Humanitarian Use Device (HUD) Informed Consent Template

This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents.

The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.” Because the research has shown a HUD to have only “probable benefit,” rather than “a reasonable assurance of effectiveness,” every HUD requires IRB approval and oversight, whether for use in clinical care or in research. For more information, read the full Humanitarian Use Device (HUD) guidance.