Survey of informed consent for registration of congenital anomalies in Europe.

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. 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 by post (amounting to 1-3 hours a case) but still estimates 15-20% loss of cases through non-response, although only 0.5% of parents actively refuse to participate. A fourth registry is not fully operational because of low notification levels related to the consent requirement. All these registries reported difficulties persuading busy clinicians to undertake the additional work of obtaining consent for the registry, or convincing clinicians of the value of collecting registry data. Healthcare professionals have also to coordinate consent procedures to avoid parents being approached multiple times. A fifth registry does not yet know how ascertainment is affected but reports less than 1% parental refusal. Of the other three registries operating opt-in consent, one registry covering a small population has research paediatric staff who examine all babies (malformed or not) born in participating hospitals, for which consent is obtained at booking. This registry reports only two parental refusals since 1990. One registry is based on interviews of cases and controls shortly after birth by clinicians who then notify the case to the registry; this registry is not aware of problems, although it has little information from clinicians on parental refusals. One registry is a voluntary association of clinicians who obtain verbal consent from their patients when registering the case and is not aware of serious problems, although this has not been formally evaluated.