The Journal of Bone and Joint Surgery has retracted a 2012 paper because of ethical violations, initially flagged by the journal in 2013.
The study, which examined the use of autologous cell therapy in treating Achilles tendinosis, claimed in its abstract to have “conducted a randomized, double-blind study on forty Achilles tendons in thirty-two patients.” Apparently, though, it wasn’t actually a clinical trial but was somehow, according to the retraction notice, “misclassified” as such “in error.”
The problem was originally flagged by the UK’s Medicines and Healthcare products Regulatory Agency, which wrote the journal to tell them that it hadn’t granted ethical approval for the study, as we reported in 2013. At the time, there was a question about whether the lead author had retained records of the results, which is addressed in the retraction notice, signed by editor-in-chief Marc F. Swiontkowski and editor-in-Chief Emeritus Vernon T. Tolo:
We regret to inform you that The Journal of Bone and Joint Surgery must retract “Skin-Derived Fibroblasts for the Treatment of Refractory Achilles Tendinosis: Preliminary Short-Term Results” by H. Obaid, A. Clarke, P. Rosenfeld, C. Leach, and D. Connell. The citation for this article is J Bone Joint Surg Am. 2012 Feb 1;94(3):193-200.
The study was initially misclassified as a clinical trial by Dr. Connell, in error, and this error was compounded by the same misclassification by the Joint Royal National Orthopaedic Hospital (RNOH) and Institute of Orthopaedics and Musculoskeletal Science (IOMS) Research Ethics Committee. Thus, the ethics approval for this study that was given by the Joint RNOH/IOMS Research Ethics Committee was issued in error.
Initial allegations regarding the conduct of this study largely resulted from the misclassification. Additionally, we have it on authority that records of the research findings were retained and are available.
The study did not meet our ethics policy criterion regarding institutional review board (IRB) approval or approval by a similar ethics board, and thus the article must be retracted.
The paper has been cited 15 times, according to Thomson Scientific’s Web of Knowledge. We’ve contacted the paper’s lead author, David Connell, as well as its corresponding author Haron Obaid and the editor-in-chief of the journal. We will update with new information if we get any.
Connell, who’s listed as an adjunct professor at Monash University, is also on the clinical advisory board of RepliCel, a company based in Vancouver, Canada, that is developing autologous cell therapies for chronic tendonitis and other conditions.
Update, 10:45 a.m. Eastern, 6/21/15: The journal has posted an update to the retraction notice:
New information has been received that mandates an update to the retraction of “Skin-Derived Fibroblasts for the Treatment of Refractory Achilles Tendinosis: Preliminary Short-Term Results,” by H. Obaid, A. Clarke, P. Rosenfeld, C. Leach, and D. Connell (J Bone Joint Surg Am. 2012 Feb 1;94:193-200). The previously published retraction notice (J Bone Joint Surg Am. 2015 Apr 15;97:667) was inaccurate in several respects.
The study was initially misclassified as a clinical trial by Dr. Connell, in error; the error was identified by the appropriate authorities during an audit, and Dr. Connell was informed of the problem. Dr. Connell did not reapply for the appropriate authorizations and ethics clearance using the correct classification.
Records of the research findings have been requested for review by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom. They were not received by that agency as of this writing, and we cannot confirm that they are available. Should they become available, that would not affect the retraction of this article, which did not meet our ethics policy criterion regarding institutional review board (IRB) approval or approval by a similar ethics board.
To preserve the public record, the retraction notice published on April 15, 2015, is repeated below.
Marc F. Swiontkowski, MD
Vernon T. Tolo, MD
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