The University of Wisconsin–Madison, as an institution receiving research funds from the National Institutes of Health (NIH), is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules. As mandated by the Guidelines, the Chancellor of the university has appointed an IBC (also known as the Biological Safety Committee) and established, as its administrative office, the Office of Biological Safety (OBS), directed by the Biological Safety Officer. Through the OBS, the IBC transmits its evaluation to the principle investigator and to Research and Sponsored Programs (RSP) or university funding committees to satisfy their clearance requirements. IBC information can be found in the UW–Madison Researchers’ Biosafety Manual.
IBC Info and Resources
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Charge to the IBC
The Institutional Biosafety Committee (IBC) serves as required under the NIH Recombinant DNA Guidelines. The committee consists of university and community representatives. University representatives will remain in the majority.
The IBC will support and critically evaluate University of Wisconsin–Madison biological safety activities intended to protect the health and safety of the university community, visitors and neighbors, ensure compliance with regulations and guidelines and implement the campus Environment, Health and Safety (EH&S) policy. As part of fulfilling its charge, the IBC will:
- Give advice and counsel to the UW–Madison EH&S Office of Biological Safety, the Graduate School, and the Chancellor concerning safe use and management of biological materials and compliance with regulations to support and achieve excellence in biological safety
- In conjunction with OBS, adopt policies that guide and support the work of OBS and promote high standards of safety, regulatory compliance and protection of human health and the environment in work involving biological materials
- Review biological safety issues in Safety Department publications and on its web site
- Perform annual reviews of campus biological safety programs and biological safety aspects of regulatory compliance documents that require annual review
- Review biological safety training programs, records, plans, and priorities as needed to help ensure optimum availability of needed and required training
- Review protocols that involve biological materials for safety, regulatory compliance and protection of human health and the environment. The review will include protocols involving recombinant DNA that are not specifically exempted under the NIH guidelines, gene transfer, biological agents of Risk Group 2 or higher as defined in the latest edition of “CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)”, or biologically derived toxins. The review will include protocols regardless of funding source. Protocol approvals will be subject to periodic renewal.
- Collaborate with other committees, including but not limited to the Chemical and Environmental Safety Committee, Animal Care and Use Committees, Radiation Safety Committee, Biosecurity Task Force, and Institutional Review Boards to assure that biological safety issues are properly addressed. Periodically review criteria for mutual referral of protocols. Collaborate with the Chemical and Environmental Safety Committee to review protocols and to review respiratory protection policies and programs
- Review proposed regulatory changes and prepare comments to agencies as judged appropriate
- Provide a forum for the campus community to raise concerns regarding the safe use and handling of biological materials and advise the chancellor in the resolution of disputes regarding biological safety issues.
The IBC is charged with the authority to suspend work in situations where the work being performed:
- Is determined to be a potential threat to human safety and health. Is in violation of the NIH Guidelines.
- Threatens UW–Madison accreditations, registrations (e.g. the Select Agent Program) and/or memberships.
- Has the potential to jeopardize the UW–Madison’s eligibility for present and/or future research funding.
The IBC will receive administrative support from the UW–Madison, Environment, Health and Safety (EH& S) Department, Office of Biological Safety.
Roles and Responsibilities
Institutional Biosafety Committee (IBC)
In addition to scrutiny of recombinant DNA proposals, the IBC and OBS assist all faculty and staff in observing safe biological laboratory practices, and endeavor to assure that all biohazardous research is carried out in secure facilities in compliance with all appropriate regulations. The IBC assesses all research elements and determines whether an investigator has adequately addressed safety issues and/or complied with regulations. If necessary, it may require an investigator to take additional safety precautions.
The IBC convenes as necessary (generally the first Wednesday of the month during the academic year) to review rDNA research and investigations that involve biohazardous materials. To facilitate the review process, investigators should submit their biosafety protocol to the OBS with sufficient lead time, minimally one month before the meeting date. Materials received less than one month before a scheduled IBC meeting will not be considered until the following meeting.
The Office of Biological Safety (OBS)
The Office of Biological Safety (OBS) fosters safe laboratory practices and ensures compliance with or implementation of policies, guidelines, or regulations set forth by university administration, the Institutional Biosafety Committee (IBC), and regulatory agencies.
This office, under the direction of the Biological Safety Officer, provides the following services:
- Advises faculty and staff in biosafety matters
- Recommends safe procedures, containment devices and equipment for all campus activities (research, teaching, diagnostic, and building services) involving biohazards
- Recommends methods of handling, transporting, decontaminating and disposing of biohazardous materials
- Provides advice, in conjunction with the Chemical Safety Program (265-5000), regarding the disposal of sharps (waste capable of creating a puncture wound) and infectious waste
- Provides consultation for containment laboratory/ventilation system design
- Provides consultation concerning the purchase of biological safety cabinets (BSC) in cooperation with the Environmental Health Program (262-1809), which offers a BSC certification program
- Provides biological safety education and training aids
- Develops educational and training programs designed to meet the specific biological safety needs of a variety of departments and staff.
- Maintains a library of safety literature
- Provides biohazard signs
- Provides training and certification for compliance with US Department of Transportation
- Provides guidance on recombinant DNA (rDNA) regulations or other aspects of genetic engineering
Other Roles and Responsibilities
The University must comply with local, 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, the Environmental Protection Agency, and the Food and Drug Administration.
- State Law Regarding rDNA Field Studies: The State of Wisconsin has enacted a law requiring that the Wisconsin Department of Natural Resources (DNR) or Department of Agriculture, Trade and Consumer Protection be notified of intended field studies of genetically engineered organisms.
- DNR Guidelines for Waste Disposal: The DNR has established regulations (Medical Waste-Oct.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.
- D Comm Regulations/OSHA Bloodborne Pathogens Standard: As a public institution, the University must also comply with regulations prescribed by the Wisconsin Department of Commerce (D Comm), including the Bloodborne Pathogens Standard mandated by the Occupational Safety and Health Administration (OSHA).
Investigators utilizing human blood and other potentially infectious human materials must meet certain requirements. The Occupational Health Program (263-2177) can assist you in this area.
Faculty and Staff of UW–Madison
Faculty and staff are responsible for observing safe practices when handling hazardous biological materials in teaching, research and clinical laboratories. These materials include pathogenic microorganisms; toxins; experimental, biologically active chemicals (carcinogens, mutagens, and teratogens); human blood, body fluids and tissues; and supplies and equipment used with such substances. In addition, all sharps and hazardous glass and plastic, whether contaminated or not, require careful handling and appropriate disposal.
Principal Investigators, faculty and others who supervise people are responsible for the use of proper safety practices by the people they supervise. Everyone is responsible for their own use of safe work practices and for following safety related instructions from their supervisors. Principal Investigators, instructors and laboratory supervisors have a special obligation to instill in their students and laboratory assistants a proactive philosophy concerning safety principles and practices.
An investigator applying for intra- or extramural research support or receiving unsolicited gifts or grants for research involving any potentially hazardous biological material and/or recombinant DNA work that is subject to the NIH Guidelines must obtain clearance for the proposed research. This is done by submitting a biosafety protocol, Biological Materials and Recombinant DNA Protocol to the OBS. The first page of the form provides administrative information, including a list of grants associated with the protocol. Once registered and assigned a safety committee number (SC#), the protocol is valid for three years. Please note that the signature of the Principal Investigator is always required. The form is available on the Biological Safety Website.
Risk assessments of planned experiments should be done prior to initiation. The investigator’s biosafety protocol can be used for safety training of staff. The criteria for submission of a protocol to the Office of Biological Safety, outlined below in Section II, encompass pathogens (human, plant, and animal), exotic organisms, harmful chemicals administered in vivo or in vitro, select agents and rDNA. Although some rDNA techniques are exempt from the Guidelines, many low-risk experiments are still subject to the Guidelines and must therefore be reported for compliance purposes. Investigators must obtain preinitiation approval from the IBC for rDNA experiments involving genetically engineered products of potential virulence and toxicity or altered drug resistance. 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 hazard potential.
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 NIH Guidelines is available electronically as a link from the Biological Safety Website. Contact OBS for assistance in interpreting the Guidelines.
The investigator is asked to describe the research protocol, with emphasis on practices and engineering controls employed to contain potentially biohazardous materials. For research involving recombinant DNA 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 investigator identifies potential hazards and describes mitigating procedures or circumstances in sufficient detail such that the OBS and IBC can independently evaluate whether adequate safety measures will be taken.
The purpose of the handbook is to assemble policies and procedural information relevant to the functions of the University of Wisconsin–Madison Institutional Biosafety Committee. The IBC Handbook has been revised as part of the UW–Madison Researchers’ Biosafety Manual.
The UW–Madison IBC is tentatively scheduled to meet on the first Wednesday of every month.
Veterinary Medicine Building, 2015 Linden Drive, Room 2255, unless otherwise arranged
1:30 p.m., unless otherwise arranged
First Wednesday of the month, unless otherwise arranged
*Information is tentative and will be confirmed in advance by announcement from the Office of Biological Safety.
IBC Member Roster
Kristen Bernard, D.V.M., Ph.D. (Chairperson)
Andrea Ladd, Ph.D. (Biological Safety Officer)
Jeri Barak, Ph.D.
Gregory Gauthier, M.D., M.S.
Peter Halfmann, Ph.D.
Akihiro Ikeda, Ph.D.
Heidi Kaeppler, Ph.D.
Matthew Reynolds, Ph.D.
Warren Rose, Pharm.D.
Nathan Sherer, Ph.D.
Peter Shult, Ph.D.
Garret Suen, Ph.D.
Masatoshi Suzuki, Ph.D.
Janet Welter, D.V.M., M.P.H., Ph.D.
Jeff Dalsin, Ph.D.
Rob Morrow, Ph.D.