Final Report on ethical issues

Task 73 Ethical issues M124 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 issues1How 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 continuously be studied to improve the evidence base Currently pregnant and breastfeeding women are typically excluded from research for reasons of risks to the foetuschild and potential liability At the same time the practice of prescription of offlabel medication exposes pregnant and breastfeeding women and their children to risks without learning for future patients2Is there a moral duty around continuous learning in healthcare for pregnant and breastfeeding women and the healthcare professionals involved in their care If so how could such a moral duty be implemented in practice If care and research become integrated in drug use in pregnancy and breastfeeding it will be virtually impossible to escape from this learning environment Ethical evaluation of a moral duty to participate in such a system is essential when regular care becomes inherently intertwined with learning components and3What are the features of a responsible and sustainable LHS for pregnant and breastfeeding women A radical turn to continuous learning from routinely collected data in the field of pregnancy and breastfeeding also requires as set of ethical criteria to render this learning environment responsible and sustainable At least ethical criteria of review informed consent fair inclusion and benefitsharing need rethinking in light of an LHS in this field To address these questions we will take an approach in which the stakeholders perspectives as well as ethical theory on principles such as responsibility solidarity equity and fairness will be translated to the context of the project We will use the method of Reflective Equilibrium Originally the Reflective Equilibrium has its roots in the ideas of the political philosopher John Rawls We will use a version of this method that has been developed by members of the project team and the Department of Medical Humanities of the Julius Centre Van Delden and Van Thiel the normative empirical reflective equilibrium It has proven to be successful in giving guidance to ethical thinking in practical contexts The aim of the Reflective Equilibrium is to produce coherence between empirical conceptual and normative data The empirical and conceptual elements will be brought into Reflective Equilibrium in order to be able to develop a framework for fair inclusion of pregnant women in a Learning Healthcare System To answer the empirical part of the questions we will conduct systematic literature studies and conduct qualitative research structured interviews with relevant stakeholders Maximum variation in context experience and views are essential in order to reach saturation in qualitative research Therefore we will interview the following group of stakeholders which will be drawn from the hospitalcatchment area a Sick pregnant women preexisting eg depression new diseases preeclampsia b Fertile sick women who want to become pregnant c Healthy pregnant women