Regulation, data management, informed consent, and legal issues for ART

The number of assisted reproduction treatments undertaken worldwide has risen steadily since 1990. However when it comes to regulation, due to political, ethical, and social reasons related to assisted reproduction practice, each country has a different perspective. Several factors contribute to these differences, including financial issues (affordability, treatment costs), customary law, cultural and belief dimensions. In addition, individual and professional options may play different roles in different societies. The different restrictions across different countries, highlight a very complex reality, whose legislation represents a constant topic of debate and undergoes continuous evolution. In the daily practice, patient counseling and informed consent have both legal and ethical dimensions. The aim of this chapter is to provide an overview of assisted reproductive technology regulation, presenting its major legal issues and to underline the specific aspects of quality or data management and informed consent in assisted reproductive technology treatments. © 2023 Elsevier Inc. All rights reserved.