December 2014

Comparative Effectiveness ResearchEthical and Regulatory Guidance

Author Affiliations
  • 1Albert Einstein College of Medicine, Bronx, New York
  • 2The Hastings Center, Garrison, New York
  • 3Harvard Medical School, Boston, Massachusetts

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Pediatr. 2014;168(12):1089-1090. doi:10.1001/jamapediatrics.2014.1764

In March 2013, the pediatric research community was rocked when the Office for Human Research Protections of the Department of Health and Human Services determined that the informed consent documents in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a National Institutes of Health–funded, Neonatal Network multicenter study, failed to include, or adequately address, basic elements of informed consent as required by Health and Human Services regulations. A firestorm of controversy ensued and continues to this day.13

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