More than 1,300 nursing home residents who participated in a Harvard-led study on preventing hip fractures, including 268 in Massachusetts, will soon be receiving letters detailing serious risks that federal regulators say they were exposed to by the researchers.
That action, ordered by the federal Office for Human Research Protections, concludes a yearlong investigation into researchers at Hebrew SeniorLife in Boston, the University of Maryland School of Medicine, and Washington University School of Medicine who conducted the study testing how well padded hip protectors cushion residents’ falls.
The regulators said the scientists — led by Dr. Douglas P. Kiel, a Harvard Medical School gerontologist — discovered that the one-sided protectors they were studying increased elders’ risk of falling, 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.
“Investigators failed to provide subjects with significant new findings about these risks developed during the course of the research which may have related to the subject’s willingness to continue participation,” the Office for Human Research Protections stated in July 5 notices that were made public Wednesday.
Earlier, regulators ordered the research centers to develop corrective action plans to ensure that their scientists follow rules designed to protect patients and that they promptly alert officials monitoring their work when problems arise.
‘Investigators failed to provide subjects with significant new findings about these risks.’
In the new notices, regulators approved each institutions’ detailed plans for tracking down and notifying the nursing home residents, many of whom had significant cognitive impairments. The residents had been enrolled in the study between 2002 and 2006.
The notices indicated that because many of the residents have probably died, investigators would be required to locate and send letters to the residents’ next of kin, legally authorized representatives, or estate administrators.
The notices show that Kiel’s team at Hebrew SeniorLife is required to notify the legal representatives of 267 of the 282 residents enrolled in Greater Boston and one study participant directly. The notice says that Hebrew SeniorLife was unable to track down the remaining 14 because it failed to collect information about the elders’ next of kin or other contact.
Kiel declined to comment and referred a call to Hebrew SeniorLife’s media office. That office released a statement that said, “Hebrew SeniorLife is dedicated to improving the lives of seniors, and research is a critical component of our mission. We will continue to hold human research subject safety in the highest regard as we conduct research that improves the lives of older adults around the world.”
Washington University School of Medicine released a statement saying it would contact all 824 residents it enrolled in the study, while the University of Maryland School of Medicine said it is in the process of tracking and notifying 246 residents.
Nursing home patients often wear padded underwear to protect frail hips. Typically, the underwear is padded on both hips. But in the study, researchers were assessing garments that were padded on just one side.
After they started enrolling patients, data increasingly indicated that the garment might be causing wearers to fall; seniors were more often having serious falls on the padded hip side than the one unprotected, according to regulators.
In concluding their investigation, regulators also sent a thank-you letter to Ed Goodwin, a Canton businessman who alerted authorities to the study’s problems, and turned over documents central to the investigation.
Goodwin discovered the problems during a lawsuit against Kiel, who had published an article about his study in the Journal of the American Medical Association. Goodwin accused Kiel of disparaging the entire hip protector industry, and during that lawsuit received copies of the researchers’ personal e-mails, which revealed that they suppressed information from patients and officials.
“As you know, most of the documents that we relied upon were provided by you,” stated the July 9 letter from regulators to Goodwin. “We thank you for providing us with the documentation. Without such documentation, we would most likely not have been able to make these determinations.”