UK Office of Research Integrity

IRB Application: Additional Study Materials

Section 4
FORM O.  Use of Any Drug Being Tested in Research

Complete Form O and include with your application submission if your research involves administration of any drug used in research outside the course of medical practice.

The IRB must assess the risk/benefit ratio, confirm that the drug has appropriate regulatory approval (or meets exemptions for such approval), and ensure that procedures for receiving, storing, dispensing, and accountability meet regulatory requirements and are appropriate for human subject protections.

Under Food and Drug Administration (FDA) regulations, research that involves use of a drug other than the use of a marketed drug in the course of medical practice, must have an Investigational New Drug (IND), unless the study meets one of the exemptions from the IND requirement [21 CFR 312.2(b)].

It is the sponsor's (or sponsor-investigator's) responsibility to make a preliminary determination regarding whether the investigational drug has an IND or meets one of the FDA exemptions from the requirement to have an IND. FDA has very specific criteria which must be met in order for a study to be exempt from IND requirements. The principal investigator (PI) is responsible for consulting the sponsor, FDA guidance, or checking with FDA to document appropriate regulatory approval. The FDA Guidance [PDF] on determining whether human research studies can be conducted without an IND provides answers to frequently asked questions and outlines a process for contacting FDA with inquiries. For a summary of the FDA guidance regarding exemption from the IND requirements, download ORI's document: Summary of FDA Regulations on Exemption from IND Requirements.

The IRB must also ensure investigators who assume the role of IND sponsor are knowledgeable about the additional regulatory and institutional requirements. If you are functioning as the Principal Investigator (PI) and sponsor for an FDA regulated product (drug, device or biologic), IRB policy requires that you complete the UK IRB Sponsor Investigator Mandatory Training or equivalent sponsor education program. For an overview of the FDA requirements for drug study sponsors investigators, see ORI's summary document: Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drugs [PDF]. For information and instructions on sponsor-investigator training, see ORI's document: University of Kentucky Sponsor-Investigator Mandatory Training [PDF].

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