Insurance and clinical trials

Dario Sacchini, Antonio Gioacchino Spagnolo, Roberta Minacori, Marina Cicerone

Risultato della ricerca: Contributo in rivistaArticolo in rivistapeer review

6 Citazioni (Scopus)

Abstract

The need for the insurance and the indemnification is a recent development in the EU regulations to protect the subjects participant in clinical trials. The Clinical Trial Directive 2001/20/EC states that the liability of the investigator or sponsor for possible injury or death of the trial subject has to be covered by insurance or indemnity. This legislation is causing problems especially for the “noncommercial” trials promoted by clinical investigators of academic or clinical research institutions for the improvement of clinical practice. Higher costs of insurance should be requested/levied only for those that have more risks than the current clinical practice for the same case.
Lingua originaleEnglish
pagine (da-a)573-573
Numero di pagine1
RivistaContemporary Clinical Trials
Volume33
DOI
Stato di pubblicazionePubblicato - 2012

Keywords

  • clinical trials
  • comitati etici
  • coperture assicurative
  • institutional review boards
  • insurance coverage
  • liability
  • research ethics committees
  • risk management
  • sperimentazioni cliniche
  • valutazione del rischio

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