De verplichte proefpersonenverzekering bij medisch-wetenschappelijk onderzoek is lang niet altijd verplicht

Translated title of the contribution: Mandatory insurance for human test-subjects participating in medical trials is in fact rarely mandatory

B. B. Sizoo*, G. Glas

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageDutch
Pages (from-to)276-279
Number of pages4
JournalTijdschrift voor Psychiatrie
Volume57
Issue number4
Publication statusPublished - 1 Apr 2015

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