International resuscitation research, exception from informed consent, and the European Union Directive 2001/20/EC

Background: United States regulations allow a narrow exception from informed consent for a subset of resuscitation research. Such an exception is also allowed under the Declaration of Helsinki. In 2001, a European Union (EU) Directive was passed, which, if enforced literally, could prohibit resuscitation research. The purpose of this study is to assess the knowledge and attitudes of healthcare workers, specifically emergency physicians, with regard to the EU Directive as it applies to resuscitation research and informed consent. Methods: A closed-response survey was distributed in six languages at the Third Mediterranean Emergency Medicine Congress in Nice, France, and to a sample of emergency physicians using a directed approach. Descriptive and bivariate statistics, with a weighting adjustment to account for a disproportionately large number of responses from one country, are reported. Results: Two hundred and thirty-two surveys (111 using a weighted analysis) were returned from 26 countries. Sixty-seven percent of EU respondents and 70% of non-EU respondents stated that their country adhered to the Declaration of Helsinki, but only 44% of EU and 43% of non-EU respondents, were aware the Declaration allowed a waiver for resuscitation research. Among EU respondents, 49% were unaware of the EU Directive and another 15%, although aware of the Directive, were unaware of its implications for resuscitation research. Conclusion: The international regulatory status of consent in resuscitation research is in flux; yet, most emergency physicians are unaware of the potential implications of the EU Directive or the provisions in the Declaration of Helsinki allowing an exemption from informed consent for resuscitation research.