A group of authors, based in private practice, submitted three manuscripts to Journal A and one to Journal B. All the manuscripts described the application and effectiveness of a spinal manipulation technique.
The first manuscript in Journal A was a case series of 21 patients. After publication, a member of the journal’s editorial board pointed out several flaws in the study design, including the fact that the authors did not say whether consent had been obtained from the patients. The editorial board member was invited to post a comment detailing his concerns; he has not done so yet.
The second manuscript in Journal A was a case report describing the application of the technique on a patient with a rare spinal disease. The manuscript was rejected on the grounds of poor quality. A reviewer also said that the authors should not be able to make a claim about the effectiveness of this technique when it was only being applied to one patient, and when one of the authors was the director of the institute that “invented” and promotes the technique. This was not picked up during peer review, partly because the author was less than clear about his competing interests.
The third manuscript in Journal A was another case report describing the technique being tested on one patient. The manuscript was rejected before peer review for this very reason.
The manuscript in Journal B was rejected after peer review. The lack of ethical approval for the study concerned the reviewer, who suggested that the results might have been fabricated because the manuscript involved the treatment of 50 patients, and in the past he had peer reviewed two manuscripts by the same authors presenting exactly the same results from the treatment of only 15 patients.
When the author was questioned about ethics approval, he said that he had previously gained consent from a specialist research society for his original study of15 patients. But when this manuscript was rejected, he retrospectively looked at some more patients to make the number up to 50. He said that he did not think retrospective case studies had to be approved by a review board. The webpage for the specialist research society cannot be located.
- Do retrospective case studies require ethical approval?
- Can we ask the authors for proof of ethics approval for their previous study of 15 patients?
- Could it be applied to the later retrospective study or do researchers normally have to re-apply for approval?
- Should we further investigate the suggestion that the author may have fabricated the results?
- What do we do if we can’t actually locate the people from whom they allegedly obtained ethics approval?
- A new intervention would require ethics committee approval.
- It seems very odd not to have included the other 35 patients.
- A real retrospective study does not require ethical approval
- From whom do authors in private practice obtain ethics approval?
- With no institution involved is it very difficult to take action.
- Get a statistician to look over the data.
- Find out who certifies the authors and send a letter to their oversight group.
- Contact the relevant research misconduct agency.
- Write to the authors, asking for details of ethics committee approval and the address of the board.