided the transposable
element does not contain any recombinant and/or synthetic DNA.
Section III-F-8. Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c),
Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and
opportunity for public comment.
Appendix C-VII. The Purchase or Transfer of Transgenic Rodents
Appendix C-VIII. Generation of BL1 Transgenic Rodents via Breeding
The breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic
rodent with the intent of creating a new strain of transgenic rodent that can be housed at BL1 containment
will be exempt from the NIH Guidelines if:
(1) both parental rodents can be housed under BL1 containment; and
(2) neither parental transgenic rodent contains the following genetic modifications: (i) incorporation of more
than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii)
incorporation of a transgene that is under the control of a gamma retroviral long terminal repeat (LTR); and
(3) The transgenic rodent that results from this breeding is not expected to contain more than one-half of an
exogenous viral genome from a single family of viruses.
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Section C: Exempt Recombinant DNA Experiments
(continued)
(please check those sections of the NIH Guidelines under which your experiments are exempt
Most experiments involving E. coli K-12 host vector systems and Saccharomyces cerevisiae and Saccharomyces
uvarum host vector systems are exempt from the NIH Guidelines. If the answer to all 3 of the following questions
are no, then the experiments are exempt according to Appendix C-II (for E. coli K-12) or Appendix C-III (for
Saccharomyces cerevisiae and Saccharomyces uvarum).
Yes
No
Please check yes or no for the following questions
Do any experiments involve Risk Groups 3, 4 or restricted organisms or nucleic acids from Risk Groups 3, 4
or restricted organisms?
Do any experiments involve introduction of genes coding for molecules toxic for vertebrates?
Will there be any large-scale experiments (more than 10 liters of culture)?
Please include only information regarding Exempt rDNA experiments in the tables below.
#
Host (s)
Indicate the host(s)
into which the
recombinant material
(rDNA, RNA, virus)
will be introduced.
Examples include: E.
coli, S. cerevisiae,
human/animal cells,
whole animals,
plants.
Species
Subspecies, variety,
serotype, strain.
Vectors
Which host-vector
system will be used
for this research?
Examples include:
bacterial plasmids,
yeast plasmids,
cultured cell plasmid
vectors, baculovirus,
AAV, other viral
vectors
DNA Sequence
List names of genes
or DNA segments
that will be evaluated
Proteins
List proteins
produced if
applicable
#1
#2
#3
#4
#5
#6
Yes
No
Please check yes or no for the following questions
Will an attempt be made to purify any of the foreign gene products encoded by the gene?
Will a virus-derived vector system that is engineered to be replication-incompetent be used?
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Section D: Non-Exempt Recombinant DNA Experiments
This section describes experiments covered by the NIH Guidelines. Check the appropriate registration category(s) for your
experiment.
Experiments that require IBC approval BEFORE initiation:
Section III-D-1-a. Introduction of recombinant or synthetic nucleic acid molecules into risk group 2 agents
Section III-D-2-a. Introduction of DNA from risk group 2 (or 3) agents into non-pathogenic bacteria or lower
eukaryotes
Section III-D-3-a. Use of infectious risk group 2 virus (or defective virus plus helper virus) in tissue culture systems
Section III-D-3-e. Use of infectious risk group 1 virus (or defective virus plus helper virus) in tissue culture systems
Section III-D-4-a. Transfer of recombinant or synthetic nucleic acid molecules EXCEPT for >2/3 of eukaryotic viral
genomes into any non-human vertebrate or invertebrate organism
Section III-D-4-b. Transfer of recombinant or synthetic nucleic acid molecules from risk group 2 (or higher risk
group) human or animal pathogens into whole animals
Experiments that require IBC notification CONCURRENT WITH initiation:
Section III-E-1. Experiments involving the formation of recombinant or synthetic nucleic acid molecules containing
no more than 2/3 of the genome of any eukaryotic virus
Section III-E-2. All components derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes
Section III-E-3. Experiments involving transgenic rodents
Some experiments require additional review/approval by NIH OBA before initiation:
Section III-A-1-a. Transfer of a drug resistant gene into microorganisms that do not acquire the gene naturally that
could compromise use of the drug to control disease in humans, veterinary medicine or agriculture
Section III-B-1. Cloning of genes for toxins with LD50 of > 10 ng/kg body weight
If your non-exempt research does not fall into any of the categories listed above, review Section III of the NIH Guidelines
and use the space below to provide a brief description of the research and the appropriate NIH Guidelines referenced.
Section of the NIH Guidelines:
Description:
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Section D: Non-Exempt Recombinant DNA Experiments (Continued)
Generation and Use of rDNA
Complete this section if you are generating and/or using non-exempt rDNA in your laboratory.
Answer questions 1-8 for EACH host-vector system.
Transgene
1. Describe the gene sequence(s) inserted into the recombinant vector:
a. Source of gene(s) (genus/species):
b. Do any of the gene sequences increase oncogenic potential, originate from an HHS or USDA select agent or toxin,
transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the
potential to increase the pathogenicity or virulence of a vector system?
No
Yes, explain below:
c. Describe the function and activity of the transgene(s):
If you are planning on using an extensive number of transgenes, list classes.
If you are using a genome-wide approach, indicate the components of the constructs in the library or libraries.
2. If any of the above genes are from a viral source, do they compromise more than 2/3 of the viral genome?
No
Yes, specify:
3. Will a deliberate attempt be made to obtain expression of the foreign gene encoded in the recombinant DNA or RNA?
No
Yes
4. Identify vector system Please check appropriate boxes below and describe host-vector systems:
Bacterial Plasmid
Adeno-Associated Virus
Adenovirus
Simple Retrovirus
Lentivirus
Viruses other than lentivirus, simple retrovirus, adenovirus or adeno-associated virus
Describe:
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Please fill out a separate section D for each additional non-exempt host-vector system used
in the lab
Section D: Non-Exempt Recombinant DNA Experiments (Continued)
5. List host cell line or packaging cells for recombinant vector propagation:
6. Viral vector system(s)
a. What % of the viral genome remains?
b. Is a helper virus required for replication?
No
Yes
7. Target Recipient(s) - Indicate the recipient(s) of the DNA (check all that apply):
Bacterial Cells
Animal Cells in Culture
Animals
Modified Tissue Culture Cell Lines into Animals
Plant Cells
Plants
DNA Vaccine, specify target recipient(s)
8. Investigators assessment of risk This work will be conducted at (check appropriate biosafety level):
Biosafety Level 1
Biosafety Level 2
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Please fill out a separate section E for each additional potentially infectious agent used in
the lab.
Section E: Research with Potentially Infectious Biological Agents
Complete this section if you are working with an agent that could cause an infection in humans, including opportunistic
infections. Provide the information requested below for each agent.
Please check yes or no for each question
Yes
No
Please Provide Details Below
1.
Name of agent (include genus, species, sub-species, strain,
etc.):
2. Will antibiotic resistance be expressed?
3. Will toxin be produced?
4. Largest volume of agent to be cultured?
5. Will agent be concentrated?
6. If agent is to be concentrated, how will it be concentrated?
7. How frequently will agent be manipulated?
8. How will agent be inactivated?
a. heat
b. chemical
c. other (list):
9. Will agent be introduced into animals?
10.
Have all personnel that will be handling this agent
received appropriate biosafety training?
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Section F: Human and Non-human Primate Blood, Body Fluids, Cell Lines,
and Tissue Explants
Identify the type and source of the materials to be used:
1. Samples to be manipulated (for human or non-human primate cells lines, indicate if cells are established or primary):
2. Source of samples:
3. If commercially obtained, please list vendor and specific cell lines:
4. Have all personnel who work with human material completed the appropriate Biological Safety/Bloodborne Pathogens
training program (please answer below and complete section J)?
5. Is laboratory equipped with biological safety cabinet or other containment equipment to safely manipulate these materials
(please answer below and complete section J)?
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Please fill out a separate section G for each additional toxin used in the lab.
Section G: Toxins of Biological Origin
Complete this section if you are working with a toxin of biological origin. Provide the information requested below for each
toxin.
1. Name of toxin(s):
2. Largest quantity in use and stored:
3. Describe how the toxin is stored:
4. Describe the toxin deactivation and disposal procedures:
5. At what Biosafety Level is this material to be handled:
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Section H: Transportation/Shipping (includes ‘hand-carrying’ specimens)
If you are involved in shipping hazardous materials and/or dangerous goods please contact the EHS department at
973-596-3059 or at healthandsafety@njit.edu
Will materials be transported outside of the laboratory in which they are being used?
(please check one)
Yes
No
Please describe the nature of the materials to be transported
Describe:
Please describe the proposed method of transport
Describe:
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Section I: Dual Use Research of Concern
Complete this section to determine if your research is considered dual use research of concernresearch that may be used
for beneficent goals as well as malevolent purposes
1. Please check any categories below that apply to your research
Increase in virulence of the pathogen
Production of a novel toxin
Enhance transmissibility of the pathogen
Alteration of the pathogen’s host range
Interfere, by-pass or diminish the effectiveness of diagnostic tools and therapeutic or prophylactic antimicrobial or
antiviral treatments
Enhance capacity for spreading or for easy release of making them weapons-grade
Not Applicable
2. Please describe how your research fits any of the above category
3. Please identify and address additional risks to employees, the environment and/or public health that this
research could present
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Section J: Protocol Specific Laboratory Safety
1. Personnel and Training
Please list all laboratory personnel involved in this protocol and indicate the dates of the required training. If training has
not yet been scheduled, please indicate pending or TBD.
Name Title
Date of Biosafety
Training
Date of BBP
Training
Other Protocol
Specific Training
2. Laboratory Inspection
Please list date of last laboratory Inspection conducted by the EHS Department. If your lab has not been inspected, please
contact EHS at 973-596-3059 or at healthandsafety@njit.edu
Building Department Room Numbers Date of Inspection
Approved Biosafety
Level
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Section J: Protocol Specific Laboratory Safety (Continued)
3. Containment and Safety Equipment
Please list type and location of containment equipment (e.g., biological safety cabinet) and date of last certification. Please
note if Biological Safety Cabinet is shared with other groups.
Containment Equipment
Location
Type/Class
Certification Date
Biological Safety Cabinet
Biological Safety Cabinet
Other Laminar Flow Device
Centrifuge with Safety Caps and Sealed Rotors
Splash Guard
Other:
4.
Equipment and Surface Decontamination
Please list the decontamination solution used, concentration, and frequency for various laboratory equipment and work
surfaces. For all human derived material 10% liqu
id chlorine bleach must be used as principal decontamination solution.
Equipment and/or Work Surfaces
Decontamination
Solution
Concentration Frequency
Biological Safety Cabinet
Laboratory Bench
Mechanical Pipetter
Reusable Safety Equipment
Other:
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Section J: Protocol Specific Laboratory Safety (Continued)
5. Spill Control
Please describe available laboratory spill control equipment and procedures used for biological spills
6. Waste Decontamination
Please describe how potentially contaminated laboratory waste, both liquid and solid, is decontaminated and subsequently
disposed. Please note location of autoclave if one is available for waste decontamination.
7. Control of Sharps:
Please describe how sharps are handled in the lab. Is an attempt made to limit the use of sharps when working with
potentially infectious materials?
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