4. Summary

There are no clear, standard guidelines to follow for CRO’s or sponsors regarding compensation to research participants for taking part in a trial. Compensation is not always monetary, it can also take the form of health services, food, or other benefits.

There are different models of compensation that studies apply, and often no compensation is given for participation alone, except to healthy volunteers in Phase I studies. Patient activists and advocates should be prepared to know more about the different regulatory frameworks in order to judge compensation related issues. In the European Union, it is mandatory to include explicit references to insurance coverage for study-related injuries in the informed consent documentation. Patient advocates should always be aware of the special needs and issues of vulnerable populations.