We have just had a paper submitted as an ethical debate in which the author details ethical concerns about a study previously published in another journal. The study involved complementary/alternative therapy for an infectious disease in children. The author alleges that the study gave insufficient protection to vulnerable subjects, who were exposed to unwarranted risks and discomfort; and that the study had violated the accepted tenets of human studies ethics and national regulations.
The submitted manuscript summarizes (with full names of people involved, their affiliations and positions) various correspondence between the author and the investigators of the published study, the Institutional Review Board that approved the study, the office for the protection of human subjects in research of the associated medical school, the country’s regulatory authority for the protection of human subjects in research and the editors of the journal that published the paper.
The country’s regulatory authority for the protection of human subjects in research found that the author’s allegations were unsubstantiated. The author claims in reaching this decision, the authority had misinterpreted aspects of the study, prompted by false statements from the Principal Investigator and the presiding IRB. The authority, the IRB and the investigators all asserted (with reasons) that certain usual human subject protections did not apply in this study. The author gives rebuttals for these assertions.
The medical school stated it would not pursue the matter because of the conclusions already reached by the reviews conducted by the IRB and the country’s regulatory authority for the protection of human subjects in research.
The journal that published the study declared that no purpose would be served to its readers by publishing further correspondence (letter from our author), again citing the conclusions of the country’s regulatory authority.
The author lists as failing in their duty all the above-mentioned people/authorities, including the editors of the journal that published the paper.
Questions: Should we consider this for peer-review?
If we ultimately publish, are there legal issues surrounding perceived defamation of character when the regulatory bodies above have found the allegations unsubstantiated?
Presumably we would have to inform the investigators/authorities involved about our plan to publish and be prepared to publish a response from them?
Would it be acceptable to publish it in an anonymised format if the author agreed to this?
The editor provided further clarification on the case pointing out that the accusations include, the editors of the journals, the institutional review boards, and members of the national agencies involved in reviewing the case. The author also alleges that the principal of the study lied to the authorities. The medical school involved is not pursuing the case as it defers to the national authority. The committee commented that what ever the editor does, they will be in trouble and added to the authors list! It was pointed out that the complaint had been taken to the highest level in the country and it is difficult to see why the editor should join in the debate and there was speculation if the material should be published. It sounded like the author wants all those involved with their heads on the block.
It was asked if the author had completed a competing interest statement, they have not. The editor thought that the author seemed to be investigating and doesn’t seem to have a personal interest. Though the author requested that no-one on the editorial board with any interest in complimentary medicine be involved in peer reviewing the paper.
The committee commented that the first port of call should be the editors lawyers, as the legal issues would take precedence. It was also pointed out that there was a contradiction in the author’s account, as since the issue had gone to the countries regulatory authority, the author would have had chances to air their view and correct the misleading statements. Apparently the author had written to the regulatory authority. Also probably the first legal advice the editor will be given is to check to see that ALL the facts in the article can be substantiated, and probably no-lawyer will advise the editor to publish as they are risk adverse.
Also it was suggested the editor should do a pubmed search on the author, as this perhaps seemed like an author who had a bee in their bonnet about complementary medicine.
The advice was for the editor to seek legal advice. The committee was unenthusiastic on taking further action. This is the sort of paper that should be sent to the press. The editor should reject the paper citing legal advice.
We took legal advice. It was felt that the risk of publishing allegations which respected bodies had already found to be unsubstantiated was too high, laying us open to a claim for defamation from the people the allegations were made about.
We rejected the manuscript, stating that the decision had been made after taking legal advice.
An internet search revealed the author to have previously been involved in various anti-complementary/alternative therapy campaigns.
To date we have not had any further correspondence with the author following rejection of the manuscript.