Mandatory insurance for human test-subjects parti-cipating in medical trials is in fact rarely mandatory
background The law on medical research with humans enables researchers to request exemption from the ‘mandatory’ insurance for such test-subjects. Because this type of insurance is expensive, some research projects are abandoned at an early stage.
aim To argue that exemption from ‘mandatory’ test-subject insurance is very rarely requested and granted.
method We discuss the problems involved, using an example from clinical practice and the literature.
results The second evaluation report concerning the law on medical research mentions that very few requests are made with regards to exemptions from this type of test-subject insurance. In fact, not only researchers but also medical-ethical committees seem to be unclear about the rules and procedures for requesting and granting exemptions. As a result, there is always a real danger that medical-ethical committees make arbitrary decisions and withhold exemptions.
conclusion More use needs to be made of the opportunities that the law provides for requesting exemptions from test-subject insurance.