Abstract

Our correspondents raise at least three issues. They question whether the research participants had been correctly informed of the risks of renal biopsy. The Scandinavian authors reply that in their hands, in the absence of severe disease, the risks are very low, and that participants were therefore correctly informed. The inclusion of the final patient with severe pre-eclampsia who experienced significant complications seems to have confused the issue. She was exposed to a higher risk and should have been informed of this. The authors defend her biopsy on the grounds that it had been indicated for clinical, albeit now obsolete reasons. This should have been made clearer in the paper. The second issue is whether pregnant women should be allowed to take such risks for the sake of contributing to research. Competent adults are normally permitted to decide for themselves whether to participate in non-therapeutic research, but the baby cannot decide for itself and I am therefore surprised that the research ethics committee (REC) approved the study. Perhaps they argued, albeit somewhat implausibly, that there were no net risks to the baby. Perhaps they reasoned that parents are the best placed to decide for their unborn children - we allow them to smoke for example. If the parents felt they were gaining a warm altruistic glow from participation, perhaps they should be allowed to take a small risk with their children. Perhaps the committee simply forgot that it was considering non-therapeutic research in a vulnerable group. It would not be the first REC to make an unethical decision. We have commissioned a commentary on this topic for a future issue. Finally BJOG has been accused of impropriety in publishing the results. I reject this. It is a good principle that unethical research should not be published but BJOG does not perform a new ethical review of papers we receive; we rely on properly constituted research ethics committees. The present paper had been with us for some time, and the original referee had raised most of these issues. As a result the editors sought a second opinion from a clinician with experience in medical ethics, who expressed some concerns, but felt that if the REC had been properly constituted the paper should be published. My predecessor John Grant agreed, and after revisions accepted the paper. I think he was correct. Whether the study was right or wrong, it would surely have been wrong, after it was completed, to have effectively restricted future access to these data. My only regret is that we did not highlight the ethical dilemmas with an editorial or commentary at the time of the original publication. We will now do this, and I hope that publication of that, and this extended correspondence, partly makes amends.

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