Survey of informed consent for registration of congenital anomalies in Europe

Eurocat is a network of population based registers of congenital anomalies in Europe covering about a quarter of the birth population in 19 countries (http://www.eurocat.ulster.ac.uk/). We surveyed registries with regard to the requirement for informed consent and its implementation.1 We sent a questionnaire on ethics and confidentiality developed by the Eurocat Working Group to 35 registries in 2003 and updated June 2004; 29 registries from 15 countries replied (table). Eight registries reported experience of opt-in informed consent. View this table: National legislation on informed consent for congenital anomaly and other clinical registers Five registries depend on medical records and notification from clinicians. One experienced a fall in registration (less than 10 written consents in the entire year in which opt-in consent was instituted, compared with 249 cases in the year before opt-in) such that an exemption was negotiated enabling a switch to opt-out consent. Currently 0.1% of parents opt out. A second registry, in which notifying clinicians ask for consent by post, is permitted to keep a reduced, anonymous set of documentation on cases without consent (about 18%). A third registry gives administrative help for clinicians obtaining consent …