The Retraction Watch category for “lack of IRB approval” as a reason for retraction — a subject we covered in our most recent Lab Times column — is growing. First there were the 90-odd retractions by Joachim Boldt, then three by Australian researchers studying Aussie-rules football players. Now, we learn that the Journal of Clinical Oncology has retracted a paper over concerns that the authors failed to obtain ethical approval to conduct their study.
The 2010 publication, by researchers at Saitama Medical University in Japan, reported on an analysis of 314 lymphoma patients being treated with chemotherapy — some, and perhaps none, of whom knew they were being studied.
Journal of Clinical Oncology and Stephen A. Cannistra, MD, Editor-in-Chief, on the basis of the results of an investigation conducted by Saitama Medical University, have concluded that the December 1, 2010 study by Niitsu et al, entitled, “Prospective Analysis of Hepatitis B Virus Reactivation in Patients With Diffuse Large B-Cell Lymphoma After Rituximab Combination Chemotherapy” (J Clin Oncol 28:5097-5100, 2010), did not comply with standard ethical principles of clinical investigation, despite claims to indicate otherwise in the published article. Specifically, Saitama Medical University determined that the authors failed to obtain Institutional Review Board approval for the research and failed to obtain written informed consent from all of the participants. Accordingly, JCO formally retracts this article.
The paper has been cited 10 times, according to Thomson Scientific’s Web of Knowledge. We had a number of questions, chief among them whether the authors had informed consent from ANY of their subjects.
We reached a representative of the American Society of Clinical Oncology, which publishes the JCO, who told us that Saitama contacted the journal about the lack of IRB approval but that the editors didn’t push the informed consent angle further.
Once they determined there were inconsistencies in meeting the IRB standards, that’s all they needed to know.
Earlier this month, Saitama posted the following notice on its website, which adds a bit to the picture:
Five researchers of the Saitama Medical University were recently involved in an unethical incidence in submitting and publishing a paper on an international journal “Journal of Clinical Oncology (JCO)”.
Based on a report from the Saitama Medical University Internal Investigating Committee, the Saitama Medical University Disciplinary Committee concluded that: i) it was unethical for the first author (= corresponding author [Nozomi Niitsu]) to perform a clinical research without obtaining written informed consents from the patients, and to publish it in the JCO, by using a false statement in the paper; and ii) it was also unethical for co-authors to sign on a consent form, without careful reading of the paper.
The Disciplinary Committee thereby decided the following disciplinary actions A and B, in light of the internal disciplinary rules of the Saitama Medical University.
A) The corresponding author was officially castigated, and a series of e-learning on clinical research activities was imposed.
B) The co-authors were officially reprimanded.
To avoid recurrence, all the researchers in the Saitama Medical University have been reminded of this incidence, by an announcemnet dispached by the Medial Research Center.
Toshio Yamauchi, MD
President, Saitama Medical University
Chair, Disciplinary Committee
Postscript: It has been announced in the Sep. 20 issue of The Journal of Clinical Oncology that the paper has been retracted by the Editorial Board.
Masami Bessho, MD
President, Saitama Medical University
We’re not sure what “e-learning on clinical research activities” might be, but we’re hoping it’s more than a few hours in front of a computer with a box of donuts.
Hat tip: Commenter Klaus