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; therefore, we are taking no further action at this time.”
The federal Office for Human Research Protections, which concluded a year-long investigation in July, said the scientists privately discussed the possiblity 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.
Nursing home patients often wear padded underwear to protect frail hips. Typically the underwear is padded on both hips. But in this study, researchers were assessing garments that were padded on just one side.
“When the study was first published in 2007, the authors acknowledged, and an editorial in JAMA anticipated that having only 1 hip protected could have altered the gait of participants and the propensity to fall to the protected side,” the journal editors wrote. “However, at that time, the authors were not forthcoming with providing information JAMA requested that would have been informative in understanding this risk.’
Officials at Hebrew SeniorLife, where Harvard Medical School gerontologist Dr. Douglas P. Kiel presided over the hip study, said in a statement Thursday that after federal investigators alerted the organization to problems more than a year ago, it immediately conducted its own probe and made sweeping changes to the research program.
“We know that when an issue like this one arises, it is rarely the responsibility of one person, and so we used our internal investigation of the study as an opportunity to examine and improve all of [our] systems for human subject protection,” Hebrew SeniorLife chief executive Len Fishman said.
He said his organization strengthened its board that monitors research, and its process for ensuring that patients who enroll in studies are better protected. That process included training for research teams and oversight committees. Hebrew SeniorLife, an affiliate of Harvard Medical School, is a nonproft that runs nursing homes, provides senior health care and conducts geriatric research.
Regulators required the three institutions that conducted the study—Hebrew SeniorLife, the University of Maryland School of Medicine, and Washington University School of Medicine—to send letters to the more than 1,300 nursing home residents who participated in the study after August 1, 2004, when scientists realized there were problems but didn’t tell the patients.
In all, 2,054 elders were enrolled in the study between 2002 and 2006.
The required notices to patients, mailed in July, detailed the serious risks that regulators say the elders may have been exposed to by the researchers.
Thursday’s online journal posting includes copies of the letters from each of the institutions. The Journal also asked that each of the institutions post a sample of the letters they sent on their websites, and a Hebrew SeniorLife spokeswoman said it would comply with that request.
The letter from Hebrew SeniorLife to more than 260 people in Greater Boston does not note that the institution was required to send the letter, but says the information is “being shared with you now as a reflection of our commitment to transparency and research participant safety.
“We regret that this information was not provided to you earlier,” it says.
A Hebrew SeniorLife spokeswoman said Thursday the institution is “not aware of any participant that was harmed as a result of a fall attributable to his/her wearing of the external hip pad.”
Federal regulators earlier this year ordered the three 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.
Hebrew SeniorLife said it has completed its in-house training for its research teams and for those who monitor them.