Protecting the identity of enrolled subjects in case reports and clinical trials
Case: We received a case report for editing, which described a major facial surgery conducted on an accident victim. The report contained photographs of the patient showing some areas of her face. Since the eyelids and the area below one eye were majorly affected, those parts had to be shown to make the results of the treatment clear. For that purpose, the author had not masked the eyes in the patient photographs and he had included this explanation in the manuscript. Our editor pointed out that protection of the patient’s identity might be a concern with the journal, but the author said that he had obtained the patient’s consent for photographs to be published. So we edited the manuscript, but the photographs were not edited as the author was sure he had followed regulations and there would not be any problems.
However, after the manuscript was submitted, the journal reviewers instructed the authors that the patient’s identity should be protected as far as possible in order to maintain confidentiality. As per ICMJE guidelines, “nonessential identifying details of patients should be omitted and informed consent should be obtained from the patients.” For example, if patients’ pictures are being used, the eye region should be masked to protect their anonymity. However, authors must be careful that this does not distort the scientific meaning of the study.
Additionally, the consent obtained from the patient for publishing the photographs was not valid because as per the case history, the patient was suffering from trauma, which could possibly lead to a temporary impairment of her decision-making ability. The journal mentioned that in such cases, consent from a guardian is required. This is valid for juvenile subjects too.
Action: The author approached us seeking our guidance on the best course of action. Our editors helped him mask the eye partially in the photograph, while keeping the eyelids unmasked. That way, the identity of the patient was not disclosed, yet the surgical procedure on the eyelids was also visible.
Regarding the informed consent of the guardian, the author informed us that the patient's parents had already given their verbal consent for publication of the case report. Therefore, it was not too difficult for the author to get the written consent. The revised consent document and the partially masked photographs of the patient were then sent to the journal, after which the manuscript got accepted.
Summary: Respect for enrolled subjects is an important ethical concern and should be strictly maintained. The privacy of the subjects should be respected by maintaining confidentiality. For instance, all personal and identifiable information like the subject’s name, date, or place of treatment, etc. should be removed. If photographs of patients are required to be published, prior consent should be obtained. Additionally, the identifying features should be masked in photographs as far as possible.
Authors should always do a thorough research on ethical issues related to reporting of clinical data and strictly follow the relevant guidelines. ICMJE has a set of guidelines concerning the protection of research participants in a clinical trial. FDA also has a detailed document covering the specifications of informed consent. Authors would do well to study these guidelines first and form a clear idea about the possible ethical issues that might arise and keep all the necessary documentation ready at the time of submitting their manuscript.
To understand why informed consent is important, read the post Informed consent.