Document Type


Publication Date





Taylor & Francis




The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. Citation2013) attack the study’s methodology itself in this issue, arguing that even on its own terms SUPPORT was fatally flawed (Macklin and Natanson Citation2020). Specifically, they argue that one arm of the study (the low oxygen arm) was not followed anywhere and could not be reasonably considered “standard care,” but was rather “unusual” and therefore experimental care (Cortes-Puch et al. Citation2016; Macklin and Natanson Citation2020). They also make useful suggestions about how to prevent future mischaracterizations of “usual care.”

Link to Publisher Site Link to Publisher Site (BU Community Subscription)



To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.