Earlier this month, the U.S. Office for Human Research Protections (OHRP) told a group of researchers led by a Harvard Medical School professor that they hadn’t been forthcoming enough about the risks elderly subjects faced in their trial.
As the Boston Globe reported:
The letter from the Department of Health and Human Services instructed the institutions to contact nursing home residents in Boston, St. Louis, and Baltimore who participated in the completed study and tell them that they should have been alerted to information about risks the scientists discovered during the research.
The scientists, led by Harvard Medical School gerontologist Dr. Douglas P. Kiel, were studying how to reduce often lethal hip fractures.
Federal regulators also ordered the research centers to develop corrective action plans to ensure that their scientists follow rules designed to protect patients and to promptly alert officials monitoring their work when problems arise.
Specifically, individuals who participated in the study, which required them to wear an undergarment with padding on one hip, may have had an increased likelihood of falling to the side of the body that was meant to be protected.
JAMA tells Retraction Watch there have been no requests to correct or retract the paper, and that the journal is waiting OHRP’s final determination. Kiel referred us to a Hebrew SeniorLife spokesperson, who said “it seems premature to make plans regarding the paper as published in JAMA.”