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Office of Research Integrity

Other Required Committee Review/Approvals

Institutional Biosafety Committee (IBC)

If your research involves recombinant DNA, infectious agents, and/or human gene transfer/therapy products, the Institutional BioSafety Committee (IBC) will need to review and provide provisional approval for your research prior to approval of your IRB application (Please note, SOME vaccine trials also require IBC review and approval. You may contact the Biological Safety Officer to help you make that determination, 859-257-1049). For research involving human gene transfer (HGT), see Guidance for Conducting Human Gene Transfer Research at UK.

In the Other Review Committees section of your E-IRB application, checkmark the lnstitutional Biosafety Committee (IBC) attribute and upload your IBC provisional approval letter if your research requires IBC review.

Please Note: If the IBC provisional approval letter is missing from your submission, your IRB approval will be withheld until the IRB receives the provisional IBC approval letter. If you have the IBC # and date of IBC approval, you may include that information with your provisional approval letter.

Medical Center/College of Medicine (Medical Center and/or College of Medicine residents, fellows or medical students as research subjects)

Prior to conducting any research involving UK Medical Center residents or fellows as subjects, the investigator must obtain the approval of the Graduate Medical Education (GME) Committee. To initiate the approval process or for questions regarding the process, please contact Amy DiLorenzo, Assistant Dean of Educational Innovation and Scholarship, via email: Amy.DiLorenzo@uky.edu.

If you are proposing research involving Medical Center residents/fellows as subjects, please check mark the “UK Medical Center Residents or House Officers” attribute under the Subject Demographics section of your E-IRB application, and “Graduate Medical Education Committee (GME)” attribute under the Other Review Committees section. 

Prior to conducting any research involving University of Kentucky College of Medicine medical students as subjects, the investigator must obtain the approval of the Office of Medical Education by contacting Chris Lakes, Ed.D., Associate Dean for Student Affairs, via: chris.lakes@uky.edu.

If you are proposing research involving College of Medicine medical students as subjects, please check mark the “College of Medicine Students” attribute under the Subject Demographics section of your E-IRB application, and the “Office of Medical Education (OME)” attribute under the Other Review Committee section. 

Note: An underlying principle of the regulations governing use of human subjects in research is that the subject's participation is voluntary and based upon full and accurate information. The student-teacher relationship raises the issue of voluntary participation. The Office of Research Integrity (ORI) has prepared guidance for enrolling University students as research subjects. To obtain a copy of the guidance, visit ORI's IRB Survival Handbook: Students as Subjects or contact ORI at 859-257-9428.
 

Radioactive Drug Research Committee (RDRC)

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 (RDRC).

To apply for IRB approval for a study involving Radioactive Drug(s), Principal Investigators must complete and submit a Medical Full Review application in E-IRB.  The RDRC reviews the research prior to IRB review in order to provide expertise and scientific comments for the IRB. 

If your research falls under the purview of the RDRC, check the Radioactive Drug Research Committee attribute in the Other Review Committee section of your E-IRB application.

For more information about the RDRC, click here.

Office of Research Integrity

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405 Kinkead Hall
University of Kentucky
Lexington, KY 40506-0057
Phone: 859-257-9428
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