Ethical aspects of insuring clinical trials

The World Medical Organization (WMO) first described this in its Declaration of Helsinki in 1962:

  • Clinical research on humans in return for fees to compensate for any health risks must never be allowed.
  • Patients/test subjects participating in a study must be insured against unforeseen damage.

Many countries have enacted laws on human research, some of which also contain obligations to pay compensation. There is no general line across Europe or worldwide. Differences are particularly evident in the specifications for the amount of compensation. In addition, market standards have been established on a voluntary basis, depending on the country. The usual amounts of compensation to cover potential damage - in Europe alone - range from 30,000 to well over 1,000,000 euros per person (!).

Cross-national policies are not feasible due to national laws and language barriers. It is crucial that each test person can read and understand the insurance conditions and references to national laws in their own language.

A separate insurance policy for each country is essential.