CommentaryThe European Clinical Trials Directive revisited: The VISEAR recommendations
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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, ResuscitationCitation 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.
Should clinical research legislation be once again reformed?
2011, Medecine et DroitScientific 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, ResuscitationCitation 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, ResuscitationCitation 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.