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-Announce the presence of a conflict and recuse themselves from participating inthe review of the protocol, except to provide information requested by the IBC.Leave the meeting during the discussion and the vote on any motion to approve,require changes, or disapprove the research in questions. (Note: When a personwith a conflict of interest leaves the room, they cannot be counted towardsquorum. If quorum is lost, the protocol will be tabled. Those who recusethemselves during a meeting will be identified as doing so in the minutes.)If a member is unsure if they have an actual or perceived conflict of interest with theresearch under review, the member shall inform the IBC Chair of the potential conflictprior to engaging in the review of the research. The Chair will review the potentialconflict, consulting with the Office of Research Compliance and Integrity (ORCI) asneeded, and determine if the member should recuse themselves from protocol review. Incases where the presence or appearance of conflict remains unclear followingChair/ORCI review, the member with the perceived or actual conflict of interest shallrecuse themselves from protocol review.B. Biosafety OfficerThe individual responsible for implementing the Biosafety program is the Biosafety Officer. TheBiosafety Officer has authority to stop operations that he or she considers unsafe. He or she musthave sufficient time and commitment to fulfill the duties and responsibilities appointed to ensuresafe use of biological materials.Specific duties of the Biosafety Officer include:- Reviewing all plans for proposed use of biohazardous materials and makerecommendations to the Biosafety Committee- Oversee all activities involving potentially biohazardous materials- Conduct training programs to ensure proper use from all authorized users- Supervise and coordinate the waste disposal program, including recordkeeping- Immediately terminate any unsafe condition thought to be a risk to public health or safety- Hold annual meetings with the Biosafety Committee.- Conduct periodic inspections.- Report to the IBC any significant problems, violations of the NIH Guidelines, and anysignificant research-related accidents or illnesses.- Provide advice on laboratory security- File an annual report with NIH/OBA which includes:(i)A roster of all IBC members indicating the Chair, contact person, BiologicalSafety Officer, plant expert (if applicable), animal expert (if applicable), humangene therapy expertise or ad hoc consultant(if applicable).(ii)Biographical sketches of all Institutional Biosafety Committee members(including community members).C. Principal Investigator/Laboratory Supervisor/Clinic SupervisorA Principal Investigators/Lab and Clinic Supervisors are people whose training and experiencehave been reviewed and approved by the IBC and use or directly supervise the use ofbiohazardous agents. Their primary responsibility is to ensure that biological materials used inhis or her particular lab or clinic are used safely and according to regulatory requirements.These individuals must have adequate and appropriate training to provide reasonable assurancethat they will use the material safely, including maintaining security of, and access to, hazardous8

material, and respond appropriately to events or accidents involving licensed material to preventthe spread of contamination. In addition they must procure and maintain adequate funding forappropriate safety supplies and lab termination.Upon approval, the authorized user shall have the following responsibilities:-Ensure that operations involving biologically hazardous materials are performed only bypersonnel who have been properly instructed and authorized.Ensure that appropriate precautions are taken for workers under their supervision.Follow proper procedures for procurement of biological materials.Provide correct and current posting and labeling of laboratory areas and biohazardcontainers.Ensure an accurate and current inventory records for all biohazard materials under his orher responsibility.Follow established procedures for biohazardous waste.Report immediately any potentially hazardous spills, exposures, loss of biologicalmaterials, or other incidents having possible biological safety implications.Provide adequate use-specific safety training for all workers under their supervision.Provide adequate security for biohazardous agents.Notify the Biosafety Officer of changes in the use, location or quantities of biohazardousagents.Arrange for disposal or transfer of all biohazardous waste promptly upon termination ofthe authorized use or application.Attend meetings, assist with safety audits, and provide documentation as required by theBiosafety Officer.Maintain each controlled area in a way that is both considerate of other users andeliminates risks to maintenance, janitorial, and security personnel if they are required toenter an unoccupied space.Maintain an inventory of all biohazardous agents.9

III.Biosafety Approval ProceduresAll research and coursework at GVSU using biohazardous/potentially biohazardous materials aresubject to review and approval by the Institutional Biosafety Committee. Principal Investigators,Department Heads, or any others wishing to use the biological agents covered in this manual mustfirst notify the Biosafety Officer well in advance of the proposed use.Individuals wishing to work with biological agents must do the following:1. Read, be familiar with, and follow the procedures outlined in this manual.2. If the agent fits one of the categories in Section I of this manual, submit a “GVSUBiosafety Application” to the Biosafety Officer prior to procurements of the biologicalagents.3.Submit with the “Application” a current curriculum vitae. The curriculum vitae shouldinclude practical experience in physically working with biological materials.The IBC will approve proposals only if convincing evidence is provided that the user iscompetent in performing all applicable phases of the proposed experiments. If, after reviewingthe proposal and supporting information, members have questions about the safety of theproposed use, they may require a personal interview with the applicant for specific details of theexperiment and/or ask that the user first make trial runs of the experiment using nonhazardousmaterials. A proposal may be approved for a period of 1 to 5 years as determined by the IBC.Subsequent approvals may be granted for a longer period, but never to exceed 5 years. Certainacademic coursework may be provided with approvals for an indefinite period. Approvals will bedocumented as part of the minutes of the meeting, unless certain conditions or modifications weremade as part of the approval, in which case written notification will be provided.Non-compliance with the provisions of this manual, the conditions of the protocol approval,requests from the IBC, or NIH requirements or any other condition that may result in substantialrisk to human health, property damage, reputational harm, or legal liability as determined by theIBC may result in termination of the approval to conduct research with biological materials orremoval of access to research space.A. Biological agents or potentially biologically hazardous materialAll work involving potentially infectious biological agents is subject to review by the IBC and iscovered by this Manual. The application form can be found at www.gvsu.edu/biosafety. IBCprotocol review and approval are required for all biological agents in Risk Group 2 and/or thosethat may require Biosafety Level 2 (BSL2). Projects requiring Biosafety Level 3 (BSL3) andBiosafety Level 4 (BSL4) are currently prohibited at GVSU.If the biological materials are identified as not requiring full IBC approval (RG 1/BSL 1) by thismanual, use may begin immediately upon approval of the Biosafety Officer or IBC Chair.Applications not requiring full IBC review do not expire, but are subject to revocation in theevent of substandard safety practices. Approved users must submit a new registration whenthere are changes to the use, location or types of biological materials or other circumstancesthat may increase the hazards. Users also must maintain a current inventory and anyadditional data necessary to verify the hazards associated with the agent.10

Guidelines for determination of biosafety levels can be found in the Centers for Disease Controlpublication Biosafety in Microbiological and Biomedical Laboratories. The NIH Guidelinesestablished a classification of human infectious agents into four “risk groups” on thebasis of hazard. These descriptions generally correlate with, but do not equate to,biosafety levels. A risk assessment will determine an agent’s biosafety level. RiskGroups (from NIH Guidelines) and Biosafety Levels (from CDC Biosafety) are definedbelow:Risk Group 1Agents not associated withdisease in healthy adulthumans.Risk Group 2Agents associated with humandisease that is rarely seriousand for which preventive ortherapeutic interventions areoften available.Risk Group 3Agents associated with seriousor lethal human disease forwhich preventive or therapeuticinterventions may be availableRisk Group 4Agents likely to cause seriousor lethal human disease forwhich preventive or therapeuticinterventions are not usuallyavailableBiosafety Level 1Biosafety Level 1 is suitable for work involving well-characterized agents notknown to consistently cause disease in immunocompetent adult humans, andpresent minimal potential hazard to laboratory personnel and the environment. BSL1 laboratories are not necessarily separated from the general traffic patterns in thebuilding. Work is typically conducted on open bench tops using standardmicrobiological practices. Special containment equipment or facility design is notrequired, but may be used as determined by appropriate risk assessment. Laboratorypersonnel must have specific training in the procedures conducted in the laboratoryand must be supervised by a scientist with training in microbiology or a relatedscience.Biosafety Level 2Biosafety Level 2 builds upon BSL-1. BSL-2 is suitable for work involving agentsthat pose moderate hazards to personnel and the environment. It differs from BSL-1in that:1. laboratory personnel have specific training in handling pathogenic agentsand are supervised by scientists competent in handling infectious agentsand associated procedures;2. access to the laboratory is restricted when work is being conducted; and3. all procedures in which infectious aerosols or splashes may be created areconducted in BSCs or other physical containment equipment.Biosafety Level 3Facilities not available at GVSUFacilities not available at GVSUBiosafety Level 4B. Human and Nonhuman Primate Blood and TissueHuman blood, tissue, cell culture, and certain other body fluids are considered potentiallyinfectious for bloodborne pathogens such as hepatitis B, hepatitis C, and humanimmunodeficiency virus. Work with human material is also regulated OSHA’s BloodbornePathogens Standard (29 CFR 1910.1030). In addition, non-human primates and their tissues poserisks of disease that may be transmissible to humans.The following are requirements for the use of human and non-human primate blood and tissueproducts:1. Complete the GVSU Biosafety Application and receive approval from the IBC.11

2. All research and academic staff as well as any other employees of GVSU with potentialto exposure to human blood must be trained in the hazards of bloodborne pathogens and‘Universal Precautions”.3. Comply with all other applicable provisions of OSHA’s Bloodborne Pathogen Standard.C. Recombinant DNABiosafety Committee will use NIH GUIDELINES FOR RESEARCH INVOLVINGRECOMBINANT DNA MOLECULES (NIH Guidelines) to determine what types of research willneed only to be registered and those that will require IBC review and approval. Informationbelow is taken from the NIH guidelines. For more information consult the full text at NationalInstitutes of Health Office of Science Policy, Office of Biotechnology ds/NIH Guidelines.pdf).i.Covered Recombinant DNAPrior to conducting work as described below, Biosafety Committee review and approvalis required1. Experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or RestrictedAgents as Host-Vector Systems2. Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, orRestricted Agents is Cloned into Nonpathogenic Prokaryotic or LowerEukaryotic Host-Vector Systems3. Experiments Involving the Use of Infectious DNA or RNA Viruses or DefectiveDNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems4. Experiments Involving Whole Animals5. Experiments Involving Whole Plants6. Experiments Involving More than 10 Liters of Culture7. Experiments Involving Influenza Viruses8. Experiments Involving the Formation of Recombinant DNA MoleculesContaining No More than Two-Thirds of the Genome of any Eukaryotic Virus9. Experiments Involving Transgenic Rodentsii.Exempt Recombinant DNAThe following recombinant DNA molecules are exempt from full approval of thebiosafety committee, but require registration.1. Those that are not in organisms or viruses.2. Those that consist entirely of DNA segments from a single nonchromosomal orviral DNA source, though one or more of the segments may be a syntheticequivalent.3. Those that consist entirely of DNA from a prokaryotic host including itsindigenous plasmids or viruses when propagated only in that host (or a closelyrelated strain of the same species), or when transferred to another host by wellestablished physiological means.12

4. Those that consist entirely of DNA from a eukaryotic host including itschloroplasts, mitochondria, or plasmids (but excluding viruses) when propagatedonly in that host (or a closely related strain of the same species).5. Those that consist entirely of DNA segments from different species thatexchange DNA by known physiological processes, though one or more of thesegments may be a synthetic equivalent. A list of such exchangers will isavailable from National Institutes of Health.6. Those that do not present a significant risk to healthD. Select AgentsA US Government multi-agency program has established the “National Select Agent Registry”.The Registry includes biological agents and toxins have been determined to have the potential topose a severe threat to both human and animal health, to plant health, or to animal and plantproducts. The Animal and Plant Health Inspection Service (APHIS) and the Centers for DiseaseControl and Prevention (CDC) have established regulations for using Select Agents.All research involving the use of a Select Agent must be approved by the biosafety committeeprior to initiating the research. In most cases, GVSU does not have the facilities to accommodateSelect Agent use.13

IV.TrainingBefore beginning work with biohazardous agents, Authorized Users must receive biosafetytraining commensurate with their assigned duties (in addition to Lab Safety Training). Studentsenrolled in classes involving biohazards may do so only if biological safety instruction isprovided as part of the coursework, clearly identified in the syllabus and is given by anAuthorized User, the Biosafety Officer, or an individual approved by the IBC.A. Biosafety TrainingAll researchers using RG 2 agents and/or recombinant DNA must complete general biosafetytraining. Training will be conducted either through classroom sessions or online modules. Thepurpose of this training is to f

- Conduct training programs to ensure proper use from all authorized users - Supervise and coordinate the waste disposal program, including recordkeeping - Immediately terminate any unsafe condition thought to be a risk to public health or safety - Hold annual meetings with the Biosafety Committee. - Conduct periodic inspections.