nstitutional Biosafety Committee

Purpose and Function

The Institutional Biosafety Committee (IBC) purpose is to review and evaluate investigator-generated safety protocols for the proposed use of biohazardous agents. Based on this review, the Institutional Biosafety Committee (IBC) shall approve or disapprove the safety protocols with periodic reports to the Safety Coordinating Committee. In addition, the Biosafety Committee shall make recommendations to the Safety Coordinating Committee regarding biohazards that may exist or arise on the UAMS campus.

Organization and Responsibility

The IBC shall be composed primarily of research personnel with appropriate expertise in infectious agents, toxicology, recombinant DNA, animals, and/or human gene therapy. In accordance with NIH/CDC guidelines, membership of the IBC should also include the Biosafety Officer(s) and two members who represent the interests of the community at large. The committee members and its chairman shall be appointed by the Chancellor. The committee chairman, or his/her designee, shall be empowered to sign for the committee to approve biohazard safety protocols on appropriate institutional forms. The committee shall meet at least quarterly or as called.

Biohazardous Agents Shall Include:

• 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 the NIH Guidelines, Institutional Review Board approval of such human gene transfer clinical trials is contingent upon IBC approval.
• Reviews the operating performance and SOPs of each newly constructed or remodeled Biosafety Level 3 (BSL3) laboratory before the laboratory opens for use.
• Samples, tissues, or cells from humans or non-human primates.

Responsibilities of the Principal Investigator (Laboratory Supervisor) include:

• Principal investigators proposing the use of biohazardous agents shall formulate safety protocols, as requested by the Biosafety Committee, detailing special procedures for the safe handling, storage, and disposal of such agents and other requested information. It is the responsibility of the principal investigator to ensure that laboratory personnel, including Animal Research Facility personnel, if appropriate, are so informed.
• Develops a risk assessment for each project to determine the containment requirements for each proposed project, to set the required biological safety level of the project, and to establish conditions with which the investigator must comply to conduct the activity.
• Sets policy for the acquisition and safe handling, transfer, and storage of biohazardous agents and materials and recombinant DNA constructs.

Membership

Membership consists of two community members, a non-doctoral member, the Biosafety Officer, and other members with expertise in biosafety, animal science, virology, bacteriology, pathology, and (human) gene therapy. Membership and qualifications are in compliance with Sections IV-B-2-a and IV-B-2-b of the NIH Guidelines. Ad hoc members may be called upon for specific expertise. The membership term is 3 years and membership may be renewed. The UAMS Chancellor may limit or extend the terms as needed.

Nominations to the Institutional Biosafety Committee (IBC) are solicited by the committee. Appointment to the committee is made through the Chancellor's Office. The IBC Chair is appointed by the Chancellor.

Contacts

• IBC Protocol submission and contact: Institutional Biosafety Committee
• IBC Chairman: Jia Liu, Ph.D., Associate Professor, Department of Microbiology and Immunology
• Biosafety Officer: Kate Loyd
• Biosafety Officer: Donka Milke

Forms, Manuals, and Policies

Online IBC Protocol: Beginning January 2022, the IBC Protocol submission uses Muse to create a Safety Submission containing the IBC Protocol information. See the training links below:

• How to Upload Your Protocol in Muse (PDF document)
• Muse Protocol Checklist instructions on How to Upload Your Protocol (PDF document)

^* Additional information can be found on the OH&S Biological Safety Division web page.

Regulations/Guidelines

1. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Department of Health & Humans Services, National Institutes of Health.
2. Biosafety in Microbiological and Biomedical Laboratories, 6th Edition, U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institutes of Health, HHS Publication No. (CDC) (CDC) 21-1112

Submission and Meeting Schedule

• Proposals to use biological agents in research may be submitted to the Institutional Biosafety Committee via Muse.
• Any questions may be sent to the Institutional Biosafety Committee or one of the Biosafety Officers.
• IBC meetings are held the first Friday of the month. Proposals must be submitted in Muse, reviewed by the Biosafety Officers, and determined to be complete before the Biosafety Officer can move the protocol to 'Committee Review'. Protocols that are moved to 'Committee Review' by the third Friday of the month will be considered at the upcoming IBC meeting. Only Biosafety Officers can put protocols on the IBC Committee Agenda.
• Protocols are approved for three years, but they must be renewed yearly over the duration to maintain current IBC approval.
• Protocol amendments should be made to inform the IBC of any protocol changes occurring between yearly approvals. Only approved protocols can be amended. To amend an approved protocol go to the protocol homepage in Muse and click Create Amendment/CR. There is an expedited administrative approval process in Muse where administrative changes, such as adding personnel, can be reviewed and approved outside of an IBC meeting.