USC Policies and Procedures for Human Subjects Research

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conducted in a manner that does not endanger the researcher, laboratory worker, student, human research subjects, the public or the environment. This program is designed to maintain a healthy work environment by educating employees on the requirements for the safe handling and use of biohazards in the laboratory such as safe work practices and procedures, personal protective equipment, and engineering controls. The program is based on government regulatory requirements, guidelines, and current professional standards. *Biohazardous materials include all infectious organisms (bacteria, fungi, parasites, prions, rickettsias, viruses, etc.) that can cause disease in humans, or cause significant environmental or agricultural impact. In addition to organisms, work with human or primate tissues, fluids, cells or cell culture are covered by the biosafety program.

Research Protocol Requiring IRB Application If a human subjects research protocol involves one or more of the following agents, an IBC application must be submitted for review and approval: 

Recombinant DNA, gene transfer, vector systems;

Infectious agents (bacteria, virus, yeast, fungus, parasitic agents);

Human biological material including those to establish human cell lines (whole blood/serum, blood component, unfixed tissue, semen, cells, other potentially infectious materials);

Known carcinogens/toxins/mutagens (refer to the IBC website);

Centers for Disease Control and Prevention (CDC) and/or the Animal and Plant Health Inspection Service (APHIS) select agents (refer to the IBC website)

DEA chemical precursors

What IBC Does 

Formulates and implements policies related to the safe use of biological materials and known chemical carcinogens;

Reviews all research protocols involving biological materials and known chemical carcinogens;

Approves or disapproves such projects based on their potential hazard and proposed containment procedures;

Chapter 13: The IRB Application and Forms USC HSPP Policies and Procedures

Page 185 of 369


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