• J Emerg Med · Jan 2004

    Clinical trials in an emergency setting: implications from the fifth version of the Declaration of Helsinki.

    • Dominique Vanpee, J B Gillet, and Michel Dupuis.
    • Emergency Care Unit, University Hospital of Mont-Godinne, Yvoir, Belgium.
    • J Emerg Med. 2004 Jan 1; 26 (1): 127-31.

    AbstractEverybody agrees that research is crucial to improve the quality of emergency care. Consent of human subjects for participation in research requires that they fully understand their role and risk, not be coerced, and be allowed to withdraw at any time without penalty. In an emergency situation, informed consent is not always possible but the need for good research data is very high. Here is the ethical difficulty, and a real conflict of values: a population that might ultimately benefit from research cannot consent to the research and are thus excluded from the potential therapeutical advances. Patients at high risk of morbidity or death, with cardiac arrest, shock, head injury, or altered mental status, are evidently incapable of providing an adequate consent, but nevertheless are often in the greatest need of innovative therapy and might be willing to assume some risk for potential benefit. In an attempt to resolve this dilemma, the new version of the Declaration of Helsinki presents updated requirements for the waiver of informed consent and the protection of human subjects in emergency research.

      Pubmed     Full text   Copy Citation  

      Add institutional full text...

    Notes

    hide…

Want more great medical articles?

Keep up to date with a free trial of metajournal, personalized for your practice.
1,694,794 articles already indexed!

We guarantee your privacy. Your email address will not be shared.