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Skip to main content Global Menu Search AcademicsAdmissionsFinancial AidStudent LifeAthleticsResearchGive AboutA–ZContactFind PeoplegoWMUVisit Secondary menuAbout A–Z Contact Find People goWMU Visit Search Main menuAcademics Admissions Financial Aid Student Life Athletics Research Give Policies Section Menu HomePolicies A-Z Committee Procedures and Submission Related Institutional Policies and CBAs Under Review Useful Resources Contact Us Policies Recombinant or Synthetic DNA Biosafety Policy Policy number17-05.7 Responsible officeResearch Enforcement officialAssociate Director Research Compliance ClassificationBoard of Trustees-delegated Policy Category17. Research and Intellectual Property Statement of policy Western Michigan University recognizes the importance of supporting a broad spectrum of research activities.  Cognizant that these activities may be accompanied by some risks, the University requires recombinant or synthetic DNA research activities be reviewed and only be conducted under the auspices of the Institutional Biosafety Committee (IBC).  This policy is in full compliance with applicable federal and state laws and regulations.  Adherence to this policy shall not exempt the research from compliance with other applicable laws, regulations or policies (e.g., research with human subjects or research with animals). Summary of contents/major changes This policy provides a clear definition of the titles and organizations with authorities and responsibilities to ensure compliance with the rules and regulations. The legal and local consequences of non-compliance are provided as well the sanctions that could be administered to individuals failing to comply with the rules, regulations, procedures, guidelines, and standard practices. No substantive changes. 1. Purpose of Policy This policy is applicable to all recombinant or synthetic DNA research or teaching activities conducted at or sponsored by or under the aegis of Western Michigan University.  No activity involving the construction or handling of recombinant or synthetic DNA molecules or organisms and viruses containing recombinant or synthetic DNA molecules shall be initiated without prior notification, and if necessary review and approval of the WMU Institutional Biosafety Committee (IBC) unless specifically exempt as described in the regulations. 2. Stakeholders Most Impacted by the Policy This policy applies to all personnel (faculty, staff, students, collaborators, visitors, and contractors) engaged in recombinant or synthetic DNA research or projects conducted under the auspices of Western Michigan University whether the research is conducted on or off campus, whether the project is funded or unfunded, or if the project includes the use of University facilities or use of  any University resources. 3. Key Definitions 3.1. Biological Agent. Biological agent shall mean infectious agents, biologically--derived toxins, and recombinant and synthetic nucleic acid molecules. 3.2. Institutional Biosafety Committee (IBC) The Institutional Biosafety Committee (IBC) is appointed by the president or delegate in accordance with National Institutes of Health guidelines and other applicable requirements and policies to review University research and teaching activities involving recombinant and synthetic nucleic acid molecules.  IBC's primary objective is to safeguard protection of personnel, the general public, and the environment. 3.3. Institutional Official (IO) University official having responsibility and authority for oversight of the IBC and application of policy compliance. 3.4. National Institutes of Health (NIH): As part of the U.S. Department of Health and Human Services, it is the principle federal agency for health research in the United States, administering numerous research projects.  3.5. Materials Transfer Agreement (MTA) A MTA is a written contract that outlines the terms and conditions of the transfer of tangible research materials between organizations. While terms and conditions may vary from one agreement to the next, the most commonly negotiated elements include: rights and ownership of intellectual property and data, publication rights, liability, and governance. MTAs cover a wide array of materials, including, but not limited to, laboratory animals, reagents, cell lines, devices, software, monoclonal antibodies, plasmids, and data. MTAs allow researchers to share tangible materials as well as receive tangible materials without necessarily having to purchase them. 3.6. Principal Investigator (PI) (as defined in NIH guidelines): A  (PI) is the lead researcher/scientist for a particular well-defined science, or other academic project who takes direct responsibility for completion of a funded or unfunded project, directing the research, and reporting directly to the sponsor, IBC, or others as required. 3.7. Recombinant or Synthetic Nucleic Acid Molecules: In the context of  NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) April 2016 recombinant and synthetic nucleic acid modules are defined as: 3.7.1. Molecules that 3.7.1.1. Are constructed by joining nucleic acid molecules and 3.7.1.2. That can replicate in a living cell, i.e., recombinant nucleic acids; 3.7.2. 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 3.7.3. Molecules that result from the replication of those described in (i) or (ii) above.  Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are not subject to this policy unless the transposon itself contains recombinant or synthetic DNA. 4. Full Policy Details 4.1. Recombinant or Synthetic DNA Biosafety Committee The Institutional Biosafety Committee (IBC) shall be comprised of no less than five members.  The Committee shall fulfill the responsibilities described in the Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH Guidelines). 4.1.1. Committee Membership: The IBC members shall be selected so that they collectively have experience and expertise in recombinant and synthetic DNA technology and the capability to assess the safety of recombinant or synthetic DNA research and to identify any potential risk to public health or the environment.  At least two members shall not be affiliated with WMU (apart from membership on the IBC) and shall represent the interest of the Kalamazoo area with respect to the health and protection of the environment. The Vice President for Research or his/her designee shall be a permanent member of the IBC. 4.1.2. Appointment of Members: Members of the IBC shall be appointed by the president or his/her designee.  A list of recommendations will be made to the president by the IBC.  Appointments should be for a period of three years (effective January 1) and initial terms should be staggered so that no more than one-third of them shall expire in any year. 4.1.3. Officers: The IBC chair shall be designated by the president or his/her designee and perform those duties normally associated with that office.  The Biological Safety Officer for recombinant or synthetic DNA (BSO) shall be designated by the president and perform the duties described in Section 4.4.3 of this policy.  The associate director research compliance shall serve as administrator and will maintain the records of the IBC. 4.1.4. Meetings  The IBC shall meet at least once annually.  A schedule of meetings shall be publicly posted.  Meetings will be open to the public whenever possible, consistent with protection of privacy and proprietary interests. A quorum for conducting business shall consist of two–thirds of current members.  At least one member not affiliated with WMU (apart from serving on the IBC) must be present.  The meetings will follow recognized parliamentary procedure. No member may participate in or be involved (except to provide information) in the review or approval of a project in which he or she has been or expects to be engaged or has a direct financial interest. When additional expertise is required, the IBC may obtain the services of consultants to provide it. 4.1.5. Reports The IBC will present an informational annual report of activity to the Vice President for Research. The Vice President for Research shall file an annual report with NIH/OBA which includes: (i) a roster of all IBC members clearly indicating the Chair, contact person, BSO/Vice-Chair, plant expert, and animal expert and (ii) biographical sketch of all IBC members (including community members). 4.1.6. IBC Records and Information: The IBC shall maintain files and records in the office of the associate director research compliance containing the following information: 4.1.6.1. The original (not a copy) project registration document submitted by the Principal Investigator for review by the IBC 4.1.6.2. Correspondence related to specific recombinant or synthetic DNA research activities 4.1.6.3. Copies of RAC, NIH/OBA and/or FDA decisions, as applicable 4.1.6.4. Proceedings related to renewal, modification, or termination of research projects 4.1.6.5. Copies of agenda and minutes of IBC meetings, along with detailed comments on projects reviewed and decisions of the IBC 4.1.6.6. Documentation of IBC membership, including credentials and training of current members 4.1.6.7. Copies of reports and correspondence related to problems, violations of NIH Guidelines, accidents, and illnesses related to research projects 4.1.7. Experimental Classes and Procedures: The different classes of experiments and particular constraints applying to each (e.g., containment requirements) are found in the Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH Guidelines).  The latest Amendment to the NIH Guidelines was published in the April, 2016 issue of the Federal Register.  The current NIH Guidelines are available upon request from the associate director research compliance or on-line ( http://www4.od.nih.gov/oba/guidelines.html ).  As these regulations are modified by subsequent agency action, those modifications shall be incorporated into this policy.  A summary description of each class of experiment and the associated required procedures are outlined in the following subsections. 4.1.7.1. Experiments that require IBC approval, Recombinant DNA Advisory Committee (RAC) review, and NIH Director approval before initiation: Experiments in this class cannot be initiated without submission of relevant information on the proposed experiment to the Office of Biotechnology Activities (NIH/OBA), the publication of the proposal in the Federal Register for 15 days of comment, review by the RAC, and specific approval by the NIH.  The containment conditions or stipulation requirements for such experiments will be recommended by RAC and set by NIH at the time of approval.  Such experiments require IBC approval before initiation.  Definitions and examples are presented in Section III-A of the NIH Guidelines. 4.1.7.2. Experiments that require NIH/OBA and IBC approval before initiation: Experiments in this class cannot be initiated without submission of relevant information on the proposed experiment to NIH/OBA.  The containment conditions for such experiments will be determined by NIH/OBA in consultation with ad hoc experts.  Such experiments require IBC approval before initiation.  Definitions and examples are presented in Section III‑B of the NIH Guidelines. 4.1.7.3. Experiments that require IBC and HSIRB approvals and RAC review before research participant enrollment: Research proposals involving the deliberate transfer of recombinant or synthetic DNA, or DNA or RNA derived from recombinant or synthetic DNA, into human subjects (human gene transfer) will be considered through a review process involving NIH/OBA and RAC. Experiments in this class cannot be initiated without submission of relevant information on the proposed human gene transfer experiments to NIH/OBA and RAC for review and approval, Investigational New Drug (IND) application submission to FDA, and application for review and approval by the IBC.  Approval must also be obtained from the WMU Human Subjects Institutional Review Board (HSIRB) and the IBC and IRB of each institution at which recombinant or synthetic DNA material will be administered to human subjects. The submission, review, and approval process is detailed in Section III-C of the NIH Guidelines. 4.1.7.4. Experiments that require IBC approval before initiation: Experiments in this class require submission of a registration document to the IBC for review and approval prior to initiation of the experiments.  Definitions and examples are presented in Section III-D of the NIH Guidelines.  Practices for the physical and biological containment for recombinant or synthetic DNA research involving plants are specified in Appendix P of the NIH Guidelines; practices for the physical and biological containment for recombinant or synthetic DNA research involving animals are specified in Appendix Q of the NIH Guidelines. 4.1.7.5. Experiments that require IBC notice simultaneous with initiation: Experiments in this class require submission of a registration document to the IBC at the time of initiation of the experiments.  Definitions and examples are presented in Section III-E of the NIH Guidelines.  Approval by the IBC prior to initiation is not required unless the IBC determines the investigator has incorrectly classified the experiments. 4.1.7.6. Experiments in this class are exempt from the NIH Guidelines:  Registration with the WMU IBC is required.  In addition, 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).  Definitions and examples are presented in Section III-F of the NIH Guidelines. 4.2. Research Facility Biohazard Warning Signs 4.2.1. Biosafety Level 1 (BL1) Facilities A biohazard sign must be posted on the entrance to the laboratory or facility whenever infectious agents are present.  The sign must include the name of the agent(s) in use and the name and telephone number of the Principal Investigator. 4.2.2. Biosafety Level 2 (BL2) Facilities  A biohazard sign must be posted on the entrance to the laboratory or facility when etiologic agents are in use.  The sign must include the name of the agent(s) in use, the biosafety level, the required immunizations, the name and telephone number of the Principal Investigator, any personal protective equipment that must be worn in the laboratory or facility, and any procedures required for exiting the laboratory or facility. 4.2.3. Biosafety Level 3 (BL3) or Biosafety Level 4 (BL4) Facilities When infectious materials or infected animals are present in the laboratory, facility, or containment module, a hazard warning sign, incorporating the universal biohazard symbol, must be posted on all laboratory/facility and animal room access doors.  The hazard sign must identify the agent(s) in use, list the names and telephone numbers of the Principal Investigator and other responsible person(s) (including the Biological Safety Officer for Recombinant or Synthetic DNA, the Animal Facility Manager, if applicable, and the Associate Director Research Compliance), and indicate any special requirements for entering the laboratory or facility, such as the need for immunizations, respirators, or other personal protective measures. 4.3. Forms and Project Registration Procedures 4.3.1. Registration for Recombinant or Synthetic DNA Research  The project registration form delineating the required relevant information for notification and/or review is available on-line or upon request from the associate director research compliance.  Project registration forms, which are obtained on-line must be completed, signed, and paper copies submitted to the associate director research compliance for review by the IBC.  It is not possible, at this time, to submit project registration forms electronically.  Project registration forms must be completed and resubmitted annually to the IBC for each project involving recombinant or synthetic DNA molecules. 4.3.2. Registration and Review Procedures 4.3.2.1. Investigators will be notified via e-mail by the IBC of the next scheduled meeting and the deadline for submission of the registration form for each project to be reviewed at that time.  This notification will include instructions to be used to access on-line forms.  The IBC will also provide each investigator with a copy of the most current NIH Guidelines (