Oppelt, Katja Anita
Luttmann, Sabine
Kraywinkel, Klaus
Haug, Ulrike https://orcid.org/0000-0002-1886-2923
Article History
Received: 18 March 2019
Accepted: 24 June 2019
First Online: 8 July 2019
Ethics approval and consent to participate
: In Germany, the utilization of health insurance data for scientific research is regulated by the Code of Social Law, specifically § 75 Book X. All involved health insurance providers as well as the German Federal (Social) Insurance Office and the Senator for Science, Health, and Consumer Protection in Bremen as their responsible authorities approved the use of GePaRD data for this study. Informed consent for studies based on GePaRD is required by law unless obtaining consent appears unacceptable and would bias results, which was the case in this study. According to the Ethics Committee of the University of Bremen studies based on GePaRD are exempt from institutional review board review.
: Not applicable
: The authors declare that they have no competing interests. Katja A. Oppelt, Sabine Luttmann, and Ulrike Haug are working at the Leibniz Institute for Prevention Research and Epidemiology – BIPS. Unrelated to this study, BIPS occasionally conducts studies financed by the pharmaceutical industry. Almost exclusively, these are post-authorization safety studies (PASS) requested by health authorities. The studies and the resulting publications are not influenced by the pharmaceutical industry.