Ethics framework for research on medicine safety in pregnancy and lactation

The ConcePTION project provides an ethical framework for data intensive research involving pregnant and breastfeeding women. The framework is designed for learning healthcare systems, an approach that can support the generation of knowledge about the impact of medicines on pregnancy and lactation.

The ConcePTION ethics framework can support projects, networks, and organisations that want to evolve into learning healthcare systems and that have already dedicated time and resources into building a data infrastructure. This can be considered a crucial phase for projects as it offers opportunities to build on existing achievements and to establish mechanisms for continuous learning that can impact health and care.

The framework also provides insights for the establishment of robust feedback mechanisms, the level of which depends on the operational level of a learning healthcare system (e.g. locally, regionally, nationally, internationally).

Lastly, the framework is built on interviews with women and data access providers in the Netherlands. The results point to the key role that solidarity and engagement plays, in changing how knowledge of medication safety and efficacy is generated. The efforts resulted in a PhD thesis by Marieke Hollestelle: Keep learning. Towards an ethically responsible learning healthcare system for pregnant and lactating people, from the University Medical Center Utrecht in the Netherlands.

What is a learning healthcare system exactly?

A learning healthcare system can be described as an infrastructure where care and research become more aligned, that is: learning from the real-life experiences of pregnant and lactating women to improve clinical practice. Typically, a learning healthcare system contains three essential building blocks: the data and its infrastructure, the learning cycle, and stakeholder involvement. The ConcePTION project represents an important part of this: a comprehensive data learning healthcare system, characterized by extensive collection and processing of both real-world data and research data.

Publications

PhD thesis: Hollestelle, M.J. Keep learning. Towards an ethically responsible learning healthcare system for pregnant and lactating people. Defense date: 16/04/2024, Utrecht University. https://doi.org/10.33540/2235 or https://dspace.library.uu.nl/handle/1874/437334

Hollestelle, M. J., van der Graaf, R., Sturkenboom, M.C.M, van Delden J.J.M. An ethics framework for the transition to an operational learning healthcare system. Learning Health Systems (2024). DOI: https://doi.org/10.1002/lrh2.10414  

Hollestelle, M. J., van der Graaf, R., Sturkenboom, M.C.M, Cunnington, M., van Delden J.J.M. Building a Sustainable Learning Health Care System for Pregnant and Lactating People: Interview Study Among Data Access Providers. JMIR Pediatrics and Parenting 7 (2024). DOI: https://doi.org/10.2196/47092  

Hollestelle, M.J., van der Graaf, R., Sturkenboom, M.C.M, van Delden J.J.M. Stimulating solidarity to improve knowledge on medications used during pregnancy. BMC Med Ethics 24, 44 (2023). DOI: https://doi.org/10.1186/s12910-023-00924-x  

Hollestelle, M.J., van der Graaf, R., Hartman, S.D., van Delden J.J.M. A Learning Healthcare System for pregnant and breastfeeding women: what do women during preconception, pregnancy, and nursing think? – A qualitative study. BMC Pregnancy Childbirth 22, 334 (2022). DOI: https://doi.org/10.1186/s12884-022-04675-2