INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
REGISTRATION FOR RESEARCH INVOLVING BIOLOGICAL AGENTS
Administrative Section: (For Administrative use only)
Registration#:
Date Received:
Verified
DATE:
Notification
Approved
DATE:
Requiring IBC
Review/Approval
I. PRINCIPAL INVESTIGATOR
I.A. Principal Investigator (Include degree, MD, PhD, DVM, other):
I.B. Status (F/T Faculty, Investigator, Assistant Investigator, Associate Investigator, other):
I.C. Department/Lab or Center of Excellence:
I.D. Site of Study (Feinstein, LIJ, other):
I.E. Contact Information:
Office Phone:
Email:
Cell or Alternate #:
I.E. Alternate Contact Information: (authorized to make decisions regarding this registration)
Name (include degree, MD, PhD, DVM, other)
Office Phone:
Email:
Cell or Alternate #:
PI Attestation
I AND all persons working and/or performing
research in my laboratory, are or will be,
trained in the proper handling of all biological
agents, including the proper use of all safety
and bio-containment equipment, PRIOR to
the initiation of any experiments.
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AGREE
INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
II. PROJECT DESCRIPTION
II.A. Project Title:
II.B. Funding Sources: Please list all funding sources being used to support this project
Award #
Grant Title
Agency
Project Period
II.C. Is this an Original Submission or Revised as per IBC recommendation?
Original submission
Revised per IBC recommendations
II.D. Will any biological agents be used in animals?
If yes, what IACUC protocol # and title corresponds with this IBC protocol?
Yes
No
What species will be used?
What agent(s) will be used?
Note: If you do not have IACUC approval, please submit an Animal Use Protocol Application.
For information or assistance, contact Michelle Aparicio at 516-562-1274 or email at iacuc@nshs.edu.
III. PERSONNEL Principal Investigator and all individuals working on this project must be listed below.
Before engaging in this work, they must be trained in the safe manipulation of all requested biological
agents.
Status (F/T
Faculty,
Name
Principal
Please describe the responsibilities of each individual
Investigator,
Other
IV. BIOLOGICAL AGENTS
IV.A. 1 Type of agent(s) :
Select all agents that will be used
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List each agent name, its origin, biological function, and
intended use
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INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
Recombinant or Synthetic Nucleic
Acid Molecule (see IV.A.2)
Microorganism
(bacteria, yeast, virus, etc.)
(for virus, complete section IV.A.3)
Human / nonhuman primate
blood, fluid or tissue
Human / nonhuman primate cell
lines or primary cells
Transgenic animals
Wild Animal blood, fluid or tissue
Select Agent/ Bio toxin
Dual Use Technology
IV.A.2 Recombinant or Synthetic Nucleic Acid Molecules
If you are requesting the use of any agents that fall under the purview of the NIH Guidelines for Research
Involving Recombinant or Synthetic Nucleic Acid Molecules, Please specify under what section the
research falls.
NIH Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules: 2013
Section III-A. Experiments that Require Institutional Biosafety Committee Approval, RAC Review,
and NIH Director Approval Before Initiation
Section III-B. Experiments That Require NIH/OBA and Institutional Biosafety Committee
Approval Before Initiation
Section III-C. Experiments that Require Institutional Biosafety Committee and Institutional
Review Board Approvals and RAC Review Before Research Participant Enrollment
Section III-D. Experiments that Require Institutional Biosafety Committee Approval Before
Initiation
Section III-E. Experiments that Require Institutional Biosafety Committee Notice Simultaneous
with Initiation
Section III-F. Exempt Experiments
IV.A.3. Viral Vector Information (Vector Description: specify vectors, transgenes, helper viruses, etc.)
Vector type:
Vector source (strain,
backbone, etc)
Vendor source &
catalog number
Gene(s) expressed
Infectious particles
produced
Is the vector
replication defective?
Vector Packaging: will you be using packaging cell line and/or helper plasmid? If yes, then complete:
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INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
Name of packaging cell
line(s), helper virus or
plasmid
Source(s) of cells
Tropism (list of species
virus infects)
Source of envelope
glycoprotein (if retroor lentivirus)
Have the vector(s)
previously passed
through animals or cell
lines? Describe.
Will the construct be
introduced to animals,
cells or both? Describe.
IV.B. Agent to be used: List all applicable agents
Agent
Select all that apply
Infectious
Non-infectious
Replication Competent
Replication Incompetent
Infectious
Non-infectious
Replication Competent
Replication Incompetent
Infectious
Non-infectious
Replication Competent
Replication Incompetent
Infectious
Non-infectious
Replication Competent
Replication Incompetent
Biosafety Level
Species Affected
Biosafety Level 1
Biosafety Level 2 or 2+
Biosafety Level 3
Biosafety Level 4
Biosafety Level 1
Biosafety Level 2 or 2+
Biosafety Level 3
Biosafety Level 4
Biosafety Level 1
Biosafety Level 2 or 2+
Biosafety Level 3
Biosafety Level 4
Biosafety Level 1
Biosafety Level 2 or 2+
Biosafety Level 3
Biosafety Level 4
IV.C. PROJECT INFORMATION: Provide a brief description of the research project(s) involving
biohazardous agents and/or recombinant/synthetic nucleic acid (rDNA) material(s) by addressing each
point. Sufficient information must be provided for the IBC to understand the general scope of the work.
a.
b.
c.
d.
e.
Overall description of the project, including the objectives and goals.
The source(s) of nucleic acids.
The nature of the inserted DNA sequences (genetic modification).
The host(s) and vector(s) to be used.
Will a deliberate attempt be made to express a foreign gene; if so, indicate the protein that will be
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INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
produced.
f. Other organisms and /or animals, if any, that will be associated with the genetically modified agent(s).
g. Describe how materials will be prepared, used (including routes of administration, quantities, duration of
use, treatment, etc.) and how excess material and waste will be handled and discarded.
h. Provide information regarding your direct experience handling/transporting/manipulating each of the
agents listed in this project. Include information regarding the use of the agents with the containment
practices and experimental protocols described. If you do not have experience with any of the listed
agents and/or procedures, please explain who will provide the training.
IV.D. Physical location of proposed experiments and agent storage: List all locations
Address
Room #
Experiments proposed for this site
IV.E.1 Personal Protection
Please list all personal protective equipment
(PPE) required for use with the proposed
agents:
(e.g., Isolation Gown, Gloves, Mask, Goggles,
Shoe Covers, Respirator, etc.)
Describe Below:
IV.E.2 Environmental Protection
Please list all environmental controls to be
implemented when handling the proposed
agents:
(i.e., Biosafety Cabinet, Fume Hood,
ventilation, Filtration, Clean Room, etc.)
Describe below:
IV.F – Disposal
Red Bag Disposal
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Yellow Bag Disposal
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Radioactive Material Disposal (Contact
Radiation Safety Office (516-562-2543) to
arrange disposal of all radioactive material
and carcasses).
INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
Red Bag – (Biohazard)
Includes animal carcasses, bedding from
animals treated with, any agent (biological,
chemical, unknown, proprietary substance,
etc.). Contaminated disposables (i.e. tubes),
gloves, paper, gowns, etc. with trace quantities
of agents. Excludes CHEMOTHERAPEUTIC
DRUGS.
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Yellow Bag (Chemotherapy Drugs)
Chemotherapeutic Drug Waste ONLY. Contaminated
bedding, gloves, paper, gowns, etc. with trace
quantities of chemotherapeutic drugs. At the end of
the day, all bags must be labeled “CHEMO WASTE”
and the investigators must contact: Environmental
Services (at NSUH (516) 562–2160 and at LIJ (718)4707427, for removal.
INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
STATEMENT OF PRINCIPAL INVESTIGATOR
▪
I attest that the information contained in this application concerning research involving
the use of biological agents is accurate and complete.
▪
I attest that I have read, understand and will comply with the NIH Guidelines for
research involving recombinant or synthetic nucleic acid molecules.
▪
I am familiar with and agree to comply with the current Federal, State, Local and
Institutional regulations and policies.
▪
I am familiar with and I agree to comply with the requirements pertaining to shipment
and transfer of all biological agents requested herein.
▪
I am familiar with the policies and procedures for safe storage, handling, utilization,
shipment and disposal of all requested biological agents. I will conduct my research in
conformance with these regulations, policies and principles.
▪
I will seek and obtain approval for this registration prior to initiation, and will report
promptly to the Institutional Biosafety Committee any unanticipated deviation from the
protocol described herein. Any unusual illnesses or reactions of any personnel engaged in this
research will be immediately reported to the IBC.
▪
Written reports will be submitted to the Institutional Biosafety Committee concerning:
1. Any accident or illness as the result of inoculation, ingestion, and inhalation of biological
agents; any incident causing serious exposure of personnel or danger of environmental
contamination.
2. Any problems pertaining to operation and implementation of biological and physical
containment safety procedures or equipment or facility failure.
Signature of Principal Investigator
Date:
The Feinstein Institute for Medical Research and Federal regulations require that all research
involving biological agents be reviewed and approved by the Institutional Biosafety Committee
(IBC) which has been structured in accordance with Federal Regulations. This Committee has
been mandated to assure the safety of the research experiments and to evaluate any potential
risk to personnel, public health, and the environment.
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INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
Appendix A: TRAINING RECORD
I.A. IBC Registration Number and Title
Number:
Title:
I.B. Department/Lab or Center of Excellence:
Chair or Head:
I.C. Site of Study (Feinstein, LIJ, other):
I.D. Principal Investigator (PI) and Authorized Alternate (AA) Contact Information:
PI
AA
Name:
Name:
Office Phone:
Office Phone:
Email:
Email:
Cell or Alternate #:
Cell or Alternate #:
I.E. Personnel: Please provide enough information for a determination of competency
Name
Status (F/T
Years of
Describe where
Date CITI Training
Faculty, Principal experience
training was, or
completed
Investigator,
with
will be, obtained
Other
requested
biological
agents
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INSTITUTIONAL BIOSAFETY
COMMITTEE (IBC)
APPENDIX B: Reference Material
Reference Material:

Recombinant or synthetic nucleic acid molecules, per the NIH Guidelines For Research
Involving Recombinant or Synthetic Nucleic Acid Molecules: 2013

Microorganisms (Biosafety in Microbiological and Biomedical Laboratories; 5th Edition,
NIH Guidelines) Examples: bacterium, fungus, parasite, virus, etc.

Human blood, fluid, tissue samples, human and non-human primate derived cell lines
(OSHA Bloodborne Pathogens, 29 C.F.R. Part 1910)

Select Agents and Toxins (7 C.F.R. Part 331, 9 C.F.R. Part 121, 42 C.F.R. Part 73)

Any biological toxin (Biological toxins are toxic substances produced by microorganisms,
animals, and plants that have the capability of causing harmful effects when inhaled,
ingested, injected or absorbed.)

Potential “Dual-Use” Technology (United States Government Policy for Institutional
Oversight of Life Sciences Dual Use Research of Concern: Sept. 24, 2014)
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