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(p. 59) Ethical Issues in the Neonatal SUPPORT Trial 

(p. 59) Ethical Issues in the Neonatal SUPPORT Trial
Chapter:
(p. 59) Ethical Issues in the Neonatal SUPPORT Trial
Author(s):

John D. Lantos

DOI:
10.1093/med-psych/9780190647254.003.0005
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date: 26 March 2019

The controversy over the neonatal Surfactant, Positive Pressure, and Oximetry Randomized Trial (SUPPORT) study of oxygen saturation targets in extremely premature babies was intense and polarizing. The fundamental issue turned on whether or not there were reasonably foreseeable risks to the babies who were enrolled in the study and, if so, whether that should have either (a) been disclosed in the consent form or (b) led institutional review boards to never approve the study in the first place. The federal Office for Human Research Protections (OHRP) took the first view. The advocacy group Public Citizen (PC) took the second. This chapter suggests that both views were wrong. Being in the study was, in fact, safer than not being in the study. The mistakes made by both OHRP and PC have dangerous implications for research ethics and regulation. They could lead to mandates for consent forms that are inaccurate and misleading.

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