Juul, Lise http://orcid.org/0000-0003-3640-7593
Frydenberg, Morten
Beck, Michelle Sand
Fjorback, Lone Overby
Article History
Received: 3 August 2020
Accepted: 28 January 2021
First Online: 17 February 2021
Ethics approval and consent to participate
: The Central Denmark Region Committee on Health Research Ethics assessed the project and concluded that the trial should not be treated as a biomedical research project in accordance with The Committee Act § 2, no. 1 and § 14, 1. There is no formal institution for ethical assessment and approval of questionnaire-based population studies in Denmark, but we adhere to the national ethical standards for public health research involving schoolchildren. The parents are informed about the study in writing. This information include that the questionnaire data will be used for research purposes only and treated confidentially. Parents are informed of the possibility to decline participation of their child completing trial questionnaires. The research complies with the General Data Protection Regulation (EU) 2016/679 of 27 April 2016 article 6(1) litra (a) and the Data Protection Act § 10(1). The pupils are also verbally informed by their teachers.The project is registered at Aarhus University’s record of processing activities under journal no. 2016-051-000001, serial number 1145. Aarhus University hereby confirms that under these conditions the project is compliant with the EU and national legislation on data protection. The trial is registered at ClinicalTrials.gov Identifier: NCT04208113. We will communicate important protocol modifications at Aarhus University’s record of processing activities and at the ClinicalTrials.gov.Data will be stored in REDCap hosted by Aarhus University. REDCap is a secure, web-based application designed to support data capture for research [CitationRef removed].The principle investigators (LJ and LOF) are responsible for the final datasets and for publishing the results. Positive and negative as well as inconclusive results will be published in international peer-reviewed journals, and all co-authors must comply with the Vancouver rules.Results will also be communicated in national journals for school teachers. Moreover, results will be presented at national and international conferences. Finally, results and implications will be available through the press and in laymen publications at e.g. websites, Facebook and Instagram.
: Not applicable.
: Aarhus University offers revenue-funded MBSR teacher training education and MBSR courses. The authors declare no competing interests.