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The European Clinical Trials Directive revisited: The VISEAR recommendations

      An editorial in Resuscitation in June 2002
      • Sterz F.
      • Singer E.A.
      • Böttiger B.
      • et al.
      A serious threat to evidence based resuscitation within the European Union.
      drew attention to the threat to the development of evidence-based resuscitation within the European Union (EU) posed by the Directive 2001/20/EC (‘The Clinical Trials Directive’) which requires prior informed written consent before subjects can be recruited to clinical trials of medicinal products. It made no direct exception for emergency situations, and therefore threatened to prevent all trials involving victims of catastrophic illness causing loss of mental capacity—such as cardiac arrest, stroke, or severe traumatic brain injury. Implementation by all EU countries was required by May 2004. The wording of the Directive permitted some flexibility so that variations were expected that might impact on emergency research. The editorial urged that representation be made at national level to take advantage of this flexibility and thus safeguard the continuing development of evidence-based resuscitation medicine. As expected, interpretation has not been uniform. Lemaire et al.
      • Lemaire F.
      • Bion J.
      • Blanco J.
      • et al.
      The European Union Directive on Clinical Research: present status of implementation in EU member states’ legislation with regard to the incompetent patient.
      have described the variations in national legislative responses to the Directive within Europe; they called on legislators to permit waivers of informed consent for emergency research, to clarify terms and definitions, and to remove the artificial distinction between interventional and observational research.
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      1. Vienna Initiative to Save European Academic Research (VISEAR), Recommendations in relation to the EU Clinical Trials Directive and Medical Research Involving Incapacitated Adults. August 2005. Presented to the European Commission (also submitted for publication to Wien Klin Wochenschr).

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      4. Consultation on amendment to the medicines for human use (clinical trials) regulations 2004 (S.I.2004/1031). Medicines and Healthcare Products Regulatory Agency MLX 326 (August 2005).