We received a paper reporting on the outcomes of treatment of an individual with obsessive–compulsive disorder and body dysmorphic disorder, which seemed not to respond to standard treatment. Following ethical review and approval, and individual consent, the individual was treated with several distinct courses of an experimental therapy. The individual’s clinical and family history, and their outcomes in response to the experimental therapy, were detailed in the paper. The editors felt that sufficient details were included to potentially identify the patient, so as outlined in our editorial policies, we asked the authors to obtain signed consent to publication from the patient.
The authors responded that they had attempted to remove all identifiers from the paper (although the editors felt that very substantial and identifying details remained), and that revealing the patient’s identity to the editorial office would violate their clinical protocol, and the principle of patient anonymity. The editors discussed this and felt that it was still very important that the patient have read the paper and agreed to its publication; secondly however, we were concerned about the journal having access to (and our ability to keep confidential) the patients’ names. We also wondered whether under HIPAA law it would even be legal for the authors to give us the patient’s identity.
Therefore, the editors proposed that we would ask the author to have the patient (or patient’s parents) sign our consent-to-publication form, and then include in the paper a statement that they had done so, but that we stop asking authors to send us copies of these forms and simply rely on the authors’ word instead. Is this acceptable?
的对um agreed that this was a curious case and raised issues relating to HIPAA law. Some argued that there is no need for a journal to know the identity of the patients reported in case reports. The authors could be asked for a statement that they have followed the correct procedures and obtained consent from the patient. But there is no need for the journal to see the consent form and hence no need to reveal the identity of the patient. If a problem arises in the future, the journal would have a reasonable defence as the onus would be on the authors to have obtained consent. The editor could request a signed assertion from the authors that they have obtained consent. Although the journal’s own consent form can be used, the Forum noted that it would be very useful to have a generic consent form so that patients need only sign a form once in the event that the paper is rejected by one journal and submitted to another journal. The Forum agreed that the editor’s proposed course of action is acceptable.
The authors were asked to confirm in their paper that the patient had seen the manuscript and agreed to its publication in an open access journal, and also to require the patient to sign our consent form, which should then be filed in case notes, but not sent to the journal. The authors did so and the manuscript went out to peer review. It was later rejected on scientific grounds. The editors discussed changing journal policy in light of this case to require that authors document, for such papers, that patients have seen the submitted paper and agreed that it could be published, and to cease requiring that authors send copies of consent forms which had been signed by patients. It was agreed to change policy along these lines and the changes are currently being made to our instructions for authors.