IBC use only
Amendment #
Office of the Vice President for Research
Research Compliance Services
IBC Registration Amendment Form
All amendments must be approved by the IBC prior to implementation
Submit amendment as an electronic Word Document to: tekechia.hester@uconn.edu
Signature page may be scanned, faxed 486-1106, or sent via campus mail to U-4097
IBC Registration No.
Principal Investigator:
Approved Registration Title:
Indicate the type of changes requested and complete the section(s) that apply:
Section I: Add Supplemental funding
Section II: Add/update University Committee Protocol(s)
Section III: Add/remove laboratory personnel
Section IV: Update Educational Awareness & Training (only complete if you have not filled this section out in
your IBC registration form)
Section V: Add/remove workspace location
Section VI: Amend experimental activities*
A. Add infectious agents or biological toxins
B. Add gene transfer method
C. Add genes, DNA, or RNA sequences
D. Add organ, tissue, or cell culture materials
E. Add new vertebrates and invertebrates
F. Add new plants
G. Add new toxin
*Questions 1-4 must be completed, along with any additional subsection requiring modification
Note: Please be sure to sign the Principal Investigator Assurance on pg.6
SECTION I: ADD SUPPLEMENTAL FUNDING (requested/received):
Grant Title:
Granting Agency
KFS Number
1. Explain how the Supplement relates to the original grant(s):
IBC Amendment Form
03/2015
1|P a g e
2. Does the supplement change your currently approved IBC Registration?
Yes
No, I confirm there are no changes to IBC approved experimental activities or safety
procedures. (If yes, complete the appropriate sections of the form. If no, sign and submit the form)
SECTION II: ADD UNIVERSITY COMMITTEE PROTOCOL
Protocol Number(s)
Committee
Most Recent
Expiration Date
Pending
(date submitted)
IACUC (Institutional Animal Care and Use Committee)
IRB (Institutional Review Board) for human subjects
SCRO (Stem Cell Research Oversight)
Other (specify):
SECTION III: LABORATORY PERSONNEL CHANGES
ADD Personnel
Name
NetID
Lab Contact?
Position/Title
NO
YES:
Enter Number
<Select>
NO
YES:
Enter Number
<Select>
NO
YES:
Enter Number
<Select>
NO
YES:
Enter Number
<Select>
Responsibilities
Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:
Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:
Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:
Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:
REMOVE Personnel
Name
1.
2.
Name
3.
4.
IBC Amendment Form
03/2015
Name
5.
6.
2|P a g e
SECTION IV: UPDATE EDUCATIONAL AWARENESS & TRAINING
Please answer all questions
Yes
4
All Personnel received a laboratory orientation by the PI or his/her designee prior to the start of work and are familiar
with the location of safety equipment (eye wash, safety shower, first aid, etc.)
All Personnel have reviewed the Laboratory-Specific Biosafety Manual (including the applicable biohazards associated
with this IBC Registration)
All Personnel have completed the appropriate EHS Training per Employee Safety Orientation (See
http://www.ehs.uconn.edu/forms/)
The PI has completed the NIH Guidelines Training and Quiz (currently not available, select N/A)
5
All Personnel are familiar with the applicable standard operation procedures (SOPs) associated with this registration
6
All Personnel are familiar with incident reporting and know where to seek medical attention in case of an exposure.
1
2
3
7
8
No
N/A
The PI or Laboratory Supervisor has instructed research personnel of applicable immunizations programs (i.e. Hepatitis
B) and testing (i.e. serum banking, respirator fit testing) prior to the initiation of work.
The PI or Laboratory Supervisor has instructed research personnel of applicable immunizations programs applicable to
the biological agents being used in this registration (i.e. vaccinia, influenza)
SECTION V: LOCATION CHANGES
Add/Remove
Location
Add
Building
Remove
Room
Clean Air Device Available in the
Room? (Select)
Room Function
(animal housing, cell culture,
greenhouse, virus propagation,
euthanasia, etc.)
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None
Is this a shared lab
space?
<Select>
<Select>
<Select>
<Select>
<Select>
SECTION VI: AMEND APPROVED EXPERIMENTAL PROCEDURES AND ACTIVITIES
Please note supplementary questions may be required for the addition of biohazardous materials. If necessary you will be
notified. Questions 1-4 must be completed under this section!
1. Summarize the change(s) requested. If adding a new project provide a description.
IBC Amendment Form
03/2015
3|P a g e
A)
ADDITON of biological agents:
Microbe, Virus, Bacteria, Fungi,
Prion, Parasite, Toxin
(Genus, species, strain)
B)
Risk
Group
Select
Agent
Pathogen to Humans,
Animals, or Plants?
<Select>
<Select> <Select>
<Select>
<Select> <Select>
<Select>
<Select>
<Select> <Select>
<Select> <Select>
Recipient of r/sNA
Construct?
(if so, specify
construct)
Specify organisms / cells
receiving microorganism
(mice, alfalfa, HeLa cells, or
not applicable)
List NEW gene transfer method:
Vector Backbone Source
Vector Technical Name
Gene Transfer Method
(e.g., bacterial plasmid, cosmid, phage, viral
vector, synthetic, YAC, BAC, transposon, etc.)
Include commercial vendor
if applicable
(e.g., pCDNA3.1 from Invitrogen,
AdEasy Adenoviral Vector System
from Agilent Technologies, etc.)
(e.g. conjugation, liposome
transfection, electroporation, viral
transduction, CaPO4, animal
nuclear transfer, microinjection,
plant gene gun, Agrobacterium
vector, etc.)
If applicable, include genus/species of source
Endogenous Control
Mechanisms
only if applicable
(e.g., replication defective, helper
dependent, ecotropic, restricted to
prokaryotic organisms, etc.)
Other (e.g., nanoparticles, liposomes, etc.):
Describe:
C)
List NEW genetic material:
Biological Source of Nucleic Acid
(Organism name and genus/species, synthetic
DNA, cDNA, RNA, etc.)
Risk Group
of Source
Organism
Nucleic Acid
Name
Nature of Insert, or
Protein Expressed
Purpose/ Use
(Name of the
gene, promoter,
regulatory
sequence,
siRNA target,
etc.)
(Toxin, marker trait, virulence
factor, DNA repair gene,
oncogene, transcription factor, etc.)
(e.g., cloning for sequencing, PCR,
expression in a microbe, expression in
OTCC, expression in organism, etc.)
<Select>
<Select>
<Select>
<Select>
D) List NEW organ, tissue or cell culture material (OTCC):
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.)
Recipient of
r/sNA?
(transient/stable)
Intended Use
(admin. to
animals,
cell culture, etc.)
Potentially
Infectious?
Yes/No
<Select>
<Select>
<Select>
IBC Amendment Form
03/2015
4|P a g e
<Select>
E) List NEW vertebrates and invertebrates:
Organism
(Genus, species, strain)
Is the organism
transgenic?
Is the organism
immunocompetent or
compromised?
What is the source
of the transgene?
Is the organism a
recipient of a
microbe?
Is the organism the
recipient of
r/sNA construct?
(Genus, species)
Provide construct
Is the organism a
recipient of
OTCC?
(Specify OTCC)
<Select>
<Select>
<Select>
F) List NEW plants:
Organism
(Genus, species, strain)
Is the organism
transgenic?
Is the organism a
recipient of a microbe?
What is the source of
the transgene?
(Genus, species)
Is the organism the
recipient of
r/sNA construct?
Is the organism a
recipient of OTCC?
(Specify OTCC)
Provide construct
G) List NEW toxins:
Biotoxin
(include genus & species of
organism from which it is
derived)
Is the toxin listed on the
HHS &USDA Select Agent
and Toxin List?
Selectagent.gov
No
Yes, maximum toxin
amount excluded from
regulation:
No
Yes, maximum toxin
amount excluded from
regulation:
No
Yes, maximum toxin
amount excluded from
regulation:
No
Yes, maximum toxin
amount excluded from
regulation:
IBC Amendment Form
03/2015
Provide the Lethal
Dose 50 ng/kg
(LD50)
Will the toxin be administered
into live animals? (If yes, select
the route of administration and add
the species receiving toxin)
Source of biological
toxin
(Specify toxin supplier or
production method)
No
Yes, Select
Add Species
No
Yes, Select
Add Species
No
Yes, Select
Add Species
No
Yes, Select
Add Species
5|P a g e
2. Describe any potential implications the change(s) may have on health and safety:
3. Provide a risk assessment for the changes described above, if applicable:
4. Will the changes affect the biosafety level?
Yes, please provide an explanation
No
Explanation:
Please attach any applicable supporting documents for proposed changes, examples include:
Attach a map of new vector(s).
New federal permits
ASSURANCE
I attest that the information contained in this IBC Amendment Request Form is accurate and complete. I agree to comply with all requirements
pertaining to the use, handling, storage and disposal of biohazardous materials as outlined in my approved IBC application and this amendment
request.
Signature of the Principal Investigator
IBC Amendment Form
03/2015
Date
6|P a g e