Informed consent procedure for clinical trials in emergency settings: the Polish perspective.

Science and Engineering Ethics
Piotr S Iwanowski

Abstract

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients' to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants' consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant's consent in emergency research exist and the regulations on surro...Continue Reading

References

Aug 27, 1999·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·H A SmithlineB J Crenshaw
Jun 4, 2002·Journal of Medical Ethics·S Lötjönen
May 3, 2003·Lancet·Nino StocchettiAndreas Unterberg
Oct 2, 2003·Annals of Emergency Medicine·Michelle H Biros
Apr 20, 2005·Journal international de bioéthique = International journal of bioethics·UNKNOWN Council of Europe, Steering Committee on Bioethics (CDBI)
Mar 7, 2006·Resuscitation·Kathleen LiddellFritz Sterz

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Citations

Feb 8, 2016·BMC Medical Ethics·Susanne RebersMarjanka K Schmidt

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