We received a paper describing the results of an analysis of pathogen gene sequences from patients who had been given an investigational drug as treatment for their infection. The study had been done in Europe. One reviewer said that the paper did not explain whether the patients had been treated in the context of a trial or not and that no information about study sponsorship, ethical approval or patient consent had been included.
The reviewer was concerned that an attempt was being made to publish data without the approval of the trial sponsors. The editors rejected the paper but recommended that the authors submit it to a sister journal at the same publishing company, but that they would need to address all of the points raised. The paper was then submitted separately to the sister journal but without any response to the reviewer’s points. The authors eventually explained that the patients in this study had been enrolled in an expanded access program for the investigational drug, which was underwritten by governmental sources. This was not regarded as a trial, and the authors explained that gene sequencing was carried out as part of routine clinical care, following national treatment guidelines.
The editors felt that there were insufficient grounds for them to follow-up further, and decided to withdraw the paper from consideration at the sister journal, recommending that the authors describe the context for the study more fully in their paper when they prepare it for publication elsewhere.
Should we have done more; is it reasonable that ethical approval and informed consent would not be needed for this study?
The Forum commented that this is probably an example of different rules for ethical approval in different countries. This would seem to be the issue here. The Forum agreed that no further action was required and that the matter should not be pursued.
The journal followed the COPE Forum’s advice and did not take further action.
An experiment on a volunteer in hospital was written up. The volunteer was an asthmatic who was stable at the time and given a combination of intravenous magnesium sulphate and salbutamol to observe the pharmacological effects. The drugs were given under supervision in intensive care as they carry some risk of cardiovascular side effects. The paper reports: "After discussion with colleagues, a volunteer was given the drugs to see what happened." There is no description of an informed consent procedure or ethics committee approval. Nor is there any report of arrangements made to cover the costs of the research, whether staff, bed use, drugs, use of equipment or arrangements for dealing with side effects.
This was clearly experimentation, but it was unclear whether this was done as part of emergency care. - The editor should write to the authors to ask them whether they obtained informed consent and ethics committee approval. - The editor should also write to the head of the institution to request an investigation.