CITY OF HOPE NATIONAL MEDICAL CENTER
BECKMAN RESEARCH INSTITUTE
INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
PROTOCOL REVIEW FORM
1.
IBC #
NEW PROTOCOL
MODIFICATION OF ONGOING STUDY
(HIGHLIGHT MODIFICATIONS)
THIRD YEAR RENEWAL
IDENTIFICATION
Principal Investigator (Last, First, Degree)
Clinical Principal Investigator (Last, First, Degree)
Department
Ext.
Project Title
Project Period
From
To
Source of Funding
Will the results from these experiments be used as pre-clinical data for an IND submission to
the FDA within the next 12 months?
Yes
No
If this application involves Transgenic/Gene Knock-out animals, check all that apply:
Acquisition and Breeding
Experimentation with Animals
Does this application involve the use of human embryonic/pluripotent stem cells?
Yes
If yes, Stem Cell Research Oversight Committee (SCRO) approval is required.
SCRO Number
SCRO Approval Date
2.
No
CHECK THE APPROPRIATE CATEGORY – Experiment(s) involving recombinant DNA:
NIH Recombinant DNA Guidelines http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
III-A
Experiments that Require Institutional Biosafety Committee (IBC) Approval, Institutional Review Board
(IRB) Approval, NIH Recombinant DNA Advisory Committee (RAC) Review, and NIH Director Approval
Before Initiation. Example of experiments are (1) Deliberate transfer of a drug resistance trait to
microorganisms that are not known to acquire the trait naturally.
III-B
Experiments that Require NIH/OBA (Office of Biotechnology Activities) and IBC Approval Before Initiation.
Example of experiments are (1) cloning of toxin molecules with LD50 of less than 100 ng/kg.
III-C
Experiments that Require IBC, IRB Approvals and NIH/OBA Registration Before Initiation. Example of
experiments are (1) Deliberate transfer of rDNA, DNA or RNA derived from rDNA, into a human research
participant.
III-D
Experiments that Require IBC Approval Before Initiation. Example of experiments are (1) Using Risk
Group 2 (RG2), RG3, RG4 or Restricted Agents as Host-Vector Systems (Link to RG definitions
http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlnes_lnk_2002z.pdf).
(2) DNA from RG 2, 3, 4 or Restricted
organisms is cloned into nonpathogenic prokaryotic or lower eukaryotic host vector systems. (3) Use of
infectious DNA or RNA viruses in tissue culture (TC) systems. (4) Use of defective DNA or RNA viruses in
presence of helper virus in TC systems. (5) Experiments involving whole animals. (6) Experiments
involving whole plants. (7) Experiments involving 10 liters or more of culture.
III-E
Experiments that Require IBC Notice Simultaneous with Initiation. Example of experiments are (1)
Experiments involving the formation of rDNA molecules containing less than 2/3 of the genome of any
eukaryotic virus.
Institutional Biosafety Committee (IBC) Protocol Review Form
Page 2
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III-F
Exempt Experiments [Answers required for 1, 2, 3, and 4; signature and date on page 3]. Example of
experiments are (1) Experiments that use rDNA molecules which are not conducted in organisms or
viruses. (2) use of rDNA molecules that consist entirely of DNA segments from a single nonchromosomal
or viral source, one or more segments may be synthetic. (3) rDNA derived entirely from a prokaryotic host
including indigenous plasmids when propagated only in that host or closely related strain. (4) rDNA that
derives entirely from a eukaryotic host including indigenous chloroplasts, mitochondria, plasmids but not
viruses when propagated only in that host or closely related strain. (5) Experiments using only synthesized
small interfering RNA’s (siRNA) to study gene expression.
3.
LIST THE OBJECTIVE(S) OF THIS PROJECT
4.
VECTOR INFORMATION: If multiple vectors are being registered, information for each should be
provided separately indicating clearly which gene(s) will be inserted into each vector.
a.
If the recombinant construct contains viral DNA, does it comprise more than 2/3 of the viral genome?
Yes
No
Name of Vector
b.
Source (give
name of vendor,
collaborator and
or organization)
Host for
Propagation (e.g.
name/strain of
bacteria, yeast)
Cell Line (s) used for
Packaging
Name of Gene
Insert
Gene Insert Information Continued
Name of Gene Insert
c.
Parent
Virus or
Plasmid
Source of Genes
or DNA sequence
(e.g. Human, Rat,
HIV)
Function of Gene
Yes
Viral Vectors Only: Is the vector Replication Incompetent?
If YES
 Is a helper virus required?
Yes
Oncogene
Yes
No
Yes
No
Protein or
Nucleic Acid
Produced
No (proceed to d. below)
No
If YES, specify:

Toxin
Provide a detailed description of all vector packaging systems to be used.
Institutional Biosafety Committee (IBC) Protocol Review Form
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 Provide details of procedures to be used to ensure that the packaged viral vectors will be free of replication
competent viruses (e.g., PCR and culture tests). Be explicit and specific. This information is mandatory, and
must be provided regardless of where the viral vectors are packaged, e.g., at COH or outside COH

d.
If using retroviral vectors, review the policy (http://resadmin.coh.org/doc/ibc1300.doc) for information regarding
testing for RCR. [Note: Lentiviral vectors packaged using a 4 (or more) plasmid system and other murine
based vectors may not need to be screened for RCRs]
For ‘b’ or ‘c’ above, indicate the host range of vectors and any modifications to expand the host range.
Amount of rDNA material produced:
liters.)
e.
small quantity or
large scale quantity (Large scale is defined as > 10
If large scale quantity is to be produced, indicate the amount/quantity:
Will transgenic or gene knock-out animals be utilized in this project?
Yes
No
If YES, provide responses to the following:

Indicate the species and source of these (e.g., name of commercial source).

Specify which gene has been knocked out or will be expressed.

Will a foreign gene be expressed besides a marker for a knock-out gene?
Yes
No
If YES, what will be expressed?
5.
If the project involves in vivo animal work, indicate the IACUC Protocol # 0 . Describe the work to be
done and the procedures to be used to dispose of animal carcasses and contaminated waste:
6.
Does this project involve Human Gene Therapy?
D Yes
No.
If YES, indicate the IRB protocol # 0.
o
For projects involving human gene therapy, copies of the response to "APPENDIX M—Points to Consider" (in
e
NIH Guidelines
for Research Involving Recombinant DNA Molecules), and the COH IRB Protocol and Study
ConsentsForm should be appended.
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Institutional Biosafety Committee (IBC) Protocol Review Form
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7. Does this project involve a high consequence pathogen or toxin?
I have read the list of agents in Appendix B and Appendix C of the City of Hope “High Consequence Pathogens and
Toxins” policy and have determined that:
No, this protocol does not involve any of the listed agent(s).
Yes, this protocol involves a listed agent(s).
a. If YES, it is
attenuated or
b. If YES, list:
c.
8.
non-attenuated
.
If YES, provide information to show that the research with the listed agent(s) does
or does not
produce, aim to produce, or is reasonably anticipated to produce one or more of the experimental effects listed
in Appendix B:
.
The highest containment level project will be conducted
BSL1
BSL2
Are you knowledgeable about the appropriate Biosafety Level for experiments in this project?
Biosafety Level Reference: Biosafety in Microbiologic and Biomedical laboratories
5th
BSL3
Yes
No
Edition.
http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
9.
Identify the location where the recombinant DNA work will be performed, including work with genetically
modified animals.
Project Component
e.g. vector packaging,
cell transduction, etc.
10.
Laboratory
Building – Room Number(s)
Is the above hood vented to the exterior of the building?
Yes
No
Will the work be conducted in a contained, closed room?
Yes
No
Biosafety
Level
Biosafety
Cabinet
Class/Type
List the names of individuals participating in this project. Provide a summary of experience and training
which demonstrates competency to safely perform the work described.
(Category III-E and III-F Experiments need not complete this item.)
Institutional Biosafety Committee (IBC) Protocol Review Form
Page 5
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Your signature below indicates that you acknowledge all requirements and restrictions of the most current
NIH Guidelines for Research Involving Recombinant DNA Molecules for the Biosafety Level you have indicated
above, that you accept responsibility for the safe conduct of the experiments to be conducted at this Biosafety
Level and that you have informed all associated personnel of the conditions required for this work.
Signature
(Principal Investigator)
ibc3200-08/2013.doc
(Date)