Lack of ethical clearance prompts expression of concern from bone journal
I regret to inform you that possible unethical author behavior has been identified with regard to a previously published article in The Journal of Bone and Joint Surgery, namely “Skin-Derived Fibroblasts for the Treatment of Refractory Achilles Tendinosis: Preliminary Short-Term Results,” with authors 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 Journal of Bone and Joint Surgery received a letter from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, stating that the trial on which this study was based was performed without authorization from the MHRA and without a favorable ethical opinion from a recognized research ethics committee, both of which are required by the Medicines for Human Use (Clinical Trials) Regulations (2004).
Additionally, the MHRA stated that permission was not obtained from the organization where the research was undertaken, as required by the Department of Health Policy. It has been reported to me that the research patients were treated at a private practice facility. There are differing reports as to whether or not the lead author, Dr. David Connell, retained records of his research findings.
It has been reported to me that there is an ongoing investigation in the United Kingdom by the General Medical Council (GMC) into possible unethical behavior. We will inform our readers of the outcome of this investigation when it is complete.
The corresponding author of the paper, Haron Obaid, tells Retraction Watch:
The principle investigator and the senior author of the paper (Dr David Connell) is currently involved in dealing with these matters. As you can see these matters are still under review, so may be it’s more reasonable to wait and see.