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Chapter 2: Institutional Biosafety Committee

    1.      PURPOSE

          West Virginia University (WVU) conducts research involving recombinant DNA (rDNA) and           receives funding from the National Institutes of Health (NIH) for at least part of this research.

          According to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid           Molecules (NIH Guidelines), an institution receiving NIH funds for rDNA research must comply           with the NIH Guidelines for all rDNA research. The NIH Guidelines also state that any institution           conducting rDNA research which is covered by the NIH Guidelines must establish an           Institutional Biosafety Committee (IBC) which will be responsible for review of that research.

          WVU has installed a Biosafety Officer (BSO) to facilitate meetings and to coordinate biosafety           activities for the entire university. The BSO also has the responsibility for conducting periodic           inspections of laboratories that use covered materials to ensure compliance with all regulations,           the NIH Guidelines and WVU policies. The IBC reports to the Vice President for Research.

  2.     RESPONSIBILITES:

          2.1.  Whole Committee

        • Review research that involves recombinant DNA, pathogens, or other biohazards, including a full risk assessment, selection of proper containment and assignment of any special provisions. The IBC may lower or raise containment within what is allowed by the NIH Guidelines based on the risk assessment.
        • Notify PIs of the results of the review.
        • Periodically review approved research.
        • Adopt emergency plans for spills or exposures.
        • Ensure that the WVU biosafety policy follows NIH Guidelines for rDNA.
        • Report any significant problems with or violations of the NIH Guidelines or any significant accidents or illnesses to the institutional official and the Office of Biotechnological Activities according to the requirements of the NIH Guidelines.

          2.2.  Individual Roles

        • Biosafety Officer- Coordinates biosafety activities for the entire university. Facilitates IBC meetings and serves as administrator of the IBC. Periodically inspect laboratories listed on IBC protocols. Submit an annual report containing the IBC roster to NIH-Office of Science Policy. Report any significant problems with or violations of the NIH Guidelines or any significant accidents or illnesses to the institutional official and the NIH Office of Science Policy according to the requirements of the NIH Guidelines.
        • IBC Chair- The IBC chair is responsible for heading the committee and leading the meetings.
        • IBC Committee Member- Responsible for reviewing and voting on protocols, providing feedback, and attending monthly meetings.
        • Principal Investigators (PI)- Responsible for submitting, amending, and renewing IBC protocols as defined in the IBC Charter. 
        • Vice President of Research- Responsible for oversight of IBC and appointing members to the committee.

3.     DEFINITIONS:

          3.1.  Institutional Biosafety Committee (IBC): An institutional committee, required by the                  NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acids, which           reviews research being conducted on all campuses involving recombinant and synthetic           nucleic acids, pathogens, toxins, wild animals, exotic pets, and human-derived materials. 

          3.2. Recombinant DNA : Molecules that are constructed outside living cells by joining natural           or synthetic DNA segments to DNA molecules that can replicate in a living cell, and the           molecules that result from the replication of those cells. This includes transgenic animals,           plants, and human gene transfer.

4.    PROCEDURE:  

          4.1. Scope of Oversight

          At WVU, the IBC is charged with review of work being conducted on all campuses involving                rDNA as well as work involving infectious agents.

          Recombinant DNA -Section Ill of the NIH Guidelines covers the different types of rDNA           research and the levels of review required for each, ranging from exempt to full review by the           NIH depending on the safety risk posed.

          Pathogens- A pathogen or infectious agent is any agent associated with disease in humans,           animals, or plants. This includes blood borne pathogens in human samples and cell lines.           There are four Risk Groups (RGs) discussed in the NIH Guidelines which generally correlate             with the biosafety levels described in the CDC publication "Biosafety in Microbiological and           Biomedical Laboratories (BMBL)".

          4.2  The Committee

          The NIH priorities of transparency and community partnership are upheld by the WVU IBC.           WVU and the IBC are committed to research that is safe for the community as well as those           doing the research.

          The committee is required to maintain at least five members with expertise in rDNA and/or           biosafety.

          WVU’s committee will be comprised of the following required members: the IBC chair, the           biosafety officer, two non-affiliated members, an animal expert, plant expert, and occupational           medicine. Additional members will ideally include lab personnel, Pl's, and experts in safety and           local health department.

        • Groups, such as OLAR or Occupational Medicine, may have multiple members on the committee.
          • The senior most ranking member of the group on the committee will serve as the primary member, with all others serving as alternate full members.
          • The senior most member attending the meeting will cast the vote for the department.

          The Vice President of Research, with advice from the biosafety officer and IBC chair, will           appoint members and select the chair of the committee.

          Committee members are appointed to a three-year term, with the option to renew.

          4.3 Meeting

          Meetings will be held monthly, in person along with a remote option, but may be more or less           frequent depending on business needs. 

          Meetings are typically held the last Monday of each month, unless it falls on a holiday.  

          A quorum requires at least 50% of voting members, either in person or participating remotely.

          The meeting must be conducted by the chair, vice chair or BSO. 

          If the type of work being reviewed requires the advice of a particular expert then this person           must be present or in rare instances, if they are unable to come in person, they may participate           by teleconference. 

          All members will have appropriate training to be able to effectively review projects. This training           will be conducted by the BSO on an annual basis. 

          Meetings are open to the public.  If you are interested in attending an IBC meeting please           contact the biosafety office. The IBC will accommodate requests when possible, in accordance           with privacy and proprietary concerns. 

          At the discretion of the Chair or BSO, confidential and/or proprietary information will be                        discussed in closed session, with a summary and voting to occur in the public session.

          A monthly meeting may be cancelled if no protocols are submitted during the month.

          4.4 Meeting Minutes

          Meeting minutes will be taken at each meeting and be posted on the WVU IBC website, once           approved. Meeting minutes, prior to June 2025, may be obtained by placing a request with the           biosafety officer or IBC chair and allowing at least two weeks for processing and, if necessary,           redaction of documents. 

          Information that may be redacted includes but is not limited to proprietary information such as           trade secrets or other intellectual property, personal information such as home phone numbers           or addresses, or information that could compromise institutional or national security.

          4.5 The Review Process:
          Anyone working with agents covered in the scope of review by the IBC must have their           research reviewed by the IBC whether the research is funded by NIH or not. This document           applies to all research areas on all WVU campuses. To initiate a review by the committee you           must submit:

        • The IBC registration form
        • Standard Operating Procedure (SOP) for any process that involves rDNA or a pathogen.
                      Note: the IBC form may require other documents to be submitted, depending on other hazards that may be                       involved in the work or as deemed necessary. 
                      
                      The documents must be sent to the biosafety officer via email. The submission email should be come from the                       primary Pl. It is fine for someone else associated with the lab to submit the forms for the primary Pl, however,                       the primary Pl must be copied on the email. A primary Pl is the Pl who is ultimately responsible for the lab space                       and thus ultimately responsible for safety. 
                    
                      Who can be a PI is defined by WVU Research Corporation General Policy 100: Principal Investigator                                    Eligibility. 

                      Proposals must be received at least 2 weeks prior to a meeting to be on the agenda for that meeting.                                        Meetings are held the last Monday of each month, unless it falls on a holiday.  
            • Submissions submitted after the 2 week deadline will be considered for the meeting agenda based on the ability of the committee to appropriately review the content and perform a risk assessment. 
                      Each proposal to be reviewed will be sent in advance to all committee members for preliminary review. The                              committee will review the material at a regularly scheduled meeting and will conduct a risk assessment based                          on the documents submitted. The committee will determine the proper containment and any other procedures                          that are deemed necessary for safety. The Pl for the lab or representatives sent by the Pl may be invited to the                          meeting to answer questions by the committee but may not be present during discussion or voting. If anyone on                        the committee, due to a conflict of interest may not be able to provide an unbiased opinion; they must be                                  excused from the discussion of the proposal in review. If someone must be excused from discussion on a                                  protocol, the minimum attendance and expertise must still be maintained using members, visitors, or ad hoc                              consultants. 
                      
                       The committee will then decide whether to approve the research. Approval requires a two-thirds vote but every                         effort should be made to gain unanimous approval. If more information is needed or if there are serious                                     problems with the proposal, the committee will notify the applicant as to what is needed and take                                               it up again at the next scheduled meeting. If there are only some small changes needed, the committee may                             approve the proposal contingent on these items being corrected. When the items are corrected, only a                                       signature from the BSO is required for full approval. If approved, a letter of approval will be sent to the                                       submitter. 

          4.6 Review types   

          As defined in the IBC Charter, the PI shall submit an IBC protocol for all research conducted on any of the campuses of           West Virginia University related to recombinant DNA, infectious agents, biological toxins, human-derived materials, wild           animals, or exotic pests.  Once approved by the IBC, the protocol is valid for three years. If any aspect of the protocol           changes within the three years, the PI shall file and amendment to the protocol with the IBC for review and approval. If           the research will continue past the three-year approval date, the PI shall file a renewal form with the IBC. If the research           is complete within the three years, the PI shall contact the IBC to close the protocol.  

                4.6.1 Approvals

                        New protocol approvals are effective for 3 years.  Protocols which only utilize screened, purchased cell lines                         can be approved by the BSO (in vitro) or BSO and veterinarian (in vivo). All other protocols require full                         committee review

                4.6.2 Renewals

                        Protocols may be renewed only by full committee review when they expire or at the discretion of the                         committee. The IBC may revoke an approval if it is determined that the research is not in compliance with NIH                         Guidelines. To renew a protocol, a complete IBC form must be submitted along with supporting documents,                         similar to a new submission. 

                4.6.3 Amendments

                        If changes are made to previously approved research, then the protocol must be amended. 

                        The Pl should make the amendment when the change occurs and not wait until the annual review. 

                        Significant Change

                        Amendments with significant changes must be reviewed by the full committee. Upon approval, a new approval                         letter and three-year expiration date will be issued.

                        A significant change would include, but not limited to: 
            • a change in research class/type or biosafety level;
            • addition of a pathogen;
            • addition of a vector type (i.e plasmid, lentivirus,lipid nano particles)
            • a major modification of a unique, non-commercial expression vector;
            • any change in an expression vector resulting in increased levels of transgene expression;
            • large changes in the nature of an inserted gene (i.e.: oncogene, virulence, origin)
            • addition or modifications to animal model
            • anything not listed in the “minor change” section below
                        Minor changes 

                        Amendments with minor changes can be approved solely by the BSO. Upon approval, the PI will be notified via                         email of the approval and the protocol expiration date will not be updated.

                        Minor changes include:
            • Additions or removal of personnel
            • Modifications to research locations
            • Addition or removal of type of human derived materials (sample type, cell line, etc.)
            • A new strain (equal or lower risk group) of a previously approved pathogen

                4.6.4 Periodic Reviews 

                Each approved project will be reviewed annually. The BSO will contact the Pl to inquire if there are any changes to                 the research. The Pl must update the IBC form to reflect any changes. The BSO will review any changes to                 determine if there is anything significant enough to require an amendment. This initial review will check not only for                 changes to the protocol but also changes in regulations, law or university policy that may necessitate changes to the                  protocol. 

5.     INSPECTIONS:

          Laboratory facilities and other areas where research under NIH guidelines is conducted will be inspected annually by           the BSO or other IBC members to ensure that work is being done at the proper containment level and in compliance           with NIH guidelines. Facilities used for research that do not fall under NIH guidelines will be inspected before IBC           approval is given for a new protocol or a protocol renewal. Inspections may be more frequent depending on the risk           level.

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