A study involving researchers affiliated with Harvard and other academic institutions, intended to look into prevention of hip fractures, actually may have exposed over 1,300 participants to increased risk of hip injury. The Office of Human Research Protections (OHRP), part of the U.S. Department of Health and Human Services, ordered investigators to send notifications to the participants, who are elderly nursing home residents, detailing the risks to which they were exposed during the 2002-06 study. This concludes a year-long investigation by OHRP.
The Hip Impact Protection Project (HIP PRO) investigated the effectiveness of padded undergarments known as “hip protectors” in preventing injury to elderly nursing home residents. The study involved thirty-seven nursing homes, testing the efficacy of a type of undergarment that contained a hip pad on either the right or left hip. The researchers found that the single-side protective garments “may have caused unanticipated changes in behavior” among participants. The researchers concluded that hip protectors offered no significant protection against hip fractures. The study was published in the August 2008 issue of Clinical Trials, and it was also included in a 2007 issue of the Journal of the American Medical Association.
Researchers reportedly began to worry about undisclosed risks to the study participants while the study was still underway. In ordinary clinical use, hip protection is provided for both hips. Data indicated that study participants were more likely to suffer falls, and hip fractures, on the hip with the padding. The study’s leaders reportedly did not disclose this fact to participants.
The study’s leader, Dr. Douglas P. Kiel, also faced a lawsuit from padded hip protector manufacturer HipSavers, Inc. in 2008. HipSavers accused Kiel of defamation for claiming that its products offered no protection against hip injury. A Massachusetts judge dismissed the lawsuit in July 2011, but by then an investigation of the study was already underway.
Discovery conducted in the HipSavers lawsuit reportedly revealed that researchers had long recognized the tendency of study participants to fall on the padded side of their garment, sustaining injuries at a more frequent rate than normal. OHRP sent a letter to the three institutions involved in the HIP PRO study on June 23, 2011 detailing the concerns over failure to disclose risks discovered in the course of the study, which HHS alleged constituted violations of its own regulations for protection of people participating in research. The letter addressed documentary evidence going back to 2004 showing that researchers were aware of an increased incidence of hip injuries among participants on the padded side. OHRP requested that the institutions take corrective action regarding the lack of disclosure.
In a follow-up letter dated February 17, 2012, OHRP rejected the researchers’ proposed action plan and ordered them to develop a new plan that involved directly informing study participants, or their next of kin, of the risks to which they were exposed during the study. OHRP approved a revised plan to notify study participants in a July 5, 2012 letter. Whether any study participants will pursue legal claims for injuries sustained during the study remains to be seen.
At Lebowitz and Mzhen, we defend the rights of Maryland seniors who have suffered injury because of nursing home abuse or neglect. To schedule a free and confidential consultation, contact us today online or call (800) 654-1949.
Letter from the Office for Human Research Protections to Hebrew Rehabilitation Center, University of Maryland Baltimore School of Medicine, and Washington University School of Medicine (PDF), June 23, 2011 (source)
U.S. Department of Health and Human Services Determines that University Researchers Deliberately Failed to Disclose Risks Caused by Study Design in Hip Protector Research Project According To HipSaver, Inc., Press Release from HipSaver, Inc., June 30, 2011
Letter from the Office for Human Research Protections to Hebrew Rehabilitation Center, University of Maryland Baltimore School of Medicine, and Washington University School of Medicine (PDF), February 17, 2012 (source)
Letter from the Office for Human Research Protections to Hebrew Senior Life (PDF), July 5, 2012 (source)
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Study Finds 21% of Short-Stay Patients in Nursing Homes Will Sustain Falls, Maryland Nursing Home Lawyer Blog, July 5, 2012
Nursing Home Fined After Staffers Failed to Help Resident Who Fell Down for Nearly an Hour, Maryland Nursing Home Lawyer Blog, May 29, 2012
Jury Awards $200 Million in Nursing Home Wrongful Death Case Where Defense Did Not Show Up, Maryland Nursing Home Lawyer Blog, January 25, 2012