nstitutional Biosafety Committee

Organization and Responsibility

Research personnel with expertise in infectious agents, toxicology, recombinant DNA, animals, and/or human gene therapy make up most of the IBC membership. In accordance with NIH/CDC guidelines, members also include Biosafety Officers and two members who represent the interests of the community.

The UAMS Chancellor appoints committee members and a chair. The chair or chair’s designee signs off on behalf of the committee to approve biohazard safety protocols.

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Membership

IBC members include two community members, a non-doctoral member, and the UAMS Biosafety Officers. Other members have expertise in biosafety, animal science, virology, bacteriology, pathology, and (human) gene therapy.

Their membership and qualifications must comply with Sections IV-B-2-a and IV-B-2-b. Ad hoc members may be called upon for specific expertise.

Members terms are three years, which may be renewed. The UAMS Chancellor may limit or extend terms as needed.

The committee solicits nominations for membership. The Chancellor’s Office makes committee appointments, and the Chancellor appoints the committee chair.

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Submission and Meeting Schedule

Proposals to use hazardous agents in research are submitted via Muse. Send any questions to the Institutional Biosafety Committee or the Biosafety Officers.

IBC meetings are held the first Friday of the month. Only Biosafety Officers place protocols on the meeting agenda, which is set two weeks before meetings to allow for IBC member review.

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Regulations and Guidelines

1. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules , Department of Health & Humans Services, National Institutes of Health (PDF)
2. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition, Centers for Disease Control and Prevention (CDC)

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Hazardous Agents

The following items require review by the UAMS IBC:

• Infectious agents at biosafety level-2 (BL-2) or higher, including bacteria, viruses, mycotic agents, parasites, prions, and virus-shedding tumor cells.
• Highly toxic compounds.
• DNA recombination involving BL-2 or higher organisms or genes.
• Gene therapy of humans (whether or not the rDNA reagent is generated at UAMS). Under NIH Guidelines, Institutional Review Board approval of such human gene transfer clinical trials is contingent upon IBC approval
• Operating performance and SOPs of each newly-constructed or remodeled Biosafety Level 3 (BSL3) laboratory before it opens.
• Samples, tissues, or cells from humans or non-human primates.

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Muse IBC Protocol

The image below is an example protocol home page in Muse. Each Muse protocol follows this workflow.

The following sections describe the steps that occur when you protocol is in each of the states in the headings.

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Responsibilities of the Principal Investigator or Designee

Principal Investigators (PIs) are responsible for:

• Ensuring compliance with all institutional requirements, laws, and regulations for their research project.
• Ensuring safety and research compliance among all participants, staff, students, animal facility personnel, and others who may encounter their laboratory hazards through appropriate hazard notification and training
• Detailing procedures for the safe handling, storage, and disposal of hazardous agents they propose using according to IBC and OH&S guidelines. PIs may also be required to provide other information on request.
• Developing a risk assessment for each proposed project to determine containment requirements, set the required biological safety level of each project, and establish conditions they must comply with to conduct projects.
• Setting policy for the acquisition and safe handling, transfer, and storage of biohazardous agents, materials, and recombinant DNA constructs.

NOTE: PIs can assign a designee, such as a lab manager, using the PI Proxy option in Muse. However, this designation must be described in the Muse protocol, and the PI bears ultimate responsibility for all aspects of the research project.

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Forms, Manuals, and Policies

Use the Muse Protocol Checklist below as a rubric for your protocol and the following information to assist you in your protocol management.

• Muse Protocol Checklist (PDF)
• Muse Additions (Link to Microsoft Sway)
• Continuing Review Instructions (PDF)
• Amendment Instructions (PDF)

Note: Only approved protocols can be amended. Only one amendment can be submitted at a time. There are two amendment types:

• Committee Amendments: require full committee review due to scientific, hazard, class, or other experimental changes.
• Administrative Amendments: do not require full committee review. This is an expedited amendment for personnel, locations, or other administrative changes.
• Biosafety Required Trainings (PDF)
• Arkansas Children's Training Documentation
• Muse Protocol Example (PDF)

Note: More information is available on the OH&S Biological Safety Division web page. Please contact the Biosafety Officers if you need assistance inputting your protocol.

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