It is with deep sadness that we announce the passing of Prof. Dr. Renaat Peleman.
In addition to being the chairman of the Ethics Committee at UZ Gent, he was also a valued member of the BAREC Board.
Our thoughts are with his family and friends.
BAREC has standardized certain fees that are not legally required. This helps optimize processes and ensures greater clarity. Regularly reviewing the updated rates is essential to ensure they stay aligned with rising costs and administrative demands.
Based on the feedback received from our members, the BAREC Board has decided on the following amounts:
1. Biobank Recognition:
The initial recognition fee and bi-annual reassessment fee is increased to €2000. This better aligns with the administrative costs and efforts involved in the biobank evaluation process and the required bi-annual report submission to the EC.
2. Retrospective Commercial Studies:
The initial fee for retrospective commercial studies is set at €656.76 (in 2025). This fee is based on the fee for a non-interventional experiment.
The amendment fee will be €164.21.
3. Commercial studies on secondary use of HBM (Human Body Material):
We refer to the above fees for retrospective studies when applying the same rates to commercial studies involving human biological material, ensuring consistency across different study types.
4. Non-Study Specific Recruitment Materials:
A €500 fee for reviewing non-study-specific recruitment materials is appropriate, covering the time and resources needed for evaluation.
To tackle key GDPR challenges, we are launching a new ad hoc working group. We are calling for members to join. Legal professionals are especially encouraged to participate and share their expertise.
The working group will focus on key action points, including:
· Developing advice on the legal grounds for processing personal data.
· Revising the confidentiality sections of the Informed Consent Form (ICF).
The working group will come to an end once the above action points are completed.
If you are interested in being part of this effort, please reach out to us at info@barec.be by 21Feb2025. Your expertise can make a real difference to provide clear guidance on GDPR issues.
We look forward to your involvement!
Not a member yet? Please contact us at info@barec.be to get the information you need to become a member.
We look forward to having you all on board (again) in 2025!
This template is intended to prepare an informed consent form (ICF) for healthy adult participants taking part in an interventional clinical trial with a trial medicine.
In December we were informed by the FAMHP, that the outstanding payments for 2018 would be paid within 4 months. The Royal Decree has been published on 19 December 2024, see below.
Het Koninklijk Besluit betreffende de toekenning van de subsidie 2018 aan ethische comités werd op 19/12/2024 gepubliceerd in het Belgisch Staatsblad. U kan de publicatie raadplegen via volgende link: https://www.ejustice.just.fgov.be/mopdf/2024/12/19_1.pdf#page=102. De tabel vermeldt het bedrag waarop uw Ethisch comité recht heeft.
L’Arrêté Royal relatif à relatif à l’octroi du subside 2018 aux comités d’éthique a été publié au Moniteur belge en date du 19/12/2024. Vous pouvez consulter la publication via le lien suivant : https://www.ejustice.just.fgov.be/mopdf/2024/12/19_1.pdf#page=102. Le tableau reprend le montant auquel votre comité d’éthique a droit.
Based on the Question & Answers document provided from the Clinical Trials Regulation (EU) No 536/2014, not all patient facing documents need to be submitted for EC review.
This template is intended to prepare an informed consent form (ICF) for adult patients participating in a clinical investigation with a medical device, that is assessed by an independent Belgian Ethics Committee recognized under the Belgian legislation of 7 May 2017.
This template is intended to prepare an informed consent form (ICF) for adult patients participating in an interventional clinical trial.
It is ethically recommended to obtain written consent from both parents, particularly if the study may have significant implications for the child or family. In the Informed Consent Form (ICF), two signature lines should be present.
Simultaneous signing is not required. The parent that is present at the on-site visit can take the ICF home which gives the other parent the opportunity to sign it too. Sufficient time should be given to participants and parents to consider before signing the ICF, allowing for both signatures to be obtained at a later time.
However, there may be situations where obtaining written consent from both parents is not feasible or appropriate, such as when one parent is unavailable (e.g. when one parent is deceased, is in jail, in single-parent households,…), or estranged and there is no indication for the principal investigator (directly or indirectly) that the absent parent has a different opinion about the participation of the child in the study. In such cases, it may be ethically permissible to proceed with obtaining written consent from a single parent, provided that prior efforts have been made to involve and inform both parents and that the decision is made in the best interest of the child.
In that case, the parent that is present at the on-site visit should be asked if the co-parent would agree to the inclusion of the child in the study. If only one parent signs, it must be clear to that single parent that his/her written consent implies the consent of the other absent parent of the child/minor. It is good practice to document in the ICF that one parent signs on behalf of both parents, including the rationale behind.
If the principal investigator has knowledge of refusal of the other parent to allow the child to participate in the study, the principal investigator cannot include the child without the written consent of the other parent.
Ultimately, the ethical principle of respect for autonomy suggests that efforts should be made to obtain consent from all relevant parties whenever possible. However, it’s important to acknowledge that there are circumstances where both parents are not available. In such cases, it’s crucial to recognize that the remaining parent signs in their own capacity, not on behalf of both parents.
It’s essential to approach these situations with sensitivity and ensure that decisions are made in the best interest of the child.