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April 2017

Addressing Ethical Lapses in Research

Author Affiliations
  • 1The Greenwal Foundation, New York, New York
  • 2University of California, San Francisco, San Francisco
  • 3San Francisco VA Medical Center, San Francisco, California
JAMA Intern Med. 2017;177(4):461-462. doi:10.1001/jamainternmed.2016.9579

The study “Association of Testosterone Levels With Anemia in Older Men,”1 published in this week’s JAMA Internal Medicine, contains an ethical error. Hemoglobin levels were measured in all 788 participants at baseline, and every 3 months during the 1-year duration of the trial. Blood obtained at baseline was stored until the end of the trial, when tests for the cause of anemia were performed. Participants with hemoglobin levels less than 10.0 g/dL at baseline were excluded from the trial and “referred to their primary care providers for evaluation of anemia.” However, the 126 participants (16%) with mild anemia (hemoglobin levels between 10.0 and 12.7 g/dL) were not told of this condition.