PMID: 25748868Mar 10, 2015Paper

Legislation hampers medical research in acute situations

Danish Medical Journal
Jakob Hartvig ThomsenJesper Kjærgaard

Abstract

Informed consent in incapacitated adults is permitted in the form of proxy consent by both the patients' closest relative (next of kin, NOK) and general practitioner (GP). In research in acute situations not involving pharmaceuticals, Danish legislation allows for randomisation and subsequent proxy consent, as soon as possible. The aim of this study was to describe the delay associated with obtaining consent and to assess whether consent from NOK or GP/Danish Health and Medicines Authority is obtained with delays beyond the intervention. In a prospective study, 171 comatose out-of-hospital cardiac arrest (OHCA) patients were randomised to targeted temperature management. Patients were randomised before NOK could be informed, and proxy consent was obtained as soon as possible. Written consent from NOK and GP were our study data. We obtained all legally required consent: 169 cases of consent were obtained from NOK, two patients gave consent before NOK, in no cases was consent denied by the proxy. Consent from NOK was obtained with a median delay of zero days (interquartile range (IQR): 0-1, max. 128 days). Delay from NOK consent to GP consent was a median of nine days (IQR: 6-23, max. 527 days). NOK fully accepted participation i...Continue Reading

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