Participant consent

We have received a paper from a GP testing the hypotheses that because 24,25 cholecalciferol has a similar structure to commercially available statins, it may act as an inhibitor of HMA co-reductase. He screened 350 patients in his practice and identified 77 who had a cholesterol concentration above 6.5 mmol per litre. Thirty-three of them agreed to return for a second test 2 weeks later.

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.

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.

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?