Download Institutional Biosafety Committee (IBC) Protocol Submittal Form

Institutional Biosafety Committee (IBC)
Protocol Submittal Form
Please download and save this form before completing applicable parts and send
► Electronic copies to [email protected] , & [email protected]
AND
► Submit a signed hard copy to IBC Committee, MIP Department, 6205 MEB
For questions call (504) 568-4062 or email [email protected].
All research conducted at this institution must conform to regulations and guidelines for biosafety that have been
established by various authorities.
The Center for Disease Control has a manual located at
http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm that is particularly informative. This form will document and
confirm that Biosafety concerns have been addressed or determined non-applicable for your protocol.
◄ IBC approval will be contingent upon concurrent IRB or IACUC approval. ►
**Note that some sections may be copied from your IRB or IACUC application**
Submission Date:
Application Type:
Initial Protocol
Renewal for IBC #
Amendment for IBC #
Category the proposed research will involve:
1. Research with Animal Usage or Human Contact (any interaction where the investigator "touches" the subject, e.g. physical
examination, surgery, or "instrumenting" the subject as in auditory testing, providing inhalers, etc.) – Complete Part A
IACUC Protocol #
(if required) or IRB Protocol #
2. Other Research not requiring IRB or IACUC approval (e.g. cell lines, fungi, bacteria) – Complete Part A
In addition to completing Part A, check and complete applicable categories:
3. Animal Research - Complete Part B
4. Potentially Infectious Agents or Biological Toxins – Complete Part C
5. Human or Non-Human Primate Materials – Complete Part D
6. Recombinant DNA/Transgenic – Complete Part E
7. None of the above categories – Complete only Part A1 through A3 and provide IRB Protocol #
(e.g. chart reviews, surveys and human studies with no face-to-face interaction or no physical contact with, or instrumentation of, the subject)
General Information (all categories)
Principal
Investigator:
Project Supervisor:
Email:
Email:
Bldg/Room:
Bldg/Room:
Department:
Department:
Phone:
Phone:
(if different from Principal
Investigator)
Project Title:
Funding Information:
Source of
Funds:
Grant Number:
Grant Title:
PI on Grant:
IBC General Information
Revised 6/02/2008
LSUHSC-NO
IBC Protocol Submittal Form
Part A: Human, Animal or Other Research
A1
Describe, in NON-TECHNICAL LANGUAGE, the objective of the protocol for research:
A2
Estimate the expected duration of the study:
A3
Is this project classified under Category 7: None of the Above?
(i.e., does not have human/non-human primate physical interaction/contact, use human/non-human primate
materials, use recombinant DNA, infectious agents or biological toxins, or involve animal research)
No, continue to A4.
Yes, this study is EXEMPT from IBC oversight. Please sign and date in box below. Submit this application
through Item A3 to the IBC Office as per instructions above. Annual reviews are not required; however,
the investigator agrees to report to the IBC Committee any changes that may affect the exempt status of
the study, and that no such change will be implemented without IBC Committee review.
Principal Investigator (signature): ________________________________ Date:____________________
A4
Describe sequentially all experimental procedures and techniques in this protocol:
A5
Identify and thoroughly address all potential hazards associated with this protocol to the personnel, clinic, and/or
the animal facility.
A6
Describe the equipment and procedures used to safely conduct this work. (e.g., universal precautions, spill
procedures, biomedical waste disposal, decontaminants/disinfectants, sharps handling, etc.)
A7
Describe the source(s) of the research material(s) used in this protocol:
A8
Do you intend to transport research material?
Yes
A8a
Transporting within the LSUHSC Campus?
A8b
A9
No
If Yes, complete A8a and A8b below.
Transporting outside the LSUHSC Campus?
Describe the equipment and procedures used to ensure the material is transported safely and in
accordance with all applicable regulations and requirements:
Beyond the standard LSUHSC-NO Biosafety Training required, have all personnel associated with this protocol
(including animal caretakers) been instructed and trained in the specific practices and techniques required to
ensure safety in the conduct of this protocol and the safety procedures for dealing with accidents related to this
protocol?
Yes; describe training provided:
No; explain why no training was provided:
IBC Part A
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LSUHSC-NO
A10
IBC Protocol Submittal Form
List all clinical, laboratories, animal research locations and/or any research locations associated with this protocol.
Approval of the proposed experiments is given only for the locations listed below. The Principal Investigator must
notify the Biosafety Officer if the locations of the experiment or the storage of materials changes.
BUILDING (include address in not
on LSUHSC Campus)
LOCATIONS
WHERE THE
EXPERIMENT
IS CONDUCTED
LOCATIONS
WHERE THE
AGENTS
ARE STORED
IBC Part A
ROOM
BIOSAFETY LEVEL
SHARED ROOM
(BSL-1, BSL-2, BSL-3)
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
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A 11
IBC Protocol Submittal Form
The following is a list of personnel who will have physical contact with humans or animals and/or who will
physically handle biological materials, biohazardous agents or recombinant DNA molecules and are conceivably
at risk from research procedures involving the use of these biological materials.
Approval of the proposed experiment is given only for the identified personnel listed below. The Biosafety Officer
must be notified if any new personnel are added (e.g., new post-doctoral fellows). List additional personnel on a
copy of this sheet as needed.
SIGNATURE from each listed personnel is required and shall indicate that he or she has been informed of
potential hazards, safe work practices, availability of medical surveillance, and that they understand and will
follow all approved laboratory practices and procedures.
Name
Title/Position
SIGNATURE
Date of LSUHSC Biosafety
Training**
(indicate if pending)
Principal Investigator
**Biosafety Training consists of the Laboratory Safety Class and the Bio Safety/Bloodborne Pathogens
Class which includes the Universal Precautions required for anyone with animal or human physical
contact. Class schedule is available on the LSUHSC-NO Office of Environmental Health and Safety
website at http://www.is.lsuhsc.edu/safety/Class%20Schedule.doc.
I attest that the information contained in this application is accurate and complete. I accept the responsibility for the safe
conduct of work with this study at the Biological Safety Level practices and procedures assigned in PART F.
I will inform all personnel, who may be at risk of potential exposure of the conditions of this work.
I will not carry out the work described in the attached application until it has been approved by the IBC and all
requirements have been met.
Principal Investigator (signature): _______________________________________ Date: _________________
IBC Part A
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LSUHSC-NO
IBC Protocol Submittal Form
Part B: Animal Research
B1 Specify Animal Species:
Mice
Rats
Rabbits
Non-Human Primates
Cats
Dogs
Frogs
Other
B2 Identify the source(s) of animals used in this project:
B3 Do you expose animals to live organism(s) or viruses?
Yes
No
B3a If Yes, what organisms/viruses? (For potentially infectious agents or biological toxins, complete Part C)
B3b If Yes, by what route(s) of administration:
Subcutaneous
Intraperitoneal
Intracranial
Intramuscular
Intravenous
Other
B4 Will knockout mice be used?
Yes
No
B5 Is any rDNA being introduced into the animal model, and/or has the genome of the animal been modified by rDNA?
Yes
No
If Yes, complete Recombinant DNA/Transgenic – Part E
B6 Is there any possibility that the research material introduced to the animal(s) (recombinant molecule, vector, toxin, or
pathogen) could remain a viable hazard in the animal secreta, excreta and/or soiled bedding?
Yes
No
B6a If Yes, describe the practices and procedures used to minimize occupational exposures:
B7 List all LSUHSC-NO Animal Care’s Standard Operating Procedures (SOP) relevant to this application (copies of
standing SOPs are not required). Depending upon the IBC risk assessment of this application, new SOPs may be
required whereby you must consult with the Animal Care Facility Veterinarians to modify or develop new SOPs
specific to the procedures and/or the biosafety hazards of the study. You will be notified of this requirement if
necessary. While the new SOPs are being developed, contingent approval of this application can be given; however,
final approval will not be given until the new SOPs are submitted for IBC review.
I accept the responsibility for the safe conduct of work with the above-mentioned animals or animal materials using the
Biological Safety Level practices and procedures assigned in PART F. I will inform all personnel, who may be at risk of
potential exposure to these materials, of the appropriate procedures for this work.
Principal Investigator (signature): _____________________________________
Date: _____________________
To be completed by the Animal Facility Manager (as applicable):
I attest that I have been informed of all potential hazards associated with this protocol and have informed my employees
of the risks. All personnel associated with this protocol have been instructed in, and will follow, all required laboratory
safety procedures in the care and handling of project animals and animal materials.
Animal Facility Manager (signature): ___________________________________
IBC Part B
Date: ______________________
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LSUHSC-NO
IBC Protocol Submittal Form
PART C: Pathogen and Toxin Registration
To be completed by laboratories handling biological agents (actual or potential human pathogens, oncogenic viruses) or
toxins.
C1 Name(s) of Biological Agent(s) or Toxin(s)
C1a
C2
Identify Specific Strain, Genotype, and risk group (NIH Guidelines Appendix B located at
http://www4.od.nih.gov/oba/rac/guidelines_02/APPENDIX_B.htm) or Chemical Abstracts Service (CAS)
Registry Number (http://www.cas.org/expertise/cascontent/registry/regsys.html).
Is the agent listed on the CDC List of Select Agents (42 CFR 72.6, Appendix A,
http://www.cdc.gov/od/sap/docs/salist.pdf)?
Yes
No
Complete for Pathogen
C3
Is antimicrobial resistance expressed?
C3a
If Yes, provide details:
Yes
No
C4
Are other markers expressed?
Yes
No
Yes
No
Is the organism inactivated prior to other manipulations?
Yes
No
C6a
Heat
Chemical
Radiation
Other:
C4a
C5
Is there a possibility of new strains being created?
C5a
C6
C6b
C7
If Yes, provide details:
If Yes, specify methods:
How do you verify inactivation?
Do you culture the organism?
C7a
C8
If Yes, provide details:
IBC Part C
No
Yes
No
If Yes, specify the amount:
Do you concentrate the organism?
C8a
Yes
If Yes, specify methods:
Centrifugation
Precipitation
Filtration
Other:
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IBC Protocol Submittal Form
Complete for Toxin
C9
Is a toxin produced as a result of or for this project?
Yes
No
C10 If you are working with a toxin, identify the amount of toxin & how it will be aliquotted (Maximum Toxin Amounts
Excluded from Regulation located at http://www.cdc.gov/od/sap/sap/toxinamt.htm).
C10a
If you are working with a toxin, does the toxin have an LD50 more than 100 nanograms per
kilogram body weight?
Yes
No
C11 The largest volume used is:
The usual volume used is:
Liters
Liters
C12 If dilutions will be prepared, identify the method & how they will be aliquotted:
C13 Containment equipment available:
Biological Safety Cabinet
Containment Centrifuge
Chemical Fume Hood
Other:
I attest that the information contained in this application is accurate and complete. I accept the responsibility for the safe
conduct of work with this/these organism(s) at the Biological Safety Level practices and procedures assigned in PART F.
I will inform all personnel, who may be at risk of potential exposure to the organism, of the conditions of this work.
Principal Investigator (signature): ____________________________________________ Date: ______________
IBC Part C
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IBC Protocol Submittal Form
Part D: Research Involving Human or Non-Human Primate Blood, Blood Components, Cell
Lines and/or Other Potentially Infectious Materials (OPIM)
D1
D2.
Identify the type of samples to be manipulated:
Whole Blood/Serum
Blood Component
Established Cell Lines
Unfixed Tissue
Cell "strains"
Other:
Cell Lines or Repository Cells infected with HIV or HBV
Tissue from animals infected with HIV or HBV
List specific samples below:
Sample Type
Sample Name
Source (Vendor, Lab Group, etc.)
D3
Is work being conducted with clinical specimens?
Yes
No
D4
Has material been prescreened for pathogens?
D4a
If YES, what pathogens was the material screened for:
Yes
No
D4b
D5
Identify any positive tests
Has the material been intentionally infected or is it suspected of being infected, with
any pathogens?
D5a
If Yes, what pathogens?
Yes
No
D5b
Will the material be infected with any pathogens as part of this protocol?
Yes
No
D5c
If Yes, what pathogen(s)?
D6
Frequency of manipulations:
D7
Types of manipulations:
Centifugration
Blending/Mixing
D8
Containment equipment
available:
Biological Safety Cabinets
Containment Centrifuge
Daily
Weekly
Sonification
Pipetting
Other
Dissection
Other
Chemical Fume Hood
Other
I accept the responsibility for the safe conduct of work with the above mentioned human blood, body fluids, and/or
tissues using the Biological Safety Level practices and procedures assigned in PART F. I will inform all personnel, who
may be at risk of exposure to these materials of the appropriate procedures for this work.
Principal Investigator (signature): _______________________________________ Date: ___________________
IBC Part D
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LSUHSC-NO
IBC Protocol Submittal Form
PART E: Recombinant DNA Research
E1
Is this project EXEMPT according to NIH Guidelines?
(http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261577)
Yes
No If Yes, indicate below applicable Section(s) from the Guidelines along with a brief
description of the protocol, sign, date, and submit to the IBC office. If No, continue to E2 below.
Principal Investigator (signature): ______________________________ Date:________________________
E2
Indicate which part(s) of Section III of the current NIH Guidelines covers your experiment.
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
Experiments Covered by NIH Guidelines
Section III-A.
Experiments that Require Institutional Biosafety Committee Approval (IBC), RAC Review, and
NIH Director Approval Before Initiation
Section III-A-1 Major Actions under the NIH Guidelines
Section III-B
Experiments That Require NIH/OBA and IBC Approval Before Initiation
Section III-B-1 Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms
per Kilogram Body Weight
Section III-C
Experiments that Require IBC and Institutional Review Board Approvals (IRB) and RAC Review
Before Research Participant Enrollment
Section III-C-1 Experiments Involving the Deliberate Transfer of Recombinant DNA, or DNA or RNA Derived
from Recombinant DNA, into One or More Human Research Participants
Section III-D
Experiments that Require IBC Approval Before Initiation
Section III-D-1 Experiments Using Risk Group (RG) 2, RG 3, RG 4, or Restricted Agents as Host-Vector
Systems
Section III-D-2 Experiments in Which DNA From RG 2, RG 3, RG 4, or Restricted Agents is Cloned into
Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems
Section III-D-3 Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA
Viruses in the Presence of Helper Virus in Tissue Culture Systems
Section III-D-4 Experiments Involving Whole Animals
Section III-D-5 Experiments Involving Whole Plants
Section III-D-6 Experiments Involving More than 10 Liters of Culture
Section III-E
Experiments that Require IBC Notice Simultaneous with Initiation
Section III-E-1 Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than
Two-Thirds of the Genome of any Eukaryotic Virus
Section III-E-2 Experiments Involving Whole Plants
Section III-E-3 Experiments Involving Transgenic Rodents
Section III-F
IBC Part E
Exempt Experiments
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LSUHSC-NO
IBC Protocol Submittal Form
E3
Describe the gene sequences used to make the recombinant (If obtained commercially, give a detailed description
and attach catalog description).
E4
Explain the function of the foreign genetic material in this experiment:
E5
Is a deliberate attempt made to obtain expression of foreign gene(s) in the cloning vehicle?
Yes
No
E5a If Yes, what proteins?
E5b Are there any hazards associated with expression of the foreign proteins?
Yes
No
E6
Name the organism(s) used as the host/cloning vehicle (Check all that apply):
Prokaryotes (e.g., E. coli K12):
Eukaryotes (e.g., mammalian cell lines)
Higher Animals (e.g., insects, amphibians,
mice, non- human primates, etc.)
E7
Are plant or animal cells to be exposed to the recombinant?
Yes
No
Yes
No
E7a If YES, list the cells or cell lines to be used:
E7b Will infectious virus, oncogenic agents or toxins be produced during this
work?
If Yes, describe:
E7c Describe the potential hazards and the planned mitigation measures:
E8
Are viruses or viral-based promoters used in this work?
Yes
No
If Yes, please explain and answer questions B7a-B7k.
E8a
Name of virus or viral promoter?
E8b
Amount of viral genomic material used:
Whole Virus
<2/3 viral genome
<1/2 viral genome
E8c
How is the virus used?
Vector
Donor of genetic information
If used as vector:
E8c1
List specific phage, virus or plasmid and the function of each:
E8c2
If you are using a mammalian expression system, please provide a comprehensive description of the
system:
E8c3
Will human or amphotropic viral vectors be utilized?
Yes
No
Yes
No
If Yes, please provide a detailed description.
E8d
IBC Part E
Is virus replication competent or mobilizable?
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IBC Protocol Submittal Form
E8d1
If YES, what is the host range?
E8e
Is the virus capable of infecting human cells?
Yes
No
E8f
Is the strain attenuated?
Yes
No
E8g
Provide detailed information on the specific strain being used:
E8h
Is a less virulent strain available?
Yes
No
E8i
Is there a potential for producing aerosols?
Yes
No
E8i1 If YES, how will the generation of aerosols be minimized or eliminated?
E8j
E8k
Virus Classification (check all that apply)
E8j1
Prokaryotic Virus
Name:
E8j2
Eukaryotic Virus
Name:
B8j3
Oncogenic Virus
Name:
Organism Risk Group (Check one). Refer to the NIH Guidelines Appendix B to determine risk group.
Risk Group 1
Risk Group 2
Risk Group 3
Risk Group 4
E9
If rDNA is being introduced into animal models, and/or has the genome of the animal been modified by rDNA:
E9a
Would it pose any threat to other animals or humans?
Yes
No
E9b
Are cells permissive to further infection?
Yes
No
Yes
No
E6b1. If Yes, please explain:
E9c
Is rDNA used to make a transgenic animal model?
E6b1. If Yes, please explain:
E9d
E9e
Is any of the rDNA in the transgene from a virus?
Yes
No
Is there any reasonable expectation that this viral segment could help mobilize part or all of the transgene,
either by itself or by interaction with other viruses (including endogenous viruses)?
Yes
No
E9f
If part or all of the transgene was mobilized, would it carry any particular risk (is part or all of the transgene
known oncogene/anti-oncogene, toxin, immunosuppressant, or could it reasonably be expected to confer
pathogenic properties on a virus that carried it?
Yes
No
If there is a possibility of viral vector sequences recombining with endogenous or exogenous helper viruses to
produce new and unpredictable forms of infectious viruses, please explain:
E9g
E10
Are the recombinant organisms/molecules:
E10a Genetically modified microorganisms or genetic elements from organisms
listed on the CDC List of Select Agents (42 CFR 72.6, Appendix A,
http://www.cdc.gov/od/sap/docs/salist.pdf) shown to produce or encode for
a factor associated with a disease?
IBC Part E
Yes
No
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LSUHSC-NO
IBC Protocol Submittal Form
E10b Genetically modified microorganisms or genetic elements that contain
nucleic acid sequences coding for any of the toxins listed on the CDC List
of Select Agents (42 CFR 72.6, Appendix A,
http://www.cdc.gov/od/sap/docs/salist.pdf), or their toxin subunits?
Yes
No
I attest that the information contained in this application is accurate and complete. I agree to comply with the NIH
requirements pertaining to shipment and transfer of recombinant DNA materials. I acknowledge my responsibility for the
conduct of this research in accordance with Section IV-B-7 of the NIH Guidelines.
I will not carry out the work described in the attached application until it has been approved by the IBC and all
requirements have been met.
Principal Investigator (signature): _______________________________________ Date:
IBC Part E
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LSUHSC-NO
IBC Protocol Submittal Form
PART F: FOR IBC USE ONLY
This section is to be completed by the LSUHSC Biological Safety Officer and/or EHS Representative
It is recommended that work be conducted in a
and/or ABSL
BSL laboratory(ies) using BSL
animal facility(ies) using ABSL
practices and procedures,
practices and procedures.
Reviewer's Name: ____________________________________________________
Date: ____________________
Laboratory(ies) and or Animal Facility(ies) certified on: _____________ By:__________________________________
Expedited Review
Full Committee Review
Technical Subcommittee Review
Lead Reviewer(s)
Date Sent for Review:
Lead Reviewer's Comments:
Full Approval
Administrative Approval
Conditional Approval
Not Approved
Action Plan:
Date of Approval:
Protocol #:
This section is to be completed by appropriate medical personnel.
Is a Medical Surveillance Program indicated?
Yes
No
If Yes, specify:
Signature: ________________________________________________________ Date: ________________________
This protocol document is approved by the LSUHSC Institutional Biosafety Committee.
Biological Safety Officer: _____________________________________________ Date: ________________________
Chairman, LSUHSC IBC: _____________________________________________ Date: ________________________
To Be Completed by LSUHSC upon Project Termination
Date Protocol Inactivated:
Biological Safety Representative: _______________________________________ Date: ________________________
IBC Part F
Revised 6/02/2008