Data anonymity

Case number: 
16-05

Case text (Anonymised)

A paper was submitted to our journal. The managing editor was concerned about patient information in the paper and queried the authors. The authors responded that the data were collected from routine samples and so consent was never obtained. The patients were lost to follow-up, and there was no ethics committee approval as it involved the study of existing data, but they did discuss with the institutional review board who said it was exempt.

The cohort was 2500 patients, all with one syndrome, in one hospital. The paper contains two tables that display data from 12 patients: sex, age, presenting symptom, as well as laboratory parameters and outcome.

Question(s) for the COPE Forum
• Are these patients identifiable?
• If we remove, say, age and sex, would that be sufficient to render the data anonymous? Would we lose clinical significance by removing age and gender for those patients, although the paper does mention that of the 12 patients most were female and gives the median age group?
• Should we publish this without patient consent?
• The study also mentions controls who underwent biopsy, but what is not clear is whether those controls were also from the same cohort and perhaps underwent biopsy as part of routine screening. Would they need ethics approval for biopsy?

Advice: 

The Forum agreed that the case was concerning. With the sophisticated knowledge and information that can be trawled from the internet, the concept of anonymity is becoming more and more difficult. However, editors have to do their best to protect patients’ identities, and it is has to be an editorial decision on the risk–benefit of publishing.

Journals have different policies on publishing papers without consent or approval, although many of the Forum participants said that they would reject a paper if there was no patient consent and/or no ethics approval.

The advice from the Forum was to contact the authors and ask for the Institutional Review Board (IRB) documentation. The editor should ask the authors to clarify why the study was exempt from ethics approval. If the authors insist the study did not require ethics approval, then the editor should ask for proof—for example, a written statement from the IRB. The editor could also contact the IRB directly with their concerns.

The Forum also advised that the issue of consent should be raised with the authors—both consent to participate in the study and consent to have the data published. Was consent received from the whole cohort? Did the authors receive consent to publish from the patients whose data were published?

For information, advice on how to anonymise clinical data can be found in this paper (Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-9)

Follow up: 

Following the discussion at the Forum, the journal asked the authors to provide any information that they had about informed consent at the time of treatment. The authors sent their translated form, which specifically mentioned they had consent for treatment and not for publication explicitly. Hence on these grounds, the editor decided to reject the paper. The editor informed the authors, who did understand and said that they could not find the patients to seek consent as they were lost of follow-up. The journal considers the case closed. 

Resolution: 
Case Closed
Year: