The medical publication Journal of the American Medical Association has taken an unprecedented measure to notify readers that a study it published had nursing home residents participating in the research at a serious risk of falling to complete the study.
According to a report from The Boston Globe, JAMA editors said a 2007 study that examined how elderly patients at three nursing homes could prevent hip fractures needlessly put study participants at risk of falling and suffering bone fractures. At the time the study was conducted, participants were not notified of the risks the research posed.
Dr. Howard Bauchner, the editor-in-chief at JAMA, said in a statement: “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.”
The study was examining the effectiveness of “one-sided hip protectors” that aimed to prevent hip fractures when a person fell. The protectors, study researchers eventually conceded, put participants at risk of falling to the side that was protected by the hip pad. The pads were being studied against undergarments that provide equal protection on both sides, padding both hips. These undergarments are typically worn by nursing home residents to prevent hip fractures if they were to suffer a fall.
Study authors from Hebrew SeniorLife in Boston, University of Maryland School of Medicine, and Washington University School of Medicine are accused of failing to notify not only the participants of the study the risks they were exposed to by taking part in the study, but also journal editors despite their insistence, and the federal agency which funded the study, the Office for Human Research Protections.
Those who participated in the study recently received notification that they were at risk of serious injuries – namely hip fractures – from their taking part in the study examining the safety and effectiveness of these one-sided hip protectors. The study lasted from 2002 through 2006. Earlier this year, following a year-long investigation, the Office for Human Research Protections ordered that the more than 1,300 participants be notified of those risks. Many of the patients in the study have since died, according to The Globe report.