Yale EHS biosafety registrations are also designed to help PIs detail key risk information. All new PIs must contact the Yale EHS Biosafety Office before or upon arrival to Yale to activate their access to the Principal Profile registration.
The Principal Profile in EHS Integrator, once completed, will trigger the required regulatory registrations.
- Biogeneral Registration
- Request to Use Infectious Agents
- Research with Recombinant or Synthetic Nucleic Acid (r/sNA) Molecules
- Human Gene Transfer (HGT) Research
- Poliovirus Survey
- Dual Use Research of Concern (DURC)
- High Speed Cell Sorters Acquisition and Use
Biogeneral: A set of core questions to determine which additional regulated registrations may be needed.
Request to Use Infectious Agents: Required for those labs proposing research with human pathogens at Yale. Work with human pathogens may not be started until approval is granted by the State of Connecticut Department of Pulbic Health, the Yale Biological Safety Committee, and the Yale EHS Biosafety Office.
Principal Investigators planning research with animal and/or plant pathogens can also fill out this form as these biohazards must also be registered with Yale EHS.
Research with Recombinant or Synthetic Nucleic Acid (r/sNA) Molecules: All non-exempt r/sNA research must be reegistered and reviewed by the Biological Safety Committee. Non-exempt r/sNA research may not start until the PI receives a written approval letter from the Committee.
PIs are advised to include all of their r/sNA research on their registration forms, including exempt and non-exempt work. Yale EHS and the Committee will confirm the exempt or non-exempt status of your research. The following help documents are provided to summarize the NIH Guidelines for Yale PIs. \
Recombinant/Synthetic Nucleic Acid Molucules Research Guidance
- RDNA Animal Experiments Covered Under the NIH Guidelines
- Recombinant DNA Experiments Registration and Approval Guidelines
- Research Involving Recombinant or Synthetic Nucleic Acid (R/SNA) Molecules
- Risk Groups and Biosafety Levels for Research Involving Recombinant and Synthetic Nucleic Acid (R/SNA) Molecules
- Table of Experiments Described in the NIH Guidelines by Section and Example
- Protocol Tracing for Institutional Biosafety Committee (IBC) Protocols*
*This document illustrates all of the steps that are involved from the initiation of a research project until it is approved, including any required follow up. Your EHS registration documents help you complete all of your requirements, but this document provides you with a broad spectrum overview of the life of a research protocol. Please contact your Safety Advisor if you have any questions regarding the protocol tracing pathway.
Human Gene Transfer Registration: Complete this registration form for any clinical research involving r/sNA. Submit the completed registration to the Yale EHS Biosafety Office. All HGT clinical trials must be approved by the Yale Biological Safety Committee before initiation.
Poliovirus Survey: Yale must document the presence or absence of poliovirus and related potentially infectious poliovirus materials.
Dual Use Research of Concern (DURC): DURC is currently limited to 15 agents listed in the Yale Policy for Life Sciences Dual Use Research of Concern. The only one of the 15 agents currently in use at Yale is Botulinum toxin. The DURC policy applies to any clinical, animal or laboratory research that involves Botulinum toxin or the other DURC agents. Such research must be registered with and approved by the Yale Biological Safety Committee serving as Yale’s Institutional Review Entity.
High Speed Cell Sorters Acquisition and Use: Yale EHS must approve the purchase of high speed cell sorters due to the significant potential hazards associated with a clog or deflection during use with biohazards. A massive amount of aerosols are created with the potential for release to the laboratory under these situations. The EHS Biosafety Office will inspect the proposed cell sorting use location and the aerosol managements system that will be used for aerosol containment. More information can be found on EHS’s Cell Sorting/Flow Cytometry page.