Arshad M. Khanani, MD – FDA 483, Oct 11, 2024

During a U.S. Food and Drug Administration (FDA) inspection conducted from October 7-11, 2024, clinical investigator Arshad M. Khanani, MD, MA, FASRS, based in Reno, NV, received an FDA Form 483 for two significant observations related to informed consent procedures in a clinical study. The first observation noted that all versions of the informed consent form (ICF) for a specific study protocol lacked crucial language assuring participants that their refusal to join or their decision to withdraw from the study at any time would not result in penalties or loss of entitled benefits. This omission indicated a deficiency in clearly communicating participant rights. The second observation highlighted an incomplete disclosure of alternative treatment options within the ICFs. While the forms presented general options, they failed to explicitly inform patients about other commercially available treatments for their medical condition, especially pertinent since the active ingredient in the investigational product is already on the market. This could lead to an inadequate understanding of all advantageous treatment alternatives. These observations indicate areas where the firm’s informed consent practices require improvement to align with federal regulations governing clinical investigations and to ensure comprehensive participant understanding and protection. The firm is expected to address these findings.