A new Editor was appointed to a society journal in a minority medical specialty. An officer of the society immediately handed him an anonymous letter from a reader of the journal complaining that an article recently published was unethical. The Editor is a personal friend both of the previous editor who accepted the paper, and the author of the paper. The paper is by a single author who gives no affiliation to an academic organisation. The report describes a cohort study of patients to whom he had given treatment X over previous years. In the world literature, treatment X has been reported to cause endocarditis in a small number of patients, the majority of whom had risk factors. The author invited his patients back for a clinical examination together with blood and urine tests for markers of endocarditis, and echocardiogram. He did not seek permission for the study from an ethics committee, and did not obtain informed consent formally from the patients, though the study’s purpose was discussed with them all. The report is of considerable scientific and clinical importance, being the first in which the presence of endocarditis after treatment X was systematically sought, and its results (no cases were found) provide some supporting evidence that the risk of endocarditis after treatment X is low. The author said that the project grew out of his initial concern for the wellbeing of his patients, and he did not realise he had passed the threshold of requiring ethics approval. The Editor’s close personal involvement at several levels makes it very difficult for him to make a decision on what action should be taken.
The committee discussed whether or not this was a retrospective cohort study without informed consent or ethics committee approval. The committee felt that this could also be an example of good clinical practice by the author in that having read about the potential for adverse effects of treatment X in patients with specific risk factors, he/she called back those patients at risk for a check up. The paper could then be said to arise from the writing up of the clinical practice. On balance the committee felt that the case as presented provided no cause for concern.