Fair access challenges in maternal-fetal surgery trials

Abstract

Maternal fetal surgery (MFS) trials have the potential to substantially increase the survival and quality of life of fetuses with life-threatening conditions, but they also entail relevant and yet overlooked fair access challenges. In this topic piece, we will present the fair access concerns in MFS trials/practice and their ethical ramifications as well as some possible ways to address them. The most obvious challenge is cost. Although the cost of the surgery itself is generally covered, costs are high for participants, including commute or housing near the hospital. This might hinder participations of parents from lower economic status. Strict eligibility criteria aimed at protecting participants further limit accessibility. These issues further affect the scientific validity of the trial. For example, the above-mentioned issues contribute to difficulties in recruitment which already lead to MFS trials delays and cancellations. They also contributed to homogeneous samples that are difficult to generalize. Hence, it is important that researcher first acknowledge the existence of fair access issues beyond those related to the cost of the surgery itself and that these issues affect participants’ right to fair access to the trial benefits as well as the scientific validity of the trial. Second, it is important that researchers actively try to foresee and reduce these issues.