Pyae Phyo Win, Thein Hlaing, Hla Hla Win
Factors influencing maternal death in Cambodia, Laos, Myanmar, and Vietnam countries: A systematic review
PloS one
lack harmonization evaluation criteria ethics committees european union eu led inconsistent ethics reviews received research sites participating multicenter noninterventional studies european general data protection regulation gdpr appears implemented national level substantial degree variance interpretation european reference networks erns struggling setting informed consent form icf registries allowing reuse data research purposes aim work develop adaptable icf research purposes used ern registries work challenge team established within european joint programme rare diseases ejp rd develop patients registry icf template allowing easy adaptation erns country sitelevel specificities ern patients representatives validated choice developing gdprcompliant template research purposes feedback received 34 ethics committees clinical patient management system icf including submission patients data ern registries eu consent regulatory framework analyzed along existing ontologies data access reuse adaptable icf developed following iterative cycles consultation review clinicians research experts ethics regulatory advisors patients representatives development pediatric material minor participants also undertaken research oriented icf templates adults parentslegal representatives patients released 26 national languages adaptable icf aims foster according patients preferences reuse registries data research purposes compliance applicable laws standards pediatric material finalized collect minors assent icf machinereadability also progressing enhance data discovery facilitate access reuse conditions