Advice BAREC patient facing documents
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.
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.
We are delighted to invite you to our general assembly on the 22nd of May 2024.
BAREC wishes to provide clear guidance on the reimbursement of contraception-related expenses in the context of clinical trials, emphasizing the principle that sponsors should cover these costs when a participant is required to use contraception as part of the study protocol.
The participants in a clinical trial should reflect the target population. Adequate reporting of race and ethnicity can potentially contribute to better understanding of cultural, social, and biological differences, enabling the identification of population groups disproportionately affected by certain diseases, along with genetic information collected from study participants.
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
Some information concerning the compensation of participants in clinical research.
Belgian Association of Research Ethics Committees (BAREC)
SYMPOSIUM 09 December 2023, The Royal Library of Belgium, Brussels
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
Ethics is not mathematics
About the necessity for Harmonisation of the assessments for clinical research CTR/MDR/IVDR
Please register here before 04 December 2023
Program
9:00 – 9:20: Registration and welcome coffee
Morning sessions for all stakeholders
9:20 – 9:30: Welcome word by the president of BAREC (Christel Vansteenkiste)
9:30 – 9:45: The messiness of research ethics (Bert Vanderhaegen)
9:45 – 10:05: Point of view of CT-College
10:05 – 10:25: Point of view of FAHMP
10:25 – 10:45: Point of view of sponsor
10:45 – 11:15: Coffee break
11:15 – 11:30: Point of view of an Ethics Committee (Minne Casteels)
11:30 – 11:45: A national EC or harmonisation and education, the better solution? (Audrey Van Scharen)
11:45 – 12:30: Panel discussion
12:30 – 13:30: Lunch
Afternoon session for Ethics Committees
13:30 – 16:00: Reflecting on the morning’s insights: A Panel Discussion on the presented information
Price
EC members
– Without lunch €20
– With lunch €50
Non-EC members
– Without lunch €50
– With lunch €80
Please make a payment to the following bank account number: BE35 0689 3066 7537
RIZIV/INAMI Accreditation for Ethics Requested
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
Clinical studies with questionnaires (outside SoC): Interventional vs non-interventional?
From BAREC, we give an advice on how to consider studies involving questionnaires (outside standard of care (SoC)) and which fall under the (Belgian) law of 7 May 2004 to be interventional or non-interventional.