Who’s the patient? Ethics in and around material-fetal surgery

PhD ceremony: Ms. M.L. Misarela Loureiro Rodrigues, 16.15 uur, Academiegebouw, Broerstraat 5, Groningen

Dissertation: Who’s the patient? Ethics in and around material-fetal surgery

Promotor(s): prof. P.P. van den Berg, prof. M. Düwell

Faculty: Medical Sciences

Maternal-Fetal surgery (MFS) consists of a series of surgical techniques which aim at correcting or improving the outcome of life-threatening or severely debilitating congenital birth defects, such as congenital diaphragmatic hernia and myelomeningocele. Today, most of MFS remains investigational, as its safety and efficacy are still to be proven. For some indications and for a small number of patients, MFS has however become the standard of care. In either case, although the fetus is the surgery’s immediate or potential beneficiary, in order to operate on it, surgeons must inevitably pass through the woman’s abdomen, uterus, and membranes, causing harms to her health that she would not endure were she to continue her pregnancy to term without MFS, were she to terminate that pregnancy, or were she to be pregnant with a ‘healthy’ fetus. This undeniable and apparently innocuous fact, is however the source of many “headaches” for pregnant women, physicians, moral philosophers, ethicists and lawyers. The different chapters of this thesis deal with some of the causes of those “headaches”, namely, 1) What is owed, morally, to those involved in MFS (women and fetuses)? 2) How should the ethical review of MFS research protocols (namely, randomized controlled trials (RCT)) proceed, on which basis, and according to which criteria should they be ethically sanctioned? 3) How much weight should be given to patient/research subject’s preferences in the design and conduct of MFS RCT? 4) Under which conditions can Dutch patients be referred for MFS for myelomeningocele? 5) How should the counseling of prospective candidates proceed?