Compensation and Reimbursement

The EU Clinical Trials Directive introduced an 'obligatory insurance/indemnity' which has substantially increased the costs and administrative burden of conducting clinical trials. The new regulation recognises that clinical trials do not always pose additional risk to the participants over normal clinical treatment. Therefore, in cases where there is no additional risk, or such risk is negligible, no specific damage compensation (insurance or indemnity) will be required. With respect to trials where there is additional risk and the sponsor is obliged to ensure adequate insurance coverage, the new regulation puts EU member states under an obligation to set up a national indemnification mechanism on a not-for-profit basis. This should be of particular value to non-commercial sponsors, for whom it has been difficult to obtain insurance coverage. (5) The EU also requires all sponsors and CRO’s to be completely transparent about financial transactions made with participants or trial sites.

The informed consent signed by the participant must contain specific references to any compensation schemes, and the insurance coverage offered to the participants should they suffer any injury or harm. The informed consent should also be specific about how the insurer can be contacted, so that participants are not necessarily required to arrange their claims through the study personnel or the CRO.