Internal guidelines and notes
| Video-opname van deelnemer in extramurale setting | This note outlines the guidelines and key considerations for the use of video recordings of participants outside the hospital setting, primarily in the home environment, in the context of scientific research. |
| Gebruik van menselijk lichaamsmateriaal voor interne validaties voor kwaliteitsdoeleinden in het kader van de zorg binnen een klinisch labo (LAG) | This note describes the conditions that must be met for sample collection from UZ/KU Leuven staff for internal validation purposes related to quality assurance within LAG care activities. |
| Flowchart Onderzoek met geartificaliseerd en geëxtraheerd materiaal | This note clarifies the administrative requirements for research involving artificial or extracted human body material without any therapeutic application in humans. UZ and KU Leuven provide a clear framework and practical guidance, including when an exception regime with administrative simplification may be applied. |
| Opnemen van gedetineerden binnen klinische proeven: ethische overwegingen | This note outlines the conditions and considerations for including detainees in clinical studies. It emphasizes the importance of voluntary and well-informed consent, the need for additional protections due to their vulnerable status, and the safeguarding of ethical and practical feasibility in research participation. |
| Decision tree use human body material | Decision tree outlining the correct use of human body material (HBM) for research, to ensure compliance with biobank legislation and related regulations. Established by BAREC. |
Interesting literature
- In-silico trial of intracranial flow diverters replicates and expands insights from conventional clinical trials
- Importance and role of independent data monitoring committees (IDMCs) in oncology clinical trials
- ‘It’s misinformation at worst.’ Weak health studies can do more harm than good, scientists say
- European non-commercial sponsors showed substantial variation in results reporting to the EU trial registry
- Violation of research integrity principles occurs more often than we think
- Methodological quality of covid19 clinical research
- EU regulators’ perspectives to Decentralized Clinical Trials
- Tolerating bad health research: the continuing scandal
- Medicine’s Lessons for AI Regulation
- Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic
- Parental perspectives on a trial using waived informed consent at birth
- Reframing consent for clinical research: a function-based approach
- Fourth controlled human infection model (CHIM) meeting, CHIM regulatory issues, May 24, 2023
- A Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
BAREC
The Belgian Association of Research Ethics Committees is an initiative of the Belgian Ethics Committees involved in the evaluation and follow up of health related research projects. The association currently represents the vast majority of ethics committees involved in the evaluation of clinical research in Belgium. They formulate advices on different topics. You can find these through this link.
