The World Medical Organization (WMO ) laid down central ethical principles for medical research on humans as early as 1962 in the Declaration of Helsinki.
One of the most important guidelines states:
✔ No financial remuneration as risk compensation - clinical research must not use fees as an incentive to compensate for health risks.
✔ Obligation to insure trial subjects - All participants in a clinical trial must be insured against unforeseen damage.
Many countries have now passed laws on human research, some of which also contain obligations to pay compensation. However, there is still no uniform, global regulation. There are particularly large differences inthe amount of compensation awarded in the event of damage.
Insurance cover: International differences
The usual compensation amounts for potential damage vary considerably in Europe alone - they range from 30,000 euros to over 1,000,000 euros per person (!). In addition to statutory requirements, voluntary market standards have also been established in many countries.
Challenge: Cross-border policies
Each test person must be able to read and understand the insurance documents in their own language. This is the only way to ensure that everyone involved is fully informed about their protection.
