Cureus has retracted a pair of case studies after the authors revealed that the informed consent they’d received from the patients had been revoked.
The fate of articles — both by authors in the United Kingdom — highlight the precariousness of papers that rely on consent from patients or, in one instance, their proxies.
One paper, “Failure of an Ancient Breast Implant Can Lead to Significant Morbidity,” described the case of a 90-year-old woman who ruptured a 60-year-old breast implant. (The first silicone breast implants arrived in 1962, so the 60-year-old prosthesis would have been among the earliest to be inserted.)
According to the retraction notice:
This article has been retracted and removed due to recently discovered issues with the patient consent process. Unbeknownst to the authors at the time patient consent was granted, the patient’s next of kin had power-of-attorney and therefore should have been consulted regarding patient consent. As a result, the patient consent form is not valid and the patient now wishes for the article to be removed. The authors have formally requested this retraction.
The second paper, “Uterine Inversion Secondary to a Large Prolapsed Leiomyoma: Diagnostic and Management Challenges,” appeared in March 2020 and came from another group in the UK led by Ahmad Sayasneh, an OB/GYN at Guy’s and St Thomas’ NHS Foundation Trust, in London. In this case, the patient was a 47-year-old woman who initially gave her consent for the authors to write up their report on her condition — which was treated successfully, according to the researchers.
But after seeing the case study in print, the woman changed her mind:
This article has been retracted and removed due to a formal request from the authors made at the behest of the patient featured in the case. No evidence of any author misconduct has been found, however, the authors wish to honor the patient’s request. The retraction request from the authors has been included below:
As the most senior academic author on the paper, and in agreement with my other co-authors, we formally wish to request the retraction of this published article. We have reached this sad decision after long discussions among ourselves as authors and after consulting the academic board in the Gynaecological Oncology Department at Guy’s and St Thomas’ NHS Foundation Trust.
Our patient gave consent for her case report to be published while she was in the hospital after a successful surgery and excellent recovery. The initial consent form signed was the surgical consent for the procedure itself which allowed us to take photos for teaching and the second informed written consent form was a standard form for publication in a journal. At that time she was very happy for the case to be published. A year and a half later she wrote to me expressing that although she signed the consent form she did not read the article before publication and she requested a copy of the publication. Later she wrote expressing her wish for the publication to be withdrawn based on that she did not consent for this particular paper. Different reasons were given in subsequent conversations but she remained adamant that the paper be removed.
Although some might argue that we can challenge these allegations, our ethical commitment to good clinical practice and putting patients first has led us to formally request the retraction of this article.
John Adler, the editor-in-chief of Cureus, told us that the authors in both cases acted appropriately:
Each of these retractions were formally requested by the authors in response to pressure from the involved patients. These two case reports are interesting and unique; in neither did the author group necessarily do anything wrong or unethical. In both the authors believed themselves to be following all necessary informed consent procedures, and even in hindsight, I do not disagree.
In one case, the patient simply changed their mind and while under no obligation to remove the article, the authors’ elected to honor the patient’s request by retracting. For the other article, the authors didn’t realize that the patient had authorized a Power-of-Attorney to another individual, from whom consent was not formally given. Out of an abundance of caution they also elected for retraction.
Quite frankly, issues such as these are hard to avoid in a complex medical world, and despite these current issues, I am loathed to change Cureus’ current standards for authors soliciting patient consent when publishing case reports. One could legitimately argue the patients reported in the 2 involved case had no right to request retraction, since no identifying patient data was involved. Ultimately it is safer and easiest for nearly all journals to respect a patient’s wishes and simply retract the article in question.
Of course, what retraction looks like to researchers is much different from what patients and the public presume it to mean. In 2018, we reported on a retraction of a paper in a BMJ journal that happened after a couple didn’t realize that giving permission to publish pictures of their infected buttocks could mean that said buttocks could end up in British tabloids. That paper was removed entirely.
Arthur Caplan, a medical ethicist at New York University (where one of us [IO] also is on the faculty, and an unpaid affiliate member of Caplan’s division), told us:
What retraction means in science is not what retraction means in the world. People assume you erased all indications of existence [of the article] from the world, but that’s not the case.
Indeed, the full text of both Cureus articles remains available to readers on PubMed Central — albeit watermarked with the word “retracted.” Caplan agreed that that state of limbo may not be satisfying to the patients or their proxies who sought the removal of the paper.
Update, 4/23/21, 1615 UTC: Graham Parker-Finger, Cureus’ director of editorial ops and tech comms, sent an additional comment:
The article content was removed from Cureus when the retractions were issued. While this is not our normal policy regarding retractions it can be necessary in select cases where patient privacy is in question. PMC will also be removing the article content, however, Cureus was not provided with a target date for the removal.
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It’s unfortunate but I’m glad the researchers are not complicit in both works.
We need to re-engineer the processes of getting informed consent to avert more of such retractions.
Interesting comment: “One could legitimately argue the patients reported in the 2 involved case had no right to request retraction, since no identifying patient data was involved. ”
During a study, consent can be retracted at any time, but it’s interesting to consider whether consent applies to published materials.