The University of Iowa is committed to the safe, legal, and ethical use of biological materials in its facilities. Acting as an agent for the University in regulating work involving such materials, the Institutional Biosafety Committee (IBC) shall ensure that work in the following four categories (the “Covered Work”) meets all applicable safety, legal, and ethical requirements:
- Work involving biological agents, including but not limited to, those agents in all risk groups defined in Biosafety in Microbiological and Biomedical Laboratories (BMBL)1
- Recombinant DNA (rDNA) as defined by the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)2
- Dual use research of concern as defined by the National Science Advisory Board for Biosecurity [NSABB, Department of Health and Human Services (DHHS)]3
- Select agents and toxins (SAT),4 regulated either by DHHS5 or by the United States Department of Agriculture (USDA)6
Part A. Name, Authority, and Formation
- The Office of the Vice President for Research (OVPR) and the Institutional Official (IO), designated and charged by the University President, have established the IBC, and the IO has the authority to appoint members to the IBC.
- OVPR and the IO have charged the IBC with the responsibility and authority to regulate the Covered Work. The IBC shall base its decisions and actions related to Covered Work on regulations and applicable guidance documents referenced above, The University of Iowa’s Biological Safety Manual, and other documents describing good laboratory practices.
- The IBC shall report to the IO regarding regulatory matters related to the Covered Work.
- The IBC membership shall be consistent with the NIH Guidelines.
- The Responsible Official (RO) and Alternate RO (ARO), designated by OVPR and charged under the SAT5 regulations, shall be members of the IBC.
- User group committees shall be established to manage the operations of the University Hygienic Laboratory (UHL) SAT/BSL3 facility and the Carver College of Medicine (CCOM) SAT/BSL3 facility.
- The user group committees shall operate under and report to the IBC.
- Membership of the user group committees shall consist of current or previous users of the facilities, in addition to the RO, the ARO, and in the case of the CCOM user group committee, a veterinarian. Efforts shall be made to ensure that together the members of each user group committee are knowledgeable regarding the range of microorganisms or toxins being studied in the facility it manages.
CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, U.S. Government Printing Office, Washington DC, 5th edition, 2007 (http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm).
Part B. IBC Administrative Aspects
- The IBC shall meet as often as necessary to address issues regarding the Covered Work.
- Administrative support for the IBC shall be provided by the Environmental Health & Safety Office (EHS) biosafety staff.
- An IBC meeting shall only be convened when a quorum (greater than 50% of the members) is present.
- When an IBC member has a conflict of interest as defined by University policy relating to a matter before the IBC, he/she shall make the conflict known and recuse him/herself from the consideration of that matter.
- The IBC shall consider in its deliberations and base its decisions relating to the Covered Work on the BMBL, the NIH Guidelines, SAT regulations, NSABB documents, the University of Iowa Biological Safety Manual, and other relevant external and internal reference documents.
- The IBC shall review all Covered Work directly, or through EHS biosafety staff who report summaries of their findings to the IBC, at least on an annual basis to ensure compliance with applicable regulations.
- Administration of the user group committees
- The user group committees shall meet as often as necessary to review and approve proposals for experiments prior to their being initiated, and to address other issues regarding the use of their respective facilities.
- The user group committees shall meet at least annually to review, and when appropriate revise, the facilities’ procedural documents.
Part C. Responsibilities of the IBC
The IBC shall ensure through the following actions that the Covered Work performed at the University meets all applicable safety, legal, and ethical requirements:
- The IBC shall make recommendations to the IO and develop proposals for policies regarding Covered Work that shall be reviewed and approved by the IO prior to implementation.
- The IBC shall educate the University community and other stakeholders regarding requirements relating to the Covered Work.
- The IBC shall maintain cooperative relationships with persons involved in the Covered Work.
- The IBC shall develop and implement appropriate administrative procedures for regulating the Covered Work.
- The IBC shall ensure that the annual report containing the IBC roster is filed in a timely manner with National Institutes of Health/Office of Biotechnology Activities (NIH/OBA) by the IO as required under the NIH Guidelines.
Specific Covered Work:
- Work involving biological agents, including but not limited to, those defined in BMBL
- The IBC shall establish, directly or through EHS biosafety staff, and/or adopt by reference, institutional procedural guidelines to ensure the safe possession and use of biological agents.
- The IBC shall establish containment levels for projects involving biological agents where formal containment levels have not been established. In such instances, the process for establishing a containment level may be initiated through submission of a Biohazard Agent Use Review form by a person who will be involved in the proposed experiments, a member of the IBC, or EHS biosafety staff.
- Recombinant DNA research
- The IBC shall ensure that all research involving rDNA complies with the NIH Guidelines.
- Dual use research of concern
- The IBC shall ensure that all dual use research of concern complies with guidance promulgated by the NSABB.
- Oversight of the SAT work
- The IBC shall ensure that all experiments involving SAT comply with all SAT regulations.
- The IBC shall review and approve revisions to the laboratory safety/operations manuals, biosecurity plans, and emergency response plans for the SAT/BSL3 laboratories.
- The CCOM SAT/BSL3 and the UHL SAT/BSL3 user group committees shall prepare and revise as needed their respective procedural manuals required under SAT regulations and submit these manuals to the IBC for review and approval. The committees also shall review and approve proposals for working with SAT or other BSL3 organisms in their respective facilities.
- The IBC shall make certain that the RO and ARO have the authority to ensure compliance with SAT regulations, and that to this end the RO and ARO conduct annual compliance audits of the laboratories authorized to possess, use, and store SAT. The IBC shall ensure that any compliance deficiencies are corrected in a timely manner.
- The IBC shall ensure at least on an annual basis that the RO or ARO has registered all persons working with SAT as required by SAT regulations.
- The IBC shall ensure that the RO and/or ARO shall report immediately the release, loss, or theft of a SAT to the appropriate entities, including but not limited to the IBC Chair, DHHS, the Iowa Department of Public Health, Johnson County Public Health, as well as the Federal Bureau of Investigation (FBI) and the University Police (if theft is involved) as mandated by the applicable regulations.