Clinical trial insurance in a comparative law perspective.
This paper presents the results of a comparative legal study on liability and insurance of clinical trials, including Belgium, France, Germany, the Netherlands, Spain, Switzerland, Sweden and the United Kingdom. In most countries the right to compensation of the trial subject is safeguarded, but the existing regimes show much variety. Seen from the perspective of the trial subject there is no justification for linking the extent of compensation to the object of the trial (involving drugs or not), to the nature of the trial (therapeutic or non-therapeutic) or to the status of the researcher (public entity or not).
Dute
Jos
J
Faculty of Health Sciences, Department of Health Law, Maastricht University, The Netherlands.
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D035881:Compensation and Redress; D005060:Europe; D006801:Humans; D007341:Insurance / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D012106:Research / Q000331:legislation & jurisprudence