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Compensation of Research-Related Injuries in the European Union.

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  • معلومة اضافية
    • الموضوع:
      RESEARCH teams; RESEARCH management; WOUNDS & injuries; COMPENSATION (Law); EUROPEAN Union
    • نبذة مختصرة :
      The planned reform of the Clinical Trials Directive has re-opened the debate over how to implement and interpret research-related injuries regulation. In the European Union (EU), clinical trials are currendy regulated by Directive 2001/20/EC, which establishes the provision of mandatory insurance before clinical trials commence but is silent on the system of liability. The proposed new Regulation will impact biomedical research assurance in all EU Member States because it points to insurance costs as being one of the causes of the fall in the number of clinical trials carried out in the EU. Despite the adoption of a risk-balance approach, the proposed new Regulation does not include a no-fault compensation system to protect subjects participating in clinical trials. An adequate protection of the rights and wellbeing of trial subjects would require not only mandatory insurance for clinical trials but also a no-fault compensation system. The new regulation should include a general clause requiring mandatory insurance and establishing liability insurance based on no-fault compensation; an exception clause, enabling the performance of clinical trials without insurance in the case of low-risk interventions or non-commercial clinical trials; and an exclusion clause, excluding compensation when there is no causal connection between injuries and clinical trial. [ABSTRACT FROM AUTHOR]
    • نبذة مختصرة :
      Copyright of European Journal of Health Law is the property of Brill Academic Publishers and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)