Observations The Washington Brief

US study criticized for experimentation with premature infants

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4198 (Published 09 July 2013) Cite this as: BMJ 2013;347:f4198
  1. Sidney M Wolfe, founder and senior adviser at the Health Research Group at Public Citizen
  1. 1Washington, DC
  1. Swolfe{at}citizen.org

Recently there have been strong, public arguments in the United States criticizing the lack of informed consent concerning risks in a US National Institutes of Health (NIH)-funded multi-center study called SUPPORT, which randomized 1316 extremely premature babies—average weight 2 lb, average gestation 26 weeks—to be maintained at higher (91-95%) or lower (85-89%) oxygen saturation levels after delivery. Conversely, investigators involved in this study, some ethicists, the NIH Director and his top officials and others, including medical journals, have staunchly defended this lack of informed consent. What underlies this sharp disagreement? Central to this dispute are conflicting views as to whether SUPPORT and similar studies are more like experiments or more like the existing standards of care.

In March, the US government’s Office of Human Research Protections (OHRP), pursuant to a complaint about the SUPPORT study two years ago, concluded its investigation with a letter1 to the lead site in the trial, the University of Alabama in Birmingham (UAB), criticizing multiple instances of the lack of information about risks in the consent forms,2 compared with the discussion of such risks in the protocol for the study.3

In particular, the study protocol makes clear that …

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