Elsevier

Resuscitation

Volume 69, Issue 1, April 2006, Pages 9-14
Resuscitation

Commentary
The European Clinical Trials Directive revisited: The VISEAR recommendations

https://doi.org/10.1016/j.resuscitation.2005.12.004Get rights and content

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Cited by (36)

  • International variation in policies and practices related to informed consent in acute cardiovascular research: Results from a 44 country survey

    2015, Resuscitation
    Citation Excerpt :

    Idiosyncrasies exist in the application of regulations related to emergency research. Specific concerns relate to the behaviour of research ethics committees 30,31 and differing interpretations.32 In Germany, emergency research is permitted by national regulations but an insurance requirement prevented such research because no insurance company was willing to insure a study involving EFIC.

  • Scientific knowledge gaps and clinical research priorities for cardiopulmonary resuscitation and emergency cardiovascular care identified during the 2005 International Consensus Conference on ECC and CPR Science with Treatment Recommendations. A Consensus Statement from the International Liaison Committee on Resuscitation; the American Heart Association Emergency Cardiovascular Care ...

    2007, Resuscitation
    Citation Excerpt :

    This directive threatens to significantly restrict resuscitation research by requiring that informed consent be obtained before subjects can be recruited into clinical trials of medical products.31 Investigators from several European countries are currently lobbying for amendments to the directive that could enable a waiver or deferral of consent so that unconscious patients can be enrolled in clinical trials without the delays inherent to obtaining consent.32 However, important randomised studies have been completed recently under the guidance of these new regulations on both sides of the Atlantic.33–37

  • Design and implementation of resuscitation research: Special challenges and potential solutions

    2007, Resuscitation
    Citation Excerpt :

    These findings imply that resuscitation trials have been restricted in the United States for more than 10 years due to the regulations related to waiver of consent in emergency research. There is concern that the European regulations are having a similar impact.39 Therefore a practical approach is necessary to facilitate implementation of research under these regulations.

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