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  1. Emergency research without consent under polish law.Joanna Różyńska & Marek Czarkowski - 2007 - Science and Engineering Ethics 13 (3):337-350.
    Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give (...)
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  • Informed consent procedure for clinical trials in emergency settings: The polish perspective.Piotr S. Iwanowski - 2007 - Science and Engineering Ethics 13 (3):333-336.
    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 (...)
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