Federal & State Regulation
Illinois Emergency Management Agency (IEMA), Division of Nuclear Safety is the regulatory body which issues the University and the Hospitals with their licenses to purchase, use, store and dispose of radioactive substances. IEMA establishes requirements for the use of radionuclides in clinical medicine and for issuance of licenses by the Department of Nuclear Safety authorizing the medical use of this material (32 Ill. Adm. Code 335).
Clinical Regulatory Compliance Subcommittee
The Clinical Regulatory Compliance Subcommittee of the Radioactive Drug Research Advisory Committee (RADRAC) is focused on assuring patient and staff safety for all clinical uses of radioactive materials. A key element of the Subcommittee's role is to monitor the compliance with applicable regulations in those areas of the Hospitals providing clinical care. Although the primary focus of the Subcommittee is the maintenance of the clinical safety and regulatory compliance, this necessarily overlaps with some types of clinical research as the two are often provided simultaneously and the same staff may be involved in both activities.
The Subcommittee will specifically focus on:
a) staff knowledge of safety procedures and regulatory requirements;
b) adequacy of staff training;
c) appropriateness and completeness of record keeping.
Radioactive Compounds in Animals & Laboratories
The use of radioactive compounds in animal research requires a coordinated approval process by both the Radiation Hazards Committee and the Institutional Animal Care and Use Committee (IACUC) as well as permission to use radioactive substances from the Office of Radiation Safety. Researchers must have an active Application for Non-Human Use of Radioactive Material approved by the Radiation Hazards Committee. In addition, researchers must complete IACUC Supplemental Form R; IACUC staff ensure coordination of this process.