Boeken, Ole Jonas
Heine, Josephine
Duda-Sikula, Marta
Patricio, Víctor
Picard, Géraldine
Buttard, Chloé
Benaiteau, Marie
Mendes, Álvaro
Howard, Fuchsia
Easton, Ava
Kurpas, Donata
Honnorat, Jérôme
Dalmau, Josep
Finke, Carsten
Funding for this research was provided by:
Charité - Universitätsmedizin Berlin
Article History
Received: 23 July 2024
Accepted: 29 August 2024
First Online: 6 September 2024
Declarations
:
: The leading ethics committee overseeing this study is the Ethics Board of the European Joint Programme on Rare Diseases Joint Transnational Call 2021 (EJP RD JTC2021). The study has received conditional ethics clearance from EJP RD JTC2021 for all Levels, contingent on the development of global procedures for informed consent in the online study (Level 3). The SAPIENCE project has successfully undergone independent peer-review and was selected for funding in the EJP RD JTC2021 call.
: Levels 1 and 2 of SAPIENCE have been granted ethical approval at all study sites (Ethikkommission der Charité – Universitätsmedizin Berlin (EA2/138/23, 13.07.2023); Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona; Comité de Protection des Personnes EST III (2023-A01446-39; NCT05954468)).
: Approvals for Level 3 are currently underway in Berlin and Lyon, with ethical approval already granted for the Spanish site.
: The study is being conducted under the Declaration of Helsinki and Good Clinical Practice guidelines, which include the protection of data and patient privacy. All participants are required to provide written informed consent before participating.
: Informed consent is obtained from participants at each study site prior to recruitment, and the inability to provide informed consent is regarded as an exclusion criterion. Consent must adhere to data protection laws, such as GDPR, and encompass a mandatory subsection specifically addressing consent for publication.
: The authors declare no competing interests.