Surgery studies lacked ethics committee approval

3Surgery Today has pulled a pair of papers that share many authors because the studies they describe were not approved by an institutional ethics committee.

One describes a case in which the researchers removed a mass from a 64-year-old woman’s small intestine; the other describes how the authors removed a growth from a patient’s pancreas. They conclude that the surgery techniques used — like a laparoscopic pancreaticoduodenectomy, a take on the “Whipple Procedure” — can be “feasible, safe, and effective” in certain patients.

The papers share several authors, including a first author, Akihiro Cho, whose affiliation on the papers is Chiba Cancer Center Hospital in Japan. They also share a retraction note, which explains how the journal learned of the issue:

The two articles listed below have been retracted as a result of a notice received from the corresponding author, Akihiro Cho, that the studies described in the articles were undertaken without the approval of an institutional ethics committee. The Editor-in-Chief has therefore determined that the articles failed to meet the ethical standards required by the Journal.

Totally laparoscopic pancreas-sparing duodenectomy,” has not been cited according to Thomson Reuters Web of Science. “A totally laparoscopic pylorus-preserving pancreaticoduodenectomy and reconstruction” has been cited 15 times.

An email to Cho’s institutional address bounced back. We’ve contacted the journal for more information and will update this post with anything else we learn.

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4 thoughts on “Surgery studies lacked ethics committee approval”

  1. Not an enlightening report. Did the specific proceedures require approval from the institutional ethics committee because the techniques were new and innovative? And therefore the case reports should not be published?

  2. Intriguing. Both retractions appear to be of case reports, in which the surgeons try a relatively new technique. If this treatment was genuinely used for clinical reasons alone it would not be expected that an IRB would need to grant approval – doctors don’t need ethics approval to treat patients according to their assessment of the best clinical approach. Case reports usually only require consent to publish from the patient as they are not research studies. Case reports of novel treatments or modifications are however a greyer area than descriptions of diagnosis and management (and surgeons push the line further than others), and it would be interesting to hear from the authors’ IRB on whether they did view this as research.

  3. This is covered in article 37 of the Declaration of Helsinki which states:
    “Unproven Interventions in Clinical Practice
    37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.”

    While the 2012 Surgery Today case report’s abstract states that a 64 year-old woman was treated, the 2009 Surgery Today abstract is vague and both articles are behind a paywall. If the 2012 article was a second case report, even if a different patient, then that’s a no-no, If it was a follow up on the 2009 single case report, then I don’t see a problem. However, the 2012 abstract has a 32 day follow up making it unlikely that it’s the same patient in 2009 and 2012 with a longer follow up.

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