A group of researchers are conducting a study of whether women aged 65 to 69 years will accept screening for breast cancer. They plan to invite these women for screening in the same way as they invite younger women for screening but will not know that they are part of a research study. The authors want advice on whether journals would be willing to publish their results, despite the fact that the women will not have given informed consent to be part of the study.
Honesty is the best policy. The women must be told that this is a survey and therefore the question the researchers want to ask may not be answered.
The journal said that it would consider the paper when submitted.
We have received a paper in which the authors have exposed a group of babies to physiologically unnatural circumstances. These circumstances do however arise quite regularly in some peoples’ lives. None of the babies had anything wrong with them, but some of them were siblings of babies who had died. Some of the babies showed physiological changes in the unnatural circumstances, which raised the possibility that they might suffer severe consequences if exposed to those circumstances in their ordinary lives. The exact meaning of this research is hard to interpret, but it does suggest that these physiologically unnatural circumstances might have severe consequences for babies. The hospital ethics committee approved the research, and the parents of all the children gave informed consent. Our editorial committee was, however, worried that this was non-therapeutic research and that the parents of the children whose siblings had died might find it very difficult to refuse consent for the research. We therefore commissioned an ethical commentary, in which the author argues that the research is unethical—partly because of the problem of consent we had identified and partly because the researchers had no clear prior hypotheses and had not done a power calculation. They have thus produced research that is very hard to interpret. (1) Is the research sufficiently unethical that we should not publish it? (2) Can we publish the research with a commentary arguing that it is unethical? If we so, should the authors be given the right of reply? (3) Or should we, as the authors argue, write the commentary ourselves rather than commission an outsider? In our commentary we could voice our ethical doubts, but say that we thought the paper was nevertheless publishable.
(1) The ethics committee have approved this study, but there is dissonance among the committee, editor and commentator. The paper has been accepted and the authors told that a commentary and editorial would be commissioned which they will see before publication. (2) This is a case of having one’s cake and eating it. (3) Ideally the chairman of the ethics committee should write the commentary.
The paper was published with a commentary on the ethical aspects.
A medical journal conducted a randomised controlled trial of papers submitted to it without getting consent from the authors concerned. An author found out and objected. Should the journal have sought consent from its authors?
Maybe this is taking matters too far and it is simply barmy to seek author consent. Should notice of this trial been given in advance and the authors been given the opportunity to opt out? Getting explicit consent from authors might have destroyed the validity of the study and introduced bias. It is common courtesy and best for the image of the journal to let authors know what is happening. Conclusion A notice should be added to the Instructions to Authors, to the effect that from time to time their papers may be used in trials of peer review and that this may slightly delay the processing time. In addition, the letter acknowledging receipt of the article might also contain notice (but with a light touch). In both cases, the authors can be given the opportunity to opt out.
The journal has now amended its guidance to authors to the effect that their paper may be included in research. Authors are also advised of this in the letter acknowledging receipt of a paper.