A leading medical journal Thursday published an unprecedented “Expression of Concern” regarding the conduct of scientists on a study that, federal regulators concluded, may have exposed more than 1,000 elderly nursing home residents in Massachusetts and elsewhere to an increased risk of falling.
The statement from the Journal of the American Medical Association, which a spokeswoman confirmed was the first in its 129-year history, said that the scientists at Hebrew SeniorLife in Boston and two other institutions were not “forthcoming” with journal editors about the potential risks when editors asked them about the issue before publishing their work in 2007.
“The failure to notify research participants about potential risks they may have experienced by participating in the study represents serious concerns regarding their protection as research participants in this study,” Dr. Howard Bauchner, the journal’s editor in chief, and Dr. Phil B. Fontanarosa, executive deputy editor, wrote in the statement posted on the JAMA website.
The editors added that there was “no evidence provided that raised concerns about the scientific integrity of the data and the veracity of the study conclusions.”
The federal Office for Human Research Protections, which concluded a yearlong investigation in July, said the scientists privately discussed the possibility that one-sided hip protectors they were studying might have increased elders’ risk of falling toward the padded side, potentially exposing them to hip fractures, yet the scientists failed to inform patients, the safety boards that monitored the study, and the federal agency that funded the research.
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