[Mandatory insurance for human test-subjects participating in medical trials is in fact rarely mandatory].

Autor:	Sizoo BB, Glas G
Jazyk:	Dutch; Flemish
Zdroj:	Tijdschrift voor psychiatrie [Tijdschr Psychiatr] 2015; Vol. 57 (4), pp. 276-9.
Abstrakt:	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.
Databáze:	MEDLINE
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