EC Research
The Ethics Committee Research UZ/KU Leuven (hereinafter referred to as “EC Research UZ/KU Leuven”) evaluates research projects involving the human person concerning medical-scientific and healthcare-related topics (clinical research) submitted by researchers of UZ Leuven, KU Leuven and the associated University Colleges (Association KU Leuven), or by external parties (not affiliated with UZ/KU Leuven). It also evaluates the use of human body material for research (cf. Law of 19 December 2008), recognizes biobanks (cf. Royal Decree of 9 January 2018), and issues advice on research involving embryos in vitro. It also reviews applications for compassionate use and medical need programs.
These tasks are performed within the framework of international ethical principles and in compliance with applicable Belgian and European legislation and guidelines.
EC Research UZ/KU Leuven is recognized by the authorities as an ethics committee authorized to issue opinions in accordance with the Law of 7 May 2004 on experiments on the human person (“the Law”), for which it received full accreditation. EC Research UZ/KU Leuven is also recognized as an ethics committee authorized to issue opinions on clinical trials and studies involving medical devices and in vitro diagnostic medical devices (in accordance with the Law of 7 May 2017, the Law of 22 December 2020, and the Law of 15 June 2022).
The review of ethical aspects of i) patient care and ii) research on bodies donated to science by testament is carried out by EC Care UZ/KU Leuven.
Mission
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EC Research UZ/KU Leuven is tasked with contributing to the protection of the general welfare, safety, dignity, rights, and privacy of patients/healthy volunteers (subjects) participating in clinical research.
EC Research UZ/KU Leuven assesses, among other things, the scientific and ethical justification of the proposed studies, the scientific design (i.e. design, statistics, sample size, …), and the completeness of the protocol; the competence of the investigators; the safety of the participants; the completeness of the information provided to participants; the method of recruitment; and the voluntary nature of participation (cf. Art. 11, §4 of the Law).
EC Research UZ/KU Leuven ensures that its opinions are always formulated independently and in the best interests of the study subjects.
In carrying out its mission, EC Research UZ/KU Leuven adheres to international guidelines concerning research involving human subjects, as described, among others, in the latest version of the Declaration of Helsinki, the World Health Organization (WHO) guidelines for Ethics Committees, and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
It operates in accordance with the relevant laws and requirements of the Belgian and European authorities.
Finally, it takes into account the guidelines of the Advisory Committee on Bioethics and the National Council of the Order of Physicians.
Composition
EC Research UZ/KU Leuven is composed in accordance with the Royal Decrees of 12 August 1994, 4 April 2014, and 9 October 2017.
It therefore consists of a number of voting members representing both genders, including a majority of physicians, at least one general practitioner not affiliated with UZ Leuven, at least two nurses, a legal expert, a hospital pharmacist, a psychologist, a philosopher or representative of the humanities trained or educated in medical ethics, an expert with knowledge in pharmacology, pharmacotherapy and pharmacokinetics, and at least one member with expertise in clinical research methodology.
At least two paediatricians are part of EC Research UZ/KU Leuven for the evaluation of files involving minors.
To ensure the independence of EC Research UZ/KU Leuven, the Royal Decree of 12 August 1994 stipulates that the positions of hospital director, chief medical officer, chair of the medical council, or head of the nursing department are incompatible with membership.
The members of EC Research UZ/KU Leuven are appointed by the Executive Committee of UZ Leuven: physicians affiliated with UZ Leuven upon proposal by the Medical Council, and nurses upon proposal by the head of the nursing department.
As stipulated by the Royal Decree of 12 August 1994, the mandate of a member has a duration of four years and is renewable. After retirement, the mandate of members is in principle renewable only once.
The chair and vice-chair(s) are appointed to their functions by the Executive Committee of the hospital; if they are physicians from UZ Leuven, this is done upon proposal by the Medical Council.
The composition of EC Research UZ/KU Leuven must ensure expertise in the principal research domains. Members avoid any conflict of interest and remain informed about international and national regulations on experiments involving humans. The members and the chair are appointed with the aim of guaranteeing a multidisciplinary and balanced composition. Attention is given to a good balance between continuity and renewal, as well as optimal interaction with the Education Guidance Committee (OBC), the Biobank, the Clinical Trial Center, and other (supporting) services.
A full member who attends less than half of the meetings during a working year without providing written advice is automatically considered to have resigned unless valid reasons were communicated to the chair.
A member who provides written advice for a meeting is considered present at that meeting, and their opinion will be taken into account. In such cases, the member may participate in the decision regarding the advice formulated by EC Research UZ/KU Leuven regarding the file, in accordance with Article 3.
Members agree that their name and expertise may be published on the website of EC Research UZ/KU Leuven.
They also agree to sign a confidentiality agreement and a declaration of potential conflicts of interest. The latter is renewed annually and is publicly available on the EC Research UZ/KU Leuven website.
Civil liability insurance for the members of EC Research UZ/KU Leuven is provided by the hospital.
In the context of the Clinical Trial Regulation 536/2014 (CTR), which entered into force in 2022, the composition of the Ethics Committee is regulated in the Clinical Trials Act of 7 May 2017, Article 6. The Royal Decree of 9 October 2017 clarifies the practical arrangements.
Consequences of the CTR for the composition include:
- At least one patient representative must be a member. This person may not practise a healthcare profession and must be present during the discussion/decision of clinical trials by the EC or must have provided written advice beforehand for the EC deliberation to be legally valid.
At least one representative of healthy volunteers must be a member for the evaluation of phase I trials with healthy volunteers. This representative may also not practise a healthcare profession and must be present at the EC meetings or must have provided written advice beforehand for a legally valid deliberation. Additionally, they must have participated in phase I clinical trials but may not participate as a subject in trials assessed by the EC of which they are a member.
For the evaluation of phase I trials, two members must also be present as indicated in Article 5 §1 (1° and 2°) of the Royal Decree of 9 October 2017, namely: one person with sufficient experience in clinical pharmacology and one person with sufficient experience in the evaluation or conduct of phase I trials.
If deemed necessary, advice is also sought from experts outside EC Research UZ/KU Leuven because of their specific knowledge in certain areas. They are subject to the same confidentiality and conflict-of-interest requirements. External experts consulted may present their advice orally during the meeting or provide it in writing beforehand.
Any potential conflicts of interest in relation to a specific study must be reported by the relevant committee member to the chair before the start of the discussion of the file. The chair, or the vice-chair if applicable, decides whether the member may attend the discussion or should leave the meeting. In any case, the member must refrain from any participation in the decision-making.
Practical organisation
The handling of submitted documents, as well as the general operation of the committee, are described in its “Standard Operating Procedures”.
For the benefit of investigators, the provisions of submitting a planned experiment are also described on the EC Research UZ/KU Leuven website.