Author A has published approximately 150 original articles since ~1994, with ~100 on one particular topic. Since some of these events were up to 16 years ago, and there are no formal records from then relating to these studies, the only information we have is the memory of the editors of the affected journals in post at the time. According to their accounts, suspicions were aroused over the validity of the data, in particular the similarity between baseline data of some of the different studies. When author A was pressed to provide raw data, he stopped responding and stopped submitting papers to the specialty journals, switching to general journals where he continues to publish. The editor of one specialty journal raised concerns with the author’s institution (in another country) approximately 12 years ago; it responded saying it saw no reason to investigate further. A letter, published in one of the specialty journals in 2000 by an independent researcher, asked the question “Why are author A et al’s data so nice?”, pointing out that the probability of such results occurring by chance were infinitesimally small, but as far as we know there have been no formal investigations of author A’s work
Following an April 2010 editorial in one of the specialty journals about research fraud in general, that mentioned this particular author by name, a correspondent raised the lack of investigation into author A, stating that his update of a systematic review was being hampered by the (suspect) influence of author A’s work in this area. The current editor-in-chief of that journal contacted the current editors of seven other affected specialty journals, who until this point were largely unaware of the problem, or its extent, having not been in post at the time the papers were submitted to their journals. We have since been discussing the problem and possible courses of action. The points raised are:
(1) Regarding the older papers:
(i) the journals themselves do not have the ability to mount an investigation;
(ii) it is unlikely that an investigator, bona fide or not, will still have original data from the older studies;
(iii) it is unlikely that author A’s institution will be interested in investigating studies so old, and we think he might have moved universities since then;
(iv) currently we do not have any firm data of wrongdoing, just suspicions. Options for gathering more data include asking the original correspondent and the systematic reviewer to provide a more formal commentary, although we have not done that yet. Meanwhile, one of the editors has gathered data on all author A’s studies: there are 135 in which author A is the first author, reporting almost 12,000 randomised patients in 17 years. Most are with one of the same three co-authors. The largest group of papers (by topic) are all very similar in design, with very little variability in baseline placebo event rates, and generally similar results although the outcome measures differ and there are one or two ‘surprising’ (at best) findings. One particular drug features in 71 studies. Dropouts are hardly ever reported.
(2) Regarding the newer papers:
(i) these may be easier to investigate since the data should still exist;
(ii) we could contact the editors of the non-specialty journals (there are many, publishing just 1-2 of A’s articles each) to alert them but the problem of having only suspicions remains (compounded by the relatively large number of journals, each with a small number of papers);
(iii) we could ask a respected academic in author A’s country to make discreet enquiries of author A’s co-investigators, some of whom may not realise what is going on, or they may have concerns themselves. However, this could be a delicate situation for such a person. We would welcome COPE’s advice on how best to proceed.
The Forum was unanimous in their opinion that this should really be resolved by the researcher’s institution. Although there is no hard evidence, it was suggested that all of the journals, as a team, approach the institution and ask the institution to conduct an investigation. It was felt that this would provide a more powerful case than a single editor on his own. Meanwhile, the editor should try and gather more evidence, perhaps by contacting the ethics committees who supposedly approved these studies. The editor may then be able to determine whether in fact the studies took place as reported. The Forum advised against informing the non-specialty journals at this point as there is no real evidence at this point, so it would be difficult for them to know what to do. The Forum also suggested that the editor should advise anybody doing a meta-analysis on this subject to include a sensitivity analysis to test the effects of including the data from these studies.
The group of editors-in-chief are planning on sending a letter to the author and the institutions. The delay has been in obtaining an independent analysis of the suspect works, which so far indicates that the likelihood of fabrication is very high.
Follow up (May 2011):
The editors are still planning on sending a letter to the author and the institutions but this has been delayed pending the analysis, which has now been submitted to journal A for publication! (It concludes that fabrication is almost certain.) Meanwhile, a separate publication scandal has distracted the editors’ attention recently.
We did not investigate ethics approval since we felt that should be for the institution to investigate. My main question is what to do with the analysis that has been submitted:
(i) process as usual and publish if accepted (after discussion with/approval by the publishers); that is, let the author/institution respond if they wish (ii) present it to the suspect author (with the analyst’s permission) and remove from the publication process for the time being (iii) present it to the suspect author’s institution(s) as per (ii) (iv) present it to the suspect author and institution(s) as per (ii)
I have sought an independent statistical review of the analysis from a respected statistician but have not had a response.
Advice on follow up:
There were various views on how to proceed in this difficult case. Some agreed with sending the analysis to the institution and the suspect author, at the same time, informing them that the intention is to publish the analysis in the journal, and then see what type of response this elicits. Others disagreed and recommended treating the analysis like any other submission (despite the fact that the review was commissioned by the journal and the editor hadn’t originally intended to publish it) — send it out for peer-review and publish it in the normal way. Most agreed that a copy of the analysis should be sent to the institution, either before or after peer-review. But the paper does not need to be peer-reviewed before it is sent to the institution.
The Forum also advised consulting the journal’s legal department before going ahead with publication.
The process of naming and describing novel species of bacteria is governed by the Bacteriological Code. As part of this process, authors are required to deposit the type strain of the novel species in at least two culture collections located in different countries, and they are also required to provide documentary evidence that the strains have been so deposited and that the deposited strains are viable and are available to other researchers without restrictions on their use for taxonomic research. This evidence takes the form of a “certificate” issued by the culture collection. This system has been developed to ensure that type strains are available for comparison with new strains isolated in the future, and to insure against collections going out of existence and/or changes in import/export regulations, etc. The priority of names is determined by the date of publication; in our journal, which is the journal of record for the description of novel species of prokaryotes, the date of publication reflects the date of acceptance (ie, papers are published in the strict order that they are accepted). Papers are not accepted for publication before suitable certificates have been provided for the type strains of any novel species described.
A culture collection curator contacted the editor-in-chief of our journal because of concerns about three type strains that had been deposited in their collection by the same group of researchers. Investigation by editorial office staff suggested that the certificates that had been provided by the authors (which took the form of unprotected Word files) might not have been issued by the culture collection concerned. The editorial office staff then undertook an investigation of the certificates from this collection provided in conjunction with all papers submitted by this group and asked the collection to confirm: (i) the specific curator responsible for handling that strain, (ii) whether they had issued a certificate for that strain and (iii), if so, the date on which the certificate was issued. This investigation suggested that a total of six certificates provided by this group had not been issued by the collection. All six were apparently signed by the same curator (who had not in fact been responsible for handling three of the strains, hence the original suspicion).
Following the COPE guidelines for suspicions of fabricated data, as the closest match to this situation, the editor-in-chief contacted the corresponding author of these papers and asked for an explanation. It then transpired that the curator had already contacted the corresponding author to request that this group stop “misusing her signature”, as she put it. The corresponding author was extremely apologetic and assured the editor-in-chief that this would not happen again. He also indicated that one of his co-authors had been responsible for obtaining certificates for these strains but that this co-author had since left his laboratory and returned to his native country. He provided a contact address for this co-author.
The editor-in-chief contacted this co-author and he admitted that he had produced the forged certificates in an attempt to expedite publication, and thereby secure priority for the names, without the knowledge of the corresponding author or his other co-authors. Again he was extremely apologetic and assured the editor-in-chief that this would not happen again.
Because bona fide evidence has therefore not been provided that these type strains have been deposited in two culture collections in different countries, the descriptions do not fulfil the requirements of the Bacteriological Code and the editor-in-chief took the following decisions: (i) a single paper that has been published in print will be retracted and (ii) four papers that have been published ahead of print but not in print will also be retracted in print, as these papers are already listed by PubMed. A sixth paper that was still under review was withdrawn by the corresponding author at the suggestion of the editor-in-chief.
A retraction statement has been drawn up after consulting the unpublished COPE guidelines on retractions and the wording has been agreed by the corresponding author and the co-author responsible for the forged certificates. The statement indicates that a certificate was provided by the named responsible author, without the knowledge of his co-authors, that was not issued by the culture collection concerned. These retractions have not yet been published.
As yet we have not contacted any of the authors’ institutions. Our preferred course of action is to contact only the institution where the responsible author is now based. The remaining authors are based in a country where scientific misconduct is a very sensitive issue and we are concerned to avoid damage to the reputations of those co-authors who were not aware of the falsification. The editor-in-chief is also considering writing an editorial to highlight this issue and to ask other collections to take steps to prevent their certificates from being similarly manipulated. We would like the advice of the committee as to the merits of this course of action.
The Forum reiterated the fact that if something is published online then it is considered published. If the strain cannot be reproduced, then the paper is in effect fraudulent. However, there is a wider question here. Should this process be considered as purely an administration step? The advice was to make sure the instructions to authors clearly state that the authors have collective responsibility. The Forum agreed with issuing a retraction statement and naming the authors responsible but also highlighting those authors not responsible. Some members of the Forum suggested approaching the new institution where the responsible author is now based. The Forum also agreed that an editorial to highlight this issue was a good idea and also asking other collections to take steps to prevent their certificates from being similarly manipulated or to ensure tighter security.
The editor heard no more from the offending author's institution to support the rumour that his employment had been terminated. The papers concerned have been resubmitted with the legitimate documentation without the offending author's name appearing on them and they are currently under review.