COVID-19 Updates New: 11/23/2020 Research Activity Level 4
The University of Vermont (UVM) is committed to minimizing the risks to faculty, staff, students, the public, the facilities, and the environment while using biohazardous materials during research at UVM. The Institutional Biosafety Committee (IBC) is responsible for ensuring that the use of biohazardous materials in research is done safely.
Required Training Through CITI
Active PIs and key personnel as listed on an IBC registration will be required to complete the CITI Program Training.
Post Approval Monitoring
The Institutional Biosafety Committee (IBC) has been working to redesign the IBC protocol review process. It was noted during this work that we needed to formalize a post approval biosafety assessment process. This regulatory requirement is noted in the NIH Guidelines for Research Involving Recombinant DNA Molecules (opens in a new window), and will also be in support of promoting a culture of safety at the University.
To address this need, the Committee has developed and approved a Post Approval Laboratory Biosafety Assessment (PDF) process. The plan is to send a team, comprised of the Biosafety Officer and alternating IBC Committee members, to visit each laboratory by the end of this year. This will provide us an opportunity to conduct a review of our laboratories and to assess our safety practices and compliance with the NIH and IBC.
The primary focus of the assessment process is to assess PPE use and management, educate and advise on biosafety and IBC compliance matters, and address any questions or concerns brought forth by principal investigators. This process is intended to be collegial and interactive, not punitive. If a biosafety or IBC compliance issue is discovered during a visit, the IBC will assist the investigators in addressing the issue.
Specific details will be forwarded separately to affected investigators prior to the commencement of the assessment process. If you have any questions about this biosafety assessment process, please contact IBC@uvm.edu.
Biosafety Assessment Process
Approved by Full IBC June 2017
In order to assist the UVM research community in adopting best laboratory Biosafety practices that help ensure a safe laboratory environment, the UVM Institutional Biosafety Committee has adopted the practice of regularly assessing laboratories associated with an active IBC protocol. Assessments are an opportunity for laboratory personnel to receive guidance on prudent laboratory/Biosafety practices and procedures, ask questions and voice concerns. This process is in addition to regular risk assessments conducted by the UVM Biosafety Officer in support of new protocols and amendments to existing protocols.
Assessment frequency will depend upon the level of risk associated with the laboratory work and the principal investigators history of compliance/non-compliance with IBC policies. In the absence of any IBC related noncompliance, the UVM IBC will adhere to the following assessment schedule:
This schedule includes teaching laboratories.
- BSL-1 laboratories – every 3 years
- BSL-2 laboratories – every 2 years
- BSL-3 laboratories – annually
The assessment team will consist of at least 2 IBC members, including a biosafety representative. The principal investigator and Lab Safety Officer of each laboratory should be present during the assessment process to address questions posed by the assessment team. Investigators will be given 2 weeks prior notice of the visit.
Assessments will include an evaluation/review of biosafety criteria referenced from lab specific IBC related SOPs, UVM Lab Safety Policies, the NIH Guidelines and the Biosafety in Microbiological and Biomedical Laboratories. The assessment checklist is located in appendix A of this document and includes the following sections:
- Biosafety Cabinets
- Personal Protective Equipment
- Safe Practices
- Training Documentation
- Biohazard Communication
- Biological Waste Disposal
Investigators will receive immediate feedback from the visiting IBC team as well as a follow up communication that documents the outcome and any further actions to be taken by the principal investigator and/or laboratory personnel.
You will need to initiate a new Master Protocol Registration (MPR) through the UVMClick – IBC module. This will require that you will fill out the SMARTForms and attach completed Standard Operating Procedures (SOPs) or Biohazardous Agent Reference Documents (BARDs) as needed. The Biosafety Officer review will be initiated by IBC staff once the MPR has been submitted.
Standard Operating Procedures and Biohazardous Agent Reference Documents
(if applicable) A Standard Operating Procedure must be submitted for each biohazardous agent listed in your registration.
|Biohazardous Agent Reference Documents -BARD (opens in a new window)|
The Biohazardous Agent Reference Document (BARD) is a general guidance resource that reviews and summarizes the nature of a pathogen or biotoxin, and offers safety requirements for work with the agent in the laboratory. During the Risk Assessment, the Biosafety Officer may recommend the use of a BARD, however, additional SOP documentation may be required as determined by the risk assessment.
Dual Use Research of Concern
- United States Government Policy (PDF)
- NIH Dual Use Research: A Dialogue
- DURC: Promoting Understanding-Cultivating Responsibility (PDF)
Human Gene Transfer
“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.”
Effective April 27, 2016, UVM Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria. If the project is sponsored, the sponsor is responsible for determining if RAC review is required.
Review and approval of a gene transfer protocol can be complex, therefore we have developed a step-by-step guide for submission of a human gene transfer protocol at UVM/UVMMC.
Federal and UVM Regulations