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Basic research designed to study the metabolism of a radioactive drug or to gain information about human physiology, pathophysiology, or biochemistry requires review by the Radioactive Drug Research Committee which was formed under the authorization of the Food and Drug Administration (FDA) and the University.
Contact:
The
University of Kentucky's Radioactive Drug Research
Committee (RDRC) is responsible for reviewing and
approving all radioactive drug research projects that fall
under the purview of the Food and Drug Administration
(FDA) regulations as specified in 21 Code of Federal
Regulations Part 361.1.
Research projects which meet the criteria for
review as outlined in the regulations must be submitted
and approved by the RDRC prior to initiation of the study.
Institutional Review Board approval is also
required before initiation of the study. The
RDRC operates in accord with 21 CFR Part
361.
Committee
members are appointed by the Vice President for Research.
The RDRC is managed administratively by the Office
of Research Integrity.
Dr. John Coupal serves as the Chairperson.
Copies of RDRC procedural guidelines may be obtained by contacting Lucindia Shouse at 859-257-3138 or Beverly Raisor at 859-257-8315. Questions regarding the federal requirements should be directed to Ada Sue Selwitz at 859-257-2978. Link to FDA's Radioactive Drug Research Committee (RDRC) Program. To apply for IRB approval for a study involving Radioactive Drug(s), use the Medical Full Review Application.
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