Institutional Bio-safety Committee
The University of Wisconsin-La Crosse, as an institution receiving research funds from the National Institutes of Health (NIH), is subject to the NIH Guidelines for Research Involving Recombinant DNA (rDNA) Molecules. As mandated by the Guidelines, the Chancellor of the University has appointed an Institutional Biosafety Committee (IBC). The Committee shall be comprised of no fewer than five (5) members who have experience and expertise in recombinant DNA technology and/or general biological safety concerns. At least two (2) members shall not be affiliated with the University, but will represent the interest of the surrounding community with respect to health and protection of the environment. Certain experiments may require individuals with expertise in plant, plant pathogen, plant pest containment procedures, animal containment principles or microbial pathogen containment to be included in an IBC review. No member of the IBC shall review his/her own research protocols. The Environmental Health and Safety Office and the Research and Sponsored Programs Office are to provide administrative support to the IBC. The Chair of the IBC will be appointed by the Provost & Vice Chancellor for Academic Affairs. An Associate Dean in the College of Science and Health has typically served as Chair. The Chair may appoint a Vice Chair to assist with IBC activities.
The other primary responsibilities of the IBC are (1) to encourage and assist all faculty and staff to develop protocols for their research and teaching facilities that will foster safe biological laboratory practices, and (2) to endeavor to assure that all biohazardous research and teaching is conducted in secure facilities in compliance with all appropriate regulations.
Responsibilities of Faculty And Staff
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.
Responsibilities of The University
UW-La Crosse must comply with state and federal regulations that apply to biological research and its residuals.
Federal Guidelines: Certain research is subject to federal guidelines and regulations prescribed by the NIH, the US Department of Agriculture (USDA), the US Environmental Protection Agency (USEPA), the US Food and Drug Administration (USFDA), and the Aquatic Nuisance Species Task Force Protocol for Nonindigenous Aquatic Species as per the Nonindigenous Aquatic Nuisance Prevention and Control Act.
State Law Regarding Recombinant DNA (rDNA) Field Studies: The State of Wisconsin has enacted a law requiring that the Wisconsin Department of Natural Resources (WDNR) or Department of Agriculture, Trade and Consumer Protection be notified of intended field studies of genetically engineered organisms.
WDNR Guidelines for Waste Disposal: The WDNR has established regulations (Medical Waste-October 1994) for the decontamination and elimination of infectious and medical wastes. Appropriate disposal of these wastes is an important aspect of a comprehensive safety program.
Wisconsin Department of Commerce (DCOM) Regulations/US Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard: As a public institution, the University must also comply with regulations prescribed by the DCOM, including adoption of the Bloodborne Pathogens Standard mandated by OSHA.
Institutional Biosafety Committee (IBC) Research Review
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.
Roles and Responsibilities of the Institutional Biosafety Committee (IBC)
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.
Institutional Biosafety Committee (IBC) & National Institutes Of Health (NIH) Approval
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.