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Article History

Received: 10 June 2024

Accepted: 28 November 2024

First Online: 18 December 2024

Declarations

:

: All procedures involving human subjects were approved by the Ethics Committee of the University of Gothenburg (462–14) and Confidentiality Clearance at Statistics Sweden. Given that all data used was psuedonymized and coded by Statistics Sweden, informed consent to participate was not obtained from the participants.

: Not applicable for Swedish register-based studies, as the contribution of personal data to research is included in the contract between Swedish residents and the Swedish state provided that the research is ethically conducted []. The Ethical committees in Sweden are generally acknowledged to represent the public, and approval from an Ethical committee can largely replace individual approvals from study participants in registry-based research. As stated by Ludvigsson et al. [], the arguments that informed consent is not needed for registry-based studies in Sweden include: 1) Many research proposals would be impossible due to the sheer number of study participants (over 1 million participants); 2) It would dramatically reduce rate of participation and statistical power of most nationwide population-based studies, and lessen the scientific validity; 3) Risk for selection bias, since consent would be notably harder to obtain in high-risk groups, where positive outcomes are most frequent; 4) Individuals with registry-based information will be dead when the study is performed, and thus, consent is impossible; 5) Most large-scale research would be prohibited due to the extreme costs of obtaining the consent of millions of individuals with health data.

: The authors declare no competing interests.