Institutional Bio-Safety committee

Life sciences research involving the use of 1 of the 15 agents/toxins identified in section 6.2.1 of the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) is subject to DURC compliance requirements, regardless of funding source(s) supporting the research. At UWL, the institutional review entity for qualifying research is the IBC. Researchers whose work involves one or more of these agents/toxins must contact the IBC chair to receive guidance on fulfilling DURC-related training and other compliance requirements. DURC requirements must be fulfilled before work on qualifying research commences. Additional information can be found at the Public Health Emergency DURC policy training.

University of Wisconsin-La Crosse faculty and staff are responsible for observing safe practices when handling hazardous biological materials in teaching and research. These materials include but are not limited to the following: pathogenic microorganisms, exotic species, toxic chemicals, human blood, body fluids and tissues, and supplies and equipment used with such substances. In addition, all sharp and hazardous glass and plastic, whether contaminated or not, require careful handling and appropriate disposal.  

Principal investigators, instructors and laboratory supervisors have an additional obligation to instill in their students and laboratory assistants a proactive philosophy concerning safety principles and practices.  Undergraduate or graduate student research that requires IBC review must be submitted over the signature of the faculty advisor/sponsor as the principal investigator of record.

A principal investigator applying for research support (regardless of the source) involving any potentially hazardous biological material must obtain clearance from the IBC for the proposed research. This is done by completing and submitting the Biological Materials and Recombinant DNA Registration form (IBC-1) to the Associate Dean in the College of Science and Health (105 Graff Main Hall). These forms may be obtained online at the bottom of this page.  

The principal investigator is asked to describe the research protocol, with emphasis on practices and engineering controls employed to contain potentially biohazardous materials. For research involving rDNA techniques, required information includes the source and nature of the DNA and host/vector system(s) and any other relevant details of the experimental protocol. 

It is important that the principal investigator address potential hazards, if any, by providing sufficient details of experimental protocol for the IBC to evaluate whether adequate safety measures will be taken.

Protocols of research proposed for graduate students must be submitted by the major thesis advisor with the advisor listed as the Principal Investigator (i.e., the graduate student is a co-advisor). This means that the advisor assumes primary responsibility for activities and individuals related to the protocol.

The IBC reviews research protocols for biohazards or other elements for which a funding agency or the University requires strict management. It assesses all research elements and determines whether an investigator has adequately addressed safety issues and/or complied with regulations. If necessary, the IBC may require an investigator to take additional safety measures. 

The IBC transmits its evaluation to the principal investigator and to the Research and Sponsored Programs Office or University Funding Committees to satisfy their clearance requirements. 

Approved protocols will remain in effect without full review for the duration of the project.  If there is a modification to the protocol, an updated IBC-1 will need to be submitted for review.  Research protocols using animals must also include Appendix A (Special Safety Protocol for Animal Handlers) and be reviewed by the Institutional Animal Care and Use Committee (IACUC). If human subjects are involved, the protocol must be reviewed by the Institutional Review Board for the Protection of Human Subjects (IRB). Investigators utilizing human blood and other potentially infectious human body fluids must meet certain requirements. The Environmental Health and Safety Office 608.785.6800 can assist you in this area. 

The IBC convenes as necessary to review rDNA research and investigations that involve other applicable biohazardous materials. Principal investigators should submit protocols sufficiently in advance to allow for a minimum three-week turnaround time. Protocols submitted during the summer may take slightly longer to review. 

The NIH has established the Guidelines for Research Involving DNA (rDNA) Molecules to assist parent institutions and funding agencies in their oversight of proposals involving any aspect of rDNA technology. NIH requires compliance with the Guidelines before any federal funding can be approved, and the IBC closely scrutinizes rDNA proposals to ensure compliance.

The IBC (usually a 2- to 3-member team) will conduct periodic, announced visits to laboratories for which protocols have been approved. The first visit will normally occur prior to the beginning of the research.

An investigator who already has a protocol for a specific procedure with a specific organism or product of an organism may be planning research using the same procedure or like procedure on a different organism or product of an organism, which is at the same or lower Biosafety Level.  In cases such as this, a new protocol may not be necessary and may be handled administratively with the IBC Office. In these cases, the investigator should submit by hard-copy letter a succinct summary of their intent. The Chair will then make a decision about whether a new protocol is needed or that the existing protocol is sufficient.

Although most rDNA research is exempt from the Guidelines, there is still concern for the safe handling of certain source materials and the creation and use of products derived from this technology. This is especially true when human subjects or disease-causing organisms are involved. In these instances and whenever genetically engineered products of potent toxicity, drug resistance or increased virulence are involved, investigators must obtain approval from the IBC. In some cases, they must also obtain approval from the NIH Recombinant DNA Advisory Committee or other federal agencies having jurisdiction. However, registration with the IBC is sufficient for proposals of lesser hazardous potential. The IBC will determine if additional approvals are required. 

Investigators contemplating proposals involving rDNA are responsible for familiarizing themselves with the current Guidelines, determining which sections pertain to their experiments and assessing the appropriate containment levels. The current Guidelines are available from the Sponsored Research, Scholarly and Creative Activities Office, and the  NIH Website . 

Another valuable document concerning biosafety is the Center for Disease Control (CDC) , Biosafety in Microbiological and Biomedical Laboratories, 3rd Ed. (May 1993), available at the CDC Website (http://www.cdc.gov/od/ohs/biosfty/bmbl/bmbl-1.htm ).

The following rDNA molecules may be exempt from full IBC review but must be discussed with the Chairperson of the IBC.

1. Those that are not in organisms or viruses.
2. Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
3. Those that consist entirely of DNA from a prokaryotic host species, including its indigenous plasmids, or viruses when propagated only in that host species (or closely related strain of the same species) or when transferred to another host species by well established physiological means.
4. DNA from a eukaryotic host species, including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host species (or closely related strain of the same species).
5. Certain specified rDNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more segments may be a synthetic equivalent.
6. Other classes of rDNA molecules that do not present a significant risk to health or the environment. These are determined by the NIH Director following appropriate notice and opportunity for public comment.