The following information is provided to guide sponsor-investigators (SI) who hold an Investigational New Drug Application (IND) in understanding and complying with the federal regulations that pertain to the conduct of research with an investigational drug. A PDF of the handout is available here. Hyperlinks to the IND regulations are included throughout so researchers may refer to the complete text of the corresponding regulations.
The federal regulations for INDs are found at 21 CFR 312. For more information about obtaining an IND and applicable forms and instructions, see 21 CFR 312 Subpart B Investigational New Drug Application and Information for Sponsor-Investigators Submitting Investigational New Drug Applications. Sponsor-investigators are also required to follow all federal regulations and University of Iowa policies and guidance for human subjects research. University of Iowa policies and guidance for human subjects research are available on the Human Subjects Office website.