We published a paper in the journal which reported on microarray expression profiling of cell lines from a specific type of cancer (not named here, to preserve anonymity). That paper suggested that a particular compound might affect the function of a protein expressed in the cell lines; this compound could therefore be a possible candidate drug for use in this type of cancer, which might be explored further in clinical trials. (This compound currently has approved uses for other cancers.)
A few months after publication, we received a short electronic letter from a researcher who said that as a result of reading the paper and other data, the researcher and his colleagues administered the candidate drug to three patients with the specific type of cancer mentioned above, who had not responded to other therapies. The researchers reported that one individual improved transiently but ultimately relapsed and that all three individuals eventually experienced a progression of their disease.
The authors did not say whether they had obtained ethical approval for this experimental therapy or whether the patients gave informed consent. We wrote to the authors to say that we could not offer to publish the electronic letter. We encouraged them to rewrite and submit this as a formal report of a clinical trial for our sister journal, but providing they also document ethical approval for the study and informed consent procedures. We never heard back from the authors.
What should we do now?
Although most of the Forum felt there was not much that could be done, some felt that this was an issue of informed consent and the editor had a duty to find out if consent was obtained. The advice was to contact the authors and ask them to provide information on whether or not consent or ethics approval had been obtained, with a deadline for an answer. If no or no satisfactory answer is received, the Forum suggested contacting the authors’ institute and asking them to investigate the issue. No allegation should be made and the authors should be informed of this course of action.
The journal wrote to the authors to ask for clarification regarding individual consent for the course of treatment, and ethical approval for the study. The authors replied to say that patients did give written consent, but no ethical approval was required or given because the course of these patients’ treatment was not carried out as a research study but instead as a course of off-label therapy, which was subsequently written up into a research paper. No further action was taken.