We had a presubmission enquiry from a group regarding a paper reporting what seemed to be an uncontrolled trial in infertile women who were given soft tissue physical therapy. The authors wanted to know if we would be interested in their paper; if it was a problem that the trial had not been registered (because, they claimed, it was not a trial as no control group was used); and if it was a problem that ethical approval had not been gained (apparently, because the intervention was not a “medical” one).
We replied that they should have registered the trial (and could do so retrospectively) in line with new WHO policies on all interventional studies and that the Helsinki Declaration would require ethical approval for research which examines the effects of an experimental procedure on human health. We asked the authors to tell us which ethics body would provide oversight for their research. The authors thanked us but did not provide the information we asked for.
We were worried that human research had been done without ethical approval and tried to find out more about the research study. (Because this was only a presubmission enquiry, not very much information was included.) Three of the authors were located at a private company in the US carrying out physical therapy and did not seem to be qualified doctors. The affiliation of one author was not clear. Two other authors were qualified doctors. The research seemed to have been carried out at the private company on women referred by themselves or by doctors.
We are not sure who to write to with our concerns. We can write to the medical board(s) and hospitals for the two doctors who are involved but have no idea what body is responsible overall for such a study. We cannot identify an ethics body at the private company.
Who is the company accountable to with respect to the human research it carries out?
As the authors were working for a private company, the advice was to pursue the issue along regulatory authority lines. The editor could write to the medical boards of the authors or the regulatory authorities at the state level. Another avenue could be to contact RESOLVE–The National Infertility Association in the US. The committee questioned if this was in fact a trial, and as there was no patient consent, could there be assault issues?
We wrote back to the authors explaining our concerns and asking for a response. The authors said that they did not think they had violated any legal or ethical requirements (in that they thought IRB approval was only required for entities regulated by the federal government, and not private physical therapy clinics). The authors also claimed their work was not experimental, so it is questionable whether this really was a trial. We plan to write to the authors to say that we cannot consider the study, and that any future research they do in humans should be approved by an appropriate ethics committee. We also plan to write to the state medical boards regarding the involvement of the medical practitioners who were involved in this research.