Ethical Aspects of the Clinical Trial Insurance
The Declaration of Helsinki of the World Medical Association (WMA) states:
- Clinical research on humans in return for fees to compensate for any health risks must never exist.
- Patients / subjects participating in a study must be insured against unforeseen harm.
Many countries have passed laws on human research, some of these include obligations to compensate for damages. There is no general line across Europe or the world. Differences are most likely to be visible when specifications on the amount of compensation are anchored. In addition, depending on the country, market standards have been established on a voluntary basis. The usual sums for covering possible damage range from 30,000 to well over 1,000,000 euros, per person(!) - only for Europe.
Policies which cover several countries are neither available nor practicable due to national laws and language barriers. Finally, each participant should read the insurance conditions and references to state laws in local language.
A specific policy for each country is indispensable.