| |
USA |
Belgium |
France |
Germany |
Italy |
Holland |
UK |
Spain |
| Compulsory insurance |
No |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| Indemnifiable injuries: death, serious harm, pain, suffering, economic losses |
Variable |
No |
No |
Death or permanent disability |
Death, serious harm, pain, suffering, economic losses |
Death and other harms |
“any injury” in phase 1 trials;
“serious harm” in phase 2 and 3 trials |
Physical injuries and their economic consequences |
| Limits to compensation (e.i.: exclusion of the harms which are inevitable in particular kind of trials; exclusion of the health problems which can depend on the natural progression of the subject’s disease) |
Yes |
No |
No |
No |
No |
Yes |
Yes |
Yes |
| Indication for the informed consent document |
Yes |
No |
No |
No |
Yes |
Yes |
No |
No |
| Differences in compensation plans according to the type of trial (phase 1, 2, 3 or 4) or to the level of risk of the trial |
Not stated |
No |
Yes |
Yes |
No |
Yes (exemption for studies with minimal risks) |
Yes (different kind of compensation available) |
Yes
(exemption for studies with minimal risks) |
| No fault compensation available |
Variable |
Yes |
Yes |
Yes |
Not clear |
Not clear |
Yes, for phase 1 trials, without “legal commitment” for phase 2 and 3 trials |
Yes |
| Exemption from insurance or special terms for public clinical trials |
Not stated |
Not stated |
Yes, exemption |
Not stated |
Yes, special terms |
Yes, exemption |
Yes, possible exemption |
Yes, possible exemption |
| Responsibility for compensation (public/private) |
Private and public |
Private |
Private and public |
Private |
Private |
Private and public |
Private and public |
Private and public |
| Temporal indications |
Not stated |
No |
No |
No |
Yes, 24-36 months after the trial completion
10 years for pediatric studies and studies with biological materials |
Yes, 5 years after subject’s participation |
No |
No |
