All Amendments Must Be Approved by the IBC Prior to Implementation

IBC Registration Amendment Form

All amendments must be approved by the IBC prior to implementation

Submit amendment as an electronic Word Documentto:

Signature page may be scanned, faxed 860-486-1106, 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/updateUniversity 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):

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

Committee / Protocol Number(s) / Pending
(date submitted) / Most Recent
Expiration Date
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 / Responsibilities
NO
YES:
Enter Number / <Select>Principal InvestigatorCo-InvestigatorCorrespondentGraduate StudentUndergraduate StudentLaboratory Personnel / Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:
NO
YES:
Enter Number / <Select>Principal InvestigatorCo-InvestigatorCorrespondentGraduate StudentUndergraduate StudentLaboratory Personnel / Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:
NO
YES:
Enter Number / <Select>Principal InvestigatorCo-InvestigatorCorrespondentGraduate StudentUndergraduate StudentLaboratory Personnel / Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:
NO
YES:
Enter Number / <Select>Principal InvestigatorCo-InvestigatorCorrespondentGraduate StudentUndergraduate StudentLaboratory Personnel / Handling biohazardous materials
Handling animals exposed to biohazardous materials
Shipping biohazardous materials
Other, specify:

REMOVE Personnel

Name / Name / Name
1. / 3. / 5.
2. / 4. / 6.

SECTION IV: UPDATE EDUCATIONAL AWARENESS & TRAINING

Please answer all questions / Yes / No / N/A
1 / 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.)
2 / All Personnel have reviewed the Laboratory-Specific Biosafety Manual (including the applicable biohazards associated with this IBC Registration)
3 / All Personnel have completed the appropriate EHS Training per Employee Safety Orientation (See
4 / The PI has completed the NIH Guidelines Training and Quiz (see
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.
7 / 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.
8 / 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 / Building / Room / Clean Air Device Available in the Room? (Select) / Room Function
(animal housing, cell culture, greenhouse, virus propagation, euthanasia, etc.) / Is this a shared lab space?
Add / Remove
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None / <Select>Yes, who:No
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None / <Select>Yes, who:No
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None / <Select>Yes, who:No
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None / <Select>Yes, who:No
Biosafety Cabinet
Horizontal Laminar Flow Clean Bench
PCR Workstation/Hood
None / <Select>Yes, who:No

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.

A)ADDITON of biological agents:

Microbe, Virus, Bacteria, Fungi, Prion, Parasite, Toxin
(Genus, species, strain) / Risk Group / Select Agent / Pathogen to Humans, Animals, or Plants? / Recipient of r/sNA Construct?
(if so, specify construct) / Specify organisms / cells receiving microorganism
(mice, alfalfa, HeLa cells, or not applicable)
<Select>N/ARG1RG2RG3 / <Select>YesNo / <Select>NonpathogenicHumans OnlyAnimals OnlyPlants OnlyHumans & AnimalsHumans, Animals, & Plants
<Select>N/ARG1RG2RG3 / <Select>YesNo / <Select>NonpathogenicHumans OnlyAnimals OnlyPlants OnlyHumans & AnimalsHumans, Animals, & Plants
<Select>N/ARG1RG2RG3 / <Select>YesNo / <Select>NonpathogenicHumans OnlyAnimals OnlyPlants OnlyHumans & AnimalsHumans, Animals, & Plants
<Select>N/ARG1RG2RG3 / <Select>YesNo / <Select>NonpathogenicHumans OnlyAnimals OnlyPlants OnlyHumans & AnimalsHumans, Animals, & Plants

B)List NEW gene transfer method:

Vector Backbone Source
(e.g., bacterial plasmid, cosmid, phage, viral vector, synthetic, YAC, BAC, transposon, etc.)
If applicable, include genus/species of source / Vector Technical Name
Include commercial vendor
if applicable
(e.g., pCDNA3.1 from Invitrogen, AdEasy Adenoviral Vector System from Agilent Technologies, etc.) / Gene Transfer Method
(e.g. conjugation, liposome transfection, electroporation, viral transduction, CaPO4, animal nuclear transfer, microinjection, plant gene gun, Agrobacterium vector, etc.) / 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
(Name of the gene, promoter, regulatory sequence, siRNA target, etc.) / Nature of Insert, or
Protein Expressed
(Toxin, marker trait, virulence factor, DNA repair gene, oncogene, transcription factor, etc.) / Purpose/ Use
(e.g., cloning for sequencing, PCR, expression in a microbe, expression in OTCC, expression in organism, etc.)
<Select>N/ARG1RG2RG3
<Select>N/ARG1RG2RG3
<Select>N/ARG1RG2RG3
<Select>N/ARG1RG2RG3

D)List NEW organ, tissue or cell culture material (OTCC):

OTCC Source
(Genus, species, strain) / Technical
Name of OTCC
(e.g. 3T3NIH, HepG2) / Passage
(e.g. primary, established) / Description
(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>YesNo
<Select>YesNo
<Select>YesNo
<Select>YesNo

E)List NEW vertebrates and invertebrates:

Organism
(Genus, species, strain) / Is the organism transgenic?
What is the source of the transgene? / Is the organism immuno-competent or compromised? / Is the organism a recipient of a microbe?
(Genus, species) / Is the organism the recipient of
r/sNA construct?
Provide construct / Is the organism a recipient of OTCC?
(Specify OTCC)
<Select>immuno-competentcompromised
<Select>immuno-competentcompromised
<Select>immuno-competentcompromised

F)List NEW plants:

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
r/sNA construct?
Provide construct / Is the organism a recipient of OTCC?
(Specify OTCC)

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 / 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, maximum toxin amount excluded from regulation: / No
Yes, SelectInjectionInhalationIngestionAbsorption
Add Species
No
Yes, maximum toxin amount excluded from regulation: / No
Yes, SelectInjectionInhalationIngestionAbsorption
Add Species
No
Yes, maximum toxin amount excluded from regulation: / No
Yes, SelectInjectionInhalationIngestionAbsorption
Add Species
No
Yes, maximum toxin amount excluded from regulation: / No
Yes, SelectInjectionInhalationIngestionAbsorption
Add Species

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 / Date

IBC Amendment Form1 | Page

11/2015