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• 1.0 Mission Statement
  • 1.1 Introduction to the Committees
  • 1.2 Governing Principles
  • 1.3 Scope of Authority
  • 1.4 Committee Membership
  • 1.5 Public Records and Open Meeting (Vermont Law)
  • 1.6 Electronic Review and Signatures

• 2.0 Operations of the IBC
  • 2.1 Types of Committee Review
  • 2.2 IBC Review Determinations
  • 2.3 Coordination with Other Compliance Committees/Divisions/Cores
  • 2.4 Conducting Business in the Event of a Pandemic or other Significant Emergency
• 3.0 Master Protocol Registration (MPR) Submission
  • 3.1 Initial PI Risk Assessment
  • 3.2 Risk Assessment
  • 3.3 Research Including Recombinant DNA or Synthetic Nucleic Acid Molecules
  • 3.4 Research Including Animals
  • 3.5 Research Including Infectious Agents
    • 3.5.1 Research including Adeno-Associated Virus
    • 3.5.2 Research Involving Human Materials and Cell Lines
  • 3.6 Research Including Biotoxins
  • 3.7 Research Including Select Agents and Toxins
  • 3.8 Research Including Human Subjects
  • 3.9 Projects Involving Plants (NIH Appendix P)
  • 3.10 Dual Use Research of Concern & Pathogens with Enhanced Pandemic Potential
    • 3.10.1  Regulatory Definitions
    • 3.10.2 Determination of Research Category
    • 3.10.3 Review Process
    • 3.10.4 Benefit/Risk Assessment and Risk Mitigation Plan
    • 3.10.5 Institutional Review Entity
    • 3.10.6 Steps to Address Changes in Research that Affects Previous Category Determination
• 4.0 Subsequent Submission Requirements
  • 4.1 Amendment to Approved Master Protocol Registration
  • 4.2 Addition of a New Funded Project to an Approved Master Protocol Registration
  • 4.3 Continuing Review of Master Protocol Registration
  • 4.4 Laboratory Accidents/Exposures/Spills (incidents)
  • 4.5 Closing a Master Protocol Registration by PI
  • 4.6 Closure of a Registration or Amendment by Committee
• 5.0 Investigator Responsibilities
  • 5.1 Study Team Member Responsibilities
• 6.0 Conflict of Interest
• 7.0 Post Approval Monitoring
• 8.0 Procedures for Managing Noncompliance
• 9.0 Animal/Biosafety Level 3 Facility
  • 9.1 Biosafety Level 3 (ABSL-3) Training Guidelines and Practices for Researchers
  • 9.2 Biosafety Level 3 (ABSL-3) Training Guidelines and Practices for Animal Care Staff
  • 9.3 VPR Letter of Support

1.0 Mission Statement

The University of Vermont (UVM) Institutional Biosafety Committee (IBC) is a standing committee that ensures that all research and teaching activities involving biohazardous materials are conducted in a safe and informed manner. The IBC is responsible for ensuring full compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and for monitoring all other research and teaching activities involving the use of infectious or potentially infectious biological materials and biotoxins. The IBC reviews all research and teaching protocols that involve the following materials without regard to the source of funding:  

• Recombinant or synthetic nucleic acid molecules as specified in the NIH Guidelines 

• Human, animal, and plant pathogens (bacteria, fungi, viruses, parasites, prions) 

• Plasmid vectors 

• Viral vectors  

• Human-derived materials (blood, blood products, cells, tissues, and clinical specimens) when used in conjunction with recombinant or synthetic nucleic acid molecules  

• Biotoxins 

• Select Agents and Toxins 

The materials listed above will hereafter be referred to in this document as “biohazardous materials” or “materials”. 

This document outlines the policies and procedures that must be followed when using or storing biohazardous materials.  Since laboratory work can involve exposure not only to these biohazardous materials, but also to other biohazards, chemical and radiological hazards, these policies should be used in conjunction with other pertinent University policies.  See Radiation Safety Committee and UVM’s Environmental Health and Safety Committee web pages for more information. 

Revised: 07/24/2024 

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1.1 Introduction to the Committees

The Institutional Biosafety Committee (IBC) at the University of Vermont (UVM) serves the UVM community.  The IBC is responsible for review of research projects and teaching-related activities to ensure that recombinant or synthetic nucleic acid molecules, infectious agents and biological toxins are handled appropriately at UVM.   

The IBC Policy and Procedure Committee, which includes Committee leadership, Biosafety Professionals, and IBC staff, convenes monthly to review changes in policy and procedures and new regulations.  

Ad-hoc Noncompliance Subcommittees, including a subset of the members and other institutional personnel as applicable, are convened as necessary to review noncompliance cases.   

Institutional Review Entity (IRE) is convened when a project appears to be Dual Use Research of Concern as outlined in Section 3.10 of this document.  This review body consists of various constituents across campus as outlined in Section 3.10.    

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1.2 Governing Principles

The NIH Office of Science Policy is where the IBC turns when developing local procedures and policies. Two primary resources are listed below: 

NIH Guidelines Web Page

This page provides up-to-date NIH news, register notices, director’s statements, etc.  This is also where the latest NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) is found.  The Guide requires that each institution establish an Institutional Biosafety Committee with the authority to approve proposed research projects and teaching activities involving recombinant or synthetic nucleic acid molecules.  The Guide details safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. 

Centers for Disease Control and Prevention (CDC)

The CDC in collaboration with NIH published the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6^th Edition.  This document contains guidelines for microbiological practices, safety equipment, and facilities that constitute the four established biosafety levels. The BMBL is generally considered the standard for biosafety.  

Revised: 07/24/2024 

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1.3 Scope of Authority

The President of the University has delegated the authority to the Vice President for Research Administration as the lead Institutional Official responsible for the assurance of compliance in the biosafety area.  The IBC policies apply to activities involving the use of biohazardous materials in research projects and applicable teaching laboratories.  It applies to research and teaching activities that are:  

• Sponsored by UVM, 

• Conducted by UVM researchers,  

• Classes taught by UVM faculty, or 

• Conducted using UVM’s property, facilities, or non-public information. 

All faculty, staff, students, and visitors are included within the scope of these IBC Policies.  

The IBC is delegated the authority to: 

1. Define the basic policies, procedures and standards as required by NIH to oversee the safe use of biohazardous materials. 

2. Review requests for the use of these materials for compliance with NIH Guidelines and the BMBL, and approve those requests which are found to conform. As part of the review process, the IBC will do the following, as applicable: 

   1. Conduct an independent assessment of the containment levels, as required by the NIH Guidelines for research involving recombinant or synthetic nucleic acid molecules.  

   2. Conduct an assessment, if applicable, of the facilities, procedures, practices, training, and expertise of personnel involved in the requested use of these materials. 

   3. Ensure compliance with all surveillance, data reporting, and adverse event reporting requirements set forth in the NIH Guidelines. 

3. Disapprove, terminate, or suspend activities involving these materials which are not in conformity with the Guidelines; 

4. Notify investigators in writing of its decision to approve or withhold approval of activities involving these materials, or of modifications required to secure IBC approval.  All decisions will be part of the IBC records maintained by the Research Protections Office; 

5. Set containment levels as specified in the NIH Guidelines; 

6. Conduct periodic review of the use of these materials to ensure that the requirements of the Guidelines are being fulfilled; 

7. Consult with the biosafety team in maintaining and following emergency plans covering accidental spill and personnel contamination resulting from use of recombinant DNA, infectious agents or biological toxins; 

8. Report to the Vice President for Research Administration any significant related illness or accident resulting from use of these materials that appears to be a hazard to public health; 

9. Report to the Vice President for Research Administration and the Office of Science Policy (OSP) any significant problems with or violation of the Guidelines; 

10. The IBC may not authorize initiation of experiments not explicitly covered by the Guidelines until NIH establishes the containment requirement.  

Institutional Relationship 

The following organizational chart outlines the direct lines of responsibility and corresponding authority. 

Revised: 07/29/2024 

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1.4 Committee Membership

Committee membership is comprised of members with varying professional and personnel backgrounds who have demonstrated a genuine interest in and commitment to the purpose of the Committee. 

Committee leadership and members serve at the discretion of the Institutional Official (IO.)  The IO has delegated signature authority to the Executive Director of Research for the appointment letters. 

Chair

• Committee Chairs are appointed by the IO
• A Committee Chair must be a University faculty Member and must have prior service as a Committee Member.
• It is the responsibility of the Committee Chair to conduct Committee meetings in accordance with established federal regulations and University operating policies and procedures.  These responsibilities, include but are not limited to the following:
  • sign official Committee action documents
  • keep abreast of relevant state and federal regulations;
  • meet as needed with the IBC Director and/or IO to discuss Committee activities;
  • meet regularly with appropriate representatives of the RPO and the Environmental Health and Safety Office to coordinate the review of  biohazardous materials throughout the University;
  • recommend, in consultation with the IBC Director, new Members to the IO;
  • ensure that new Members are properly oriented to and educated about their duties and responsibilities;
  • initiate activities designed to keep the campus and community apprised of IBC activities; and
  • assist appropriate University administrators in the preparation of federal reports and assurances and meet with inspectors/site visitors as necessary.
• No method for removal is delineated, as all Members are appointed and serve at the discretion of the IO.
• The Chair is appointed for renewable two-year terms.

Associate Chair

An Associate Chair is nominated by the Chair from among Membership of the IBC. Responsibilities of the Associate Chair are to

• conduct the meetings of the IBC in the absence of the Chair or if there is a conflict of interest by the Chair's participation,
• sign official Committee action documents and approve Committee actions as delegated by the Members or by designation of the Chair;

The Associate Chair is appointed for renewable two-year terms.

Regular Members

Membership will comply with all relevant federal and state regulations.  Every effort will be made to consider gender and cultural diversity.

• The IO appoints all Committee Members, after receiving recommendations from the IBC Chair and the IBC Director.
• When vacancies occur, suggestions for Membership will be sought, after which formal recommendation(s) for new Member(s) will be made by the Committee Chair and the IBC Director to the IO.
• The IO will in no case make a final appointment without prior consultation with the Committee Chair and the IBC Director.
• Committee appointments will usually be for renewable two-year terms, serving at the discretion of the IO.
• Consideration is given to achieve a balance between new and experienced Members when determining which appointments will be renewed.
• No specific attendance requirements are delineated, however it is required that Committee Members demonstrate a genuine interest and commitment to the purpose of the Committees.
• No method for removal is delineated, as all Members are appointed and serve at the discretion of the IO.     

Ex Officio Members

An ex officio member is defined as a member who serves by virtue of an office or position held.  An ex officio member may be appointed by the IO as a voting member, a non-voting member, or an alternate member.

• The University Biosafety Officer will serve ex officio as a regular member with full voting privileges.
• The RPO Director will serve as an ex officio member.  This individual may serve as an alternate member if so appointed.
• Additional ex officio or alternate members may be appointed at the discretion of the IO.

Alternate Members

An alternate member is defined as a member who substitutes for a specific member or members with similar qualifications, experience or membership category.  When an alternate member substitutes at a meeting, they appear as “substitutions” on the minutes.  Alternate members may be appointed under the following conditions:

• Must be appointed by the IO and listed in IBC rosters submitted with regulatory documents.
• Must be designated to serve as the alternate for a specific member or members who have the same attributes (e.g. scientific member can only substitute for another scientific member.)
• Alternates must receive same onboarding training as non-alternate members.
• Must receive all proposal materials in advance of the meeting for review if they will be voting during the meeting.
• Alternate members are advised to "vote their conscience" as opposed to representing the position of the regular member for whom they serve.
• If both the regular voting and alternate member both attend a meeting, only the regular voting member may vote.  An alternate member may only be required to vote when necessary to achieve or maintain quorum. 

Committee Composition

At a minimum the Committee will consist of not less than five regular voting Members and at a minimum will include the following:

• One or more individuals with expertise in recombinant DNA technology, infectious agents, and/or biological safety, and/or physical containment.
• At least two members who are not affiliated with UVM (including family members) and who represent the interests of the surrounding community with respect to health and protection of the environment.
• At least one individual with expertise in plant, plant pathogen, or plant pest containment principles before reviewing and approving experiments involving plants with biosafety level 2 or greater.
• At least one scientist with expertise in animal containment principles before reviewing and approving experiments involving animals with biosafety level 2 or greater.
• A Biological Safety Officer has been appointed.  This is a NIH required appointment based on current BSL-3 activities.   

In addition, it is recommended that the membership include:

• An individual representing laboratory technical staff;

An individual who meets the requirements of more than one of the categories detailed above may fulfill more than one requirement, if the minimum number is met. 

Consultation

The Committees may, at their discretion, obtain consultation from individuals with expertise in specialized areas, such as gene therapy or biosecurity, to assist in the review of complex issues which require expertise beyond or in addition to that available on the IBC. The IBC shall consult with General Counsel and other University Officials, as indicated, to address issues pertaining to institutional policies, applicable law, and standards of conduct and practice. These individuals are not allowed to vote.

General liability insurance coverage 

Actions by members carried out as a function of their Committee appointments are included under the University's general liability insurance coverage.

Remuneration

Regular membership on the IBC will be without monetary compensation.

Legal Implications of Membership

Actions by the Members carried out as a function of their Committee appointments are included under the University's general liability insurance coverage.

Conflict of Interest

If an IBC Member has a conflicting interest in a protocol (including, but not limited to being a principal investigator, a co-investigator, or a consultant on that protocol), that Member may only provide information as requested by the IBC and will not be assigned to officially review nor vote on that protocol.

Code of Conduct For Committee Members

This Code of Conduct is a set of behavioral expectations intended to assure that our Committee members uphold the highest level of integrity and ethical standards.  Members must not discuss, disclose, or reproduce any protocol-related information, except as necessary to carry out responsibilities or as required by law.  Members must limit their electronic access to that which is required to fulfill their Committee duties.  Members must never access any research protocols to satisfy personal interest or curiosity.  Any printed materials for review should be returned to the IBC or shredded after use. 

Committee Member Training

New Members meet with the Chair and the IBC analyst for training and basic introductory materials are provided to acquaint the new Member with the Committee and its functions prior to participation in a meeting. Additional materials are provided for reference during protocol review.

Documentation of Training Completion

Records of completion dates are maintained in RPO shared folder. 

Continuing Education

Continuing education is accomplished by retaking the required IBC CITI tutorials at least once every three years, attendance at webinars, regional or national meetings and conferences.   Additional education is provided as topics discussed during the monthly Committee meetings.   

Revised: 08/13/2024 

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1.5 Public Records and Open Meetings

Federal Freedom of Information Act (FOIA) 

The Freedom of Information Act (FOIA) is a federal law that generally provides that any person has a right, enforceable in court, to obtain access to federal agency records.  FOIA applies only to federal agencies.  Each state has its own public access laws that are consulted for requests for access to state and local records.  Vermont and in turn the University has its own laws and process for records.  

Vermont Public Records Act 

The University of Vermont is a public body subject to the Vermont Public Records Act (1 V.S.A. §316)(a). Under this law, any person may inspect or copy any public record of a public agency. The definitions of public agency; public records and documents are included in 1 V.S.A. §317. 

However, research data and protocols are exempt from disclosure under Vermont law §317(c)(23).      Because these records are exempt from public disclosure, the FOIA cannot be used to inspect or copy records.   Researchers should forward any request for inspection or copies of research records to the Vice President for Executive Operations according to the UVM Records and Document Request policy.   

Revised: 4/12/22 

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1.6 Electronic Review and Signatures

All reviews, initial, continuing and amendments are reviewed electronically by the IBC members as assigned.  Members receive an email notice that a review is pending.  They proceed to the electronic record by either utilizing a link embedded within the email or they proceed directly to the system home screen where they will find their review task(s).  Members are required to authenticate into Click using their UVM NetID and password prior to completing their review.  Each electronic review is stamped with the name of the individual carrying out the review activity (electronic signature), and the time and date that the electronic signature was applied to the review. 

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2.0 Operations of the IBC

The IBC will follow these operating procedures.  These procedures will be reviewed periodically, at least once every three years, to ensure compliance with all pertinent laws governing the use biohazardous materials.  Changes to these operating procedures will be developed in consultation with the RPO and the UVM Environmental Health and Safety Office and will be reported to the Institutional Official.   

The institution will provide the IBC with resources, office space, professional staff, and support staff sufficient to carry out their responsibilities efficiently and effectively and to serve as day-to-day liaison with appropriate University administrative offices, project investigators, other institutional safety and ethics boards, and various regulatory and funding agencies. 

Convened Meetings  

The Committees meet monthly if there are agenda items.   

Meeting Notices 

Meetings are noticed on the IBC website in conformance with the Vermont Open Meetings Law (1 V.S.A. Section 310) while affording researchers with the protections of the Vermont Public Records Act Law (1 V.S.A. Section 316).  The agenda, including the time and location of the meeting, are distributed in advance to all members.  All pre-meeting protocol materials are located within the electronic submission and review system.  All members have access to this system. 

Conducting Initial and Continuing Review 

Initial and continuing IBC reviews and approvals of a Master Protocol Registration (MPR) will occur in compliance with NIH Guidelines. Continuing reviews will be preceded by IBC receipt of an appropriate progress report from the investigator.  Reviewer forms and internal checklists are utilized as a guide to ensure that these criteria have been met. 

Review Decisions and Process for Appeal 

Review decisions will be forwarded to the researcher in writing.   Review decisions may not be overridden.  However, the Vice President for Research Administration shall have the final authority to disapprove, restrict or terminate a study which has received IBC approval. There is no process delineated for appeal of Committee decisions. However, there is no prohibition for resubmission of specific requests or protocols for additional review by the Committee. 

Protocols Requiring More Frequent Review 

Determination of which studies require review more often than annually is done at the time of protocol review, on a case by case basis, depending upon protocol specific factors, including, but not limited to, the level of risk. 

Modification to a MPR 

The IBC requires that changes in approved research be reviewed prior to initiation.  Changes implemented prior to Committee approval is considered noncompliance.   

Accidents/Incidents 

The IBC is required to report significant problems, violations of the NIH Guidelines, or any significant research-related accident or illness by the Institution. See section 4.4 for further details. 

Removal from Consideration 

RPO staff will have the authority to remove from further Committee consideration, a study which has obtained initial approval, when the PI fails to respond to ongoing clarifications or training requests. The PI will be required to close the study in UVMClick-IBC. 

Documentation 

The IBC, through the administrative staff, is responsible for reporting findings, actions as well as requesting clarifications to the investigators in writing, and to the appropriate offices within the institutions’ administration through reports and meeting minutes to institutional officials through their representatives on the Committee, and to sponsors of research, if so required. 

Authority to Sign IBC Documents 

a. Results of Reviews, Actions and Decisions whether Full or Expedited 

Depending upon the nature of the required conditions, the IBC designates any of the following individuals or groups of individuals to determine that the conditions of approval have been satisfied: 

• The IBC chair; 

• Another member; 

• An IBC Analyst/Member or; 

• Other qualified IBC administrative staff person, who need not be an IBC member. 

Individuals designated by the IBC must have appropriate expertise or qualifications. For some conditions, the review of response materials from investigators will require scientific or other technical expertise. In such cases, the IBC Chair will review the responsive materials or designate another individual who has the appropriate expertise. 

Follows are some examples of conditions in which IBC Analysts/Members have been designated to review and approve response materials. 

• Correction of minor grammatical and typographical errors in the MPR; 

• Requirement to revise the protocol in a specific manner as dictated by the Committee. 

b. Administrative Review and Approval 

Administrative items are reviewed and approved by IBC Analysts/Members or appropriate IBC staff. IBC Analysts/Members may consult with the Committee chair prior to approval. Below are examples of administrative items. 

• Correction of omission of sponsor 

• Changes to Key Personnel 

• Continuing Reviews (IBC Analyst)  

c. Routine Internal Correspondence 

Any action, letter, memo or e-mail between the Committee or IBC staff and the faculty or staff of the University that provides information concerning the review of research protocols by the Committee or IBC staff and which do not imply or appear to imply approval of this activity may be signed by the staff member. 

d. Decisions Made by the Chair 

Any letters, memos or email sent representing the decision or opinions of the Chair or Vice Chair of the IBC, as long as such correspondence does not imply review and approval, may be signed by IBC staff if so designated by the IBC. 

Electronic Reviews  

All reviews, initial, continuing reviews and modifications are completed electronically by the IBC members as assigned. Members receive an email notice that a review is pending. Members are required to authenticate into the electronic system using their UVM NetID and password prior to completing their review. The system validates the member’s authentication credentials based upon the member’s role in the system and determines available actions for each person. The electronic review is stamped within the system with the name of the individual carrying out the review activity (electronic signature), and the time and date that the electronic signature was applied to the review. 

Members only access records that they have been assigned to review. 

Voting Requirements 

1. Definition of Quorum: A majority of the total number of regular voting members will constitute a quorum. If less than a majority of the total number of regular voting Members is present, if an ex officio nonvoting member(s) is available, that individual may be included to constitute a quorum.  If a quorum is lost at any time during the meeting, the meeting shall be adjourned and no further action taken until a quorum is attained. 

2. Official Committee action (non-exempt) on new MPRs involving biohazardous materials will be by formal vote (exceptions previously noted under E.4) at convened meetings of a quorum of Committee members. 

3. All meetings will be conducted using Robert’s Rules of Order as guidance, with deviations made as deemed appropriate by the Chair. 

4. Selection of specific protocols for review by members is determined by the Committee's administrative staff and/or Chair.  If an IBC member has a conflicting interest in a MPR (including, but not limited to being a principal investigator or a co-investigator) that member may only provide information as requested by the IBC and will not be assigned to officially review nor vote on that protocol. 

5. IBC members may participate in a convened meeting of the IBC via telephone or video conferencing.  Those members have access to the research protocol materials in advance of the meeting within UVMClick-IBC. 

IBC Record Requirements 

The IBC keeps all records in accordance with all pertinent regulations. This record keeping includes the following. 

Membership rosters - The institution is required to maintain a current list of IBC members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IBC deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant. UVM rosters indicate regular voting versus alternate members, as well as alternate replacement assignments. Rosters are updated each time there is a change in the Committee membership. Copies of curriculum vitae are obtained and kept on file for all primary and alternate members. 

 Written procedures and guidelines including, but not limited to, the Research Manual and all website content. 

Minutes of meetings document  

• attendance of members, consultants, and guests  

• discussion of controverted issues,  

• actions taken,  

• basis for requiring changes in research or disapproving research, 

• a record of voting (for, opposed, abstaining, recusal),  

• members arriving and leaving the meeting once the meeting is called to order,  

• names of members who recuse themselves because of a conflict of interest along with the fact that a conflict is the reason for the recusal, 

• which alternate member is replacing a primary member,  

• a record and vote of members who participated in the convened meeting via phone or video conferencing. 

Approved minutes will be signed by the Chair or designee, scanned, and maintained as a PDF in a shared electronic file. 

A report of business conducted by the designated review process is available in the UVMClick-IBC system. 

Protocol/MPR files are either in paper or electronic form. Both the paper and the electronic files include protocols, continuing reviews, amendments, risk assessments, and reported incidents. Once closed, any paper files are stored off-site and can be retrieved within 24-48 hours. Protocol files, whether paper or electronic will be destroyed after the protocol has been closed for at least three years. 

Communications to and from the IBC are maintained in the protocol file. 

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2.1 Types of Committee Review

The IBC will review and have authority to approve, require modifications in (to secure approval), or disapprove all research and teaching activities involving biohazardous materials. These review categories are employed for new master protocol registrations (MPR), amendments to add new projects to existing registrations, and continuing review. 

Preliminary Reviews

In all cases, there are two preliminary reviews that require completion prior to review by the Committee. 

Biological Safety Team Review

New master registrations and amendments with new projects will be forwarded to the biosafety team for recommendations on  risk mitigation practices relevant to the proposed research or teaching activity. The biosafety team’s risk assessment document and feedback will be appended to the electronic MPR.

In the event there is insufficient time for a biosafety team member to conduct a pre-review within the posted submission deadlines, the protocol will be placed on an agenda and the IBC will conduct the review after completion of an IBC Analyst Pre-Review. The biosafety team member is also an IBC member and will be part of the discussion.  A post-approval monitoring visit to assess operating procedures may be stipulated depending upon the outcome of the IBC’s review. 

IBC Analyst Pre-Review

The IBC must receive sufficient information regarding proposed activities to make the determinations as required by regulations.  Before placing a submission on the agenda, the IBC Analyst will conduct a pre-review of submitted materials.  A specific regulatory checklist is followed to determine if the submission is ready for review by the IBC. If the submission is incomplete or lacks information necessary to conduct a review, it will not be reviewed until the information is provided.  Once it is determined that the submission is satisfactory, the review will continue.  

Committee Review (convened meeting)

The IBC employs the convened meeting review process for review and approval of submissions that propose to use non-exempt biohazardous materials in a risk group category greater than or equal to RG-2 and/or requiring Biosafety Level 2 (BSL2) containment practices. Research or teaching activities involving RG-1 agents and/or recombinant or synthetic nucleic acid molecules may also require review by the IBC depending on the nature of the proposed work.

Notification to Research Community

Committee meetings are noticed on the Committee website. Submissions are added to an Agenda on a rolling basis after preliminary pre-reviews are complete.

Notification to the Committee

Distribution of the Agenda to all members occurs approximately 2 weeks in advance of the convened meeting.   All new MPRs, amendments, incidents and other business requiring full committee action are placed on the Agenda for discussion.

Access to the MPR Materials

Committee members have access to all of the MPR materials through the electronic submission and review system.

Reviewer Assignments

Primary and Secondary Reviewers are assigned by the RPO Analyst to review the submission and all provided materials.  Efforts are made to match the primary reviewer’s expertise to the project’s subject matter. Reviewers are encouraged to contact the PI to resolve/clarify major concerns prior to the meeting . The reviewers summarize the proposed research or teaching activities for the full Committee at a convened meeting and answer questions during the discussion.  An approval memo or a request for further clarification will be sent to the principal investigator. 

Designated Member Review 

The regulations have flexibility to allow for a designated member review process.  A new MPR or amendment to add a new project to an existing MPR may be reviewed by a designated member of the IBC under one or more of the following conditions: 

• The proposed work is equivalent to work already approved under the existing registration, as determined by the IBC, and there are no substantive differences that would change the biosafety and or public health considerations for the proposed project.
• The proposed work receives a preliminary category of BSL1.

Assigning Reviewers

The submission will be assigned to a designated member for review once the preliminary reviews are complete.  The Chair reserves the right to also provide the materials to each member of the Committee for review. If no additional clarifications or requests for a Full Committee review at a convened meeting are received, an approval will be signed at the discretion of the Chair.  An approval memo or a request for further clarification will be sent to the principal investigator. 

Review Simultaneous with Initiation

The regulations allow for review simultaneous with initiation of the project if the experiments are designated as BSL1 and fall under Section III-E of the NIH Guidelines. In these instances, researchers will follow the designated review process listed above. 

Exemption Determinations

The regulations allow exemption from IBC review for experiments falling within Section III-F. Though these projects may be exempt from the Guidelines, they still need to be forwarded electronically to the IBC for a formal determination and review of other Federal, State, and local biosafety standards that may apply.  The Chair will make the determination of exemption.

Section III-F.    Exempt Experiments

The following recombinant or synthetic nucleic acid molecules are exempt from the NIH Guidelines and registration with the Institutional Biosafety Committee is not required; however, other federal and state standards of biosafety may still apply to such research (for example, the Centers for Disease Control and Prevention (CDC)/NIH publication Biosafety in Microbiological and Biomedical Laboratories).

Section III-F-1.  Those synthetic nucleic acids that:  (1) can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.  If a synthetic nucleic acid is deliberately transferred into one or more human research participants and meets the criteria of Section III-C, it is not exempt under this Section.

Section III-F-2.  Those that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.

Section III-F-3.  Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.

Section III-F-4.  Those that consist entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well-established physiological means.

Section III-F-5.  Those that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).

Section III-F-6.  Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent.  A list of such exchangers will be prepared and periodically revised by the NIH Director with advice of the RAC after appropriate notice and opportunity for public comment (see Section IV-C-1-b-(1)-(c), Major Actions).  See Appendices A-I through A-VI, Exemptions under Section III-F-6--Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from the NIH Guidelines.

Section III-F-7.  Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA.

Section III-F-8.  Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c), Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment.  See Appendix C, Exemptions under Section III-F-8 for other classes of experiments which are exempt from the NIH Guidelines.

Administrative Review/Approval

IBC staff will review and approve study team member changes and continuing reviews. 

Revised 08/13/24 

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2.2 IBC Review Determinations

The IBC shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research and teaching activities covered by this policy, including exempt research activities. 

APPROVED 

This decision indicates that the initial review of a master protocol registration (MPR) at a convened meeting or via designated review has been approved without requiring either further (a) changes to the MPR or (b) submission of clarifications or additional documents. 

CLARIFICATIONS REQUESTED FOR INITIAL APPROVAL 

This decision indicates approval is pending satisfactory resolution of conditions or clarifications that the IBC requires to approve the MPR. Under this scenario, for full review MPRs, further review by the IBC at a subsequent convened meeting is not necessary to secure final approval. 

The designated review process is employed to review the response from the investigator. The IBC directs that the IBC chairperson (or other individual(s)) to review and determine on behalf of the IBC whether the changes, clarifications, and/or additional documents to be submitted by the investigator(s) are satisfactory. 

If under the designated review of the response, the IBC chairperson (designated reviewer) is unable to approve the MPR because he/she cannot make the determinations required for approval, they can either refer the project to the IBC for further review and action at a convened meeting, or defer approval of the MPR and require that the investigator (a) make changes to the MPR, or (b) submit clarifications or additional documents prior to further review by the IBC chairperson (or designated reviewer(s)).  

DEFERRED (tabled) 

This action is taken under full Committee review any time the IBC cannot make one or more of the determinations required for approval but with major revisions may be found to be approvable. When deferring a project, the IBC, under its authority to require modifications in order for an investigator to secure approval, may require that the investigator (a) make changes to the MPR or (b) submit clarifications or additional documents.  The research may not proceed until the IBC reviews, at a subsequent convened meeting, the revised MPR and approves it. 

DISAPPROVED 

This action is taken under full Committee review when the determinations required for approval of the research cannot be made, even with substantive clarifications or modifications to the MPR. If the IBC decides to withhold approval of a MPR, it will include in its written notification a statement of the reasons for its decision. 

The above review determinations also apply to follow on submissions to an approved MPR including amendments and continuing reviews.   

ADMINISTRATIVE HOLDS, SUSPENSIONS OR TERMINATIONS 

All currently approved research is subject to modification or change in approval status, as deemed necessary by the IBC. The IBC has the authority to suspend or terminate research for not being conducted in accordance with IBC requirements or federal regulations; or if it has been associated with unexpected harm to personnel or the environment. The Investigator also has the option to place the research on administrative hold.  

Administrative Hold 

An administrative hold is a voluntary action by an investigator to temporarily or permanently stop some or all approved research activities. Administrative holds are not considered suspensions or terminations, and do not meet reporting requirements to the Office of Science Policy. Administrative holds must not be used to avoid reporting deficiencies or circumstances that otherwise require reporting to federal agencies. The Principal Investigator may place an administrative hold on research if; a complaint is received; an allegation of non-compliance is reported to the IBC; or a discovery by the investigator of new potential risk to personnel or the environment.  The Investigator must notify the IBC of the hold through an amendment.  

During administrative hold, the research remains subject to continuing review and requirements for reporting non-compliance and incidents. 

The IBC designee may make recommendations for additional education and/or compliance interventions for the Investigator and research personnel as the result of an administrative hold. At any point, the IBC Committee can suspend the research, which will result in required regulatory reporting. 

Suspension 

A suspension of IBC approval is a directive of the convened IBC, Biosafety Officer or IBC designee either to stop temporarily some or all previously approved research activities, or to stop permanently some or all previously approved research activities. All suspensions are immediately reportable to federal agencies. 

The Biosafety Officer has the authority to suspend previously approved research when required for the urgent protection of personnel and/or the environment and insufficient time exists for the convened IBC to review the issue. Any suspension of research by the above individuals is placed on the next available agenda of a meeting of the full IBC.  The convened IBC will review the circumstances that led to the suspension and will make the determination to uphold or overturn the suspension. The IBC will recommend corrective actions if the suspension is upheld. 

During suspension, the research remains subject to continuing review and requirements for reporting non-compliance and incidents. 

The IBC Chair, Biosafety Officer, or designee notifies the investigator of the suspension and the reason for the suspension. 

Termination 

A termination of IBC approval is a directive of the convened IBC or IBC designee to permanently stop all previously approved research activities. All terminations are reportable to federal agencies. MPR approval will not be terminated without first undergoing temporary suspension and completion of a review following the Noncompliance Policy and Procedures process. 

Previously approved research may only be terminated by the convened IBC, including MPRs originally approved under designated procedures. 

Terminated protocols are considered closed and no longer require continuing review. 

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2.3 Coordination with Other Compliance Committees/Divisions/Cores

Animal Use (IACUC) 

Review by the IBC is independent of the review by the Institutional Animal Care and Use Committee (IACUC).  However, there is representation on both committees that communicate and coordinate regarding Biosafety issues in animal studies.  Initiation of the animal component of the study is contingent upon the completion of and approval of IACUC process.  

Human Subjects (IRB)  

Review by the IBC is independent of the review by the Institutional Review Board (IRB).   

Sponsored Project Administration (SPA)  

SPA requires documentation of protocol approvals prior to release of funds.   IBC staff share protocol statuses with SPA for this purpose. 

Institutional Review Entity (IRE) Subcommittee 

The IRE is a subcommittee of the IBC.  Researchers who believe that they may be conducting DURC are required to submit a MPR to the IBC for review and initial determination.  The IBC and IRE work closely to ensure proper oversight of DURC.  See Section 3.5 for the organizational framework for oversight of DURC.    

UVM Core Facilities 

An ancillary review will be sent to the director of each core facility when an MPR indicates their use.  

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2.4 Conducting IBC Business in the Event of a Pandemic or other Significant Emergency

IBC Meetings 

Internal policies state that convened meetings are required for 1) initial review of Master Protocol Registrations (MPR) that propose the use of non-exempt biohazardous materials in a risk category greater than or equal to Biosafety Level 2 (BSL2); 2) any amendments that have the potential to increase Biosafety Level; 3) determinations of level of seriousness for noncompliance cases.  While optimal, there is no requirement to conduct the convened meeting in person.  Use of teleconferencing or audio/video conferencing is permissible.  If quorum cannot be achieved, convened meetings will be postponed until enough members can be present.   

Security of IBC remote meetings will be assured by using only University-approved videoconferencing software logging in only with UVM credentials.  Guest presence will be controlled by the meeting owner which, is typically a RPO staff person.  IBC videoconference meetings will not be recorded.  Quorum of members will assured by a count of those in attendance prior to opening the meeting and a second time after moving into open session prior to the protocol vote.   

Minutes of meetings will be captured following current methods for in-person meetings.  The manner of engagement of each member will be noted (e.g. in-person, telephone, video.)  Votes to go in or out of sessions, as well as to vote for specific registrations, will occur by the Chair asking for members who approve an order of business by asking “All approved say aye”, “All opposed say nay”, “All abstaining say aye”. Members participating through video conferencing can also use the chat feature to add comments to the discussion.   Members with conflicts will sign out of the meeting during the vote and IBC staff will invite them back into the meeting when the conflicting MPR discussion is complete.  Meeting guests will be invited during discussion of their registration and signed out once that discussion is completed. 

MPR Review 

New BSL2 MPRs or amendments to MPRs representing a potential for an increase in biosafety level must be reviewed in a convened meeting.  Convened meetings can proceed as described above.   

New BSL1 MPRs or amendments to existing MPRs which do not change the safety level can continue to be reviewed through the current designated review process. 

MPR review documentation will be through the UVMClick-IRB electronic MPR submission software.   

Biosafety Team Risk Reviews

The biosafety team member’s  review of risk will continue to be conducted when new work is proposed as long as the laboratory remains in operation.

Post Approval Monitoring  

Post Approval Monitoring visits will be placed on hold until normal working conditions are in place.  

Training 

If personnel refresher training expires during the emergency, personnel are allowed to continue their work as long as they have received previous training and have demonstrated proficiency.  There will be no consequences; however, once working conditions have been restored, personnel must complete refresher training in accordance with the IBC policy.   

Pause in Research Activities 

If laboratory activities are required to be placed on pause secondary to institution-wide policy to address a public health situation, the IBC does not require notification in the pause of work.   

Revised: 07/29/2024 

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3.0 Master Protocol Registration Submission

Researchers may now submit one master protocol registration (MPR) to cover multiple projects with similar biosafety levels.  Additionally, teaching laboratories that utilize biohazardous materials must submit a MPR describing the work and safe handling procedures being conducted in the teaching laboratory.  Adopting this model will reduce regulatory burden.  Researchers/professors will combine multiple teaching, or internally- and externally-funded projects under one MPR.  Laboratory activities requiring BSL-1 and BSL-2 work practices may be combined.

A/BSL-3 or BSL-3 research and research meeting criteria for Dual Use Research of Concern (DURC) or Pathogens with Pandemic Potential (PPP) require individual master protocol registrations due to their complexity and different regulatory requirement from BSL-1 and BSL-2. 

Since the MPRs are grouped together based upon biosafety levels, it is important that this level is established early in the review process for a new project.  The following tools can help researchers make an initial determination of the appropriate risk group, containment level and work practices. 

The NIH/CDC BMBL 6th edition will help get you started in making a risk assessment.  

The American Biological Society Association maintains an excellent reference for risk groups. 

Implementation Guidance for the USG for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PPP).   You may use the DURC/PPP self-determination tool to Assess whether your research meets the criteria for Category 1 or Category 2 research under the new USG DURC/PPP policy.

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Revised 03/18/2025

3.1 Initial PI Risk Assessment

It is the responsibility of all PIs to provide an initial assessment of the risk factors and risk levels involved in their proposed activities.  In many instances, the PI has significant experience working with similar biological agents or recombinant DNA and is in the best position to estimate the appropriate biosafety level (BSL-1, BSL-2 or BSL-3) for the laboratory. 

Guidance

The following guidance on risk assessment is provided to assist PI’s in conducting an accurate and effective risk assessment. The steps listed below are modified excerpts from the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition publication:

Step 1: Identify agent hazards and perform an initial assessment of risk. Consider the principle hazardous characteristics of the agent, which include its capability to infect and cause disease in a susceptible human host, severity of disease, and the availability of preventive measures and effective treatments.

Step 2: Identify laboratory procedure hazards. The principle laboratory procedure hazards are agent concentration, suspension volume, equipment and procedures that generate small particle aerosols and larger airborne particles (droplets), and use of sharps. Procedures involving animals can present a number of hazards such as bites and scratches, exposure to zoonotic agents, and the handling of experimentally generated infectious aerosols.

Step 3: Make an [initial] determination of the appropriate biosafety level and select additional precautions indicated by the risk assessment. Note: The IBC will make the final biosafety level determination. 

Step 4: Evaluate the proficiencies of staff regarding safe practices and the integrity of safety equipment.

In conducting a risk assessment, the PI should ensure that laboratory workers have acquired the technical proficiency in the use of microbiological practices and safety equipment required for the safe handling of the agent, and have developed good habits that sustain excellence in the performance of those practices.  

Revised 08/13/24 

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3.2 Risk Assessment

The ongoing practice of biological risk assessment is the foundation of safe laboratory operations.  Risk assessment requires careful judgement and is an important responsibility for principal investigators (PIs).  Institutional leadership and oversight resources, such as Institutional Biosafety Committees (IBC), animal care and use committees, biological safety professionals, occupational health staff, and laboratory animal veterinarians also share this responsibility.   

The institution supports researchers by requesting that a biosafety team member review new protocol submissions (e.g. initial master protocol registrations and amendments) to assess if the risk group and biosafety level are accurate and to make suggestions to improve  procedures for handling biohazardous materials.

If there is insufficient time for a biosafety team member to conduct a pre-review within the posted submission deadlines, the protocol will be placed on an agenda and the IBC will conduct the review.  The biosafety team member is also an IBC member and will be part of the discussion.  A post-approval monitoring visit to assess approved operating procedures may be stipulated depending upon the outcome of the IBC’s review. 

Note:  The UVM IBC reviews applicable protocols involving human subjects who are being treated at The University of Vermont Medical Center (UVMMC).  The biosafety team works with specific UVMMC service lines (see gene therapy) to assist with same.    

Risk Groups

Agents are classified into four Risk Groups according to their relative pathogenicity for healthy adult humans as follows:

• Risk Group 1 (RG-1) agents are not associated with disease in healthy adult humans.
• Risk Group 2 (RG-2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
• Risk Group 3 (RG-3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
• Risk Group 4 (RG-4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.

Risk Factors

The following factors should be considered when conducting a risk assessment and determining the level of containment:

• Pathogenicity of the biohazardous material(s) - Consideration should include disease incidence and severity.
• Route of transmission (e.g., parenteral, airborne, by ingestion) - When planning to work with a relatively uncharacterized agent with an uncertain mode of transmission, the potential for aerosol transmission should be strongly considered.
• Agent stability - Should include a consideration of factors such as desiccation, exposure to sunlight or ultraviolet light, or exposure to chemical disinfectants.
• Infectious dose of the agent and communicability - Consideration should include the range from the healthiest immunized worker to the worker with lesser resistance.
• Concentration - Include consideration of the milieu containing the organism (e.g., solid tissue, viscous blood or sputum, liquid medium) and the activity planned.
• Volume - >10 liters is considered large scale and is subject to further review and higher containment level.
• Origin of the biohazardous material(s) - Consideration should include factors such as geographic location, host, and nature of the source.
• Availability of data from animal studies - This information may be useful in the risk assessment process in the absence of human data.
• Established availability of immunization/vaccine or treatment - The unavailability of immunization/vaccine or treatment may impact the risk involved in the use of biohazardous material(s).
• Gene product effects, such as toxicity, physiological activity, and allergenicity.

Biosafety Level (Biological and Physical Containment Level)

The final risk assessment determination (RG-1 to RG-4) is used to set the appropriate biosafety level (BSL-1 to BSL-4) for the biohazardous material(s). The biosafety level describes the degree of physical containment and biosafety practices required to confine these materials and to reduce the potential for exposure of laboratory workers, persons outside the laboratory, and the environment. 

The following is a general description of the biosafety levels as described in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th edition:

• Biosafety Level 1 (BSL-1) is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and present minimal potential hazard to laboratory personnel and the environment. BSL-1 laboratories are not necessarily separated from the general traffic patterns in the building. Work is typically conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design is not required, but may be used as determined by appropriate risk assessment. Laboratory personnel must have specific training in the procedures conducted in the laboratory and must be supervised by a scientist with training in microbiology or a related science.
• Biosafety Level 2 (BSL-2) builds upon BSL-1. BSL-2 is suitable for work involving agents that pose moderate hazards to personnel and the environment. It differs from BSL-1 in that 1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; 2) access to the laboratory is restricted when work is being conducted; and 3) all procedures in which infectious aerosols or splashes may be created are conducted in a biosafety cabinet (BSC) or other physical containment equipment.
• Biosafety Level 3 (BSL-3) is applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through inhalation route exposure. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures. All procedures involving the manipulation of infectious materials must be conducted within BSCs, other physical containment devices, or by personnel wearing appropriate personal protective equipment.  A BSL-3 laboratory has special engineering and design features.

NOTE: There are also biosafety levels for work with infectious agents in vertebrate animals. For a complete description of the animal biosafety levels, consult the BMBL. https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf

The biosafety level may be equivalent to the Risk Group classification of the agent or it may be raised or lowered based on the results of the risk assessment. If you have any questions regarding the risk assessment or appropriate containment level, you may consult with the IBC. The IBC makes the final determination of the appropriate biosafety level.

Revised 08/13/24 

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3.3 Research Including Recombinant DNA or Synthetic Nucleic Acid Molecules

In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:  

(i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;  

(ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or  

(iii) molecules that result from the replication of those described in (i) or (ii) above. 

As a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines. 

Section III of the NIH Guidelines details the type of experiments covered by the Guidelines and the level of reviewed required.   

Revised: 07/24/2024 

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3.4 Research Including Animals

MPRs which involve the exposure of animals to recombinant and/or synthetic nucleic acid molecules, infectious agents or biotoxins require review by the IBC and the Institutional Animal Care and Use Committee (IACUC) committees. This includes the generation of new strains of genetically-modified animals using transgenic, homologous recombination or genome editing approaches.   

The office allows simultaneous reviews with the IBC and IACUC committees.  However, to protect animals, the IACUC approval will not be released until IBC has approved appropriate containment conditions required for the animal experiments and animal housing.   

Both the IBC and the IACUC will review incident reports and changes in projects submitted during the course of the research.   

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3.5 Research Including Infectious Agents

Infectious agents include any biological agents and biologically derived materials that present a risk or potential risk to the health of humans or animals, either directly through infection or indirectly through damage to the environment. 

Categories of Potentially Infectious Materials

• Human, animal, and plant pathogens (bacteria, parasites, fungi, viruses, prions).
• All human blood, blood products, tissues, and certain body fluids when used in conjunction with infectious agents or recombinant or synthetic nucleic acid molecules.
• Cultured cells and potentially infectious agents these cells may contain.
• Clinical specimens.
• Infected animal and animal tissues.

Centers for Disease Control and Prevention (CDC)

The CDC has set forth an advisory document, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), regarding best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.  The IBC uses this document to conduct review of these types of projects. To address the requirements of the BMBL, the principal investigator must:

•   Limit or restrict access to the laboratory when work with infectious agents is in progress. The PI must include a determination of who may be at increased risk and appropriately limit or deny access.

•   Establish policies and procedures to limit access to those individuals who have been advised of the potential hazards and meet specific entry requirements (e.g., immunization). 

•   Ensure that laboratory personnel are offered, at no cost, appropriate immunizations or tests for the infectious agents handled or potentially present in the laboratory (e.g., hepatitis B vaccine, tuberculosis skin testing).

•   Select and provide appropriate personal protective equipment required for work with biohazardous materials. 

•   Ensure that laboratory and support personnel receive appropriate training on the potential hazards associated with the work involved, the necessary precautions to prevent exposures, the exposure evaluation procedures, and that personnel receive annual updates or additional training as necessary for procedural or policy changes.

•   Develop standard operating procedures incorporating biosafety procedures or a biosafety manual prepared specifically for the laboratory, advise personnel of special hazards, and require them to read and follow instructions on practices and procedures.

Local Requirement for Standard Operating Procedures 

For projects including infectious agents and certain viral vectors, a standard operating procedure or an applicable Biohazardous Agent Reference Document (BARD) is required as part of the MPR submission. BARDs were developed by the IBC to assist researchers in development of these procedures. Researcher may use the BARDs as written or the BARDs may be edited as applicable.  The standard operating procedure template and BARDs may be found here.

Revised: 07/24/2024 

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3.5.1 Research Including Adeno-Associated Virus

Adeno-associated virus (AAV) and recombinant adeno-associated virus (rAAV) are commonly used for gene expression with fewer associated biosafety concerns when compared to viral vectors that are persistent and able to integrate into the genome. The IBC will apply the following criteria for determining the appropriate biosafety containment and handling of AAV:  

• BSL-1 Transgene does not express an oncogene or toxin, viruses generated without helper virus, acceptable verification that helper virus is not present, or propagation in insect cell lines 

• BSL-2 Transgene that expresses an oncogene or toxin, viruses that are propagated in human cell lines without further purification before use, known presence of helper virus, or lack of acceptable verification of purification  

Registrations including rAAV must attach the Adeno-Associated Viral Vector (AAV) BARD with completed Summary of Biosafety Level Requirements for AAV Use (located on the last page of the BARD document). 

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3.5.2 Policy on Research Involving Human Materials and Cell Lines

Background 

At the present time, the UVM IBC only reviews work involving human-derived materials when used in conjunction with recombinant and/or synthetic nucleic acid molecules, infectious agents, or when used for studies involving animals.  The default position of the IBC and Risk Management & Safety has always been that human-derived materials, including primary and established human cell lines, are considered potentially infectious.  Because of the potential for contamination with blood-borne pathogens (BBPs), human materials must always be handled using containment practices required for RG-2 agents, thus requiring the use of BSL-2 containment practices for in vitro laboratory work involving human materials/cell lines or ABSL-2 containment practices when human materials/cell lines are used in animals. 

BSL-2 and/or ABSL-2 containment practices must be used for the duration of the experiment or until such time steps are taken to inactivate pathogens that may be present in the human materials (e.g., by cell/tissue fixation, extraction, etc.). 

IBC Approval of Changes in Containment Practices when Human Materials and Cell Lines are in Use

Under certain circumstances, the PI may request a reduction in biosafety level for work involving certain human materials/cell lines as part of an approved IBC registration. The following conditions must be met for the IBC to consider a reduction from BSL-2/ABSL-2 to BSL-1/ABSL-1: 

1. The PI must provide documentation demonstrating that the human materials/cell lines are certified to be free of (test negative for the presence of) BBPs.
   1. The PI must articulate the scientific and biosafety rationale for a reduction in biosafety level and the specific research activities covered by the request.
      1. This would typically involve research with established human cell lines that are 1) certified as pathogen-free, and 2) obtained from a source providing documentation indicating that the cells may be handled safely using BSL-1 containment practices.
      2. A risk assessment must be provided by the PI describing the potential health consequences to research personnel of an accidental exposure to the human materials/cell lines. The consequences must be consistent with the proposed use of A/BSL-1 containment practices.
      3. The use of established human cell lines or other human derived materials in animals (e.g., xenotransplantation studies) requires both IBC and IACUC review. The justification for a reduction to ABSL-1 containment must include an assessment of the impact of zoonotic disease transmission and the susceptibility of animal subjects to infection by human pathogens.

The UVM biosafety team will review the requested reduction and provide recommendation to the IBC for consideration. 

Roles and Responsibilities:

The Principal Investigator (PI) is responsible for: 

• Obtain IACUC and IBC approval for animal research involving human cell lines and human derived materials
• Ensure that all staff and students, including the PI, who handle human cell lines or human derived materials complete the bloodborne pathogen training
• Provide access to the Hepatitis B immunization program for employees
• Notifying OACM of implantation or injection of human cell lines/tissues into research animals by labeling cages with biohazard treatment cards with the date and time of injection

Environmental Health and Safety/Biosafety team is responsible for: 

• Oversight of the University’s Bloodborne Pathogen Program, including annual training for those conducting research with human-derived materials.
• Recommendations regarding PI risk assessment 

The IACUC is responsible for: 

• Approve research with human cell lines or human derived materials injected or implanted into laboratory animals. 

The IBC is responsible for: 

• Approve research with human cell lines or human derived materials when used in conjunction with recombinant and/or synthetic nucleic acid molecules, infectious agents, or injected or implanted into laboratory animals
• Establish biocontainment levels and special handling requirements based upon the risk assessment conducted by the BSO.  

Laboratory Animal Resources (OACM) provides: https://oacm.w3.uvm.edu/

• Provide hands-on animal handling training in the Animal Care Facilities
• Provide PPE for use by researchers
• Provide labels for use by researchers to flag animals exposed to human‐derived materials
• Provide ABSL-2 animal room access (once hands-on training has been completed)

Revised: 07/24/2024 

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3.6 Research Including Biotoxics

Biological toxins can include metabolites of living organisms, degradation products of dead organisms, and materials rendered toxic by the metabolic activity of microorganisms.  Some toxins can also be produced by bacterial or fungal fermentation, by the use of recombinant and synthetic nucleic acid molecule technology, or by chemical syntheses of low molecular weight toxins.  Protocols utilizing biotoxins must be reviewed by the IBC prior to use.  

For more information and a list of biotoxins refer to https://emergency.cdc.gov/agent/agentlist.asp

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3.7 Select Agent Program at UVM

In Winter of 2025, the sole select agent (brucella) being studied at UVM was removed from the Select Agent Toxin list, therefore UVM deregistered with the Federal Select Agent Program. 

Revised 03/28/25 

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3.8 Research Including Human Subjects

IBC will interact with the Institutional Review Board (IRB) in the review of research that includes human research participants; including, but not limited to, Recombinant DNA/Human Gene Transfer (HGT) and research with biologically derived toxins or infectious agents.  In general, the IBC advises the IRB on risk assessment and biosafety issues according to the NIH guidelines.   

Process to Obtain Approval  

Food and Drug Administration Approval 

FDA approval is required prior to any institutional review. Feasibility approvals are required from the following hospital services, regardless of sponsorship.  

• Investigational Drug Pharmacy 

• Environmental Health and Safety Department 

• Infectious Disease 

• Infection Prevention 

Each of these services lines will need to see the following materials: 

• Clinical Trial Protocol 

• Investigational Drug Brochure 

• Standard Operating Procedures for Drug Preparation 

• Standard Operating Procedures for Transport of the Drug 

• Standard Operating Procedures for Handling Drug by Clinical Staff 

IBC Review 

Once all service lines have agreed that the project can be conducted, the MPR can be submitted to the IBC for review.  Data entry of the project into Click to include the following uploads:  

• Hospital service line approvals; 

• Clinical Trial Protocol; 

• Investigational Drug Brochure; 

• Informed consent draft. 

IRB Review 

Once the IBC has provided a provisionary approval, the human subject protocol can be submitted for review by the Institutional Review Board. 

Note:  All previous requirements to obtain approval from the Recombinant DNA Advisory Committee and to register with NIH no longer exist as of August 2018. 

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3.9 Projects Involving Plants

Projects involving plants require review by the IBC committee.  Consultants may be called upon to address these types of protocols.   

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3.10 Dual Use Research of Concern & Pathogens with Enhanced Pandemic Potential

The Office of Science Policy released the US Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential in May 2024. Institutions must be following this new policy by May 6, 2025. 

This new policy combines and replaces the following three US Government policies: Policy for Oversight of Federal Life Sciences Dual Use Research of Concern (2012 & 2014), and the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (2017). 

The policy establishes that U.S. research institutions attest to the federal government that they are implementing oversight of federally funded Category 1 and Category 2 research (see section 3.10.2) in accordance with the research oversight framework under the Policy.  UVM will voluntarily apply this policy to non-federally funded research as well.  Oversight will include a new Institutional Review Entity (section 3.10.5) which will assist researchers with the proper identification of Category 1 and Category 2 research as well as assist with development, final review and approval of risk-benefit assessments; and appropriate risk mitigation plans for Category 1 and Category 2 research. 

Scope

All IBC researchers are required to make initial and ongoing determinations of the risk category to ensure compliance with the policy regardless of funding source. 

When is Determination Required?

There is more than one point when determination is required. 

• At time of research proposal submission for consideration of funding.
• At time of progress reports (continuing review).
• During the course of experimentation, as necessary.

Responsibilities Outlined in the Policy

Institution

• Establish and implement internal policies and practices that provide for the identification and ongoing oversight of Category 1 and Category 2 research and ensure Category 1 and Category 2 research is identified through appropriate Principal Investigator (PI) and Institutional Review Entity (IRE) review.
• Establish an appropriately constituted Institutional Review Entity (IRE) authorized by the institution to carry out required oversight processes as outlined in Section 3.10.3 Required Process.
• Certify at the time of seeking funding (e.g., by signing the face page of a grant application) that their research institution fully follows the research oversight framework under this Policy.
• Ensure that internal policies establish a mechanism for the PI to refer an existing project to the IRE if, at any time, the research uses a biological agent or toxin that meets the criteria as Category 1 or Category 2, or if the PI otherwise believes the project should undergo IRE review.
• Designate an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource regarding oversight of Category 1 or Category 2 research. The ICDUR serves as the liaison (as necessary) between the research institution and the federal funding agency.
• Provide education and training on research oversight for Category 1 or Category 2 research for individuals conducting life sciences research that may be within the scope of this Policy.
• Institutions should also address Category 1 or Category 2 research in existing courses on research ethics and/or the responsible conduct of research.
• Maintain records of personnel training on research oversight for at least three years after the completion of the funded project, unless a longer period is required by law or regulation.
• Maintain appropriate records of IRE reviews and completed risk mitigation plans for the term of the research grant, contract, cooperative agreement, or other agreement or transaction, plus three years after its completion, unless a longer period is required by law or regulation.
• Establish a mechanism to ensure that the resulting biological agent or toxin from Category 1 and Category 2 research are properly accounted for and destroyed when no longer needed if not already required to do so by existing law and regulation.
• Report instances of failure to follow this Policy, as well as mitigation measures undertaken by the research institution to prevent recurrences of similar failures, within 30 calendar days of research institution awareness or research institution receipt of notification of a failure to the federal funding agency.
• As necessary, assist the PIs of life sciences research when questions arise about whether their research may entail further review or oversight.
• Establish an internal mechanism for PIs to appeal institutional decisions regarding research that is determined by the IRE to meet the definition of Category 1 or Category 2 research.
• On an annual basis, provide formal assurance to relevant federal funding agencies that the research institution is operating consistent with this Policy.
• Make relevant information available to local authorities on Category 1 and Category 2 research, as appropriate.

Principal Investigator

• Be knowledgeable about and comply with or follow all applicable institutional and U.S. government policies, requirements, and regulations for oversight of biological agent and toxin research.
• Assess their research at the proposal stage, and continuously throughout the research lifecycle, to identify whether there is research reasonably anticipated to be within scope of
• Category 1 (i.e., that (1) includes one or more of the agents specified in Section 4.1.1, and (2) is reasonably anticipated to result in one or more of the experimental outcomes specified in Section 4.1.2); or within scope of
• Category 2 (i.e., that (1) involves, or is reasonably anticipated to result in, a PPP as specified in Section 4.2.1, and (2) is reasonably anticipated to result in one or more of the experimental outcomes or actions specified in Section 4.2.2).
• Following identification of potential Category 1 or Category 2 research, notify the federal funding agency and research institution, develop a new protocol registration (DURC/PPP is a new regulatory category and a separate protocol registration is required), refer the research to the IRE, and be prepared to develop a risk-benefit assessment and a risk mitigation plan.
• Work with the IRE to assess the risks and benefits of the proposed research and submit the risk-benefit assessments and draft risk mitigation plan for Category 1 or Category 2 research to the federal funding agency for review and approval when appropriate:
• If research is being proposed as part of a new funding proposal, submit the risk-benefit assessments and draft risk mitigation plan to the federal funding agency for review and approval following scientific merit review.
• If the research is being funded under an existing funding mechanism but has not yet been reviewed by the federal funding agency, then submit the risk-benefit assessments and draft risk mitigation plan to the federal funding agency for approval before conducting such work.
• If research is first identified as potentially within scope of Category 1 or Category 2 during experimentation, halt further work and work with the IRE to develop the risk-benefit assessments and risk mitigation plan for submission to the federal funding agency for further review and approval to continue.
• Conduct Category 1 and Category 2 research in accordance with the provisions identified in the risk mitigation plan approved by the federal funding agency.
• Provide annual progress reports for Category 1 research and semiannual progress reports for Category 2 research, and as requested by the federal funding agency (e.g., as part of terms and conditions of award or risk mitigation plans), for review, evaluation, assessment, and, where necessary, clarification or confirmation.
• Ensure that laboratory personnel conducting life sciences research within the scope of this Policy (i.e., those under the supervision of laboratory leadership including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) have received and maintain education and training on all research oversight policies and processes and demonstrated competency.
• Communicate Category 1 and Category 2 research in a responsible manner. Communication of research and research findings is an essential activity for all researchers and occurs throughout the research process, not only at the point of publication. When researchers are planning to communicate Category 1 and Category 2 research results, it is their duty to ensure that it is done in a responsible manner, and follows any measures outlined in the risk mitigation plan approved by the federal funding agency.

Institutional Contact for DURC (ICDUR)

The ICDUR serves as the internal resource for issues regarding compliance with and implementation of the requirements for the oversight of research that falls within the scope and/or meets the definition of DURC or PPEPs. If questions arise regarding compliance, implementation of this Policy or when guidance is needed about identifying DURC, PEPPs or developing risk mitigation plans, the ICDUR serves as the liaison (as necessary) between UVM and the relevant program officers at the Federal funding agencies. 

Education and Training

As a baseline, all researchers will be required to complete the updated CITI module that aligns with these new changes. The IBC will develop a self-determination tool, templates for risk/ benefit analysis and risk mitigation plans, and educational presentations regarding the steps needed to complete the DURC/PEPP review process. Educational sessions will be held with Sponsored Projects, researchers and departments upon request.  Researchers are responsible for protocol specific training within their labs. 

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3.10.1. Regulatory Definitions

• “Biological agents” are any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), infectious material, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious material, capable of causing:
• Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
• Deterioration of food, water, equipment, supplies, or material of any kind; or
• Deleterious alteration of the environment.
• “Biosafety” is the application of practices, controls, and containment infrastructure that reduces the risk of unintentional exposure to, contamination with, release of, or harm from pathogens, toxins, and other associated biological materials.
• “Biosecurity” is the application of security measures designed to prevent the loss, theft, misuse, diversion, unauthorized possession or material introduction, or intentional release of pathogens, toxins, biological materials, and related information and/or technology.
• “Current eradicated and extinct PPPs” include Variola major and minor, and Influenza A virus subtypes H1N1 (1918) and H2N2 (1957-1968). Any research with these PPPs is considered Category 2 because of the heightened consequences of biosafety or biosecurity incidents that could occur from directly handling or possessing such pathogens, even without any enhancement to virulence or transmissibility.  Category 2 oversight is also required for experiments that generate, use, reconstitute, or transfer an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security, regardless of whether the experiment enhances the PPP.
• “Dual use research” is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes.
• “Dual use research of concern (DURC)” is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
• “Federal funding agency” is a federal department, agency, institute, center, or office that funds or sponsors intramural or extramural research at research institutions in the United States or internationally, with biological agents or toxins where the research is within Category 1 or Category 2 under this Policy.
• “Institutional Contact for Dual Use Research (ICDUR)” is the official designated by the research institution to serve as an internal resource for application of this Policy as well as the liaison (as necessary) between the institution and the relevant federal funding agency.
• “Institutional review entity (IRE)” is the entity established by the research institution to execute the institutional oversight responsibilities of the Policy.
• “Pathogens with pandemic potential (PPP”) is defined as a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans. As a general benchmark, “wide and uncontrolled spread” typically refers to pathogens expected to exhibit sustained human-to-human transmission in a population under specific conditions, or an effective reproductive number (Rt) greater than one. Conditions that aid in transmission are
  • Relative lack of pre-existing population immunity to the pathogen,
  • Environmental stability of the pathogen,
  • Respiratory route of transmission, and
  • Lack of availability of or access to non-medical and medical countermeasures (MCMs) to contain the pathogen.

The absence of one of these conditions alone is insufficient to rule out pandemic potential. Example:  Influenza A virus subtype H1N1 (1918) is considered to have pandemic potential because it may be able to spread widely in a population despite the existence of MCMs.

The definition recognizes the devastating consequences a highly transmissible novel pathogen with only moderate morbidity and/or moderate mortality can have on public health, the health care system, and national security, like SARS-CoV-2.

• “Pathogens with enhanced pandemic potential (PEPP)” as defined in the Policy is “a type of PPP resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential.”
  • “Progenitor agent” within the PEPP definition refers to the starting pathogen of the proposed experiment, which may be a PPP in its wild-type form or a pathogen that is not considered a PPP in its wild-type form, but that when modified meets the definition of a PEPP.
• “Reasonably anticipated” describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur but excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.
• “Risk/Benefit Assessment” is developed by PI and IRE of the potential benefits and the potential risks of the proposed research in a clear and thorough manner.  This assessment will be used to develop the risk mitigation plan.
• “Risk Mitigation Plan” (RMP) is a document that describes what the PI and IRE have determined to be appropriate measures to reduce identified potential risks.

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3.10.2   Determination of Research Category

These are the time points when the research category determination is required.

• At time of proposal submission for consideration of funding.
• At time of progress reports.
• During the course of experimentation, as necessary.

To assist researchers, the IBC has developed a DURC/PEPP Self-Determination Tool. Below are expanded explanations of the criteria. 

NOTE: As you are aware, UVM uses a master protocol registration (MPR) process, however, such a one-to-many method is not recognized by our federal funding agencies.  Each new protocol, (or protocol amendment as it were at UVM), therefore, requires its own determination under this new policy. Currently, major MPR levels follow the highest biosafety level and training required for the research with separate MPRs for BSL1/2 or BSL-3. To facilitate compliance with the unique DURC requirements, research determined to be Category 1 or Category 2 will require a new, separate MPR. 

Category 1- Dual Use Research of Concern

• Involves one or more of the biological agents or toxins (A/BSL-4 and some A/BSL-3) listed in Appendix C of the Implementation Guidance (p62).
• It is reasonably anticipated to result, or does result, in one or more of the experimental outcomes listed below; and
• Based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC. 

Category 2 - Pathogens with Pandemic Potential (PPP), Pathogens with Enhanced Pandemic Potential (PEPP) & Eradicated or Extinct PPP

• Involves, or is reasonably anticipated to result in, a PPP as specified in Section 4.2.1 of the Policy (p13) and Appendix B of the NIH Guidelines (p39);
• Is reasonably anticipated to result in, or does result in, one or more of the following experimental outcomes or actions as specified below;
• Based on current understanding, the research institution, federal funding agency, and/or Departmental multidisciplinary review entity assesses that the research is reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security as specified in Section 4.2.3 of the Policy.

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3.10.3   Review Steps for both Federally funded and Non-Federally Funded Projects

Federally Sponsored Projects Steps

Below you will see a process flow provided through the implementation guidance as provided by the Office of Science Policy. We have identified each step by number and explained what needs to happen at each of the steps.

Step 1: PI Initial Assessment and Notification

1. PI must complete the DURC/PEPP Self-Assessment Tool.
2. PI will receive an outcome email determination from the tool.
3. The PI submits the research proposal including their categorization to the federal funding agency.
4. Behind the scenes, a copy of the tool outcome is forwarded to the IBC email box where IBC staff will be responsible for ensuring the IRE is notified.

Step 2: Federal Funding Agency Notification

1. If the project was deemed Category 1 or Category 2 and is likely to be funded, the funding agency will notify UVM’s ICDUR to initiate an IRE assessment of the PI’s categorization.

Step 3: Institutional Review Entity Risk Assessment

1. The PI will submit a new protocol registration to the IBC through UVMClick.
2. Ancillary reviews will be assigned to IRE members only.  Assigned reviewers will review the proposed protocol and determination of categorization for the project within 2 weeks.
3. The IBC review will not take place at this time.
4. The ICDUR will provide the IRE verification determination within 30 days to both the federal funding agency and the PI.

Step 4: Federal Funding Agency Verification

1. The funding agency will verify UVM’s categorization of the research through the UVM ICDUR.
2. If the research is found to fit one of these categories, the PI and IRE must collaborate to provide a benefit/risk assessment and risk mitigation plan for submission to the federal funding agency (step 5 below).
3. If the funding agency verifies the research does not meet Category 1 or Category 2, nothing further is required at time of proposal.  Protocol can be submitted to the IBC for review and approval.

Step 5: Risk/Benefit Analysis and Risk Mitigation Plan (Collaboration between PI and IRE) 
And
Step 6: Departmental Review of Category 2 Research

If the federal funding agency verifies the research as Category 1 or 2 the PI and IRE must develop and submit benefit/risk assessment and a risk mitigation plan for review for approval by the funding agency. The type of agency review is dependent upon the assigned category as outlined in the table below.  See Section 3.10.4 Benefit/Risk Assessment and Risk Mitigation Plan for guidance on conducting a risk assessment and developing a risk mitigation plan for consideration.

Step 7: Research Conduct and Ongoing Oversight

1. Whether Category 1 or Category 2 or neither, all research must be reviewed and approved by the IBC prior to any activities.
2. The PI is responsible for continued assessment of the research activities. The self-determination tool may be used to assist with ongoing oversight.
3. IBC regular cycle post approval monitoring visits, unless the IBC or risk mitigation plans require increased frequency of review, will be conducted and documented.
4. Additionally, categories will be reviewed at the time of annual review by the IRE/IBC.

Non-Federally Funded Projects

Non-federally sponsored projects will follow the steps outlined below.  The institution has chosen to extend this requirement to non-federally sponsored projects to safeguard public health, agriculture, food security, economic security, or national security. 

Step 1: PI Initial Assessment and Notification

1. PI must complete the DURC/PEPP Self-Assessment Tool.
2. PI will receive an outcome email determination from the tool.
3. Behind the scenes, a copy of the tool outcome is forwarded to the IBC email box where IBC staff will be responsible for ensuring the IRE is notified.

Step 2: Institutional Review Entity Risk Assessment

1. The PI will submit a new protocol registration to the IBC through UVMClick.
2. Ancillary reviews will be assigned to IRE members only for an initial verification. Assigned reviewers will review and determine categorization for the project within 2 weeks.  Notice will be sent to the PI.
3. If Category 1 or 2, the PI will develop a benefit/risk analysis and risk mitigation plan and upload it to the IBC submission.
4. Once all submission requirements have been met, the protocol registration will be placed on an IRE/IBC meeting for review.  The PI will need to be present. 

Step 3: Research Conduct and Ongoing Oversight

1. Whether Category 1 or Category 2 or neither, all research must be reviewed and approved by the IBC prior to any activities.
2. The PI is responsible for continued assessment of the research activities. The self-determination tool may be used to assist with ongoing oversight.
3. IBC regular cycle post approval monitoring visits, unless the IBC or risk mitigation plans require increased frequency of review, will be conducted and documented.
4. Additionally, categories will be reviewed at the time of annual review by the IRE/IBC.

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3.10.4  Benefit/Risk Assessment and Draft Risk Mitigation Plan (Step 5)

Benefit/risk assessments and risk mitigation plans will be required for research in Category 1 and Category 2.  The PI will initially draft these documents and submit to the IRE for discussion and review (section 3.10.5).  The PI will be an invited guest to the IRE Committee meeting where their research is being discussed. 

Benefit and Risk Assessment

The PI will be required to complete and submit through Click form “Step 5:  PI Benefit/Risk Analysis and Draft Mitigation Plan.”  The form was developed to assist the PI in assessing benefits and risks and provides guidance on how to develop an adequate risk mitigation plan.  Themes are expanded upon below.   

Points for the PI to Consider When Conducting the Benefit/Risk Analysis

• Are there other ways in which the potential benefits of the research could be achieved that would reduce the anticipated risks?
• Could the knowledge, information, products, or technologies of concern be more readily applied to improvements in surveillance, development of medical countermeasures (MCMs), or other beneficial purposes than to malevolent applications? What reasons or evidence support the answer to this question?
• What is the time frame in which potential benefits might be realized? Does it rely on other research endeavors?
• How might the potential benefits and the anticipated risks be distributed across different human, animal, and plant communities? Who or what will be the likely beneficiaries of the potential benefits? Who or what will bear the anticipated risks? Is it likely that one or more specific populations will bear the burden of the anticipated risks?
• Considering the anticipated risks along with potential benefits, are the risks of such a feasibility and magnitude that they warrant proceeding after developing and implementing a risk mitigation plan? Are the potential benefits of significant magnitude to warrant proceeding despite the risks?
• What is the most responsible way to proceed? Do measures in the risk mitigation plan effectively and measurably reduce the anticipated risk?

Risk Mitigation Plan Strategies

The PI will be required to develop a risk mitigation plan for Institutional Review Entity review.  The PI will complete and submit IBC worksheet, Step5/Part 1: PI Benefit/Risk Analysis and Draft Mitigation Plan. 

Points for the PI to Consider When Developing the Risk Mitigation Plan

Consider Standard Mitigations Already in Place

• The researchers are required by the terms and conditions of the grant or contract to adhere to biosafety and containment practices and procedures in the NIH Guidelines.
• Biosafety and containment best  practices and procedures can be found in the BMBL.
• The NIH Guidelines require that the biosafety aspects of the research be reviewed and approved (where appropriate) by an Institutional Biosafety Committee.
• The research has been reviewed for its Category 1 or Category 2 potential by an appropriately constituted IRE.
• The PI and researchers are required by the terms and conditions of the grant or contract to undergo training in the safe conduct of research with the biological agent(s) or toxin(s) in question.
• The researchers have a designated management plan for the full life-cycle of biological agent(s) or toxin(s) generated from the research; from time of creation, appropriate inventory and access controls, tracking (if transferred to or shared with third parties), and ultimate safe destruction.
• The researchers are required by the terms and conditions of the grant or contract to undergo training in the responsible conduct of research and/or research ethics as required by the institution and federal guidelines.
• The researchers are required by the terms and conditions of the grant or contract to be enrolled in an occupational health surveillance program, when appropriate.

Supplemental Risk Mitigation Measures that Can be Implemented

• Apply specific additional biosafety or biosecurity measures to more effectively mitigate the identified risk(s).
• Modify the experimental design or methodology. This might include utilizing an attenuated strain or employing other molecular/genetic containment measures that limit a strain’s ability to proliferate outside a laboratory environment or within different hosts (e.g., humans).  Careful consideration should be given as to whether the proposed modifications could affect the ability to achieve the scientific aims.
• Consideration of how the existence or absence of countermeasures should inform the design of the research and communication of its results. The existence of countermeasures may help to decrease concern about the consequences of misuse. Countermeasures may include drugs, biological products, public health practices, pesticides, or devices intended for diagnosis, detection, mitigation, prevention, or treatment.
• For research involving an agent for which there are no existing countermeasures, consider whether the research aims could be met by utilizing a strain or toxin that is sensitive to countermeasures.
• Develop a plan and methodologies for responsibly communicating the findings of the research, any time during the lifecycle of the project.  The Guidance for Responsible Communication of DURC Findings (Section F of the Companion Guide) can be used to facilitate consideration of the risks and benefits of communicating the findings of DURC and to develop a responsible communication plan.
• Determine the venue and mode of communication.
• The decision regarding communication is not necessarily a binary (yes/no) one. Rather, a range of options for communication should be identified and considered.
• Research findings are communicated at many points throughout the research process. The responsible communication of research findings should be considered at each point. 

Possible risk mitigation measures: 

• Consider changing the timing, mode, or venue of communication for the DURC in question.
• Establish a mechanism for prepublication or pre-communication review by the institution and/or the appropriate USG funding agency.
• Consider the need to redact specific information concerning security concerns.
• When communicating, emphasize the biosafety and biosecurity measures that were in place throughout the course of the research.
• Emphasize public health or broader significance. For example, describe specifically how the findings may inform the development of countermeasures, disease surveillance, preparedness, and response efforts.

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3.10.5  Institutional Review Entity (IRE)

The IRE is established to implement internal policies and practices that provide for the identification and effective oversight of DURC and Pathogen of Pandemic Potential (PPP) at the University of Vermont. 

Authority and Membership

The IRE has been given the authority by the Vice President for Research to establish and maintain a committee to execute the requirements outlined in the policy.  The committee will be composed of no less than 5 voting members, including the Chair. Members will have expertise in biology, infectious diseases, public health, ethics, and local/national security. The IRE consists of the 

• IRE Chair,
• Biological Safety Officer,
• ICDUR,
• Researcher
• Researcher 

All members of the Institutional Biosafety Committee will be alternates of the IRE.  

In addition to the voting membership, the following University of Vermont ad-hoc, non-voting members, may participate in the discussion portion of the meeting

• Principal Investigator of the study,
• University Chief Safety and Compliance Officer,
• Veterinarian,
• Police Services,
• General Counsel,
• Communications, or
• Risk Management 

The PI will always be an invited guest.

Institutional Contact for Dual Use Research (ICDUR)

The institution will delegate an ICDUR to serve as the institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of research that falls within the scope of this policy.  The ICDUR serves as the liaison (as necessary) between the institution and the relevant program officers at the USG funding agencies, or for non-USG funded research, between the institution and NIH (or the USG agency to which NIH refers the institution). 

IRE Function

The IRE will:

• Maintain sufficient breadth of expertise to assess the dual use or pathogens of pandemic potential from the relevant life sciences research conducted at the University.
• Understand risk/benefit assessment procedures and how to develop risk mitigation plans.
• Recusal of any member of the institutional review entity who is involved in the research project in question or has a direct financial interest, except to provide specific information requested by the review entity.
• Engage in an ongoing open dialogue with the PI of the research to educate and support initial and ongoing categorizations of research.
• Annually review active mitigation plans and report any changes in research or mitigation plans to the appropriate USG agency within 30 days.
• Maintain records of institutional reviews, completed risk/benefit analysis, and risk mitigation plans.

Review Procedures

Verification Requested by the Federal Sponsor

The IRE Chairs will be assigned an ancillary review to the protocol which will already be in the UVMClick protocol system.  The Chairs will review the protocol alongside the initial self-determination tool outcome to verify the initial categorization. 

That verification will be documented and submitted to the funder by the ICDUR.

Benefit/Risk Analysis and Draft Risk Mitigation Plan

Once funding has been assured, the IRE will work with the PI to establish the benefits and risks and create an appropriate risk mitigation plan that will in turn be submitted to the funder for additional critique. 

The IRE members will be assigned as reviewers within the Click system at the same time as the IBC reviewers are assigned. 

The IRE meeting will take place just prior to the IBC Committee meeting, adjourning prior to opening the IBC Committee Meeting. This will help to ensure the IBC committee has all the necessary information to conduct their review. 

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3.10.6 Procedures When Research Changes and May Result a Change in Categorization

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4.0 Subsequent Submission Requirements

Once a Master Protocol Registration has been approved, the principal investigator has the responsibility of informing the IBC of changes in PI, key personnel, reporting incidents, submitting an annual continuing review, and closing the registration when the master protocol registration is no longer needed.  Submissions are made to the IBC through the UVMClick system using the Amendment, Incident, Continuing Review, and Closure Request activities.  

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4.1 Amendment to Master Protocol Registration

Principal investigators revising a currently approved MPR must complete an Amendment smart form in UVMClick, revise appropriate smart form pages, and submit 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. 

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4.2 Addition of a New Funded Project to an Approved Master Protocol Registration

The IBC MPR is not grant specific and there is no need to submit multiple registrations for different funding sources. When a new grant is funded, an amendment to the existing MPR should be made to add the new source of funding and any new work involving biohazardous materials resulting from the approved grant. The amendment smart form should describe any new materials and any changes in research activities involving those materials. New or revised SOPs or BARDs must be submitted for review and approval as well.  

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4.3 Continuing Review of Master Protocol Registration

Annually, UVMClick-IBC will send a continuing review reminder to the principal investigator and his/her delegated proxy three months before the approval of an MPR is due to expire. Additional reminders will be sent at two months and one month prior to expiration.  The principal investigator or proxy must log into the system and complete a continuing review smart form and submit to the Committee for review.  

Once approved, the Committee will return a signed approval memo to the principal investigator.  

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4.4 Laboratory Accidents/Exposures/Spills (Incidents)

All biological exposures (i.e., life-threatening events), illness, or significant accident leading to, or potentially leading to illness or that is environmentally dangerous to humans and/or animals must be reported to the IBC as soon as possible. 

The Chair and biosafety Team a near miss.  All incidents 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 applicable, additional research committee meetings will be convened 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.  Noncompliance issues will be reviewed following the Noncompliance Policy Procedures.   

The IBC will share information about the reported event as applicable with the Office of Animal Care Management, the Institutional Animal Care and Use Committee, and the Institutional Review Board.   

The NIH Guidelines specifically require the reporting of significant problems, violations of the NIH Guidelines, or any significant research-related accident or illness by the Institution, the Institutional Biosafety Committee, or the Principal Investigator. 

The Institutional Official will report in writing, incidents that involve recombinant and synthetic nucleic acid molecules to: 

Office of Biotechnology Activities 

National Institutes of Health 

6705 Rockledge Drive, Suite 750, MSC 7985 

Bethesda, MD 20892-7985 (20817 for non-USPS mail) 

Phone: 301-496-9838 

Fax: 301-496-9839 

 Following recommendations from the IBC, the Institutional Official will inform external agencies such as the CDC, local public health department, State agencies, and funding sources about the incident and corrective actions. 

Revised: 07/29/2024 

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4.5 Closing a Master Protocol Registration

In the event that the entire registration is closing, notification must be done by completing a Closure Request activity in UVMClick. This provides an opportunity for the researcher to update the Committee with any activities and describe the disposition of any remaining biohazardous materials. The closure request will be reviewed by the IBC and the researcher will be sent an official closure letter. The UVM biosafety team  will be copied on the closure letter.

Revised: 7/24/24

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4.6 Closure of Registration and Amendments by Committee

The IBC may require that an approved registration be closed in the following circumstances:

• If the work on a research protocol has not yet begun after a three-year period.
• If it is determined the principal investigator is no longer affiliated with UVM.  In this instance, the Department Chair will be contacted to close the protocol or to assign a new PI.
• Closure may be required because of noncompliance. This would only occur after IBC review and communication with the investigator. Termination of IBC approval is reportable to the appropriate federal department or agency head and institutional officials. 

In any of the situations described above, the IBC office will notify the PI, as well as his/her department chair, of the study closure. 

Remove from Committee Consideration (registrations/amendments not yet approved)

The IBC may discard a new registration or amendment from continued consideration in the following circumstances:

• If the PI fails to respond to the IBC’s initial request for revisions and/or clarifications within 30 days post pre-review by the IBC Analyst (i.e., submission would be in clarification requested (pre-review) state.
• If the PI fails to respond to the IBC’s request for revisions and/or clarifications within 6 months post Committee review.  (i.e., submission would be in the modifications required state.

Notification of Committee Closure or Removal of Protocol

In any of the situations described above, the IBC office will notify the PI, as well as their department chair, prior to study discard or closure. 

Contact your IBC Analyst if sponsors, individuals, or processes outside of your control do not allow adherence to the response timeline criteria. Exceptions to response timeline criteria may be allowed on a case-by-case basis.

What If I Need to Reopen a Closed Protocol?

If an investigator needs to reopen a protocol after it has been formally closed with the IBC, the investigator would be required to submit a new protocol for review and approval. 

Revised: 07/24/2024 

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5.0 Investigator Responsibilities

Investigators are responsible for complying with the IBC Policies and Procedures and any additional reporting requirements specified either by the sponsor or the regulating body. For example, any project that includes animals must be in compliance with the University’s Institutional Animal Care and Use Committee.

In addition, the principal investigator’s primary responsibilities include, but are not limited to the following:

Delegation of Responsibilities

PIs must personally perform or delegate to qualified co-investigators or research staff all the necessary tasks to carry out their studies.  Even when specific tasks are delegated, the PI remains ultimately responsible for proper conduct of the study and fulfillment of all associated obligations.

Proxies are staff who are assigned by the PI to create, edit, and submit protocol materials on their behalf through the electronic protocol submission software.  Proxies have the same control as the PI. 

Proper Training and Oversight of the Research Team

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

• Reviewing with all laboratory staff the master protocol registration documents that describe the potential biohazards and the precautions to be taken (e.g., hazards and risks, immunizations, personal protective equipment required, decontamination, storage and disposal, spill procedures).
• Instructing staff in aseptic techniques and in the biology of the organisms used in the experiments so that the potential biohazards can be understood and appreciated.
• 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 the master protocol registration documents 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)
• Required web-based training: UVM has subscribed to the web-based training program, Collaborative Institutional Training Initiative (CITI). Personnel must complete the BSL-2 Basic Course in CITI and the Dual Use Research of Concern and Pathogens with Pandemic Potential..  Other required trainings as applicable to your master protocol registration, may include Animal Biosafety, Nanotechnology, or Select Agents. Web-based training is required and must be completed every three years. Reminder letters will be sent to personnel as their training expiration date nears. Reference the CITI Program Training page for additional information about required training and to check training completions.   If working in BSL3 level containment, training requirements are described in Section 9.1 and 9.2.  (NOTE: The IBC Committee will not approve key personnel until this requirement has been met.)
• Instructing and training laboratory staff in the practices and techniques required to ensure safety and the procedures for dealing with accidents.
• Informing laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested.
• Supervising the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed.
• Investigating and reporting any significant problems pertaining to the operating and implementation of containment practices and procedures in writing to the IBC, NIH/OSP (as required), and/or other appropriate regulatory authorities.
• Correcting work errors and conditions that may result in the release of these materials.
• Ensuring the integrity of the biological and physical containment (biosafety level).

Adherence to Approved Projects

It is the principal investigator’s responsibility to conduct research in accordance with an IBC approved master protocol registration and ensure adherence at all times by the research team. This includes making sure that amendments and other follow-on submissions are submitted for IBC review in a timely manner, and then once approved, any changes are implemented by the research team.

Follow-on submissions include:

• Continuing Review reports
• Adverse events or incident reports
• Amendments regular or Amendments to add new grant funded projects
• Changes to research team
• Premature closure/suspension of activities
• Final study closure.

Access to Research Records

The investigator must provide direct access to all research records to the IBC staff. Research records refers to documentation of procedures and observations and other data pertinent to the research investigation.  Dependent upon the project sponsorship there may be others with access needs, such as regulatory authorities. 

Retention of Research Records

The regulatory mandated duration for records retention varies depending on which regulations apply to the research in question. UVM investigators need to ensure that their plan for record retention complies with the federal regulations as well as UVM Records Retention policy (PDF).

Revised 03/28/25

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5.1 Study Team Member Responsibilities

Study team members are individuals carrying out research or teaching activities with biohazardous materials or an individual overseeing activities with biohazardous materials in an academic setting. Team members are responsible for: 

• Conducting activities in a safe manner and following laboratory procedures. 

• Reporting incidents to their supervisor/PI and/or the IBC. 

• Reviewing and understanding the Master Protocol Registration and its scope and safety requirements. 

• Completing applicable safety and laboratory specific training. 

• Acting as proxies on the PI’s behalf. 

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6.0 Conflict of Interest

As an academic research institution, we must continually dedicate ourselves to the integrity of the research enterprise.

IBC Members

All IBC members are required to disclose significant financial interests (SFI) in accordance with the University of Vermont Financial Conflict of Interest in Sponsored Research policy.

Selection of specific protocols for review by members is determined by the Committee's administrative staff and/or Chair. If an IBC member has a conflicting interest in a protocol (including, but not limited to being a principal investigator, a co-investigator, or a consultant on that protocol), that member may only provide information as requested by the IBC and will not be assigned to officially review nor vote on that protocol.

Investigators

Investigators are required to annually update their Significant Financial Conflict Interest Disclosure and complete training every 4 years through the CITI Program.  More information regarding COI policy and procedures can be found on UVM’s Research Integrity site. 

Revised 03/31/25

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7.0 Post Approval Monitoring

To assist the UVM research community in adopting the best laboratory Biosafety practices that help ensure a safe working environment, the UVM Institutional Biosafety Committee has adopted the practice of regularly assessing laboratories associated with an active IBC registration.  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 site visits from a UVM Biosafety Team member.   

Assessment Frequency

Assessment frequency will depend upon the level of risk associated with the laboratory work and the principal investigator’s compliance history.  In the absence of any IBC related violations, 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 IBC has the discretion to request an off-cycle assessment when concerns arise involving complex procedures, investigators who are still in training, or compliance issues. 

Process

A notice of visitation will be sent to the PI two weeks prior to the visit. RPO staff have been delegated authority by the Committee to conduct these visits, inviting IBC member(s) as needed. There are three potential outcomes:

1. Visits without concerns will be documented in a report and signed off by RPO staff as completed.
2. Visits with concerns or opportunities for improvement (no serious noncompliance) will be discussed with the PI and documented in a report to include any corrective actions. Corrective actions will be followed up at a subsequent visit as needed.  Depending upon the findings, a draft report will be reviewed by Committee leadership for additional thoughts on corrective actions.
3. Outcomes of a visit that include the potential for serious noncompliance will be managed following Policy Section 8. Procedures for Managing Noncompliance. 

Updated: 3/31/25

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8.0 Procedures for Managing Noncompliance

It is the responsibility of the Institutional Biosafety Committee (IBC) to address noncompliance with University policies and procedures.  To exercise this authority, the IBC is empowered to inspect laboratories, procedure areas, animal housing areas, and to sequester research or training records. The IBC may receive reports via external complaints, internal complaints, Incident Reports, random and directed site visits with Biosafety Risk Assessments, and investigator or laboratory worker self-reporting. The IBC encourages faculty, staff and/or students to report instances of noncompliance.

This document describes the procedures for handling these matters.  This policy is not all encompassing, and the IBC reserves the right to use its discretion in individual cases. 

Definitions

Noncompliance is defined as the conduct of research in a manner that deviates from the approved protocol or disregards or violates federal regulations and/or institutional policies. Noncompliance may result from intended or inadvertent actions or omissions by study personnel, and can range from relatively minor or technical deviations to serious deviations that threaten the safety of personnel or the environment. 

Serious Noncompliance is defined as noncompliance that, in the judgement of the IBC, potentially increases the risk of harm to personnel or the environment.

Continuing Noncompliance is defined as a pattern of noncompliance (recurring or ongoing) that, in the judgement of the IBC, may indicate an underlying deficiency in knowledge of the regulations or IBC requirements or an unwillingness or inability to comply with these regulations/requirements. 

General Noncompliance Review Procedures

The investigation of potential noncompliance begins when the IBC becomes aware of potential noncompliance. This may include an allegation (unproved assertion) of noncompliance, a self-disclosure of noncompliance, or any other indication that noncompliance may have occurred.  The process for the review of potential noncompliance involves initial administrative review, followed by an inquiry/fact finding process if indicated. Once complete, the IBC makes a determination as to whether the noncompliance is serious, continuing, or neither. The IBC determination will be documented in a summary report that contains a corrective action plan in cases of serious or continuing noncompliance. This process is detailed below, however at any point in the review process, the IBC Chair or Associate Chair, University Biosafety Officer, University Veterinarian, RPO Director or Assistant Directors, or another Institutional Representative designee may at their discretion:

• Recommend intervention for the safety of personnel or the environment
• Recommend the suspension of research activities
• Inform, involve, and/or provide salient documents to the PI, members of the research team, the Department Chair, Dean, Legal Counsel, or Institutional Officials, as appropriate
• Initiate reporting per federal regulations
• Initiate a monitoring visit
• Recommend immediate corrective actions

Process of Noncompliance Review and Determination

Initial Review of Allegation or Indication of Noncompliance: When there is an allegation or indication of noncompliance, the first step is an administrative review to determine if, in the judgement of the person(s) conducting the review, there is the potential for serious or continuing noncompliance. The initial review may be conducted by the RPO Director, RPO Assistant Director(s), an IBC Chair (Associate Chair or Chair), University Biosafety Officer, University Veterinarian or another Institutional Representative. Allegations/indications which are determined to have no potential to be serious and/or continuing noncompliance are resolved with either no follow-up (i.e. when an allegation or indication has no merit) or directly with the PI.

Inquiry/Fact Finding Process: If it is determined that the noncompliance has the potential to be serious or continuing or if questions remain following the initial review, then an inquiry (fact finding) process will begin.  The particular circumstances of the noncompliance will determine when the fact finding begins and when the committee is briefed. The fact finding may be conducted by any IBC designee including a sub-committee or subcommittee member, the RPO Director, Assistant Director(s), an IBC Chair (Associate Chair or Chair) or other Institutional Representatives. The IBC may be briefed at any point throughout the fact finding process, as deemed appropriate by the designee. The fact finding process continues until the designee has arrived at a recommendation of determination (i.e. serious noncompliance and/or continuing noncompliance, or neither). A fact finding report is then prepared and includes the recommendation of determination and draft corrective actions.  This fact finding report will be shared with the PI, and if applicable, other person(s) involved.  All parties will be provided an opportunity to respond to any factual inaccuracies within the report before the committee deliberates. 

Deliberation by the IBC: At a convened meeting, the IBC will consider all available information and make a determination as to whether the fact finding revealed serious noncompliance and/or continuing noncompliance, or neither. The following factors will be taken into consideration by the IBC or designee in making their initial determination as to whether the noncompliance is serious and/or continuing noncompliance. As each situation is unique, the indicators of noncompliance that are important in one case may not be relevant in other cases. 

Factors in the Determination of Serious Noncompliance: 

• Level of risk or potential risk to personnel or the environment
• Severity of safety violation
• Frequency or number of minor deviations or errors
• Intent
• Threat to integrity of the IBC review processes and requirements for the protection of  personnel or the environment (i.e. falsification of IBC documents)
• Other factors that, in the judgement of the IBC or designee, are relevant to the situation being reviewed.

Factors in the Determination of Continuing Noncompliance: Similarity of noncompliance to previous deviations and/or noncompliance within the same registration or across registrations if the principal investigator has more than one registration.  Likelihood that instances of noncompliance will continue without intervention

Final Determination of the IBC: If, in the judgement of the committee, the noncompliance is neither serious nor continuing, this determination will be shared with the PI. If, in the judgement of the committee, the noncompliance is serious and/or continuing.  The designee will prepare a summary report including the IBC’s determination and an approved corrective action plan.  This report will be shared with the PI, who will be given 7 days to review it before it becomes final. 

Development of Corrective Action Plans:

The IBC/Biosafety Officer/designee will develop a proposed plan for corrective actions based on the information gathered during fact-finding and input from the principal investigator and/or other affected individuals. The proposed plan may:

• Require no further action
• Require minor corrective actions to achieve compliance
• Require additional education
• Require the investigator and/or other affected individuals to develop and implement procedures to prevent recurrence
• Review internal departmental or institutional mechanisms and systems for opportunities to prevent recurrence or similar occurrences by others
• Require additional oversight (e.g., by other faculty member or department process)
• Require more frequent IBC reviews
• Require internal monitoring visits or monitoring plans
• Suspend or terminate individual protocols
• Restrict researcher’s research activities

Requests for Reconsideration

A PI may request a reconsideration of the IBC’s determination. Requests must be limited to claims that either (1) the process was faulty, resulting in considerable risk that the outcome was incorrect; or (2) that the findings and/or corrective actions imposed by the IBC were excessive or unjustified.  The written request must be submitted within 7 days of receipt of the summary report and must specify the nature of any claimed procedural error or the perceived unfairness of actions taken. Reconsiderations will be conducted by an IBC Chair (Chair or Associate Chair), Biosafety Officer, or Designee. The reconsideration process will result in one of three outcomes, either the summary report will stand and it will become final, the summary report will be modified and become final, or further investigation is necessary and will be initiated.

Required reporting

When noncompliance is determined to be serious and/or continuing, the final report will be forwarded to federal regulators as required, and to the Institutional Official, the Departmental Chair, the Dean, and sponsors, as applicable.

Guiding Principles for Noncompliance Review

Protection of Personnel and the Environment:  The University of Vermont 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. 

Fairness:   The IBC strives to maintain a review that is impartial and honest, free from self-interest, prejudice or favoritism, including member recusal if such a self-reported or identified conflict arises.   

Communication: The committee will communicate with the PI during the review process at points determined to be appropriate by the IBC designee. 

Confidentiality: All IBC discussions and documents regarding a situation of noncompliance are considered sensitive and will be handled in a confidential manner and in accordance with state and federal regulations.  The IBC cannot, however, guarantee complete anonymity to informants or witnesses. Confidentiality will be maintained to the extent possible to protect privacy and prevent retaliation, while still allowing for a full and fair review. Information may be shared, as described above under Required Reporting.

Conflict of Interest:  Any IBC member who feels that they have a conflicting interest must recuse themselves from reviewing the issue of noncompliance.  IBC members who are also listed as key personnel on the protocol(s) will not participate in the review but may be asked for information. 

Procedures: In addition to what has been stated within this policy, the Committee will follow all applicable procedures that are outlined within the Policy and Procedures document. 

Revised 03/31/2025

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9.0 Animal/Biosafety Level 3 Facility

The University of Vermont’s Animal/Biosafety Level 3 (A/BSL-3) Facility is a high-containment core facility designed for both in vitro and in vivo research requiring containment at biosafety level 3 (BSL-3) and animal biosafety level 3 (ABSL-3), to include work with select agents or toxins. Research conducted within the facility furthers the understanding and development of vaccines, diagnostics, and treatments of potentially life-threatening infectious diseases. The A/BSL-3 core is located within the Vermont Department of Health Laboratory (VDHL), adjacent to the UVM Colchester Research Facility (CRF). Use of these shared spaces is formalized in the VDH-UVM Joint Facility at Colchester Operations Agreement.  

The Vice President for Research (VPR) is the lead Institutional Official responsible for the assurance of research compliance in the biosafety area.   The VPR has delegated oversight to the Institutional Biosafety Committee (IBC).  This core is supported by the Division of Safety and Compliance’s Environmental Health and Safety Department (EH&S), Office of Animal Care Management (OACM), and the Larner College of Medicine’s (LCOM) Senior Associate Dean for Research (SAD-R).  Management authority is delegated in the Joint Agreement to the following two joint University of Vermont and Vermont Department of Health Lab committees:  

1. Joint Operations Committee: primary role consists of assessing and updating administrative protocols, development of new administrative protocols, administrative oversight for the buildings and grounds, and problem solving; and  

2. Joint A/BSL-3 Management Committee: develops and provides ongoing review of administrative, safety, and research protocols, and problem solving. Agenda items that address operational needs are voted on by the members.  The operational needs are brought forth to the VPR by the A/BSL-3 Scientific Liaison member.  Operational needs requiring VDHL assistance will be brought forth to the VDH Commissioner of Health by the VDHL BSL-3 Lab Manager member.   

Responsibilities 

The responsibilities for the appropriate conduct of research within this space are shared between UVM and VDH.  Below is an organizational chart and the responsibilities of each role. Click on the image to see an enlarged version. 

*UVM and VDH will each appoint 3 members to include BSO/RO, administrator, and one other member for a total of 6 members.
**UVM and VDH will each appoint 3 members of their choice who are affiliated with their institution for total of 6 members.

Vice President for Research 

The Vice President for Research is the lead Institutional Official at UVM that is responsible for the assurance of compliance in the biosafety area.   

Institutional Biosafety Committee (IBC) 

The UVM Institutional Biosafety Committee reviews all work with recombinant or synthetic nucleic acids in compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The IBC also reviews work with infectious agents and toxins of biological origin in compliance with the current Biosafety in Microbiological and Biomedical Laboratories (BMBL) edition, as well as work with Select Agents or Toxins in compliance with the CDC Federal Select Agent Program (FSAP) regulations. The Committee’s A/BSL-3 responsibilities include:  

• Reviewing and approving new and ongoing registrations including risk mitigation measures and procedures to be used.  Successful probationary approval of a new registration or new pathogen/toxin indicates researcher is allowed access to the facility for additional training and practice.   

• Advising core users on policies and procedures related to A/BSL-3 containment and the use of select agents or toxins.  

• Determining appropriate medical surveillance, as applicable, as part of protocol review.  

• Advising UVM administration on the suspension of access privileges for staff found to be in violation of policies and procedures governing core use.  

It is the responsibility of the IBC to recommend to the VPR pertinent safety guidelines relating to procedures and facilities used in biological research.  

Joint A/BSL-3 Management Committee 

The Joint A/BSL-3 Management Committee convenes to review all matters pertaining to the safety, security and scientific aspects of the protocols being carried out in the A/BSL-3 Facility.  The membership consists of three individuals from both UVM and VDH.  Issues that cannot be resolved at this committee level will be brought forth to the Joint A/BSL-3 Operations Committee for consideration. 

Joint Operations Committee 

The Joint A/BSL-3 Operations Committee is composed of three UVM and three VDH employees and is charged with development and review of administrative protocols relating to VDHL/CRF complex, administrative oversight for the buildings and grounds, and problem solving and joint decision making.  

UVM Larner College of Medicine 

The UVM Larner College of Medicine (LCOM) appoints a member to the Joint Operations Committee and is responsible for communicating with VDHL and to all users of the core: 

• Scheduling of planned maintenance activities. 

• Maintaining a UVM facility calendar for researchers to document when they will be using the facilities. 

• Purchasing and maintenance of shared equipment. 

Office of Animal Care Management (OACM) 

OACM Staff are responsible for the following regarding the ABSL-3 facility: 

• Regular animal husbandry tasks, including decontamination and processing of used cages. 

• Housekeeping in the animal holding rooms, anteroom, ABSL-3 corridor, and ABSL-3 decontamination room (i.e., researchers clean their individual animal procedure rooms), including safety tasks, except for those conducted by VDHL.   

• Maintenance of the cage wash area. 

• Maintenance and operation of the ABSL-3 autoclave. 

• Assistance with the safe management of biological waste in the ABSL-3. 

• Providing hands-on animal handler training to research personnel. 

• Advising researchers on animal welfare. 

Environmental Health and Safety’s Biosafety Officer (BSO) and Responsible Official (RO) 

UVM Environmental Health and Safety (EH&S), through its BSO and/or RO, is responsible for the following when A/BSL-3 research projects are proposed and active:  

BSO or RO 

• The BSO performs risk assessment and primary safety review of proposed protocols, including procedures, use of equipment, work practices, and personal protective equipment. 

• The RO has the authority and responsibility to act on behalf of the entity for the select agent program. 

• The RO may delegate duties to the Alternate Responsible Official (ARO) and others to achieve effective oversight of the UVM Select Agents Program. 

• The BSO/RO serves as member of Joint A/BSL-3 Management Committee. 

• The BSO/RO develops and updates safety, security, and incident response plans for review and approval by IBC. 

• Liaises with VDHL BSO/RO for A/BSL-3 core operations and planning. 

• Monitors facility activities for safety and compliance and implements corrective actions as necessary. 

• Consults on the safe implementation of A/BSL-3 research activities to ensure compliance with CDC, NIH, OSHA, USDA, FSAP, and state criteria.   

• Provides initial and ongoing education. 

• Works with mentors to establish and/or verify competency of new researchers.   

• Receives reports of safety and security issues, as well as reports of incidents, and works with the IBC or appropriate to correct those issues. 

• Enforces the biosafety, security, and incident response plans and associated regulations. 

• Assists with the safe shipping of biohazardous materials and transportation between laboratories. 

• Responds to incidents, emergencies, spills, etc. in accordance with Incident Response Plan. 

EH&S is also responsible for the development and implementation of occupational health services as set forth in that section of the A/BSL-3 facility Biosafety Plan. 

Scientific Liaison 

• Under the IBC, may act as senior mentor for new A/BSL-3 Principal Investigator. 

• Subject matter expert in Research Plan Feasibility and Scientific Merit Review process.   

• Provides oversight of new researchers to establish and/or verify competency along with BSO/RO. 

• Acts as Alternate Responsible Official (ARO) for select agent program. 

• Facilitates communications among all stakeholders.  

Principal Investigator (authorized users of the facility) 

The Principal Investigator (PI) has the responsibility to: 

• Ensure that all work is conducted in compliance with NIH, CDC, OSHA, and other applicable guidelines, such as FSAP regulations when working with Select Agents or Toxins, and follow the Biosafety, Security, and Incident Response Plans.   

• Identify the initial risk level and periodically reassess the risk. 

• Train, mentor and oversee the conduct of key personnel. 

• Apply appropriate safety practices and procedures within their laboratories. 

• Obtain prior IBC review and approval. 

• Obtain prior IACUC review and approval as applicable. 

• Maintain the laboratory and equipment, including housekeeping and safety tasks.  

Research Personnel (authorized users of the facility) 

Research personnel have the responsibility to: 

• Ensure that all work is conducted in compliance with NIH, CDC, OSHA, and other applicable guidelines, such as FSAP regulations when working with Select Agents, and follow the Biosafety, Security, and Incident Response Plans.   

• Learn the operating procedures for the laboratory, the potential hazards of the infectious agents in use, and emergency procedures. Help maintain the facility in good working condition.  

• Understand, through discussions with the PI and possible consultation with an occupational health provider, their personal limitations when working with these agents, report symptoms and/or illnesses suggestive of a laboratory-acquired infection (LAI), and any event that may result in an exposure or result in the creation of a potential hazard.  

• Report any irregular laboratory conditions or accidents following the Incident Response Plan. 

• Report any security issues following the Security Plan. 

• Complete the required training and mentorship and complete a competency review by the Biosafety Team and mentor. 

• Assist in the maintenance of the laboratory and equipment, including housekeeping and safety tasks.  

Vermont Department of Health Laboratory (VDHL) 

The VDHL houses the A/BSL-3 facility and is responsible for communicating to UVM: 

• Any changes in VDH policies or procedures. 

• Scheduling of planned maintenance activities in coordination with UVM. 

• Facility issues that may impact the day-to-day operations. 

VDHL personnel grant access badges to UVM personnel for facility entry. 

Research Plan Feasibility and Scientific Merit Review (for new users) 

Unity of effort between the Principal Investigator, mentor, department chair, scientific liaison, designated college official (i.e., Senior Associate Dean for Research), and Office of the Vice President for Research (OVPR) ensures successful safety, training, and research outcomes. New investigators who are interested in using the A/BSL-3 core facility must complete the New Researcher Request to Use A/BSL-3 Facility form. The completed form facilitates the following sequence of events:   

1. The Principal Investigator expresses A/BSL-3 research interest to his/her research mentor and department chair. The Principal Investigator must demonstrate a research history leading to a logical evolution to A/BSL-3 research (i.e., education, training, funding history).  Institutional technical expertise requirements are below. 

2. The department chair must assess research potential, necessary investment and training, and the Principal Investigator’s ability to meet A/BSL-3 core facility use criteria.   

3. The department chair should consult with the LCOM Senior Associate Dean for Research as part of the decision-making process.   

4. The IBC Scientific Liaison will provide a review/recommendation summary to the respective designated college official to either:  1) endorse the PI’s research plan for submission to the IBC for review, or b) provide actionable feedback to the PI to address next steps.  The designated college official will then review those research projects that are endorsed by the department chair and IBC Scientific Liaison to assess the proposed facility use and how the research fits into LCOM’s and UVM’s overall strategic plan. 

5. If the new researcher has been approved to use the facility through this process, the research project may be submitted to the IBC for review.  As part of the submission, the PI must identify a qualified A/BSL-3 research PI (scientific mentor).  

Technical Expertise Requirement 

Researchers wishing to utilize the A/BSL-3 facility must meet the minimum prior experience criteria as outlined in Section 9.1 Biosafety Level 3 Training Guidelines and Practices for Researchers.  

Pre-Entry Training Program 

Each researcher will be required to enter a training and mentoring program based upon their prior experience.  See section 14 of A/BSL-3 Biosafety Plan for further information. Training will culminate in a proficiency test by the Biosafety Team and mentor.  Once proficiency is met, applicable VDH requirements for full access will be provided to the researcher. 

Animal husbandry staff are required to complete a set of training requirements specific to their tasks prior to entering the facility.  See Section 9.2 Biosafety Level 3 (A/BSL-3) Training Guidelines and Practices for Animal Care Staff for additional information. 

Access to the Core Facility 

Use of the A/BSL-3 facility is restricted to those researchers, animal care staff, and Biosafety Team members approved for entry by the Institutional Biosafety Committee.  The IBC will review the UVM training and mentoring documentation, as well as the VDH documentation of completion of required training specific to VDH.  Researchers and animal care staff may then be able to be approved for full, independent access to the facility.  

Submitting to the IBC  

Registration for a project that involves Risk Group 3 agents requires prior IBC review and approval.  This review will be conducted by the Full Committee.  The submission requirements are the same as submissions for BSL-2 research projects and can be found on the IBC webpage.   

Risk Assessment 

As part of the Committee review, an initial risk assessment will be conducted by the Biosafety Team.  This must take place prior to work.   

Specific Types of Research Conducted in the A/BSL-3 Core Facility Requiring Additional Steps 

Select Agents and Toxins 

Select Agents are organisms or toxins that have been identified as potential agents of biological or agricultural terrorism. Institutions and individuals who possess Select Agents or toxins must be registered and cleared by U.S. Government agencies, which may include the Federal Bureau of Investigation (FBI); Centers for Disease Control and Prevention (CDC), Division of Regulatory Science and Compliance (DRSC); and/or Unites States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Division of Agricultural Select Agents and Toxins (DASAT).  

If the investigator plans to use select agents or toxins, he/she needs to work with the UVM BSO/RO and the CDC to amend UVM’s Select Agent Registration to include those agents or toxins they wish to use. Investigators must submit their research protocol to the IBC for review and approval prior to initiating the CDC registration process. For further information regarding select agents, please refer to Section 3.7 Research Including Select Agents and Toxins. 

Dual Use Research of Concern (DURC) 

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.  

Certain gain-of-function (GOF) studies with the potential to enhance the pathogenicity or transmissibility of potential pandemic pathogens have raised biosafety and biosecurity concerns, including the potential dual use risks associated with the misuse of the information or products resulting from such research. 

Projects that include dual use research of concern agents/toxins will follow the review procedures as outlined in Section 3.10 Dual Use Research of Concern. 

ABSL-3 Experimentation in Animals 

All experiments involving the introduction of infectious agents or potentially hazardous biological materials into animals must also be reviewed and approved by the UVM Institutional Animal Care and Use Committee (IACUC). 

Revised: 11/20/23

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9.1 Biosafety Level 3 (A/BSL-3) Training Guidelines and Practices for Researchers

Background Information 

Biosafety Level 3 (A/BSL-3) is applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure. Laboratory researchers and their research personnel must receive specific training in handling pathogenic and potentially lethal agents and must be supervised by scientists competent in handling infectious agents and associated procedures. The A/BSL-3 laboratory has special engineering and design features. 

The minimum requirements for a Principal Investigator to register an A/BSL-3 research program are: 

• Terminal degree (PhD and/or MD)  

• Two years of practical hands-on or oversight experience working at BSL-2 or ABSL-2 with human pathogens within the last 5 years 

• Nomination by Department Chair (provided through the Researcher Request to Use A/BSL-3 Facility Form) 

• Identify and obtain training commitment from A/BSL-3 scientific mentor 

• Completion of A/BSL-3 research training program 

• Establishment of an approved research training plan for trainees including laboratory staff and predoctoral or postdoctoral trainees. 

The minimum requirements for non-PI researchers to participate in an A/BSL-3 certification program are: 

• Bachelor’s degree in an applicable scientific discipline 

• Nomination by Principal Investigator (provided through the Researcher Request to Use A/BSL-3 Facility Form) 

Two years of practical hands-on experience working at BSL-2 or ABSL-2 within the last 5 years is preferred for all A/BSL-3 researchers.  

UVM research personnel must complete the training plans outlined below to be authorized to work in the A/BSL-3 facility located in the Vermont Department of Health Laboratory (VDHL) in Colchester, Vermont.  All personnel working in the A/BSL-3 facility must adhere to all UVM and VDHL A/BSL-3 Standard Operating Procedures (SOPs). These may include following federal regulations for CDC Select Agents and Toxins if these agents are in use in the facility by VDHL or UVM personnel. UVM personnel working with animals at animal biosafety level 3 must complete additional training, which is agent-specific, as outlined below.  

Roles 

Mentor – an individual who has previously completed the training process and has been working independently in an A/BSL-3 facility for at least 2 years.  This may be the PI of a registration, laboratory personnel, or an approved external body. 

Trainee – individual undergoing the training process to obtain access to the A/BSL-3 facility. 

Animal Care Personnel – Animal husbandry staff and veterinary support staff requiring facility access to perform job duties involving housekeeping, cage changing, animal welfare monitoring and provision of veterinary care. 

Scope of A/BSL-3 Training 

All research personnel must complete steps #1-18 as outlined on the Official Training Record for New A/BSL-3 Users for researchers new to the UVM A/BSL-3 facility. Training includes a mixture of online and in-person classroom/didactic training, orientation to the facility, and practical, hands-on training with a mentoring period.  

Animal care personnel will be provided with all general and facility-specific training, as appropriate, by an experienced ABSL-3 user, e.g., researcher, BSO or University Veterinarian. ABSL-3 training will also include all applicable ABSL-3 husbandry and animal care training, which will be provided by the OACM Facility Manager or University Veterinarian.  See separate guidance for animal care personnel.  

Mentorship Procedures 

Because experience and training can be accomplished at different rates, mentorship periods will vary in length for each trainee. Ideally, the mentor will be a UVM faculty member, researcher, or senior staff.  

If independent access is not granted after 12 months, trainees may continue to work under mentored supervision in A/BSL-3 laboratories. Trainees may also work at A/BSL-2 for an additional year and then request to receive additional training to be granted independent access for the A/BSL-3 facility. Mentors and the UVM BSO will consult with the PIs to determine the best solution on a case-by-case basis. 

Principles of Mentored A/BSL-3 Training 

The Principal Investigator (PI) of an A/BSL-3 registration is ultimately responsible for ensuring that research personnel have received the appropriate training by an approved A/BSL-3 mentor. The A/BSL-3 mentor may be the PI or an experienced, authorized A/BSL-3 facility user with full access, assigned by the PI and approved by the UVM IBC. The mentor must have at least 2 years of experience working with RG-3 agents in an A/BSL-3 laboratory. It is also recommended that the mentor have hands-on experience commensurate with the type of experiments that will be conducted by the trainee. A mentor may be assigned from the PI’s own laboratory or be obtained from another internal or external resource (e.g., different research group, external A/BSL-3 contractor).  

The UVM BSO participates in the initial orientation phase and the final validation phase of the training program as described below.  The BSO is also available for consultation during the mentoring process.  

A/BSL-3 Training Requirements 

The guiding principles and metrics of mentored training (i.e., steps #13 and #14 on the training plan checklist found in the forms section) are specified below. 

13. Complete A/BSL3 orientation/training with UVM BSO 

1. Entry 1 (Donning/Doffing and Entry/Exit) 

2. Entry 2 (Biological Spill and Emergency Responses) 

3. Entry 3 (Experimental SOPs and Specific Work Practices) 

4. There are two different training tracks.  

• General Laboratory Research (In Vitro): This track is designated for personnel that will conduct research with agents in the in vitro BSL-3 suites only. 

• Animal Research (In Vivo): This track is designated for personnel that will conduct experiments or assist with animal procedures at ABSL-3 only.  

• If researchers are conducting both in vitro and in vivo work, both tracks are required.  

Of note, Animal Research training is not required for personnel engaged in animal husbandry only. 

14a. Mentored rehearsal of A/BSL-3 procedures in an A/BSL-2 laboratory 

Option 1: Locally mentored (supervised) training 

• Personnel will follow A/BSL-3 practices and procedures but work with an RG-2 agent. Training verification will be completed using the attached worksheet to document the proficiency and competence of the trainee in A/BSL-3 work practices at A/BSL-2.  

• The number of directly supervised hours is dependent upon the individual’s combined experience and demonstrated competency and is solely at the discretion of the mentor and BSO. Disagreement between the mentor and BSO will be adjudicated through the IBC.   

• Qualifications for mentors: 

• Minimum of 2 years of A/BSL-3 experience. 

• Experienced with the specific agent the trainee will be studying or with other RG-3 agent(s) requiring similar biosafety work practices. 

• Approved to work independently in the A/BSL-3 facility. 

• Must be full time faculty, researcher, or senior staff. 

• The PI must submit an amendment to the IBC registration through UVMClick to add this new trainee and propose a mentor. The request must include a section describing all the above qualifications of the mentor. IBC approval may be granted through the IBC designated review process to allow access to the A/BSL-3 facility in a training capacity. 

Option 2: Externally mentored (supervised) training  

• In rare instances where a UVM affiliated mentor is unavailable, a non-UVM affiliated mentor may be used for A/BSL-3 training either on-site at UVM or off-site at another A/BSL-3 institution.  

• PI (or perhaps Department, LCOM) would fund the training. 

• Proposed external A/BSL-3 training must be reviewed and approved by the Policies and Procedures Subgroup of the IBC.  

• The UVM BSO will perform a UVM facility orientation with the trainee prior to the external training. 

• Certification/completion of training from the external trainers will be required. 

• This certification must include the completion of the attached BSL-3 and/or ABSL-3 training checklists.  

• An independent proficiency assessment of A/BSL-3 work practices will be completed by the UVM BSO prior to granting access.  

As an example, the Ragon Institute of MGH, MIT and Harvard provides BSL-3 training in a fee-for-service model. The portfolio of training includes the technical execution of experimental procedures. 

14b. Initial proficiency evaluation at A/BSL-2   

• Trainees will be evaluated by their approved mentor and the BSO for proficiency with microbiological techniques and procedures as applicable. 

• External mentors will be required to provide certification of competency for the trainee.  

• Evaluation will be performed to identify competence in the area described in the enclosed Techniques Evaluation Worksheet (Form A). 

• Once found competent, the trainee will move onto mentored training within the A/BSL-3 facility.   

14c.   Mentored training of research/work practices at A/BSL-3 for General Laboratory Research & Animal Research  

Trainees must be mentored and always directly supervised by an IBC approved mentor until they are proficient in all A/BSL-3 practices and procedures in the A/BSL-3 facility.  

• The mentoring period will vary for each trainee and will be determined by the mentor and BSO (typically 15-30 hours for individuals with some experience and typically 30-60 hours for individuals with no previous experience in A/BSL-3). The number of directly supervised hours is dependent upon the individual’s combined experience and demonstrated competency and is solely at the discretion of the mentor and BSO. Disagreement between the mentor and BSO will be adjudicated through the IBC.   

• Training verification will be documented by the mentor by completion of the attached A/BSL-3 Training Proficiency Certification Checklist (Form B). The trainee must demonstrate proficiency and competence in all relevant areas specified on the checklist. 

• The mentor will submit the completed checklist to the PI (if not the mentor) and UVM BSO. 

14d. Secondary proficiency assessment of A/BSL-3 work practices by the Biosafety Team  

• The BSO will independently assess the proficiency of the trainee in each of the areas specified in the Training Proficiency Certification Checklist (Form B). 

• The BSO will complete his/her section of the attached training proficiency checklist to certify the trainee has demonstrated competency in each of the areas specified in the training checklist.   

• The BSO will review the training checklists and authorize trainees to have independent access. The BSO will notify the PI and IBC when final authorization is issued. 

• The UVM BSO will coordinate with the VDHL BSO to complete final VDHL trainings and approve independent access. 

Revised: 10/03/23

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9.2 Biosafety Level 3 (A/BSL-3) Training Guidelines and Practices for Animal Care Staff

Animal care personnel will be provided all general and facility-specific training, as appropriate, by their employer, an experienced ABSL-3 user, e.g., researcher, BSO or University Veterinarian. ABSL-3 training will include all applicable ABSL-3 husbandry and animal care training.  Training completion documentation will be maintained by the Animal Care Laboratory Supervisor.   

Initial ABSL-3 Training  

Prerequisites 

• Read and understand ABSL-3 animal care specific SOPs and the Biosafety Manual  

• Candidate must enroll in Occupational Health Program and receive medical clearance to work in ABSL-3.  

General Training  

The following training will be completed, and, in some instances, staff will be required to demonstrate proficiency.   

• Overview of ABSL-3 facility 

• Layout 

• Equipment 

• HVAC system 

• Emergency equipment (shower, eyewash, spill kit) 

• Procedures for removal or maintenance of equipment  

• Entry and exit procedures 

• Building 

• Facility 

• Donning/doffing PPE  

• Animal handling  

• Bringing animals into ABSL-3  

• Cage change in BSC 

• Handling and disposal of soiled cage bedding  

• Disposal of carcasses  

• Biosafety cabinet (BSC) use 

• Preparation and decontamination of BSC 

• Cage change in BSC – buddy system and single person 

• Waste management 

• Autoclave operation for each type of biohazard waste  

• Chemical waste 

• Incident/Emergency  

• Emergency contact list 

• Spills inside BSC 

• Spills outside BSC 

• Animal escapee 

• General facility failures 

• Critical system alarms (e.g. HVAC, freezer, etc.) 

• Medical emergencies 

• Security issues  

• Case scenarios; incidents during business hours vs. after hours  

Agent Specific Training 

• Review new or updates to Agent/Protocol/Research registrations  

• Agent-specific safety data sheet (PSDS)  

• Specific animal handling precautions 

• Specific decontamination procedures 

Annual Refresher Training  

• Confirmation the following safety training courses are up to date 

• Bloodborne pathogen 

• Lab safety 

• IIPP 

• Waste management  

• Confirm ABSL-3 medical clearance is current 

Revised: 5/10/23

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9.3 New Researcher Request to use A/BSL-3 Facility

A link to the form is available below.

Request to use A/BSL-3 Facility

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