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.
Here’s the notice, which appeared this month:
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:
Committee Report
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 CommitteePostscript: 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
Don’t malign the donuts. Raising your blood sugar while reading might improve learning.
I think this may be just the tip of the iceberg, possibly relating to pressure on researchers to publish prospective, randomized, placebo controlled studies when it might be more appropriate to get retrospective observational data. I mentioned before that it is very difficult to get cancer patients to give informed consent to studies in which they may perceive that they are being deliberately held back from life saving treatments as placebo controls.
Conrad, a quick reading of the abstract of the paper makes it clear the study had nothing to do with any prospective, randomized, and/or placebo-controlled study.
Moreover, I don’t think there are many placebo-controlled studies on cancer patients (only, perhaps, with respect to drugs that are administered to handle side-effects of the cancer or the cancer treatment).
You’re right. I was thinking of “usual care.” Which is actually sometimes a placebo in the sense that it doesn’t help any.
The barbaric society now has one word for all wrongs – unethical. Not reading your paper is unethical. Meanwhile, researchers did nothing wrong to the patients, they are unethical in something else. And what that informed consent is? Everyone should know the formula of the ingredients in the syringe? Of course, the informed consent is a fiction: even the researcher has no idea about the patient’s reaction, he is just studying this, he doesn’t know what he is doing also, not all the ingredients. He doesn’t know about all the viruses, as Koprovski did not know, even though he was warned. Who actually needs that fiction? You either trust your doctor and make yourself available for his experiments or you don’t. Is telling lies to patients ethical? Or anything is justified once you got their signatures on the informed consent papers? That is the goal, isn’t it? Yet, it would never be difficult to prove that “informed” is fraud.
A lot of times, it is difficult to separate clinical practice from a ‘study’. (remember the checklist problem that Peter Provonost encountered with the IRBs?) We found that the established dose of a drug established in one ethnic population was too high for another ethnic population which experienced very serious adverse effects observed. We proceeded to attenuate it upfront without a ‘study’ so as to avoid killing patients, while capturing data carefully and systematically to ensure we were doing the right thing, while informing our patients that it was institutional practice to reduce the upfront dose. Would it be unethical to report the results of that series, looking back?
More comments
“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”
– This is incorrect, and propagates the ‘myth of informed consent’. Clinical research can be performed with study waivers. Unless the comments were specific to this paper.
” and to publish it in the JCO, by using a false statement in the paper;”
– This is true, but may not alter the validity of the study
You know, I always got the feeling that my clinical practice was a sort of “study”–just the results were filed in my mind, not publishable. Don’t tell what’s his name. It wouldn’t have been a study if I had somehow been “trained” to treat all such patients the same from the start. And ignored the results.