Institutional Biosafety Committee Charter
(Approved 09/23/2010---Revised 08/12/2013)
The Institutional Biosafety Committee is charged by the Vice Chancellor for Research to provide oversight of all research involving recombinant or synthetic nucleic acid molecule technology in compliance with National Institutes of Health (NIH) Guidelines. The Committee is further charged with oversight of research involving biohazardous material to protect public health and the environment.
In accordance with NIH Guidelines (IV-B-2), the Committee shall be constituted as follows:
- There shall be at least five members, selected so that they collectively have experience and expertise in recombinant and synthetic nucleic acid molecule research and to identify any potential risk to public health or the environment.
- At least two members shall not be affiliated with MU, and who represent the interest of the surrounding community with respect to health and protection of the environment.
- At least one member shall have expertise in plant, plant pathogen, or plant pest containment principles.
- At least one member shall have expertise in animal containment principles.
- At least one member shall have human gene transfer expertise (ad hoc consultant as needed).
- The Director of the Office of Animal Resources shall be a member.
- The MU Biosafety Professional shall be a member.
- Unless otherwise specified, appointment term is for three years and will be renewed annually.
- The Vice Chair may assume any of the Chair responsibilities when the Chair is not available.
- Each voting committee member should recommend one alternate member. The alternate will be called upon and will have full voting rights when substituting during the regular committee members absence.
The Committee shall:
- Determine the appropriate biosafety containment level for each research protocol.
- Review all new and modified research protocols involving the use of recombinant or synthetic nucleic acid molecues, infectious agents, and select agents (as defined by CDC and USDA). Different levels of review will be used depending on the potential hazards.
- Notify Principal Investigators of the results of each research protocol review.
- Conduct periodic reviews of all research protocols involving the non-exempt use of recombinant or synthetic nucleic acid molecules to ensure compliance with NIH Guidelines.
- Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant and synthetic nucleic acid molecule research.
- Investigate any research-related accidents or illnesses involving potential biological hazards and file reports, as required, with the NIH Office of Biotechnology Activities.
- Investigate allegations of noncompliance with NIH Guidelines or other unsafe acts.
- Provide a forum for development and modification of campus biosafety policies.
Principal Investigator Responsibilities
Principal Investigators shall comply with the NIH Guidelines and:
- Submit new and modified (renewal or amendment) research protocol applications to the Committee as required.
- Not commence research on new or modified protocols prior to the receipt of written approval from the Committee for protocols falling under Sections III-A, III-B, III-C, or III-D of the NIH Guidelines.
- Participate in the annual review of each of their research protocols involving the use of recombinant or synthetic nucleic acid molecules.
- Ensure they and all laboratory staff are appropriately trained including, at a minimum: containment methods, disinfectant and disposal practices, utilization of personal protective equipment, and required actions in the event of a spill.
- Ensure required safety practices and techniques are employed.
- Comply with all other requirements of the IBC approval, inspections and MU Biosafety program as outlined in the MU Biosafety Manual.
General Committee Procedures
- Meetings shall be held regularly. Additional meetings may be called as required.
- A quorum consists of fifty percent of the Committee membership plus one.
Research Protocol Review Procedures
- Protocols involving a) non-exempt recombinant or synthetic nucleic acid molecule research and b) other biohazardous material (as defined in Section 1.2 of the MU Biosafety Manual).
- These protocols shall be reviewed by the full committee and discussed at a Committee meeting. Protocols may be approved, conditionally approved, or disapproved. Approval is by majority vote of those present.
- Protocols involving blood borne pathogens.
- These protocols shall be reviewed by the Chair and the Biosafety Professional. Protocols may be approved, conditionally approved, or disapproved. Approval is a joint decision of the Chair and the Biosafety Professional. The Chair shall report on the results of these reviews to the full committee. Any member may request a full committee review of a protocol.
- Protocols involving a) exempt recombinant or synthetic nucleic acid molecule research, b) non-recombinant synthetic nucleic acid molecule BL1 classification research and c) other non-research BL1 operations.
- These protocols are reviewed by the IBC Chair and Biosafety Professional, but are not subject to full Committee review.
- Protocol modification
- Major modifications or renewal protocols require a new protocol application and full Committee review and approval.
- Minor modifications require amendment with review and approval by the Chair and the Biosafety Professional.
- Protocols containing proprietary information.
- Principal Investigators who believe that their research protocols contain proprietary information shall identify such research in writing to the Chair and the Biosafety Professional at the time the protocol is submitted for review. Grounds for classifying information as proprietary include, but are not limited to: new and/or novel ideas; it is specified as such in a written contract or agreement; new commercial uses of a process, device or chemical; and potentially patentable items.
- Protocols identified as containing proprietary information may be discussed in closed session. Records of votes and discussion that do not reveal the proprietary information will be maintained.
Principal Investigators who disagree with Committee decisions may request an audience at a Committee meeting. Should there still be disagreement; the Principal Investigator may appeal to the Vice Chancellor for Research, who shall make the final decision.