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).
- Recombinant DNA (rDNA) as defined by the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH Guidelines).
- Dual use research of concern as defined by the Department of Health and Human Services (DHHS).
- Select agents and toxins (SAT), regulated either by DHHS or by the United States Department of Agriculture (USDA).
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 applicable regulations and 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) designated by OVPR and charged under the SAT regulations, shall be a member of the IBC.
- User group committees shall be established to manage the operations of the State Hygienic Laboratory (SHL) SAT/Biosafety level 3 (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.
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.
- An IBC member shall recuse himself/herself from participating in any aspect of the review of a research project if any one or more of the following circumstances exists:
- An IBC member holds a significant financial interest in the project.
- An IBC member is part of the project team, or has a parent, spouse, domestic partner, or child who is part of the project team.
- An IBC member holds either a subordinate or supervisory role relative to a principal investigator or co-investigator of the project that reasonably could affect his/her impartiality or the perception thereof.
- An IBC member serves as a mentor to a graduate student, post-doctoral scholar, or any other trainee involved in the project.
- An IBC member has any other personal interest or role that leads that IBC member, in his or her own best judgment, to believe that he/she lacks impartiality in relation to the project.
- 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 Institutional Review Entity (IRE) shall review rDNA research identified as Dual Use Research of Concern (DURC) in compliance with the United States Government Policy for Institutional Oversight of Life Sciences DURC and the University’s Institutional DURC Oversight Program. The results of all such reviews of DURC shall be submitted to OVPR for further consideration.
- The IBC will periodically review the University’s Institutional DURC Oversight Program.
Oversight of SAT work
- The IBC shall ensure that all experiments involving SAT comply with all SAT regulations.
- The CCOM SAT/BSL3 and the SHL 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 review and approve revisions to the laboratory safety/operations manuals, biosecurity plans, and emergency response plans for the SAT/BSL3 laboratories.
- 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 with the U.S. Federal Government all persons working with SAT as required by SAT regulations.
- The IBC shall ensure that the RO or ARO shall report immediately the release, loss, or theft of a SAT to the appropriate entities, which may include, but not be 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.
- ARO, Associate Responsible Official
- BMBL, Biosafety in Microbiological and Biomedical Laboratories (BMBL).
- BSL, Biosafety level
- CCOM, Carver College of Medicine
- DHHS, Department of Health and Human Services
- DURC, Dual use research of concern
- EHS, Environmental Health & Safety Office
- IBC, Institutional Biosafety Committee
- IO, Institutional Official
- NIH Guidelines, NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH Guidelines)
- NIH/OBA, NIH/Office of Biotechnology Activities
- NSABB, National Science Advisory Board for Biosecurity
- OVPR, Office of the Vice President for Research
- RO, Responsible Official
- SAT, Select agents and toxins
- SHL, State Hygienic Laboratory
- USDA, United States Department of Agriculture