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.
Minacori, R., Sacchini, D., Cicerone, M., Spagnolo, A. G., Insurance and clinical trials, <<CONTEMPORARY CLINICAL TRIALS>>, 2012; 33 (4): 573-573. [doi:10.1016/j.cct.2012.02.015] [http://hdl.handle.net/10807/11651]
Insurance and clinical trials
Minacori, Roberta;Sacchini, Dario;Cicerone, Marina;Spagnolo, Antonio Gioacchino
2012
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.
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