JAMA has issued its first-ever Expression of Concern over a 2007 study of hip protectors in the elderly that came under scrutiny from Federal regulators.
After review of the reports from [the Office of Human Research Protection] 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)
In February, JAMA told us that there hadn’t been any requests to correct or retract the paper, and that they were awaiting OHRP’s final determination. In yesterday’s letter, the editors write:
Based on information reported to JAMA by Hebrew SeniorLife, Washington University School of Medicine, and the University of Maryland School of Medicine in response to our requests, there was no evidence provided that raised concerns about the scientific integrity of the data and the veracity of the study conclusions; therefore, we are taking no further action at this time. If additional information should become available about the ethical conduct of this study, about harms to patients that occurred by virtue of failure of notification of possible risk, or about the scientific integrity of the research, we will evaluate that information carefully and determine whether additional notifications will be necessary.
Along with yesterday’s Expression of Concern, the journal published the text of letters that the OHRP required the institutions to send study participants.
Hebrew SeniorLife officials, according to the Globe:
said in a statement Thursday that after federal investigators alerted the organization to problems more than a year ago, it immediately conducted its own probe and made sweeping changes to the research program.
“We know that when an issue like this one arises, it is rarely the responsibility of one person, and so we used our internal investigation of the study as an opportunity to examine and improve all of [our] systems for human subject protection,” Hebrew SeniorLife chief executive Len Fishman said.
Expressions of Concern are, as Retraction Watch readers probably know, far more rare than retractions.
The study by Harvard and Hebrew SeniorLife’s Douglas Kiel and colleagues has been cited 62 times, according to Thomson Scientific’s Web of Knowledge.
Hat tip: Mike Delaney