In which circumstance can a clinician use a HUD without obtaining IRB approval?

The use of a Humanitarian Use Device (HUD) typically requires adherence to regulations and guidelines, including obtaining Institutional Review Board (IRB) approval. However, there are specific circumstances under which a clinician may use a HUD without prior IRB approval. One of the recognized situations is when there is an urgent need for treatment, particularly if waiting could negatively impact the patient's health.

In this context, clinicians may utilize a HUD in situations where unnecessary delays might harm the patient. The rationale for this exception stems from ethical considerations in medical practice — healthcare providers must prioritize patient welfare. When immediate intervention is necessary to prevent significant harm or to alleviate a critical condition, the ability to enact treatment provided by a HUD without prior bureaucratic processes is justified. This aligns with the overarching principle of beneficence in medical ethics, where the primary focus is on doing good and ensuring patient safety.

In contrast, while compassionate use and training scenarios have their own regulations, they do not typically allow for the same level of flexibility for HUD usage without IRB oversight as urgent clinical situations do.