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IRB Application: Additional Study Materials
Section 4
FORM
O-1. Use
of Approved Drug(s) for Unapproved Use
If you are conducting research involving use of FDA approved drug(s) for unapproved use, complete Form O-1 and include it with your application submission.
Certain uses of approved drugs for unapproved uses require an IND. It is the PI's responsibility to make a preliminary determination regarding whether to obtain an IND and to include the information in the IRB application (Form A, Form O-1, and possibly Form O). For assistance in making a preliminary determination, contact FDA, or visit the Center for Drug Evaluation and Research (CDER) FAQ's web page.
For a summary of the FDA regulations outlining exemption from the IND requirements, download ORI’s document: Summary of FDA Regulations on Exemption from IND Requirements.
Your responses to the questions on Form O-1 will determine whether your research meets the criteria for exemption from IND requirements. If your research does not meet the criteria for exemption from IND requirements, and you are not using the University of Kentucky Medical Center’s Investigational Drug Service (IDS), you will also need to include Form O (Use of Investigational New Drug) in your IRB application submission.
If you are proposing research which involves use of an approved drug for an unapproved use, and/or an IND, please mark the appropriate selection(s) in the space provided on the General Information Sheet [Section 1, Form A].
PIs who are also sponsors and hold an IND have additional responsibilities. For an overview of the Food and Drug Administration (FDA) requirements for sponsors/PIs with INDs, see ORI's document: Summary FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug. For information and instructions on sponsor-investigator training, see ORI's document: University of Kentucky Sponsor-Investigator Mandatory Training.