Lab Research Requiring IBC Approval
Investigators involved in research carried out in a laboratory at Weill Cornell Medicine must obtain IBC approval prior to working with:
- Recombinant or synthetic nucleic acid molecules,
- Biological agents classified as Risk Group 2, 3, and 4 in the NIH Guidelines
- Research involving select agents as listed by the USDA/CDC
How to Register Laboratory Research
WCM Laboratory Safety Policy requires Principal Investigators to register their laboratories with Environmental Health and Safety (EHS) and obtain applicable committee approvals (Laboratory Safety Registration) prior to initiating research.
The Institutional Biosafety Committee’s (IBC) focus is on biological and biohazards identified in the registration.
The IBC submission and review process takes place in the Research Safety module within the Weill Research Gateway (also known as WRG-RS).
- To initiate a new IBC-LR contact Environmental Health and Safety at ehs@med.cornell.edu or (646) 962-7233.
- To amend previously approved IBC-LR contact the ibc@med.cornell.edu or your designated EHS Safety Advisor (SA) to assist with the amendment process.
- The IBC-LR renewal process will be initiated by the IBC office. Sixty days before the expiration date, the Principal Investigator and/or designated representative will be notified to review renewal form of the IBC-LR within the WRG-RS.
Note: Designated representative (e.g. Laboratory Coordinator/Manager) can review and edit the IBC- LR however only the Principal Investigator can officially route the registration to the IBC.
All IBC Laboratory Registration approval and expiration dates are based on geographic location of the Principal Investigator’s laboratory and will stand approved for a period of up to two years. IBC approval must be received prior to the commencement of the research project.
IBC approval is contingent upon adherence to the EHS Research Biosafety Manual and IBC Incident Reporting Policy, which specifies that incidents involving biohazards, recombinant nucleic acid and select agent research that involves WCM laboratory personnel must be reported to the WCM IBC and Environmental Health and Safety consistent with policy.
Specific recommendations on biosafety practices and information on biosafety level criteria can be found in the WCM Research Biosafety Manual, Appendix G of the NIH Guidelines, and in the CDC's Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition
If the research involves the introduction of recombinant or synthetic nucleic acid molecules or biological agents into an animal model then an Animal Biosafety Level (ABSL) for containment of the agent must assigned by the IBC. IBC approval is required before Institutional Animal Care and Use Committee (IACUC) approval will be provided for animal research involving the above mentioned agents.
WCM investigators who intend to perform research involving human embryonic stem cells must submit notification to the Tri-Institutional ESCRO Committee. This requirement applies to all HESC research, regardless of the funding sources.
For more information on Tri-Institutional ESCRO, visit the Human Embryonic Stem Cell Research website.
Laboratory Training
Investigators including graduate students, medical students, principal investigators, physicians, post-doctoral fellows, and lab technicians are required to complete laboratory safety training on an annual basis (365 days) under OSHA regulations.
All investigators working with, recombinant or synthetic nucleic acid molecules both exempt and non-exempt, are required to use appropriate facilities, train laboratory personnel, and be in compliance with NIH and WCM Institutional policies.
The Principal Investigator is ultimately responsible for the registration, training, safe handling of research materials handled by their personnel at the approved Biosafety Level.
Vector Biosafety Training is available by contacting EHS and requesting an in-service session for you or your laboratory.
Laboratory Links
SARS-CoV-2 and IBC requirements under the NIH Guidelines
Biosafety Considerations for Contained Research Involving Gene Drive Modified Organisms
The Major Actions under the NIH Guidelines
Investigator Responsibilities under the NIH Guidelines
Animal Experiments under the NIH Guidelines
Dual Use Research of Concern (DURC)
Updates on Federal Biosafety and Biosecurity Policy
Laboratory Resources
Biosafety in Microbiological and Biomedical Laboratories (BMBL 6th Edition)
Bloodborne Pathogen Information (OSHA)
WHO Laboratory Biosafety Manual 4th Edition (2020)
Pathogen Safety Data Sheets and Risk Assessment
IBC Laboratory FAQs
Do I need to complete the “Short Form” as a part of my grant application?
No. Laboratory Safety Registration “Short Form” previously completed by Gant Applicants as a part of grant submission via Electronic Routing Form (ERF) is no longer used because Grant and contract submissions and review process takes place in the Sponsored Programs module within the Weill Research Gateway (also known as WRG-SP).
Why do I have to complete a Laboratory Safety Registration (LSR)?
A Laboratory Safety Registration is required for all PI’s conducting research and/or laboratory work conducted at WCM-owned and/or WCM-leased laboratory spaces.
Can I start my research prior to completing Laboratory Safety Registration (LSR) and obtaining applicable committee approvals?
No. Failure to submit Laboratory Safety Registration or obtain approval, before commencement of the research may cause violation of WCM institutional policies and research non-compliance.
Do I have to submit a Laboratory Safety Registration if I am not applying for grants?
Yes. A Laboratory Safety Registration is required for all PI’s conducting research and/or laboratory work conducted at WCM-owned and/or WCM-leased laboratory spaces. At WCM, the Laboratory Safety Registration is not based on particular grant, project, contract, or cooperative agreement. Rather it is based on all the characteristics of the research performed in the lab by the Principal Investigators and theirs research fellows/lab members.
I receive no funding from NIH. Do I have to register my recombinant DNA protocol?
Yes. Since the WCM receives funding from NIH grants, ALL recombinant DNA research conducted at the WCM has to comply with the NIH Guidelines and institutional policies. All recombinant DNA research must be reviewed by the IBC.
Do I need to submit a Laboratory Safety Registration every time I submit a grant application?
No. If your research (set of experiments) described in your new grant is alreday included under your IBC approved registration.
Yes. If your research (set of experiments) described in your new grant is not included under your IBC approved registration.
In this case your IBC Laboratory Registration must be amended. Contact your lab Safety Advisor (SA) at (646) 962-7233 or the IBC at ibc@med.cornell.edu to initiate the amendment.
I am a WCM Research Associate, Instructor, Post-doc or Student submitting my own grant proposal. Do I need my own Laboratory Safety Registration?
No. Grant Applicants e.g., WCM Research Associates, Instructors, Post-docs or Students working under the supervision of a PI or in a PI's laboratory must refer to PI’s approved Laboratory Safety Registration. The PI/ Lab manager must confirm that your grant work and all of your research activities are represented in the labs approved Laboratory Safety Registration and if necessary amend current Laboratory Safety Registration.
To amend current IBC-LR please contact your EHS Safety Advisor (SA) or the IBC at (646) 962-7233 or via email at ibc@med.cornell.edu.
Who reviews/approves the Laboratory Safety Registration?
Environmental Health and Safety in collaboration with the IBC and Radiation Safety Committee (RSC) (if applicable to your research) reviews the Laboratory Safety Registration. The review consists of assessing, biological safety, chemical safety, radiation safety, fire safety and hazardous waste management.
How long does the EHS/IBC/RSC review process take?
A typical review takes up to four weeks to be completed and will require an inspection of the laboratory spaces covered under the Laboratory Safety Registration.
Who can I call for help in completing the Laboratory Safety Registration?
Contact your SA or Environmental Health and Safety for assistance or questions regarding the Laboratory Safety Registration at (646) 962-723 or at ehs@med.comell.edu.
For technical support contact with the WRG please contact the WRG Support Team at WRG-Support@med.cornell.edu
How do I find out the status of my Laboratory Safety Registration?
To check the status Laboratory Safety Registration, log in to WRG-RS click “Search for Items” button, Select criteria, check “Research Safety”, select “Record Owner” and type the last name of the Principal Investigator next click “Search” button you should see the Type of Laboratory Registration: EHS Registration = Research Safety Checklist, IBC Registration = Institutional Biosafety Committee Registration and status of each record e.g., Approved, Under Review, Closed.
If uncertain contact Environmental Health and Safety at ehs@med.cornell.edu or (646) 962-7233 to verify status of your Laboratory Safety Registration.
Who must sign the Laboratory Safety Registration?
Only the PI whose name is listed on the Laboratory Safety Registration can sign and route the registration for review to the IBC.
How do I get access as a lab coordinator/manager in WRG?
To receive access to the WRG-RS (Research Safety) module, a Department Administrator (DA) will need to complete and submit the WRG Departmental Access Request Form. Instructions are available here.
I share a lab with an investigator who has an approved Laboratory Safety Registration, does their registration apply to my work in the shared lab?
Yes. If you are listed under the LABORATORY ROSTER, your research (set of experiments) is covered under the IBC approved registration and your Laboratory Safety Training is up to date.
No. If your research (set of experiments) are not covered under the IBC approved registration or if you are not listed under the LABORATORY ROSTER.
In this case the IBC Laboratory Registration must be amended, and ROSTER updated. Contact your lab Safety Advisor (SA) at (646) 962-7233 or the IBC at ibc@med.cornell.edu to initiate the amendment.
How do I find my record or record status in WRG-RS?
To check the status Laboratory Safety Registration, log in to WRG-RS click “Search for Items” button, Select criteria, check “Research Safety”, select “Record Owner” and type the last name of the Principal Investigator next click “Search” button you should see the Type of Laboratory Registration: EHS Registration = Research Safety Checklist, IBC Registration = Institutional Biosafety Committee Registration and status of each record e.g., Approved, Under Review, Closed.
My lab work is deemed by the IBC as “No IBC Applicable Work” or “Exempt Work” do I and my lab personnel need to complete the Laboratory Safety training on an annual basis?
Yes. All investigators working in the WCM-owned and/or WCM-leased laboratory spaces (excluding dry or computational laboratories), are required to complete Laboratory Safety training on an annual basis.
What type of research must be registered with the IBC?
Research involving:
- Recombinant or synthetic nucleic acid molecules,
- Biological agents classified as Risk Group 2, 3, and 4 in the NIH Guidelines
- Select agents as listed by the USDA/CDC, must be registered with the IBC
- Human gene transfer research and, clinical trials involving the use of biological products in human subjects.
How do you add agents to a previously existing IBC registration eform?
To update an approved IBC registration within WRG-RS, please contact your EHS Safety Advisor and provide the type of agent and description of work that will be done. Depending on this information, an amendment may be created for immediate update or the addition can be made during the next lab registration renewal.
What is the Risk Group (RG) Classification for SARS-CoV-2 under the NIH Guidelines?
In Appendix B-II-D of the NIH Guidelines (April 2019), coronaviruses other than SARS-associated coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) are classified as RG2 agents. SARS-CoV and MERS-CoV are listed as RG3 agents. This classification reflected the state of knowledge prior to the emergence of the novel coronavirus SARS-CoV-2, and the Appendix is intended to serve as a resource and is not meant to be all-inclusive.
Table 1 in Appendix B of the NIH Guidelines provides the basis for the classification of biohazardous agents by RG. RG3 agents are those that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
At the present time, SARS-CoV-2 best meets the definition of a RG3 agent and Institutional Biosafety Committees (IBCs) should consider the agent to be RG3 as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines.
The RG classification may change over time as additional information about the virus, such as potential treatments or the development of an effective vaccine, becomes available.
What is the appropriate Biosafety Level (BL) for handling SARS-CoV-2?
The Centers for Disease Control and Prevention (CDC) has issued Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). Laboratories working with SARS-CoV-2 should adhere to this guidance. IBCs may stipulate additional biosafety precautions based on their risk assessment of the specific modifications to and manipulations of the agent. At this time, IBCs should consider the agent to be RG3 as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines.
What is the procedure for drawing blood within a lab and its lab members?
The following conditions must be met to draw blood in a lab:
Safety First:
- Review and follow best practices in phlebotomy as detailed in the WHO Phlebotomy Guide (2010).
- Review the Weill Cornell Bloodborne Pathogen Exposure Control Plan
Regulatory Requirements:
- The collection of blood samples for research purposes is a common practice. In all cases, justification for the volume selected should be included in the IRB protocol and Informed Consent Form (ICF).
- Blood draw must be done by a licensed health care professional (e.g., phlebotomist)
Warning:
There is a real concern for working with your own cells in a research laboratory setting:“No-one should work with their own blood samples if the intention is to transform lymphocytes. In the event of an accidental exposure, the immune system will not challenge these transformed cells. Similarly, individuals should not work with the blood of colleagues with whom they share work space.”