Ethical Issues in a Trial of Maternal Gene Transfer to Improve Foetal Growth

Abstract

This chapter investigates the ethical issues associated with a proposed European gene transfer trial which would recruit pregnant women with severe early onset foetal growth restriction (Details of the research programme may be found on the programme website, http://everrest-fp7.eu. The clinical trial is building on ongoing preclinical studies, and is likely to begin recruitment towards the end of 2016. The trial has been registered with the US ClinicalTrials.gov (NCT02097667) and the UK Clinical Research Network (ID 15717)). The gene transfer is targeted on the pregnant woman, rather than her foetus, and seeks to improve blood flow and promote vascularisation of the uterus. Transfer of the vector across the placenta to the foetal blood supply should not occur in clinically significant quantities, and no modification of the foetal genome is planned or foreseen. In this chapter, I consider first whether such an intervention is in theory ethically acceptable. I then consider whether a trial of such an intervention meets regulatory guidelines. The core ethical issue here is how to weigh maternal and foetal interests. There is scant regulatory or legal guidance on this point. Here I assess the one- and two-patient models of foetal interests that dominate the ethics literature and find that neither model adequately captures the uniqueness of the pregnancy. The interests of the pregnant woman and her foetus are, in the vast majority of cases, co-dependent and intertwined. In this proposed trial (as in many other trials in conditions affecting foetal growth and development), the primary risk is potential exploitation of the pregnant woman’s vulnerability, derived from her desire to undertake significant risks in order to gain potential benefits for the foetus.