Ethical concerns about a study involving human subjects

Case number:
13-14

Case Audio:
Audio

Case text (Anonymised)

A manuscript was submitted to our journal describing a study of a new drug. The manuscript had only one author who gave their affiliation as a company that we can find no record of online. It describes a study in which they appear to have developed a new drug, carried out a toxicology study in mice and then, because no adverse effects were seen, tested it on one patient and five healthy volunteers. There appear to have be no stages in between. There is no statement of informed consent in the manuscript. There is a statement that says the study was reviewed by the institution’s human subjects committee but we cannot find a record of the institution.

We had ethical concerns about the study so we asked the authors for more information, specifically: the details of the ethics committee that approved the study; whether they had informed consent from the patient and healthy volunteers; whether the trial had been registered before it commenced; how the patient and controls were recruited; what information the patient and controls were given before they agreed to participate; where the study took place; what safety/monitoring was in place in case of any adverse effects; what approval was obtained (eg, from the country’s drug regulatory body) before this drug was injected into a human for the first time; and what other research had already been carried out on this new drug? The author responded to our email asking to withdraw the manuscript but did not answer any of our questions. We responded that we had serious ethical concerns and therefore would not be withdrawing the manuscript at this time. We informed the author that we would be investigating the potential ethical issues and asked again for answers to our questions. We have heard nothing from the author since.

The author is based in a country that does not appear to have a national medical board and is not affiliated to an academic institution or hospital. The affiliation given is the company that we can find no record of. The author’s email address is not an institutional or company email address. We have contacted the professional society for the medical specialty of the author but they have informed us that the author is not a member and therefore they cannot investigate. We have also searched for the author on the registry of the regional medical board for the region in which the author is based, and they are not registered with them either. We do not want to reject the manuscript until an appropriate body has agreed to investigate but we are struggling as to how else to report this.

Questions for the COPE Forum
(1) Does the Forum agree that we should continue to try and find someone to investigate this before we reject?
(2) Does the Forum have any suggestions on how we can report this?

Advice: 

The Forum agreed that the editor had made a tremendous effort in trying to resolve this case. The Forum reiterated that in instances where a paper is rejected or withdrawn, there is still a responsibility to pursue any suspicions of misconduct. In this case, where the author wishes to withdraw the paper, it was agreed that the editor had probably done as much as he could. In some countries, this type of behaviour might be considered criminal, and a last resort might be to inform the legal authorities in that country.

The Forum advised that there is always the possibility that the paper is a hoax, but the editor has to assume, until otherwise proven, that the author has submitted the paper in good faith and should investigate this as far as possible. This is a particularly difficult case as it is a single author paper. If there had been more than one author on the paper, the journal could have applied the revised criteria of the International Committee of Medical Journal Editors (ICMJE). The fourth criterion states that all authors are accountable for all aspects of the work and are responsible for ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. However, this is not applicable in this case as there is only one author.

The only other suggestion was for the editor to write an editorial on this topic, emphasizing that this type of behaviour is unacceptable.

A Forum member suggested this paper may be of interest http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2245850

Follow up: 

After the case was discussed at the forum, the journal made one further attempt to report the unethical research. This was successful and the case is now being investigated by the relevant governmental department in the country where the research was carried out. The editor also discovered that while he had been trying to resolve this case, the article had been published in another journal. He informed the editor of that journal of the duplicate submission and his concerns.

Follow up (June 2014):

After the relevant governmental department agreed to investigate, the manuscript was rejected by the journal. The journal did not receive a response from the editor of the other journal in which the article had been published.

Resolution: 
On-going
Year: