INSTITUTIONAL BIOSAFETY

COMMITTEE (IBC)

REGISTRATION FOR RESEARCH INVOLVING BIOLOGICAL AGENTS

Administrative Section: (For Administrative use only)

Registration#: / Date Received: / Verified DATE:
Notification / Requiring IBC Review/Approval / Approved DATE:

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. / AGREE

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? / Yes No
If yes, what IACUC protocol # and title corresponds with this IBC protocol?
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 .

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.

Name / Status (F/T Faculty, Principal Investigator, Other / Please describe the responsibilities of each individual

IV. BIOLOGICAL AGENTS

IV.A. 1 Type of agent(s) :
Select all agents that will be used / List each agent name, its origin, biological function, and intended use
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:
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 retro- or 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 / Biosafety Level / Species Affected
Infectious
Non-infectious
Replication Competent
Replication Incompetent / Biosafety Level 1
Biosafety Level 2 or 2+
Biosafety Level 3
Biosafety Level 4
Infectious
Non-infectious
Replication Competent
Replication Incompetent / Biosafety Level 1
Biosafety Level 2 or 2+
Biosafety Level 3
Biosafety Level 4
Infectious
Non-infectious
Replication Competent
Replication Incompetent / Biosafety Level 1
Biosafety Level 2 or 2+
Biosafety Level 3
Biosafety Level 4
Infectious
Non-infectious
Replication Competent
Replication Incompetent / 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.  Overall description of the project, including the objectives and goals.
b.  The source(s) of nucleic acids.
c.  The nature of the inserted DNA sequences (genetic modification).
d.  The host(s) and vector(s) to be used.
e.  Will a deliberate attempt be made to express a foreign gene; if so, indicate the protein that will be 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 / Describe Below:
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.)
IV.E.2 Environmental Protection / Describe below:
Please list all environmental controls to be implemented when handling the proposed agents:
(i.e., Biosafety Cabinet, Fume Hood, ventilation, Filtration, Clean Room, etc.)
IV.F – Disposal
Red Bag Disposal / Yellow Bag Disposal / Radioactive Material Disposal (Contact Radiation Safety Office (516-562-2543) to arrange disposal of all radioactive material and carcasses).
Red Bag – (Biohazard) / Yellow Bag (Chemotherapy Drugs)
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. / 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)470-7427, for removal.

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.

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 Faculty, Principal Investigator, Other / Years of experience with requested biological agents / Describe where training was, or will be, obtained / Date CITI Training completed

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)

IBC Registration Form

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