Retraction Watch

Tracking retractions as a window into the scientific process

Patients did not okay publishing brain surgery details

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BioMed Central has retracted a paper after realizing it shared details on the brain surgeries of four patients without their consent.

Darlene Lobel, a neurosurgeon at the Cleveland Clinic in Ohio, agreed to the retraction, and told us she didn’t know that she needed consent from the patients since all identifying details had been removed. The paper describes a technique for craniotomy — opening up the skull to access the brain — and included CT scans of hemorrhaging and swelling that the patients experienced, as well as other details such as their gender and age.

Here’s the retraction notice:

The Publisher has retracted this article [1] because it appears that the authors did not obtain the necessary consent to publish their case details from the patients described. The article is no longer available online in order to protect the patients’ privacy. Darlene Lobel has agreed to retraction, Daniel Miller could not be reached by the journal for comment on the retraction.

Decompressive craniectomy without durotomy for traumatic coma and uncontrollable intracranial hypertension” was published in  Journal of Trauma Management and Outcomes in 2013, and is not indexed by Thomson Reuters Web of Science.

Lobel told us the backstory from her perspective:

I didn’t realize when we submitted the paper that consent needed to be obtained for the four patients in the case series, otherwise I would have done that before submission. We had excluded all identifying information from the CT scans and used no names in the case descriptions. This paper was presenting a new technique to perform craniotomy that may result in reduced morbidity and mortality, as the patients we described had better outcomes than expected.

We wanted to know how the issue came to light, so we asked a spokesperson for BioMed Central (BMC) for more details. She said:

I would refer you to the retraction notice.  If you have further questions, we recommend that you contact the authors themselves.

Lobel told us what happened after she learned from an editor that the paper needed patients’ consent:

I contacted [co-author] Dr Miller to ask him to please obtain the consent from the patients. I had been working at Community Medical Center [in Fresno, California with Miller] as a locum tenens neurosurgeon, and my term had ended at that point, so I did not have access to the medical records. Therefore I could not obtain phone numbers or addresses to contact the patients to obtain consent at that point.

I contacted Dr Miller multiple times, but he did not reply, except after a few attempts, he emailed me and asked me if the consent situation had been resolved. I emailed him back and explained that I was not authorized to obtain consents at that point, so he would have to do it. I never heard from him again.

I assume Dr Miller is still working at CMC, but I have not heard from him in over a year.

Daniel Miller is affiliated with the University of California San Francisco, and has not replied to our emails.

Lobel added:

I am very disappointed that the manuscript had to be retracted, but I feel it is important to comply with editors’ requests.

We contacted the University of California, and will update this post with anything else we learn.

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Comments
  • Ken July 1, 2016 at 7:10 am

    This doesn’t necessarily need consent from the patients, what it does need is consent from an IRB who will decide whether consent from the patients is needed.

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