There is much law and many guidelines surrounding the whole issue of the indemnity for human volunteers when it comes to clinical trials. The system that had been put in place to protect individual volunteer drug trialists seems largely to have worked by the fact that there are so few examples of legal cases being issued. However, recent events have shown that when the system fails it fails somewhat spectacularly. The difficulty for groups such as the ethics committee is that lawyers look for targets to try and meet the difference between the claims and the monies available and it might therefore always be possible that the ethics committee becomes centre stage in terms of the pursuit of the action.
References
1.
Department of Health expert group, under the chairmanship of Professor Gordon Duff, set up to learn from the Parexel clinical trials incident.
Directive 2001/20/EC of the European Parliament and the Council of 4th April on the approximation of laws, regulations and administrative provisions relating to the implementation of good ethical practice in the conduct of clinical trials on medicinal products for human use. The European Parliament, 2001. Available at http://www.eortc.be/Services.Doc/clinical-EU-directive-04-April-01.pdf.
Medicines for Human Use (Clinical Trials) Regulations2004. (SI 2004, No.1031).
7.
GoudsmitFRiosCWadlundJ. Insuring international clinical trials: navigating the quirks and avoiding the quagmires. The Journal of Biolaw & Business2005; 8(3).
