Informed consent in medically assisted procreation in Italy: medico-legal and ethical challenges shaping physician responsibility.

Abstract

Background: Informed consent represents a fundamental requirement in healthcare and is a key expression of patient autonomy. In the Italian context, its application in the field of medically assisted procreation (MAP) raises specific medico-legal and ethical questions. Recent developments, including updated MAP guidelines and evolving case law, further underscore the need to reflect on the specificities of informed consent in this setting.

Objectives: This study aims 1) to trace the differences between informed consent in MAP and standard healthcare consent in Italy, and 2) to examine the medico-legal and ethical implications of these differences for physicians, whose obligations have come to extend beyond clinical information to encompass ethical, legal, psychological, and relational dimensions, particularly with regard to duties of information and professional liability.

Materials and methods: This study adopts a qualitative, interdisciplinary approach based on a critical review of Italian legislation, case law, and bioethical and medico-legal literature. Sources were selected for relevance to MAP, with particular attention to complex scenarios such as embryo management after partner separation, post-mortem embryo transfer, and cryopreservation.

Results: In Italy, informed consent in MAP differs substantially from standard healthcare consent because of its joint nature, its function beyond the therapeutic sphere, its temporal extension, and its partial irrevocability after fertilization. These features transform consent into a complex, processual act with long-term legal, ethical, and relational implications. As a result, the physician's role is not limited to the provision of technical information, but requires enhanced professional responsibility in ensuring adequate, comprehensible, and context-sensitive communication.

Discussion: In this perspective, structured counselling, repeated informational processes, and careful documentation become essential not only to support autonomous decision-making, but also to prevent or mitigate medico-legal risks. These considerations highlight the need for specific professional training in communication and counselling within MAP settings, to adequately address the complexity of consent in this field.