Concerns about a biologic product used in procedures at a New York hospital prompted a complaint by a researcher against his supervisor, according to a recent New York Times article. The Food and Drug Administration (FDA) had issued a warning letter to the product manufacturer, citing concerns about the manufacturing process and also stating the product needed an IND for it to be used in humans. We note the Times article cites a draft study publication stating the use of the product in humans had been approved by an institutional review board and “been granted a waiver of consent.” The consent waiver claim leaves us scratching our heads a little bit.