Lack of ethical clearance prompts expression of concern from bone journal

jbjsThe Journal of Bone and Joint Surgery has issued an expression of concern about a paper whose authors may not have obtained proper ethical clearance.

Here’s the notice, signed by editor in chief Vernon Tolo:

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.

3 thoughts on “Lack of ethical clearance prompts expression of concern from bone journal”

  1. This is not a terribly unusual situation, although it is becoming far less commonly encountered in the US. Very often, physicians in practice who have little or no research experience undertake activities which, in the view of sponsoring institutions and regulatory agencies, are investigational, but are viewed by the practitioner as nothing more than an empirical clinical therapeutic trial. I don’t think that most of these cases have fraudulent intent, but simply naivete on the part of the physician. That does not excuse the lapse, and it is appropriate to withdraw such reports, but it would be better to work with offending physicians to help them understand what is required rather than simply to castigate them.

  2. I serve on university research ethics board and am wondering if there is any precedent for an ethics board reporting failure to get ethics approval to a journal?

    1. I don’t know if there are precedents for reporting by a university ethics board. But this case seems more serious. The journal was contacted by the “Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom” which must be what the british people call a QUANGO. There is also an investigation by the General Medical Council, which can remove a license. There seems to be quite a storm brewing over the actions of the authors, and obviously the MHRA considers it within their remit to contact the journal.

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