Legislation hampers medical research in acute situations

TY - JOUR

T1 - Legislation hampers medical research in acute situations

AU - Thomsen, Jakob Hartvig

AU - Hassager, Christian

AU - Bro-Jeppesen, John

AU - Køber, Lars

AU - Boesgaard, Søren

AU - Møller, Jacob Eifer

AU - Nielsen, Niklas

AU - Wanscher, Michael

AU - Kjærgaard, Jesper

PY - 2015/3

Y1 - 2015/3

N2 - Introduction: 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. Methods: In a prospective study, 171 comatose out-ofhospital 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. Results: 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 nine days (IQR: 6-23, max. 527 days). Conclusion: NOK 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. Funding: This 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 registration: not relevant.

AB - Introduction: 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. Methods: In a prospective study, 171 comatose out-ofhospital 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. Results: 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 nine days (IQR: 6-23, max. 527 days). Conclusion: NOK 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. Funding: This 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 registration: not relevant.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Body Temperature Regulation

KW - Coma

KW - Denmark

KW - Emergencies

KW - Family

KW - Female

KW - General Practitioners

KW - Humans

KW - Male

KW - Middle Aged

KW - Out-of-Hospital Cardiac Arrest

KW - Prospective Studies

KW - Third-Party Consent

KW - Time-to-Treatment

KW - Young Adult

M3 - Journal article

C2 - 25748868

SN - 2245-1919

VL - 62

SP - 1

EP - 5

JO - Danish Medical Journal

JF - Danish Medical Journal

IS - 3

M1 - A5037

ER -