FOR IBC USE ONLY:
Rev. 6/26/13
IBC Reg. Number: ______________
IBC Approval Date: ______________
Institutional Biosafety Committee (IBC)
Office of Research Compliance
438 Whitney Road Extension, Unit 1246
Storrs, Connecticut 06269-1246
Expiration Date:
______________
NIH Section:
______________
IBC REGISTRATION
Instructions:
1.
Submit the MUA application as an electronic Word Document to:
Cindy Hall, IBC Coordinator, Office of Research Compliance
Email: cindy.hall@uconn.edu
2.
Submit a completed signature page by campus mail to:
Cindy Hall, IBC Coordinator
c/o EHS, Unit 4097
3102 Horsebarn Hill Rd.
Storrs, CT 06269
FAX: 860-486-1106
After a completed MUA is received, an e-mail will be sent by the IBC Coordinator acknowledging receipt and indicating
the date for IBC review. Other valuable information is available at www.ibc.uconn.edu.
SECTION I: ADMINISTRATIVE INFORMATION
A. CONTACT INFORMATION:
Primary Investigator:
PI Job Title:
PI E-mail:
Department:
Department Address:
Building Name:
Office Phone Number:
Fax Number:
Lab Contact:
Lab Contact Job Title:
Lab Contact E-mail:
Campus: Storrs
Unit Number:
Office Room Number:
Lab Phone Number:
Emergency Phone Number:
Biological Agent Use Registration (BAUR) Number (Required):
(If you do not have a BAUR number, please contact Biosafety)
If applicable, check this box AND on a separate page (document) designate the portion
of this protocol that is deemed confidential to protect proprietary or patentable
information.
B. TYPE:
New Research
New Teaching
Amendment
Renewal/Re-registration
(current Reg. #
(former Reg.#
)
)
C. OTHER UNIVERSITY APPROVALS (CURRENT OR PENDING) REQUIRED FOR THIS PROJECT:
Institutional Animal Care and Use Committee (IACUC) - Protocol #:
Institutional Review Board (IRB) - Protocol #:
Stem Cell Research Oversight Committee (SCRO) - Protocol #:
Radiation Safety - License #:
D. GENERAL TITLE FOR PROJECT BEING REVIEWED BY IBC:
D2. DOES YOUR PROJECT INVOLVE ANY OF THE FOLLOWING? MARK ALL THAT APPLY:
The deliberate transfer of drug resistance trait to microorganism that are not known to acquire the trait
naturally, if such acquisition could compromise use of the drug to control disease agents in humans,
veterinary medicine or agriculture. III-A-1-a (IBC, RAC, NIH)
Are you increasing the pathogenicity and/or drug resistance of a pathogen?
Experiments involving the deliberate formation of recombinant or synthetic nucleic acid molecules
containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD 50 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). III-B-1 (IBC, OBA, NIH)
Will your experiment be placing (increasing) toxin producing components into a microorganism which would be lethal
to vertebrates at the levels listed above?
Experiments Involving the Deliberate Transfer of Recombinant or Synthetic Nucleic Acid Molecules, or
DNA or RNA Derived from Recombinant or Synthetic Nucleic Acid Molecules, into One or More Human
Research Participants. III-C-1 (IBC, IRB, RAC)
Experiments using Risk Group 2, 3, 4, or Restricted Agents as Host-Vector Systems. III-D-1 (IBC)
Does your experiment involve the introduction of recombinant or synthetic nucleic acid molecules into pathogens as
vectors?
Experiments in which DNA from risk group 2, 3, 4 or Restricted Agents is cloned into non-pathogenic
prokaryotic or lower eukaryotic host-vector systems. III-D-2 (IBC)
Will the non-pathogen or lower eukaryotic host-vector become pathogenic?
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. III-D-3 (IBC)
Will the use of a helper virus create a functioning pathogen?
Experiments involving whole animals. III-D-4 (IBC, IACUC)
This section covers experiments involving whole animals in which the animal's genome has been altered by stable
introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line
(transgenic animals) and experiments involving viable recombinant or synthetic nucleic acid molecule-modified
microorganisms tested on whole animals.
Experiments involving whole plants. III-D-5 (IBC)
Based on present understanding, will the use of recombinant or synthetic nucleic acid molecules in association with
plants have the potential for detrimental impact on the natural ecosystem?
Experiments involving whole plants: does not have the potential for detrimental impact to the natural
ecosystem. III-E-2 (IBC notification)
Experiments Involving the Formation of Recombinant or Synthetic Nucleic Acid Molecules Containing No
More than Two-Thirds of the Genome of any Eukaryotic Virus. III-E-1 (IBC notification)
2
E. EXACT GRANT TITLES SUBMITTED TO GRANTING AGENCIES COVERED BY THIS MUA:
Exact Grant Title
Granting Agency
1.
2.
3.
4.
5.
6.
7.
8.
F. UCONN CO-PRINCIPAL INVESTIGATORS:
Name
Department
Not Applicable
BAUR #
(if applicable)
Role of Co-PI
(animal challenge experiments, cell culture,
cloning, etc.)
3
SECTION II: RESEARCH/TEACHING FACILITIES
A. UCONN RESEARCH/TEACHING LOCATION(S):
Where are experiments performed? Where are animals housed? What is the biosafety level (BSL)
containment for the room(s)? Include shared spaces such as departmental equipment rooms and if
applicable, laboratories of UConn Co-investigators.
Building Name
Room
Number
BSL
Containment
of Room
(BSL-1, BSL-2,
or BSL-3)
Use of the Room
(animal housing, laboratory, cell culture, cloning,
virus growth, shared lab space/equipment room etc.)
select
select
select
select
select
select
select
select
B. OTHER PROJECT LOCATION(S):
Will you be collaborating with other institutions/facility on this project?
Collaborator AND
Institution/Facility Name
YES, list
Role of Collaborator
(animal challenge experiments, cell culture,
cloning, etc.)
NO
If known,
BSL
Containment
(BSL-1, BSL-2,
or BSL-3)
select
select
select
select
4
SECTION III: RESEARCH PROTOCOL DESCRIPTION
NOTE: PLEASE AVOID OR EXPLAIN ACRONYMS. PLEASE CHECK SPELLING AND GRAMMAR.
A. RESEARCH/TEACHING PROJECT OBJECTIVE:



In two to three sentences, describe the objectives of this project.
Use language that would allow non-scientists to assess the potential risks to human health and the
environment.
Do not cut and paste from your grant applications.
B. PROJECT DESIGN:
Briefly describe the experimental protocol to achieve these objectives.





Use language that would allow non-scientists to assess the potential risks to human health and the
environment.
Do not cut and paste from your grant applications.
Standard experimental procedures can be referred to by common name, but novel procedures and
significant modifications to standard protocols should be described.
If applicable, include maps of any non-standard vector systems (particularly viral vectors, even if
commercial) that you plan to use and describe them in sufficient detail to allow the appropriate risk
assessment.
For collaborative work with co-PIs and collaborators (within and outside the University), specify the role of
each investigator in the project.
5
C. COMPREHENSIVE RISK ASSESSMENT / POTENTIAL ENVIRONMENTAL IMPACT:
Describe aspects of the experimental protocol that could have potential human and environmental
impact.
1) Provide an assessment of the risk to human and/or animal health for each infectious agent, vector
system, or any other potential biohazards. Consider the bulleted statements in your assessment to
convey potential risks to the IBC.







What is the virulence/pathogenicity of the agent/vector/molecule?
route of transmission
concentration and quantity of the agent used
host range
availability of prophylactic (e.g., vaccines) and therapeutic treatments
environmental stability
possible harmful effects of expressed genes (e.g., oncogenes, toxins, antibiotic resistance genes,
allergenicity), etc.
1) a: If the E. coli K-12 statement applies to this project, mark the box:
This project involves the use of E. coli K-12. As per the US EPA, “E. coli K-12 is a debilitated strain which
does not normally colonize in the human intestine. It has also been shown to survive poorly in the
environment, and has a history of safe commercial use, and is not known to have adverse effects on
microorganisms or plants.”
2) Will your project include laboratory procedure hazards such as potential aerosol generation, use of
sharps (e.g., needles), use in animals (e.g., bites, use of anesthetics during inoculations), etc. Please
explain.
3) How will you prevent/minimize exposure, accidental infection, and environmental release? (e.g.
appropriate training of laboratory workers, use of PPE, equipment and engineering controls,
microbiological practices, use of general anesthetics during animal inoculations, disinfection
procedures, disposal of animals, etc.).
4) Are you using or producing cloned or transgenic animals?


5) Are you using or producing transgenic plants?


(if yes, explain below)
What are you using them for?
How are they contained to prevent accidental release to the food chain (e.g. livestock) and/or the environment
(e.g. rodents, rabbits, and fish)?
(if yes, explain below)
Describe containment measures that will be implemented in the growth chamber or greenhouse.
If you are conducting a field trial with a transgenic plant, describe the field location and all containment
measures that will be used. Provide copies of USDA/APHIS permits, as applicable.
6
D. RESEARCH MATERIALS FROM OTHER SCIENTIST(S) OR INSTITUTION(S):
If you plan to receive new research materials such as DNA sequences, plasmids, cell lines,
microorganisms, etc. from scientists at other institutions (even if co-PIs), companies, or repositories,
please specify the nature of the research materials and how they will be transported (e.g.
shipped via FedEx) to your lab.

If applicable, provide information about Material Transfer Agreements and the Cell Line / Biological
Materials Registration Documents (see the Office of Sponsored Programs web site at the link below).
Materials Transfer Agreement: Office for Sponsored Programs, University of Connecticut

In some cases, you may be asked by the IBC to provide documentation regarding the hazard
potential/containment level of the research material(s).
Not Applicable, all research materials are currently present in my laboratory and I do not plan to
receive new research materials.
7
E. PERSONAL PROTECTIVE EQUIPMENT (PPE), PROCEDURES AND PRECAUTIONS:
Indicate the personal protective equipment (PPE), procedures and precautions that will be used in the
research project by checking ‘yes’ or ‘no’ in the adjacent box. Explain if necessary.
Appropriate Precautions
PPE Used
Yes
1. Gloves
1.
2. Lab coat, smock, etc.
2.
3. Eye protection (safety goggles, safety glasses, etc.)
3.
4. Respirator. Specify type (e.g., N95 disposable):
4.
No
5. Other (face masks, splash shields, etc.):
Note: If you answer “NO” to any item(s) 1-4 above, please explain why you are
deviating from standard lab safety practices. If applicable, explain why a respirator
is not required (e.g., “work that has the potential for aerosol generation will be
performed inside a biosafety cabinet”):
Explanation:
Laboratory Door Sign
6. Laboratory door hazard signage posted
Precautionary Measures
Yes
No
6.
Yes
7. Work performed in a certified Biological Safety Cabinet (BSC)
7.
8. Centrifuge tubes closed, rotor has gasket, or safety centrifuge cups
8.
9. Containment used for aerosol generating activities such as electroporation, sonication,
French Press, homogenization, vortexing, etc.
9.
No
10. Other:
Note: If you answer “NO” to any item(s) 1-4 above, please explain why you are
deviating from standard precautionary measures:
Explanation:
Flow Cytometry / Cell Sorting
11. Will you use flow cytometry or cell sorting for this project?
Yes
No
11.
Note: If you answer “YES”, please explain nature of sample(s)/material(s) to be
analyzed/sorted (eg, fixed/unfixed cells) and describe how potential biohazardous
aerosols will be contained:
Explanation:
8
SECTION IV: RESEARCH ELEMENTS
This section covers the recombinant DNA (rDNA), microbes, plants, animals, organs, tissues, and cell
cultures used in the research program. It also covers the plan for disposal of laboratory waste and any
permits from agencies outside the University.
A. RECOMBINANT DNA SUBJECT TO THE NIH GUIDELINES FOR RESEARCH INVOLVING
RECOMBINANT DNA MOLECULES (NIH GUIDELINES):
It is not necessary to provide details about every gene, vector, or construct; categorical descriptions that are
useful in assessing risks are acceptable. Avoid or explain acronyms when describing gene source and vectors.
1. NUCLEIC ACID / GENE / INSERT Source(s). Describe the biological source of the nucleic acids.
Provide any additional information under comments.
Biological Source of
Nucleic Acid Name
Nature of Insert, or
(Name of the gene, promoter,
Nucleic Acid
Protein Expressed
(Organism name and
genus/species, synthetic
DNA, cDNA, RNA, etc.)
regulatory sequence, siRNA
target, etc.)
(Toxin, marker trait, virulence
factor, DNA repair gene,
oncogene, transcription
factor, etc.)
Use / Purpose
(e.g., cloning for sequencing,
PCR, expression in a
microbe, expression in
OTCC, expression in
organism, etc.)
Comments:
2. VECTOR Description(s). Representative examples of each category of vector are sufficient.
Provide any additional information under comments.
Vector Backbone
Vector Technical
Gene Transfer Method
Endogenous Control
(e.g.,
transformation,
Source
Name
Mechanisms
conjugation, liposome
Include commercial vendor
(e.g., bacterial plasmid,
only if applicable
cosmid, phage, viral vector,
synthetic, YAC, BAC,
transposon, etc.)
If applicable, include
genus/species of source
if applicable
(e.g., pCDNA3.1 from
Invitrogen, AdEasy
Adenoviral Vector System
from Agilent Technologies,
etc.)
transfection, electroporation,
viral transduction, CaPO4,
animal nuclear transfer,
microinjection, plant gene
gun, Agrobacterium vector,
etc.)
(e.g., replication defective,
helper dependent, ecotropic,
restricted to prokaryotic
organisms, etc.)
Comments:
9
B. MICROORGANISMS / BIOLOGICAL AGENTS:
List all microorganisms (microbes) including those used to propagate recombinant plasmids and
vectors or produce foreign proteins (e.g., non-pathogenic E. coli K-12 or yeast).
1. Are you using microorganisms in your research?
YES, complete table
NO
2. Are the microorganisms attenuated or inactivated in any way?
YES, explain below under comments
NO
3. Are you intentionally planning to express any toxins or potential toxins?
YES, explain below under comments
NO
4. Are you planning Large Scale Production (>10 liters) of any of the organisms?
YES, explain below under comments
NO
Microbe
Virus, Bacteria, Fungi,
Prion, Parasite
(Genus, species, strain)
Risk Group*
(see note
below)
Pathogen to
Humans,
Animals, or
Plants?
(if so, specify)
Specify organisms /
cells receiving
microorganism
(mice, alfalfa, HeLa cells,
or not applicable)
Recipient of
rDNA
Construct?
(if so, specify
construct)
select
select
select
select
* For information on Risk Groups, please review APPENDIX B of the NIH Guidelines.
Comments:
C. ORGAN, TISSUE OR CELL CULTURES (OTCC):
Identify the living organism that is the source of the OTCC, the nature of the cell lines, and whether the
OTCC is modified by rDNA. Note that established human AND non-human primate (NHP) cell lines
are potentially infectious (as are primary human and NHP cells and tissues), and Biosafety Level
2 containment is required for handling these materials.
1. Are you using organs, tissues or cell cultures in your research?
OTCC
Source
(Genus,
species,
strain)
Technical
Name of
OTCC
(e.g. 3T3NIH,
HepG2)
Passage
Description
(e.g. primary,
established)
(diploid,
oncogenic,
helper/packaging,
immortalized,
etc.)
YES, complete table
Recipient of
rDNA?
Intended
Use
(transient/stable)
(admin. to
animals,
cell culture,
etc.)
NO
Potentially
Infectious?
Yes/No
(see note
above)
Comments:
10
D. VERTEBRATES AND INVERTEBRATES:
Identify the organisms and mark (Y/N) in appropriate categories.
1. Are you using vertebrates, invertebrates in your research?
YES, complete table
NO
2. Are novel lines of transgenic animals being created?
YES, explain below
NO
Explanation:
Organism
(Genus, species,
strain)
Is the
organism
transgenic?
What is the
source of the
transgene?
Is the organism
immunocompetent or
compromised?
Is the organism
a recipient of a
microbe?
(Genus, species)
Is the organism
the recipient of
rDNA construct?
Is the
organism a
recipient of
OTCC?
(Specify OTCC)
select
select
select
3. If applicable, mark the animal containment level: Transgenic Animals_APPENDIX Q
N/A
BL1-N
BL2-N
BL3-N (BL3-N containment facilities are not
currently available at UConn)
Comments:
E. PLANTS:
Identify the organisms and mark (Y/N) in appropriate categories. If a microbe is administered to the
organism, identify the microbe (genus, species).
1. Are you using plants in your research?
YES, complete table
NO
2. Are transgenic plants being generated?
YES, explain below
NO
Explanation:
Organism
(Genus, species, strain)
Is the organism
transgenic?
What is the source
of the transgene?
Is the organism a
recipient of a
microbe?
(Genus, species)
Is the organism
the recipient of
rDNA construct?
Is the organism
a recipient of
OTCC?
(Specify OTCC)
3. Mark the applicable containment level: Transgenic Plants_APPENDIX P
N/A
BL1-P
BL2-P
BL3-P (BL3-P containment facilities are
not currently available at UConn)
Comments:
11
12
F. BIOSAFETY LEVEL:
1. Mark the appropriate BIOSAFETY LEVEL* for this project:
BSL-1
BSL-2
BSL-3
* For more information on Biosafety Levels, please review APPENDIX G of the NIH Guidelines.
2. Explain why this Biosafety Level is necessary:
Explanation:
G. DISPOSAL AND DISINFECTION OF BIOHAZARDOUS MATERIALS:
Indicate the method(s) used to inactivate biohazardous materials within your research facility. If a
disinfectant is used, state its name, the final concentration used, and the minimum exposure time.
Material to be Disinfected/Inactivated
Disposal Method / Disinfection Procedure
Surfaces: biosafety cabinets, work surfaces,
equipment, etc.
(e.g. wipe with 10% household bleach and allow a 10 min
contact time, or wipe with 1% Wescodyne and allow a 10
min contact time)
Liquid waste: cell cultures, microorganism
cultures and stocks, etc.
(e.g. treat with household bleach to a final concentration of at
least 10% for 30 min or longer before disposal down the drain)
Solid (non-sharps) waste: intact plastic culture
dishes, flasks, and tubes, gloves, paper towels,
etc.
(e.g., collect in autoclave bag, autoclave for 60 min, seal,
label, place in box-bag unit, and request EH&S pick up)
Sharps waste: needles, syringes, scalpel blades,
microscope slides, pipettes, pipette tips, razor
blades, used glass vials/dishes, etc.
(e.g., collect in an approved sharps container, autoclave for
60 min, place in a box-bag unit, and request EH&S pick up)
Other (explain): research animal waste, mixed
waste such as biological + radiation, growth
chamber/greenhouse plant waste, etc.
13
H. OTHER REGULATORY REQUIREMENTS:
1. USDA/APHIS Permits: The Animal and Plant Health Inspection Service (APHIS) of the US Department of
Agriculture (USDA) regulates transgenic plants, animal pests and exotic organisms through a
permit/notification process. For example, any field trial with transgenic plants requires approval from USDA.
These permits usually have conditions concerning the facilities and the containment procedures.
 Do you have or do you anticipate obtaining a USDA-APHIS permit
for your research? Explanation:
YES, explain
NO
 Are materials used in this protocol subject to any other federal permit
YES, explain
NO
YES, explain
NO
requirements? Explanation:
 Are you conducting field trials for transgenic plants?
Explanation:
2. OSHA Bloodborne Pathogens Standard: The standard requires that all employees with occupational
exposure to bloodborne pathogens participate in a training program at the time of initial hire and at least
annually thereafter.
 Does your research/teaching involve the use of human-derived
substances (e.g. blood, blood components, body fluids, tissues,
secretions) or human-derived cell lines?
YES
NO
3. Respiratory Protection:
 Are there conditions for which staff must wear respiratory protection?
YES, explain
Explanation (this must be consistent with your answer in section III E, PPE used, item 4):
NO
4. DOT Shipping Certification: The U.S. Department of Transportation (DOT) and the International Air
Transport Association (IATA) require that all persons involved in shipping Infectious Substances, Patient
Specimens, Genetically Modified Organisms and other biological materials receive bi-annual training. The
training must include information about the proper classification, packaging, marking, labeling and
documentation of the materials being offered for transport. Biological Health and Safety offers this training on
a recurring basis. Call 486-3613 or visit the website at the link below for more information.
Environmental Health & Safety | UConn
 Do you plan to ship, infectious substances, diagnostic/patient
specimens, live organisms, or other biological materials
(e.g. plasmids)?
YES, specify
NO
Specify the nature of the research materials, the location and name of the
investigator/collaborator or company/repository that will receive the materials, and how the
material will be transported:
 If applicable, provide information about Material Transfer Agreements (see the Office of Sponsored
Programs web site at the link below).
Materials Transfer Agreement: Office for Sponsored Programs, University of Connecticut
14
SECTION V: PRINCIPAL INVESTIGATOR CERTIFICATION
1. I (we), the Principle Investigator(s), certify that I have answered all questions on this document truthfully
and with appropriate completeness.
2. I (we) certify that all appropriate safety training and hazard communication information (i.e. Employee
Safety Orientation Form; Workplace Hazard Assessment Form for Laboratories) have been provided
for myself and everyone working under my supervision.
3. If applicable, I (we) certify that registration with the CT Department of Public Health for work with
human pathogens has been completed and is current. Department of Public Health Registration
4. I (we) certify that all shipping and transfer of biological materials is being conducted according to
federal regulations and University policy.
5. I (we) certify that this research/ teaching is being done according to the IBC ‘Policies and Procedures’
statement.
6. I (we) certify that this research/ teaching is being done according to all University of Connecticut
policies.
7. I (we) certify that this research/ teaching is being done according to NIH r-sDNA Guidelines.
Principal Investigator Name (print or type):
_________________________________________
Signature of Principal Investigator
__________________
Date
DEPARTMENT HEAD: I am familiar with this project in my department and request an assessment for its
adherence to current NIH Guidelines by the Institutional Biosafety Committee and appropriate action by
that committee.
Department Head Name (print or type):
_________________________________________
Signature of Department Head
__________________
Date
15