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December 19, 2012

Expression of Concern: Kiel et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007;298(4):413-422.

Author Affiliations

Author Affiliations: Dr Bauchner is Editor in Chief and Dr Fontanarosa is Executive Deputy Editor, JAMA.

JAMA. 2012;308(23):2519. doi:10.1001/jama.2012.14079

We hereby issue an Expression of Concern regarding the conduct of the research reported in the article entitled “Efficacy of a Hip Protector to Prevent Hip Fracture in Nursing Home Residents: The HIP PRO Randomized Controlled Trial,” published in the July 25, 2007, issue of JAMA.1 This study has been the subject of an investigation conducted by the Office for Human Research Protections (OHRP) in the Department of Health and Human Services regarding 45 CFR part 46, federal regulations that govern the ethical conduct of research.

After review of the reports from OHRP dated June 23, 2011,2 February 17, 2012,3 and July 5, 2012,4 and evaluation of additional information requested by JAMA and provided to us by the participating institutions (Hebrew SeniorLife [an affiliate of Harvard Medical School], Washington University School of Medicine, and the University of Maryland School of Medicine), we concur with the OHRP determination that 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. Therefore, we are issuing this Expression of Concern regarding the ethical conduct of this study. When the study was first published in 2007, the authors acknowledged1 and an editorial in JAMA5 anticipated that having only 1 hip protected could have altered the gait of participants and the propensity to fall to the protected side. However, at that time, the authors were not forthcoming with providing information JAMA requested that would have been informative in understanding this risk.2(p9)