When is IRB approval required for an investigation involving a significant risk HUD?

IRB approval is required for an investigation involving a significant risk Humanitarian Use Device (HUD) when the study is collecting data on a new indication or for a different purpose than those already approved. This is important because the Humanitarian Use Device designation specifically applies to devices intended to benefit patients with a rare condition, and any new indication or alteration in use must be closely monitored to ensure the safety and welfare of participants.

When researchers are planning to evaluate a device for a new use or indication, it is imperative to obtain ethical oversight through IRB approval. This is to ensure that the risks are thoroughly assessed, informed consent is properly gathered, and that the study adheres to ethical standards, especially since significant risk devices can carry heightened implications for patient safety.

Other scenarios, like whether the device is new or only under specific emergency conditions, do not inherently require IRB approval unless they fall into the context of a study assessing a new indication. Therefore, the emphasis on IRB involvement for investigational studies collecting data on new indications ensures that the research is performed responsibly and ethically, safeguarding the interests of the participants.