Radioisotopes & Radioactive Drug Research Advisory Committee

What Are Radioactive Compounds?
RADRAC Committee
  Mission & Staff
  RADRAC Committee Membership
RADRAC Submission Form
Clinical Regulatory Compliance Subcommittee
Radioactive Compounds in Animals & Laboratories
Federal & State Regulation

What Are Radioactive Compounds?

"Radioactive material" means any solid, liquid, or gaseous substance which emits radiation spontaneously. [ 420 ILCS 40/4(i)]

RADRAC Committee

Mission & Staff

The RADRAC is charged with the responsibility for review, approval and surveillance of radioactive drugs as well as the purchase and use of radioisotopes in humans (including research and routine) within The University of Chicago and University of Chicago Hospitals. 

University and University Hospitals Combined
Human Use of Radioisotopes and 
Radioactive Drug Research Advisory Committee (RADRAC)

Chair:	Daniel Appelbaum 834-2012  E-mail address: dappelbaum@radiology.bsd.uchicago.edu
Vice Chair:	Bill O'Brien-Penney, Ph.D.  702-0910 E-mail address: bpenney@radiology.bsd.uchicago.edu
Staff Contact:	James Lynch 702-6505

 

 

 

 

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RADRAC Committee Membership

The University of Chicago and University Hospitals Combined Human Use of Radioisotopes and Radioactive Drug Research Advisory Committee
AMB S-152 · MC 1108 · (773) 702-6505 
Members are appointed by the Provost * = recognized member to vote on FDA issues 

Name	Room	Mail	Phone
RADRAC Chair:
Daniel Appelbaum Assoc. Prof. Radiol. and Clin. Dir., Nuclear Med. dappelbaum@radiology.bsd.uchicago.edu			834-2012
RADRAC Vice-Chair:
Bill O'Brien-Penney, Ph.D., Vice Chairman, RDRC  Associate Professor, Clinical Radiology, Dept. of Radiology bpenney@radiology.bsd.uchicago.edu	AMB Q-200	MC 2026	702-0910 Pager #7193
Committee Members:
Daniel Applebaum, M.D. Assistant Professor, Departments of Radiology & Nuclear Medicine dapplebaum@radiology.bsd.uchicago.edu			834-2012
Chester Reft Ph.D. Asst. Prof., Medical Physics Residency Program Director, Medical Physics, Dept. Rad. & Cell. Oncology creft@radonc.uchicago.edu	TC 326	MC 1100	702-9913 Pager #4149
Ron Edwards Radiation Physicists, Safety Office University of Chicago Hospitals redwards@uchospitals.edu	CLI L-12	MC 0958	702-2624
Dr. Steven Chmura Asst. Prof.& Residency Program Dir. Dept. Rad. & Cell. Oncology schmura@radonc.uchicago.edu			702-7919
Kathy Shanahan Clin. Dir., Mitchell 4, Patient Srvcs. Sector kathleen.shanahan@uchospitals.edu			702-0258
*James Marsicek Associate Director, Radiation Safety  Office of Radiation Safety  Fax #702-4008  james_marsicek@fpm.uchicago.edu	M-031A	MC 2106	702-6299
Glen McKeown Associate General Counsel, Office of Legal Counsel gmckeown@uchicago.edu	ADM 503		702-5799
Judd Johnson Assoc. Director of Operations, Facilities Operations Facilities, Design & Construction, BSD jjohnson@bsd.uchicago.edu			702-8259
Neal Scherberg, Ph.D.  Assoc. Dir., Endocrinology Lab, Adult and Pediatric Endocrinology, Diabetes Metabolism, Dept. Med. nscherbe@medicine.bsd.uchicago.edu	AMB M-143	MC 3090	702-6941
Carol Zuiches Assoc. VP for Researh Administration & Director, University Research Administration University Research Administration (URA) czuiches@uchicago.edu	Bookstore 3rd floor		702-8604
R. Parker Ward, M.D., FACC Dir., Cardiology Fellowship Prog. Dept. Med. , Assoc. Prof., Adult Echocardiography Lab, Cardiology pward@medicine.bsd.uchicago.edu	AMB B116B	MC 6080	834-0343
Monica Geyer Asst. Dir. Specialty Imaging Srvs. Radiology, BSD mgeyer@radiology.bsd.uchicago.edu			834-3953
William Huffman Associate VP Facilities, Design & Construction Facilities, Design & Construction whuffman@bsd.uchicago.edu			5-9139
Alternate Members:
Steven Beaudoin (alternate for Marsicek) Director, Safety and Parking Services Facilities Services sbeaudoi@uchicago.edu	Y202A		834-1131
Gretchen Pacholek Ass't Manager, Inpatient Nursing., MITCHELL 4 ADMIN gretchen.pacholek@uchospitals.edu
Jennifer Palombizio Safety Dir., Safety & Regulatory Compliance, Facilities, Design Construction, Hosps. jennifer.palombizio@uchospitals.edu
Yonglin Pu Asst. Prof., Nuclear Medicine, Radiology, BSD ypu@radiology.bsd.uchicago.edu			834-7629
Elizabeth Early Assistant Director, Business Analytics RADIOLOGY Elizabeth.Early@uchospitals.edu			834-5351
Ex-Officio:
Millie Maleckar  Director of Regulatory Compliance for Human Subjects IRB, BSD Dean's Office mmalecka@bsd.uchicago.edu		MC 1108	702-6505
Administrative Staff:
James Lynch Assoc. Director of Education/Quality Assurance IRB, BSD Dean's Office jlynch@bsd.uchicago.edu		MC 1108	702-6505

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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.

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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. 

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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).

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