Participation and Informed Consent
DELETION
The study applied the Declaration of Helsinki ethical standards and adhered to the legal requirements for research on humans in Germany as stated in the guidelines for good clinical practice and the Medical Devices Act (Medizinproduktegesetz) issued by the Ministry of Health of Germany and implemented by the Federal Institute for Drugs and Medical Devices.With the invitation letter, participants were informed about the study purpose and procedures in an age group–appropriate manner by means of a detailed brochure; all web-based information was also available in 5 languages. Children and adolescents were asked to assent their participation with a mandatorily complemented consent of their legal representatives. Consent or assent to participate could be given on the web or on paper, whereas additional consent or assent to get the gargle sample analyzed had to be provided on paper (Data protection measures were implemented according to the Basic Data Protection Regulation (article 6, paragraph 1, letter a Datenschutz-Grundverordnung) and the Federal Data Protection Act. The manner of data collection and scope and content of data collected were authorized by the data protection officer of Heidelberg University. The consent forms provided information about the data protection measures and pseudonymization of data to identify individuals who tested positive; data analyses were conducted with anonymized data only. Withdrawal from study participation and deletion of data were possible at any time during the study. Participants were informed that the data could be used beyond the study for other research purposes related to SARS-CoV-2 or other respiratory viruses; however, the gargle samples were destroyed after study completion.Compensation for study participation was not provided.