Wargers, Annemieke
Elphick, Christopher M.
Mölenberg, Famke J. M.
Senequier, Amandine
Manios, Yannis
Mavrogianni, Christina
Murray, Claire
Queral, Judit
Tarro, Lucia
Williams, Craig A.
Vlachopoulos, Dimitris
Jansen, Wilma
Funding for this research was provided by:
Horizon 2020 Framework Programme (101006251)
Article History
Received: 21 December 2023
Accepted: 9 July 2024
First Online: 25 July 2024
Declarations
:
: This study is registered in ClinicalTrials.gov (NCT05002049) on 12/08/2021. All SEEDS activities followed the principles of the Declaration of Helsinki [], the International Conference on Harmonization Good Clinical Practice (ICH GCP) guideline [], and the General Data Protection Regulation (GDPR).The 4 pilot countries (Greece, the Netherlands, Spain, and the United Kingdom) obtained approval for the study from their corresponding Ethics Committee. Informed consent was collected from stakeholders participating in focus groups in line with GDPR legislation.Greece: The study was approved by the Bioethics Committee of Harokopio University (ethical approval code: 953/10-3-2021) and the Greek Ministry of Education (approval code: 140715/ 3-11-2021).The Netherlands: The Medical Research Ethics Committee of the Erasmus Medical Centre, Rotterdam, The Netherlands decided that the regulations from the Dutch Medical Research Involving Human Subjects Act (Dutch abbreviation WMO) do not apply to this research protocol. Therefore permission was granted by the committee for the execution of this study and for publications in a later stage of the study (permission ID: MEC-2021-0396).Spain: The Drug Research Ethics Committee (CEIm) of the Pere Virgili Health Research Institute (Reus, Spain) granted the permission for executing this study and for publications in a later stage of the study (nº Ref. CEIM: 085/2021).The United Kingdom: The study has been approved by the Sport and Health Sciences Ethics Committee of University of Exeter, ref. numbers (21-03-24-B-02, 21-07-14-B-04).
: NA.
: The authors declare no competing interests.