Ethical reflections on organizing the first human trial of artificial womb technologies

To investigate how to protect participants in the artificial womb technology (AWT) human trials.

We compared randomized controlled trials and single arm trials to understand which trial design best balances the interests of science and participants. We also compared AWT trials with comparable settings to understand how to protect participants.

Randomized trials might fail in reaching a sizeable sample, which could pointlessly expose participants to risks. Furthermore, parents who choose to participate in the trial might expect to receive AWT. Failed expectations might distress parents and hinder the therapeutic relationship. The trial is divided into two steps. First, delivery into AWT involves two participants: the mother and the fetus. As AWT requires a C-section, the procedure cannot be carried out without the mother's consent regardless of fetal benefit. Treatment in AWT, involves one participant: the infant. As for any other invasive intervention, the AWT trial should be suspended if harmful.

A single arm trial could prevent some of the methodological and ethical challenges of the randomized trials. Moreover, better decisional tools should be developed to help parents decide whether to participate in the AWT trial. For example, using visual aids or showing the AWT.