Save the date: Symposium 2026
We are delighted to invite you to our next joint CT-College – BAREC symposium on 28 March 2026.
Author: Editor
Symposium 2026
We are delighted to invite you to our next joint CT-College – BAREC symposium on 28 March 2026.
ICF template for interventional clinical trials with IMP on adult patients (CTR-studies)
This template is intended to prepare an informed consent form (ICF) for adult patients participating in an interventional clinical trial.
As a kind reminder, the use of the ICF templates will become mandatory as of 1 August.
Symposium AZHerentals – “Think global – research local” (28/11/2025)
Beste,
Met veel enthousiasme nodigt de wetenschappelijke cel van AZ Herentals u uit op het symposium:
📅 Vrijdag 28 november 2025
📍 AZ Herentals – Le Paige
Wetenschappelijk onderzoek leeft – ook buiten de muren van universitaire centra.
Tijdens deze inspirerende namiddag richten we de aandacht op wetenschappelijk onderzoek in ziekenhuizen. We tonen hoe praktijkgericht, relevant en innovatief onderzoek vanuit het werkveld een concrete bijdrage kan leveren aan de vooruitgang in de gezondheidszorg. Onderzoekers, artsen en experten uit verschillende instellingen delen hun inzichten, ervaringen en best practices rond onderzoek in de klinische praktijk.
Het programma is samengesteld met inspirerende sprekers uit universitaire én regionale ziekenhuizen, waarbij concrete praktijkvoorbeelden en strategische inzichten elkaar afwisselen.
Waarom deelnemen?
- Ontdek hoe onderzoek binnen ziekenhuizen écht het verschil maakt
- Laat u inspireren door sprekers met ervaring in multicentrisch onderzoek, datagedreven zorg en innovatie
- Netwerk met collega’s uit het onderzoeks- en zorglandschap
Dit symposium is een unieke gelegenheid om ervaringen uit te wisselen, kennis te delen en samen de rol van lokale onderzoeksinitiatieven in een globale context te versterken.
Inschrijven
👉 Inschrijven kan via: https://onlineregistrations.eu/events/herentals2511/forms/inschrijven
We hopen u op vrijdag 28 november in AZ Herentals te mogen verwelkomen!
Met vriendelijke groet,
Namens de wetenschappelijke cel van AZ Herentals
Paediatric clinical trials: single parent or both parents’ signature needed?
This advice was endorsed by the College Board on 20/06/2025
v2 dd 04JUL2025
Under the EU Clinical Trials Regulation, the informed consent of a singular legally designated representative is sufficient for enrolling a minor in a clinical trial. Belgian law, through the Clinical Trials Law of 7 May 2017 and the Law of 22 August 2002 on Patients’ Rights, clarifies that this representative must be someone who exercises parental authority or is the child’s legal guardian.
According to Articles 373 and 374 of the Belgian Civil Code, parental authority is typically exercised jointly by both parents, regardless of whether they live together. In practice, each parent is presumed to act with the consent of the other, unless a court has ruled otherwise. While this legal presumption facilitates everyday decisions, it may not be appropriate for high-stake matters such as the clinical trial participation of a minor.
It is therefore 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.
The ethical principle of respect for autonomy thus suggests that efforts should be made to obtain consent from all relevant parties whenever possible.
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 the single parent present then signs either in his/her own capacity, or 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, even not if the single parent has signed 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.
Q&A Pregnancy follow-up
This Q&A was approved by the College Board on 20/06/2025
v1 dd 04JUL2025
Question
What should be considered in the follow-up of a pregnant participant and pregnant partner in an interventional clinical trial?
Answer
In a clinical trial, a new medicinal product is being investigated. In order to optimise the knowledge about any potential teratogenic or embryotoxic/foetotoxic effects of a medicinal product and the doses and concentrations at which such effects will develop, it is desirable to gather information and to monitor both pregnant participants/partners and their offspring.
Pregnant participant
The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the foetus either before the placenta is fully developed or subsequently, if they can cross the placenta to at least some extent. Medicinal products may have a different impact at different stages of pregnancy.
The follow-up of a pregnant participant is subject to pharmacovigilance requirements. This means that the study sponsor is obligated to monitor and report all adverse events, including those occurring during pregnancy, to the competent authorities. Efforts should be made to collect data on the drug effects as well as the outcome for both mother and fetus.
Consent for the follow-up of the pregnant participant’s health condition and the processing of personal data is not requiredto the extent there is a legal obligation to report the adverse event. In such cases, the legal basis under the GDPR would be Article 6(1) (c) of the GDPR (legal obligation) and the justification for the processing of special category data would be Article 9(2)(i) of the GDPR (reasons of public interest related to public health to ensure high standards of quality and safety of health care and of medicinal products or medical devices). This has been confirmed by both the EU Commission (in Q3, 1) and the European Data Protection Board (in section 2.1) for clinical trials under the CTR.
Even though there might not be an obligation to collect consent for the processing of personal data, data subjects always need to be informed about the processing of their personal data (Article 13 and 14 GDPR).
On the other hand, an informed consent form (ICF) for the follow-up of the health status of the (born) child for drug safety purposes is necessary (“infant authorization”). It is preferable to obtain two signatures on the specific ICF for further follow-up of the child (see also: https://barec.be/paediatricclinical-trials-single-parent-or-both-parents-signature-needed/), although this follow-up can also be included in the Main ICF signed by the participant upon joining the clinical trial.
Pregnant partner
The follow-up of a pregnant partner involves collecting data on the health and development of the pregnant partner (and optionally the child) without interventions. This follow-up should be detailed in the clinical trial protocol of the CTR-study, including the duration of the follow-up (including that of the child). The follow-up should be specified in time, e.g. until x months after birth.
Written consent from the pregnant partner is required (unless it concerns purely the registration of a product’s safety and there is a legal obligation to report the adverse event).
This follow-up falls under the Law of May 7, 2004, on experiments on the human person. We refer to Article 62 of the Advisory Committee on Bioethics, which notes that the clinical trial (interventional drug study (e.g. CTR-study)) in which a male participant is involved is distinct from the observational study set up in case of his partner’s pregnancy (monitoring effects on pregnancy). These are two separate studies, but they can and should be described within a single study protocol of the CTR-study.
While elements of earlier guidance—such as Article 62 of the Advisory Committee on Bioethics—date from before the implementation of the CTR and may not fully reflect the current regulatory context, they still provide useful considerations. BAREC emphasizes that, under the CTR, the follow-up of a pregnant partner should be regarded as part of the original clinical trial and reviewed by the same EC responsible for the main CTR-study.
Because the law of May 7, 2004, on experiments on the human person, is applicable to the follow-up of the pregnant partner, this also implies that Article 29 of this law (liability and insurance) applies. Therefore, a compliant insurance clause should be included in the ICF for the pregnant partner. Participation of the pregnant partner in this observational study is voluntary. A thorough and adequate
Pregnant partner ICF is required. It is acceptable if this ICF is submitted via an amendment when this exceptional situation arises.
A separate ICF for the child (“infant authorization”) can be prepared if data on the child’s health status concerning the drug’s safety will be collected once the child is born but it is also possible and preferable to include this follow-up in the Pregnant partner ICF. It is recommended to secure two signatures on the ICF for continued follow-up of the child.
There may also be additional requirements for the pregnant partner beyond simply collecting their data, such as completing questionnaires or participating in phone contacts. In that case, it qualifies as an interventional study. This means that a separate ICF is definitely needed to properly inform the partner and obtain consent for their participation in the interventional aspects of the study.
Justification follow-up
The necessity of conducting follow-up, particularly of the pregnant participant, pregnant partner, or child, should take into account e.g. the available preclinical and clinical data regarding drug exposure during pregnancy, known effects of similar substances on pregnancy or fetal development and the pharmacokinetics of the investigational drug, especially its half-life. The drug’s half-life will determine
how long the substance remains active within the body and its potential to cause long-term effects. However, in case (pre)clinical data show the investigational drug or its metabolites binding covalently
to the target, the pharmacokinetic half-life is likely to underestimate the duration of action and the pharmacokinetics cannot be used as surrogate for the duration of the pharmacodynamic effects.
If the drug or any metabolites have a short half-life, meaning it is rapidly cleared from the system, the need for prolonged follow-up may be reduced. In such cases, a more limited or shorter follow-up period could be justified, especially if there is no evidence suggesting long-term residual effects of the drug on pregnancy or fetal development.
When determining the follow-up strategy, the study protocol should outline a clear rationale, supported by pharmacokinetics.
Passing of Prof. Dr. Renaat Peleman
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.
Harmonisation of fees
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.
Join our new GDPR working group
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!