Keck School of Medicine Events

Research Ethics ForumResearch Forum

Risk, Consent, and the Ethics of Comparative Effectiveness Research
September 2013
Thursday, September 12, 2013
12:00 PM - 1:00 PM
Norris Research Towers LG, 503/504
More informaion   Flyer and more information .

Alexander Capron, LLB, Director of Research Ethics, SC CTSI
University Professor Professor of Law and Medicine Keck School of Medicine of USC. Co-Director, Pacific Center for Health Policy and Ethics and
Donna Spruijt-Metz, MFA, PhD, Director, USC/CESR Mobile and Connected
Health Program, Associate Professor, Dept. of Preventive Medicine, Director, Responsible Conduct of Research, Office of Research Advancement
Keck School of Medicine of USC, will be presenting.
The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) provides a vivid "ethics case study" for comparing different "established" treatment regimes. SUPPORT involved 1300 infants born between 24 and 27 weeks of gestation. Between 2004 and 2009, researchers at 23 academic medical centers compared the rates of retinopathy and neurological damage from randomizing these infants to receive supplemental oxygen at a rate that aimed to achieve either 85-89% or 91-95% O2 saturation, both of which were within the existing standard of care in these (and other) neonatal intensive care units. The consent forms for the study did not fully disclose the risks that are inherent in these treatments. Although not anticipated, the infants receiving the oxygen in the lower range had a slightly higher death rate. Four years after the end of the study, the federal Office for Human Research Protections (OHRP) informed the 23 institutions that they were out of compliance with the federal rules on research with human subjects. Three months later, after criticism from the Director of NIH and a number of bioethicists, OHRP withdrew the letter and then announced a public meeting on what "risks" count in comparative effectiveness trials and how they should be conveyed to research subjects.

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