As a result, the federal agency is now ordering the researchers to develop a plan to contact nursing home residents in Boston, St. Louis, and Baltimore who participated in the study and may unwittingly have been placed in peril.
The conclusions of the federal report were based, in large measure, on private e-mails exchanged among the researchers, including Harvard Medical School gerontologist Dr. Douglas P. Kiel.
“The investigators themselves, in candid e-mails to one another, recognized the significance of these findings,’’ the letter states. “Yet, in the face of these developments, efforts were made to either ‘slant,’ or completely fail to report … information to the groups … that might have found this information highly relevant in their deliberations.’’
The study included more than 2,000 patients, many of whom had significant cognitive impairments.
Nursing home patients often wear padded underwear to protect their 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 to enroll patients in 2002, data from the study increasingly indicated that the one-sided padded underwear might be causing the very problems it was designed to prevent - seniors were more often having serious falls on the padded hip side than the one unprotected, according to the regulators.
Despite the fact that investigators learned risks existed, federal regulators said, they failed to disclose it to research participants; to the National Institutes of Health, which funded the study; and to other officials overseeing the research.
The regulators found that by October 2004, if not earlier, investigators had become “sufficiently aware of the risk of increased falling to the pocketed side and the associated risk of possible hip fractures, but failed to inform subjects who were enrolling during this time of these reasonably foreseeable risks.’’
