Ethics, institutional review and studies from private practice
A manuscript was submitted to our journal regarding a chart review of a novel treatment of a musculoskeletal disease, done at a private clinic in a western country. The patients had given informed consent for the novel treatment, but there was no ethical approval.
We contacted the authors, who have replied that ethics approval could not be obtained, and indeed was not needed, because the private clinic is not affiliated to a university and because the study was merely a retrospective chart review. The five authors on the paper are all affiliated with universities with ethics committees. We also noted that the owner/director of the private clinic is not listed as an author.
We have also found that on the clinic’s website there is a reference to a “research study” regarding this novel treatment, which was started nine years ago. The retrospective chart review of the submitted manuscript dates back to approximately the same time. We are concerned that this current chart review may be based on a prospective study without ethical approval. We are also concerned about competing interests, as the director of the clinic, who presumably has been performing this treatment, is not listed as an author, nor named in the acknowledgements.
We have written to the authors regarding our concerns and are awaiting a reply.
Should we also contact the authors’ institutions?
Who do we contact regarding ethical practices at a private clinic?
What more should be done?
The COPE code of conduct states that if an editor considers research presented in a submitted paper may be unethical, then the matter should be investigated. This would be so even if ethical committee approval had been obtained. However, contacting the institutions of the authors may not achieve very much as the work was conducted at the private clinic and they are affiliated with outside universities, having been brought in at the invitation of the clinic’s director. Indeed, one of the authors said that his institution had already contacted him regarding the study, independently of the editor.
If the editor feels the study is unethical, the paper should be rejected. The authors’ institutions should not be contacted; however, the appropriate regulatory body for the clinic should be informed about the editor’s concerns, and any investigation should be left to this authority. The editor should ask for a response and make a note that he might need to remind the regulatory authority from time to time.
After much discussion back and forth, we finally understood exactly what was being done to the patients in the research project. While not a completely new therapy, it was a novel application of an existing technique, had not previously been studied, and was not approved for use by any ethics committee. We did reject the paper, but have not heard back from the licensing body of the independent clinic. I have asked for an update from them, however.