A research paper was submitted to our journal and underwent several rounds of peer review and editorial curation. We were on the point of acceptance when we realised there were some images that were submitted along with the paper where patients were perfectly identifiable but we did not have the signed informed consent forms. We therefore asked the authors for the consent forms (corresponding to about 10 different patients). We received these on the same day of the request. Although we don’t usually question the veracity of the consent forms, in this case all the writing on the forms seemed to come from the same person, the dates were in the same hand, and all were dated on the same day that we asked the authors for the form. It therefore seems highly unlikely that they did not have the forms beforehand. Some of the signatures, although corresponding in theory to different people, also seemed very alike. We also felt it was suspicious that the authors were able to return all the forms on the same day, since the authors are from a hospital and it usually may take days or weeks to chase down one patient, let alone 10, given the geographical spread.
Questions for the Forum
- What course of action should we take?
- Do we simply accept the forms as being legitimate, knowing we have no ability or resources to investigate these matters?
Several Forum participants reported that they had had similar experiences, and that such papers had sometimes later appeared in another journal. It is easier to detect such practices in some fields than others, and in some countries collecting patient consent forms is not permitted, making signs of fraud much more difficult to detect. Journals may also find it hard to find sufficient resources to take further action, especially if they are dealing with a hospital, which may not have the same research integrity staff as a university.
In the current case, and based on the details given, it seems reasonable for the editors to be concerned about the consent forms that have been submitted, as well as any future version of them. Moreover, if the authors have manipulated these forms, what assurances do the editors have about the integrity of the remainder of the paper?
COPE’s flowchart on dealing with ethical problems in a submitted manuscript suggests that the journal contact the institution where the research was done in order to get their help in appraising the raw data, or to educate or discipline the researcher. However, as noted, this may be less productive in the case of a hospital than a university.
One option would be to accept the paper but to publish it without the images in order to minimise the risk of harm. It would not be sufficient to take mitigating actions like covering the eyes of the participants (see a recent review by PubMed on publishing photographs in medical journals which highlights some of the problems with this, and Sections 4.2.11 and 5.8.3 of the AMA Manual of Style).
Overall, however, it seems more appropriate to reject the paper due to concerns about the validity of the consent forms and to inform the authors of the reason for educative purposes. The editors should also consider whether there is enough evidence to suggest research misconduct, in which case the authors’ institution should be informed (in neutral terms, with the authors potentially copied).
The editors may find COPE’s guidance on consent for publishing medical case reports useful, which highlights the need for trust in author declarations. There are also relevant ICMJE guidelines on protecting research participants.
The journal has rejected the paper in line with COPE advice.