Interim Report on ethical issues

Task 7.3: Ethical issues (M1-24) (UMCU, EFGCP, EIWH, UPPS, GSK, Sanofi). The approach of ConcePTION to collect data on safety of medicines during pregnancy and breastfeeding is similar to what is increasingly being called a Learning Healthcare System (LHS). In an LHS, care and research are aligned to accelerate research and outcomes for patients and to overcome current problems, such as low inclusion rates and complex informed consent procedures. Taking an LHS approach to knowledge generation in the field of pregnancy and breastfeeding may broaden the opportunities to strengthen the evidence base, among others by learning from routinely collected data. However, applying an LHS approach to the field of pregnancy and breastfeeding comes with at least three open ethical issues: 1. How should we weigh the risks of the current status quo (where women hardly participate in research and we do not learn) versus the benefits and risks of participating in a system where pregnant and breastfeeding women will continuous