The Surfactant, Posititive Pressure, and Oxygenation Randomized Trial (SUPPORT) trial randomly assigned 1,316 premature babies to receive different levels of oxygen supplementation in a comparative effectiveness research study. However, in 2013, the US Office of Human Research Protections (OHRP) determined that the parents were not properly informed of the potential risks involved in the study, which included blindness, brain damage and death. Upholding this decision, the OHRP has now issued guidance clarifying its position on what types of risks must be disclosed to study subjects in comparative effectiveness research studies. Read more here. (Source: Nature.com, 10/24/14).
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