Contacting Research Ethics Committees with concerns over studies

Case number: 
02-11

Case text (Anonymised)

A paper was submitted, detailing a small overseas trial of a drug treatment of a politically controversial disease. The treatment was moderately toxic. The paper was seen by two referees (A and B), who had considerable criticisms of the methodology used. Comments were also received from C, who was invited to review but refused, because s/he did not want his/her name known to the authors under the terms of the journal’s open peer review policy. C said that there was little justification for this trial and therefore could not imagine it having been granted research ethics committee approval. C also mentioned that the study was funded using non-peer reviewed, government funds. Another referee (D) was consulted, who again did not want his/her identity to be revealed to the authors, but reiterated C’s concerns. The paper was rejected on methodological grounds, but with an offer to see if the authors could address the criticisms. The authors revised and resubmitted the paper, which was sent to the more critical referee (B). His view was that the authors had done little to improve it. Another referee (E) was consulted, who was also sent the comments from C and D. E was happy to take part in open peer review, and concluded that the trial had little biological justification;was poorly conducted and reported; and that it was of such poor quality that the research ethics committees who approved it must be informed. The editors rejected the paper and wrote to the two research ethics committees who approved the study, enclosing B and E’s signed reports (with their permission). The authors were informed, and wrote a letter expressing their outrage that the journal had contacted the research ethics committees. It proved difficult to identify contact details for the research ethics committees that approved the intervention part of the study. Should the editors do more? Should the authors be asked to provide full details of their research ethics committees now and in the future?

Advice: 

_ The authors should have been contacted first and asked to respond to the doubts raised before the editor went to the research ethics committees. _ Write to the authors’ institution to check that the research ethics committee approval process had been correctly undertaken. _ Research ethics committee approval of potentially unethical research implicates the employer, so it would have been difficult to approach the employer first with these concerns. _ Open peer review policy needs to be explicit: it is open at all times, except in cases of suspected misconduct. _ Ask the authors to respond to doubts about the paper. (The editors had gone back to the ethics committees and wanted to re-review the articles. Did they have a duty of confidentiality to the author?) _ Ideally, the ethics committee should contact the authors directly. If the authors refuse to send the articles then public interest in the ethics committees being able to review the work would justify a breach in editorauthor confidentiality. But the editor should inform the author of any such action. _ The willingness of editors to breach editor-author confidentiality, where public interest justifies a breach, should be made explicit. _ Authors may not be aware of this fact and some rely on a lack of communication between journals to perpetrate duplicate submission and publication. _ It is usually the case that where the author is open about papers and their submission to another journal, that there are legitimate reasons to send the other papers elsewhere and sufficient differences in the papers to justify separate publication. _ In North America there was a fear of litigation arising out of such cases, but following the Tarasoff case, where it was held that the duty to warn and protect identifiable third party interests overrides a duty of confidentiality, a breach of confidentiality can be justified. In Belgium the duty of confidentiality is absolute, but there is no EU law on the issue.

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