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Insurance Coverage – Clinical Trials

On many occasions during previous meetings of BAREC, several members have expressed the wish to discuss harmonisation of insurance amounts used in the frame of clinical trials. 

In response to this request expressed by the members, part of the BAREC forum meeting of November the 22nd, 2017, has been dedicated to the topic. A debate has been organised and led to a proposal shared with the members in order to reach a consensus. 

This resulted in an advice proposal that was submitted to the General Assembly on May the 17th, 2018, for approval by the members. 

A majority of the present members (or representatives) supported the proposal as formulated below. As a consequence, the General Assembly approved the proposal, that should be considered as an advice from BAREC regarding minimal insurance amounts to be used, especially in the context of industry-sponsored clinical trials.

The Belgian Association of Research Ethics Committees strongly recommends that Ethics Committees request at least following minimal insurance amounts for coverage: 500.000 EUR/participant – 2.500.000 EUR/occurrence – 5.000.000 EUR/experiment or in the aggregate.

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