The use of radioisotopes at The University of Chicago and The University of Chicago Hospitals is done under licenses issued by the Illinois Emergency Management Agency (IEMA), Division of Nuclear Safety. These licenses contain the policies and procedures that we agree to follow to meet the regulations promulgated by IEMA and other regulatory agencies. All individuals at our institutions are bound by the terms of these licenses and regulations. IEMA has the authority to level fines for violations. In cases of willful violation or material false statement (lying to cover up violations), individuals may be held civilly and even criminally liable.
The University maintains a "Type A License of Broad Scope". This means that in order to greatly reduce paper work with and direct oversight by the IEMA, Division of Nuclear Safety, the University has established a radiation safety committee (the Radiation Safety Committee (RSC)), and a radiation safety officer (RSO) and staff to locally authorize policies and procedures to be followed to maintain regulatory compliance. The individual members of the RSC must include a member of management, the RSO, and radioactive material users. At the University, only the material users vote on decisions made by the Committee.
The Hospital maintains an "Institutional Type License". This type of license differs from a Broad Scope License in that it is restricted to medical uses. This license requires a Human Use / Radioactive Drug Research Committee. This Committee must also include management, and the RSO. It must include physicians in each of the use categories, and it must also have a representative of the nursing staff. This Committee authorizes medical protocols using radioisotopes under the Hospital License and also authorizes certain research use in humans under the University Broad Scope License. This Committee wears several hats. Certain protocols are authorized under FDA 21 CFR 361.1 regulations. In this function, non-technical members do not vote. On all other decisions, all members of the Committee vote.
The Office of Radiation Safety is charged with maintaining regulatory compliance and carrying out the policies and procedures established by these committee’s. The Office develops proposed policies and procedures in response to regulatory changes, licensing actions, and inspections by regulators. The Office submits proposed changes to policy and procedures to the appropriate committee. In cases where the changes require amendments to our licenses, the Office may negotiate the proposal with IEMA, Division of Nuclear Safety prior to submission to the committee. Once one of the committees approves the proposal, it becomes policy immediately unless a license amendment is required. Upon approval by the committee, a license amendment must be submitted to IEMA, Division of Nuclear Safety, if required. In this case the policy does not become effective until it has been approved by IEMA. Once established, the Office and all users must follow the policy.
The Office of Radiation Safety personnel primarily fulfill the majority of the policies and procedures. However, there are certain procedures principal investigators and radioactive material users are required to follow. All radioactive material users are welcome to call or visit the Office of Radiation Safety to discuss any concerns they may have. We strongly recommend that new principal investigators meet with us to discuss the requirements placed on laboratories and get a feeling for the sorts of resources we can provide to assist you in starting your use of radioactive material.
Every university has slightly different procedures and requirements. This is a result of process of negotiating a license with the regulatory agencies and the faculty committee. Licenses are living documents that may be modified within certain limits. We welcome suggestions, but cannot promise to act on them. If you have a suggestion for changes in our policies, please contact James Marsicek, jmarsice@uchicago.edu.
Staff Members
Steven Beaudoin, Director
James Marsicek, Associate Director/Radiation Safety Officer
Matthew Rumick, Health Physicist
Donald Samaan, Health Physicist
Ever Ellingstad, Health Physicist
Yayun Song, Health Physicist
Karen Seawood, Administrative Assistant
Aundraetta Holts, Project Assistant