IBC Policy 100 - Regulatory Charge

Adopted September 18, 2005

I. Policy Purpose

 This policy describes the regulatory basis for the Institutional Biosafety Committee and the scope of the committee’s oversight.

II. Policy Definitions

BMBL refers to the current edition of the Biosafety in Microbiological and Biomedical Laboratories, published by the CDC. The BMBL provides recommended guidance and best practices for the safe handling of biological hazards in laboratory settings.

CDC refers to the Centers for Disease Control and Prevention, a federal agency within the Public Health Services which acts to promote public health and protect against health threats.

NIH refers to the National Institutes of Health, a federal agency within the Public Health Service that regulates research involving recombinant or synthetic nucleic acid molecules, including certain work with humans, animals, and plants when such work falls under the scope of the NIH guidelines.

NIH Guidelines means the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules; the set of regulations detailing safety practices and containment procedures for research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

r/sNA refers to recombinant or synthetic nucleic acid molecules. These molecules are subject to the federal NIH Guidelines cited above.

Regulated activities include any research, teaching, and/or contracted service activity conducted by SIUC faculty, staff, volunteers, and students.

III. Policy Statement

The Institutional Biosafety Committee (IBC) operates under the authority of the Institutional Official (IO) who is the Vice Chancellor for Research (VCR) at Southern Illinois University Carbondale (SIUC). The IBC is administered by the Office of Research Compliance (ORC) in the VCR’s office.

SIUC faculty, staff, and students must comply with the policies established by the IBC when conducting teaching or research activities using recombinant or synthetic nucleic acid molecules, and biological hazards when conducting regulated activities as described in the NIH Guidelines and the BMBL.

This policy does not include regulatory oversight of bloodborne pathogens, activities which are established by the Occupational Safety and Health Administration.

IV. General Procedures

Faculty, staff, and students who intend to work with recombinant or synthetic nucleic acid molecules, or who intend to work with biological hazards as described in the BMBL, must first obtain permission from the IBC by completing a Memorandum of Understanding and Agreement (MUA) and receiving approval from the IBC.

All people working with such agents must be appropriately trained as described in Policy 350.

Principal Investigators who receive MUA approval must follow the approved plans as described in the MUA for safe handling, storage, and disposal of biological hazards and/or recombinant or synthetic nucleic acid molecules. The MUA must include plans to prevent unintentional release of hazardous materials, to contain and clean up any spills, and to report any release or personnel exposure to the IBC.