• Danish medical journal · Mar 2015

    Randomized Controlled Trial Multicenter Study

    Legislation hampers medical research in acute situations.

    • Jakob Hartvig Thomsen, Christian Hassager, John Bro-Jeppesen, Lars Køber, Søren Boesgaard, Jacob Eifer Møller, Niklas Nielsen, Michael Wanscher, and Jesper Kjærgaard.
    • Hjertemedicinsk Klinik B, 2142, Hjertecentret, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark. jesper.kjaergaard@rh.regionh.dk.
    • Dan Med J. 2015 Mar 1;62(3).

    IntroductionInformed 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.MethodsIn 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.ResultsWe 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).ConclusionNOK fully accepted participation in a clinical trial after OHCA with short delays in consent. Consent from GPs was associated with long delays beyond the intervention, which make GPs less appropriate for proxy consent of incapacitated adults in acute situations. The Ethics Committees' approval of the trial justified by their competence and authority, combined with the NOK´s insight into the patient's wishes may be a relevant and feasible alternative to the current consent procedure.FundingThis work was supported by the European Regional Development Fund through the Interreg IV A OKS programme (NYPS ID: 167157) with regards to authors JHT, CH, NN and JK.Trial Registrationnot relevant.

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