The Feinstein Institute for Medical Research at Northwell Health requires 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 ensure the safety of the research experiments and to evaluate any potential risk to personnel, public health, and the environment.
INSTRUCTIONS:
PRE-CLINICAL RESEARCH: Submit a completed Risk Assessment/Mitigation form and Standard Operating Procedure (SOP along with your IBC registration. If applicable, Institutional Animal Care and Use Committee (IACUC) approval must be obtained prior to the initiation of biological agent use in animals.
CLINICAL RESEARCH (Human Subject): Submit a completed Risk Assessment/Mitigation form, and SOP along with your IBC registration, Investigator Brochure, sponsor’s protocol including informed consents. IRB approval must be obtained prior to the initiation of biological agent use in humans.
REQUIREMENTS PRIOR TO SUBMISSION OF AN IBC REGISTRATION:
- RISK ASSESSMENT/MITIGATION: Complete a Risk Assessment/Mitigation form in consultation with the Biosafety Officer (BSO) prior to submission.
- Standard Operating Procedure (SOP):
SOP outlining proper work practice with biological agent must be developed. Contact BSO for Pre-Clinical Research BSL-2 SOP template.
- MEDICAL SURVEILLANCE: Contact Employee Health Services (EHS) to enroll in the medical surveillance program. All research personnel participating in biological agent researchmust enroll in the Medical Surveillance Program and obtain clearance from EHS.
Contact Employee Health Services to enroll at: .
In the subject line of the email state: Research Study
In body of the email provide: Last Name, First Name, Contact Number, Title of Research Study
- TRAINING: All applicable training must be completed for all individuals listed on this registration prior to submission. Training requirements contained within the risk assessment form. Regulatory training is administered through Collaborative Institutional Training Initiative (CITI)
Double click on boxes within the registration form to activate check box options.
REFERENCE MATERIAL:
· Recombinant or synthetic nucleic acid molecules, per the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules: 2016
· Microorganisms (Biosafety in Microbiological and Biomedical Laboratories; 5th Edition, NIH Guidelines) Examples: bacterium, fungus, parasite, virus, etc.
· Select Agents and Toxins (7 C.F.R. Part 331, 9 C.F.R. Part 121, 42 C.F.R. Part 73)
· Potential “Dual-Use” Technology (United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern: Sept. 24, 2014)
ADMINISTRATIVE USE ONLY:
Registration#: / Date Received:Requires IBC Review / Pre-Clinical Clinical
Date IBC Review: / Date Approved:
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:
I.E. Funding Source(s): Please list all sources funding this project
Who is sponsoring the study?
Grant Industry Private Funds Other: specify
Award # / Project Title / Agency/Sponsor / Project Period
I.F. Principal Investigator Contact Information:
Office Phone:
Email:
Cell or Alternate #:
I.G. Alternate Contact Information: (PI Designee and/or Study Coordinator authorized to make decisions regarding this registration)
Name (degree, MD, PhD, DVM, RN, NP other):
Office Phone:
Email:
Cell or Alternate #:
PRINCIPAL INVESTIGATOR ATTESTATION
I AND all persons working and/or performing research in my laboratory are 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. Will any biological agents be used in animals? / Yes No
If yes, what IACUC protocol # and title corresponds with this IBC registration?
Note: If you do not have IACUC approval, please contact the IACUC Office for information or assistance at .
II.C. Will any biological agents be used in humans? / Yes No
If yes, what IRB protocol # and title corresponds with this IBC registration?
I understand I must obtain institutional approval from the Human Research Protection Program (HRPP) prior to the initiation of the use of the biological agents in humans outlined in this registration. / Agree
III. BIOLOGICAL AGENTS
III.A. TYPE OF AGENT(S):
Select all agents that will be used / List each agent name, its origin, biological function, and intended use / Total Quantity
on site
Recombinant or Synthetic Nucleic Acid Molecule
Microorganism
(bacteria, yeast/fungi, virus, parasites, carriers/ticks, mosquitoes, etc.)
Transgenic animals
Xenotransplantation (Clinical therapeutic research only)
Select Agents and Toxins
Other Biological Toxin
Dual Use Research of Concern (DURC)
III.B. RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES
If you are requesting the use of any agents that fall under 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
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
III.C. VIRAL VECTOR INFORMATION
Vector type:
Vector source (strain, backbone, etc.)
Vendor source & catalog number (append product information)
Gene(s) expressed
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)
III.D. 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. PROJECT INFORMATION:
- Submit Risk Assessment and SOP along with this Registration Form.
- Append available SDS and relevant material description of each agent and investigator brochure, if applicable.
- If agents will be used in either humans or animals please ensure congruence with the corresponding IRB or IACUC protocol.
a. Provide a brief description of the research project(s) associated with the use of the biological agents described in this registration. Sufficient information must be provided for the IBC to understand the general scope of the work.
b. As the PI, please provide information regarding your direct experience handling, transporting, and manipulating the agents listed in this registration. If you will not be directly handling the material, describe your role.
V. PERSONNEL
Principal Investigator and all individuals handling the material described in this registration must be listed below. Before engaging in the work described, personnel must be trained (as part of the risk assessment) in the safe handling and manipulation of biological material.
Name, Degree, Status (PI, faculty, Research Assistant, Technician) etc. / Please describe the responsibilities of each individual involving biological agent(s)
STATEMENT OF PRINCIPAL INVESTIGATOR
▪ I attest that the information contained in this registration 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 Employee Health Services.
▪ Written reports will be submitted to the Biosafety Officer 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: