FDA 483 - Catholic Health Initiatives Institute for Research and Innovation IRB - March 03, 2026

During an inspection conducted between February 23 and March 3, 2026, the Food and Drug Administration (FDA) identified a significant compliance issue at the Catholic Health Initiatives Institute for Research and Innovation IRB (also known as CommonSpirit Health Research Institute IRB) in Englewood, Colorado. This Institutional Review Board (IRB) is tasked with the ethical oversight of clinical research involving human subjects. The primary violation detailed in the Form 483 involves the IRB’s failure to ensure the proper documentation of informed consent. Specifically, the FDA investigator observed that the IRB approved a research study protocol without requiring the use of an officially sanctioned informed consent form. This is a critical omission, as the documentation of informed consent is a fundamental safeguard designed to ensure study participants are fully aware of risks and voluntarily agree to participate. This inspection was conducted under the regulatory framework of the Food, Drug, and Cosmetic (FD&C) Act. While these observations do not constitute a final agency determination, the company is required to respond. Catholic Health Initiatives must address the findings by detailing corrective actions already implemented or planned to prevent future occurrences. The firm may also submit formal objections to the observation. Prompt and thorough resolution is necessary to ensure the protection of research participants and compliance with federal standards.