Abstract
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.
| Translated title of the contribution | Mandatory insurance for human test-subjects participating in medical trials is in fact rarely mandatory |
|---|---|
| Original language | Dutch |
| Pages (from-to) | 276-279 |
| Number of pages | 4 |
| Journal | Tijdschrift voor Psychiatrie |
| Volume | 57 |
| Issue number | 4 |
| Publication status | Published - 1 Apr 2015 |