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.

IBC Training

Biosafety Research Training (IBC)

  • As of November 1st, CITI training will replace current online biosafety trainings located on the Environmental, Health and Safety (EH&S) website.
    • Note 1:  This change in the online training does not affect the requirement for all key personnel working with BSL-2 to attend classroom training as provided by the ESF Safety Class Signup page.
    • Note 2:  EH&S, in some instances, requires that OSHA Blood Borne Pathogen training be completed on an annual basis.  A blood borne pathogen module has been included in the list of optional CITI modules.  Please be sure to check with EH&S at safety@uvm.edu to see if this is a requirement for you.
  • Active PIs and key personnel as listed on IBC protocols will be required to complete the CITI training within the next six months.   Log into CITI using the instructions found on our CITI Program Training page. 
  • The training includes modules specific to biosafety levels.  Personnel working on BSL-1 protocols must complete the BSL-1 Basic Course and personnel working on BSL-2 protocols must complete the BSL-2 Basic Course AS WELL as the classroom training.
    • Note:  While it is not required, the Committee encourages PIs and key personnel to complete the higher level BSL-2 training as it is a more comprehensive training including all BSL-1 information.  
  • If you have an associated IACUC protocol, you will also be required to complete the new CITI IACUC training.
  • Refresher training is now required to be completed every 3 years.  Reminders of this requirement will be forwarded as your training nears expiration.

Policy Statement:

The UVM Laboratory Health and Safety Policy states that  "The University of Vermont is committed to providing a healthy and safe working and learning environment, and to supporting environmentally sound practices in the conduct of University activities. It is University policy to comply with all applicable regulations and requirements related to research and teaching in laboratories. All University activities are to be conducted in a manner that ensures the protection of students, faculty, staff, visitors and the environment."

In support of this policy, the IBC Researcher Manual Section 7.A. Proper Training and Oversight of the Research Team states:

"The principal investigator is responsible for ensuring that the research team has appropriate training prior to and during the conduct of the study...

Faculty members, principal investigators and others responsible for directly, or indirectly, supervising labs will support and encourage a culture of safety and the use of best practices in laboratory protocols and procedures. This includes communicating safety and health as a core value, understanding the risks and requirements associated with the laboratories they oversee, assuring that appropriate precautions are taken against hazards and unsafe practices, that proper personal protective equipment is made available to all personnel, that workplace equipment and machinery is routinely maintained, that required medical surveillance of impacted employees is conducted, that regular safety inspections are performed and documented, and that students and employees receive job and hazard-specific safety training. (NOTE: This excerpt is taken from the UVM Laboratory Health and Safety Policy)

If laboratory work requires a containment level of BSL-2 or greater, the PI needs to ensure that key personnel have completed the IBC required “Biosafety for Work at BSL-2 Containment” in-class training (NOTE: The IBC Committee will not approve key personnel until this requirement has been met.)

IBC Submission Guide

Initial Submission - Full, Simultaneous, Exempt, Designated or Identical

Full Review

For projects requiring full IBC review (non-exempt biohazardous materials in a risk category greater than or equal to Risk Group 2, the researcher must complete a Protocol Form, as well as develop a Standard Operating Procedure for any biohazardous agents or toxins when applicable, and submit to the IBC Committee for review. 

  • The IBC may take one or more of the following actions:
    • Approve the project without modification.
    • Approve the project subject to stipulations and/or minor modifications.
    • Table the decision pending additional information.
    • Disapprove the project.
  • The researcher may not initiate the project until IBC approval is given.
  • For protocols utilizing recombinant or synthetic nucleic acids, infectious agents or biological toxins complete the following forms and submit as in pdf format to ibc@uvm.edu.

Simultaneous Review

  • Those projects determined to have  BSL1 containment may be initiated prior to approval.
  • The determination that the research fits within the “review simultaneous” category will be made by the Biological Safety Officer and the Chair. 
  • The researcher will receive a memo stating that activity may begin.  The project will be placed on the next available agenda for full IBC review.
  • The researcher may be asked for further clarifications after the full review and the IBC may take one or more of the following actions:
    • Approve the project without modification.
    • Approve the project subject to stipulations and/or minor modifications.
    • Table the decision pending additional information.
    • Disapprove the project.
  • For protocols utilizing recombinant DNA only, infectious agents or toxins complete the following forms and submit as a PDF to ibc@uvm.edu.

Exempt Review

  • According to federal regulations, IBC review is not required for certain categories of research activities that involve little or no risk to human subjects. 
  • However, the University has an obligation to be apprised of all potentially biohazardous materials being used under its auspices in the event any questions or problems arise and in order to assure that, regardless of risk, all University personnel as well as the environment are protected.
  • Therefore, these projects must be registered with the IBC by the submission of protocols.
  • Exempt experiments, as defined by the NIH Guidelines, found in Section III-F of the guidelines, will be determined by the Biological Safety Officer and confirmed by the Chair, or designee. 
  • The Chair or designee may request a review by the full IBC if there is question regarding the project’s status. 
  • Exempt protocols will not be subject to further IBC review. 
  • Note that any revisions to the research affecting the biosafety level may affect the determination of exemption and therefore must be prospectively submitted for review to confirm the status.
  • For protocols utilizing recombinant DNA, infectious agents or toxins complete the following forms and submit as a PDF to ibc@uvm.edu.

Designated Review - Projects deemed Equivalent to a Previously Approved Project

  • The IBC may determine that a proposed project is equivalent to a project that has been previously approved.
  • The Chair and Biosafety Officer make this decision.
  • There can be no substantive differences since the previous project that would change the biosafety and public health considerations. 
  • Designated protocols will be posted for IBC Member review for 5 business days.  Approval will be granted afterwards if no concerns are brought forward.

Forms Needed for Initial Submission Review

 

Additional Review Requirements

Animal Research with Biohazards

  • Any projects proposing to utilize vertebrate animals requires review and approval from the Institutional Animal Care and Use Committee (IACUC).
  • All protocols utilizing animals must have UVM veterinary review prior to submission.  Contact the Office of Animal Care Management for assistance.
  • The IACUC is charged with reviewing all research projects and activities involving vertebrate animals to assure the humane care and use of animals in activities related to research, testing and teaching.
  • If your project utilizes vertebrate animals, you must have approval from both committees (IBC and IACUC) prior to beginning the project.

Human Subject Research with Biohazards

  • Any projects proposing to include human subjects, requires review and approval from the Institutional Review Board (IRB).
  • The IRB is charged with reviewing all research projects and activities involving human subjects to assure that human subject rights and welfare are protected.
  • If your project utilizes human subjects, you must have approval from both committees (IBC and IRB) prior to beginning the project.

 

Maintaining Approval (Amendments, Change in PI or Key Personnel, Continuing Reviews and Incidents)

Continuing Review

  • Annually, the Committee will forward to the principal investigator a reminder to submit a Continuing Review Form which must be completed and returned to the Committee for review and continued approval. 
  • The Biological Safety Officer will make a determination if a risk assessment needs to be conducted for this review.  If a risk assessment is necessary, your lab will be contacted for a site visit.
  • Once approved, the Committee will return a signed approval memo to the principal investigator.

Amendments

  • Principal investigators revising a currently approved project must complete an Amendment form, revise the protocol and submit one copy of each to the IBC for approval.
  • Changes involving modification of biological agents, significant procedure changes (including change of the responsible principal investigator), changes to personnel, or changes that increase the risk of the project and/or the biosafety level must be approved by the IBC prior to implementing the changes.
  • Once approved, the Committee will return a signed approval memo back to the principal investigator.
  • NOTE: If the amendment involves vertebrate animals or human subjects, additional review by other committees may be required prior to implementation.

Forms Needed for Amendments

PI or Key Personnel Changes

  • Protocol must have up-to-date key personnel rosters at all times
  • Appropriate safety training must be completed prior to working with biohazards
  • If BSL2 or greater, the PI needs to ensure that key personnel have completed the IBC required “Biosafety for Work at BSL-2 Containment” in-class training (NOTE: The IBC Committee will not approve key personnel until this requirement has been met.)
  • Once approved, the Committee will return a signed approval memo back to the principal investigator.

Forms Needed for Key Personnel Changes

Incident Reporting

  • Report all biological exposures, illness, or significant accidents or spills as soon as possible utilizing the Incident Report form.
  • The chair and Biosafety Officer of the IBC reviews all reports of biological exposures.
  • All biological exposures will be reported to the IBC at a regularly convened meeting at which time the IBC may require additional safeguards or changes in procedures.
  • If a biological exposure results in death or is life-threatening, a full IBC, and if applicable, additional research committee meetings, will be convened as soon as possible to discuss the incident, and all biosafety procedures associated with the event. 
  • In some instances the Chair of the IBC may suspend all relevant biohazardous materials use by the PI pending clearance from the IBC and consultation with medical specialists.
  • The IBC will provide information about the reported event to the Office of Animal Care Management and the Institutional Animal Care and Use Committee (when applicable), and the Institutional Review Board (when applicable), and other Institutional Officials as necessary.

Forms Needed for Incident Report

Protocol Closure

  • It is the responsibility of the investigator to notify the IBC when a project is completed.
  • Projects that have been completed, withdrawn or terminated are closed immediately upon notification.
  • Notification can be done at time of continuing review or off cycle with an email to the Research Protections Office staff.

 

IBC Forms

  • Prior to the transition date, all forms must be emailed to the IBC by 4:30 on day of deadline. 
  • Electronic signatures on the forms are accepted
  • Submit in pdf format to ibc@uvm.edu

Initial Submission - Full, Simultaneous, Exempt, Designated or Identical

Biological Review Requirements

  • All new protocols must be reviewed and signed off by the UVM Biological Safety Officer (BSO) prior to submission to the IBC Office. 
  • Investigators must contact the BSO prior to the deadline to allow enough time for a meeting and possible site visit to the lab. 
  • Send protocol to BSO, Jeff.Labossiere@uvm.edu, in word format so that he may track suggested changes.
  • Once reviewed and signed off by the BSO, protocols and any supplemental materials must be converted to pdf format and emailed to the IBC by 4:30 on day of deadline.
  • New protocols will not be considered for IBC review until this has been completed and the BSO has signed off on the protocol.
IBC Forms Library
Initial Submission Notes

File Protocol Form (DOCX)

The Biological Safety Officer must complete and sign the risk assessment section of the form prior to submission.

10/17

 

Standard Operating Procedure

Standard Operating Procedures for work with biohazardous agents or toxins

IBC Forms Library
Initial Submission Notes

Microsoft Office document icon Standard Operating Procedure (DOC)

(if applicable) A Standard Operating Procedure must be submitted for each biohazardous agent listed in sections 2.2 and/or 3.2 in the protocol.

2/16

 

 

Maintaining Approval (Amendments, Change in PI or Key Personnel, Continuing Reviews and Incidents)

Ongoing Submissions

IBC Forms Library Continued
Continuing Review Notes

Continuing Review Form 

(Online through InfoEd)

The Research Protections Office has recently made changes to the IBC continuing review process.  Effective with the February 2nd notices, we will be forwarding to you (and/or your contact) through the InfoEd system, a continuing review form that will now include the currently approved protocol information.  You will open the form attached in that email, and then complete the current status, update the funding and research materials, and apprise us of any problems during the last review period on this pre-populated document.

This change has been made to reduce researcher burden and to support increased compliance. 

1/15

IBC Forms Library Continued
Amendments Notes

Microsoft Office document icon Amendment Form (DOC)

If you only have key personnel changes, you must use the "Request for Change to Key Personnel" found below.

5/16

Microsoft Office document icon Request to Change PI or Key Personnel Form (DOC)

Any persons working on a BSL2 protocol must complete UVM mandatory safety on-line, and  BSL2, in-class training.

10/17

IBC Forms Library Continued
Incidents Notes

Microsoft Office document icon Incident Report Form (DOC)

Use this form to report to the IBC any incidents (E.g. accidental exposure, spills that may be environmentally dangerous, events requiring any type of medical attention) or any noncompliance with NIH guidelines.

6/17

 

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.

Office presentation icon Human Gene Therapy Review Procedures (PPT)

Other Resources: