Abstract 42: Research on Research: International Heterogeneity of Waiver of Consent's Regulations for Studies Conducted in Emergency Settings
The globalization of the resuscitation science through multicentre international trials highlights the need to provide an international perspective to regulatory aspects of the trials to enable the science to grow while protecting human rights. The purpose of this regulatory comparison is to compare the different regulations approaches in emergency research in North America (Canada, USA) and in Europe (European Directive, France).
Hypothesis: The heterogenity of regulations for research in incapacited patients jeopardizes emergency research through geographical variability in protecting human rights.
Methods: Systematic analysis of regulatory issues associated with emergency research in 3 different countries (2 in North-America and 1 in Europe) and of the Directive 2001/20/EC of the European Parliament and of the Council.
Results: Table 1
Conclusion: This analysis emphasizes the lack of international standardization of regulatory measures and ethical approach to clinical trials involving incapacitated patients. The variability in regulations, and consequently in local board's assessments, is problematic introducing geographical variability to human rights in clinical trials. This review can be used to plead a case for harmonization of regulatory measures across countries involved in clinical trials.
- © 2010 by American Heart Association, Inc.