Schmidt, Daniel http://orcid.org/0000-0001-8205-4755
,
Kollan, Christian
Stoll, Matthias
Hamouda, Osamah
Bremer, Viviane
Kurth, Tobias
Bartmeyer, Barbara
,
Article History
Received: 16 June 2020
Accepted: 17 December 2020
First Online: 22 January 2021
Ethics approval and consent to participate
: The RKI is the German national public health institute, therefore the Federal Commissioner for Data Protection is the responsible entity for studies which are conducted by the RKI. Information on HIV infection collected in ClinSurv HIV corresponds to the data reported to the RKI according to legal requirements implemented by the national Protection against Infection act (IfSG) of 2001. All patient data collected in ClinSurv HIV are generated during routine care. The German Federal Commissioner for Data Protection therefore waived the need for ethical approval for the ClinSurv HIV study.The study protocol for the HIV-1 Seroconverter cohort was initially approved in 2005 by the Ethics Committee of the Charité, University Medicine Berlin (EA2/105/05), with approval amended and confirmed in 2013. Participants provide their written informed consent to participate in this study. The ethics committee approved this consent procedure.
: Not applicable.
: DS, BGB, VB, OH and MS declare that they have no competing interests. CK is small shareholder in companies manufacturing antiretroviral drugs. TK reports outside of the submitted work to have received honoraria from Eli Lilly, Newsenselab, and Total for providing methodological advice, and from the BMJ for editorial services.