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This study reviews emergency research in Denmark, examining consent procedures and the use of proxy consent. Findings will inform ethical practices in clinical trials involving vulnerable populations.

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Area of Science:

  • Clinical Research Ethics
  • Emergency Medicine
  • Regulatory Affairs

Background:

  • Informed consent is crucial in clinical research but challenging in emergencies.
  • Proxy consent via legal guardians is used when participants cannot consent initially.
  • Danish emergency trials require ethics committee and, if applicable, Danish Medicines Agency approval.

Purpose of the Study:

  • To systematically identify all emergency trials conducted in Denmark.
  • To evaluate consent procedures and proxy consent utilization in these trials.
  • To gather quantitative and qualitative data on consent practices.

Main Methods:

  • A two-phase study involving a systematic review and a national survey.
  • Systematic review to identify all Danish emergency trials across legislative periods.
  • National survey of trial researchers on consent denial, non-obtainment, and opinions.

Main Results:

  • Data extraction from identified trials.
  • Quantitative survey data on participant consent rates.
  • Qualitative insights into researchers' views on consent procedures.

Conclusions:

  • The study will provide a systematic evaluation of consent procedures in Danish emergency trials.
  • Findings will highlight the practical application and challenges of proxy consent.
  • Results aim to inform ethical guidelines and improve consent processes in emergency research.