2 - BIOBANK - August 23, 2018
Law on human material, consolidated version
Compendium - Biobanks dated July 20, 2018
Submission for to ethics committee
A submission form has been developed in consultation with different stakeholders and is intended to harmonize the way advice should be asked to the ethics committee as part of the recognition process of a biobank.
Therefore, BAREC suggests the use of this submission form as a first step in the harmonisation of the work of ethics committees with regards to the evaluation of biobank activities.
Notification to the authorities (next step) : Please refer to following AFMPS / FAGG web pages.
Etablissements de matériel corporel humain
Instellingen voor menselijk lichaamsmateriaal | FAGG
1 - INSURANCE COVERAGE - CLINICAL TRIAL- May 17, 2018
On many occasions during previous meetings of BAREC, several members have expressed the wish to discuss harmonization 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.
E-mail : webmaster[@]barec.be
Date de création : 10/09/2018