The Ethics Committee Research UZ / KU Leuven (hereinafter referred to as “EC Research UZ/KU Leuven”) evaluates research projects on humans relating to medical-scientific and healthcare related topics (clinical research) submitted by investigators of UZ Leuven, KU Leuven and the associated Colleges of higher education (Association KU Leuven) or external parties.
EC Research UZ/KU Leuven is recognized by the government as an ethics committee to provide opinions in accordance with the Act of 7 may 2004 and is fully recognised (OG032). It is also certified to provide opinions in accordance with the Act of 7 May 2017.
The law of 7 may 2004 - amended by Royal Decree 78, among others – defines an experiment as follows: “Any test, study or research carried out on the human person for the purpose of developing knowledge specific to the exercise of healthcare professions”.
It concerns projects whereby data (or a part) can be collected prospectively with a view to research. The EC's prior opinion for these projects is required by law and binding.
The treatment of ethical aspects of patient care is handled by another committee, EC Care UZ/KU Leuven.
EC Research UZ/KU Leuven's mission is to contribute to the protection of general welfare, safety, dignity, rights and privacy of patients/healthy volunteers (subjects) participating in clinical investigations.
EC Research UZ/KU Leuven assesses, among other things, the scientific and ethical justification of the proposed studies, the scientific scope (i.e. design, statistics, numbers) and completeness of the protocol, the suitability of the investigators, the safety of the participants, the completeness of the information provided to the participants, the voluntary nature of the participation (cf. Experiments Act 7 May 2004, Art 11, § 4 and Act of 7 May 2017).
It assesses, if requested by the FAMHP, the applications for compassionate use, medical need, biobanks (see. BRD 9 January 2018) and the VHP files (voluntary harmonized procedures). It also evaluates the procurement and use of human tissue for research and advises on research on embryos in vitro.
In its mission, the EC Research UZ/KU Leuven respects international guidelines on human research as described in the latest version of the Declaration of Helsinki, the World Health Organisation (WHO) guidelines for ECs and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
It works in accordance with the relevant laws and requirements of the Belgian and European administrations.
And finally, it takes into account the guidelines of the Belgian Advisory Committee on Bioethics and the National Council of the Order of Physicians.
The requirements to be met by the composition of the EC are described, on the one hand, in the Royal Decree amending the Royal Decree of 23 October 1964 determining the standards to be observed by hospitals and their services of 12 August 1994 (Royal Decree of 12 August 1994), the Act of 7 May 2004, the Royal Decree of 4 April 2014 establishing implementing measures of the aforementioned Act of 7 May 2004 (Royal Decree of 4 April 2014) and, on the other hand, in the Act of 7 May 2017 and in the Royal Decree of 9 October 2017 implementing the Act of 7 May 2017 on clinical trials of medicinal products for human use (Royal Decree of 9 October 2017).
For the evaluation of EudraCT studies, the composition must meet the requirements specified in the Act of 7 May 2017 and in the Royal Decree of 9 October 2017.
To ensure the independence of EC, the Royal Decree of 9 August 1994 provides that the capacity of hospital director, chief medical officer, chairman of the medical council of a hospital or head of the nursing department of a hospital, or manager, member of the management, managing director or member of the board of directors of a marketing authorisation holder of a medicine is incompatible with membership.
The members of the EC are appointed by the board of directors of UZ Leuven. For the physicians connected to UZ Leuven, this is done on the proposal of the medical council, for the nurse(s) on the proposal of the head of the nursing department.
The chairman and vice-chairman of the EC are appointed in these positions by the board of directors of UZ Leuven; if they are physicians this is on the proposal of the medical council.
A member's mandate is for four years and is renewable. After emeritus/retirement, the members' mandate is renewable only once in principle, see internal rules.
For the assessment of EudraCT studies, the composition must be in accordance with the Act of 7 May 2017 (article 6) and the Royal Decree of 9 October 2017. A number of additional requirements are described in here.
This legislation does not lay down a maximum number of members. An EC must be made up of a majority of physicians, and (at least) one patient representative. The latter may not have a healthcare profession and is required to attend the discussion of Eudract studies or at least provide a prior written opinion for a legally valid deliberation.
For the assessment of phase - I trials, the composition of the EC must additionally comply with the following, as described in article 5 of the Royal Decree of 9 October 2017,
- one member who has adequate experience in clinical pharmacology;
- one member who has adequate experience in assessing or conducting phase I clinical trials;
- one representative of the healthy volunteers. This representative may not have a healthcare profession either and must attend the meetings of the EC or at least provide a prior written opinion for a legally valid deliberation of the EC. In addition this person must have taken part in the clinical trials phase 1.
The chairperson takes into account an adequate composition of the EC, taking into account the aforementioned elements.
In addition, the EC only deliberates validly when:
- more than half of the effective or deputy members are present
- members-healthcare professionals within the meaning of the Act on the exercise of healthcare professions, coordinated on 10 May 2015, including at least two physicians, and members who do not have this capacity, are present
- for Eudra CT studies, the representative of the patients referred to in Article 6, §2, 10°, of the Act, or the deputy, is present.
Opinions are issued by consensus or, failing that, by a majority vote of the members present. In the event of a tie, the chairperson's vote is decisive.
If the attendance quorum referred to above is not met, EC may invoke a written procedure to deliver opinions. The chairperson determines the time for members to give their opinion. Any member who has not delivered a negative or positive opinion within the time set by the chairman is deemed to have abstained.
If a member cannot be physically present, they may participate in the meeting or in the discussion of certain items on the agenda through available communication techniques (including telephone, mobile, video conference, skype, etc.). They are then considered to be present at the relevant meeting. Similarly, a member who delivers a written opinion for a meeting is considered to be present at the relevant meeting and this person's opinion shall be taken into account at the meeting.
The composition of EC Research UZ/KU Leuven should ensure expertise in the main research areas. The members are authoritative in their field and guard against any conflict of interest. They keep abreast of international and national regulations on experiments on humans. The members and the chairman are elected after due consultation and with a view to ensuring a multidisciplinary and balanced composition. Attention is paid to a good balance between continuity and renewal and to optimal interaction with the education-support committee (OBC).
A member who attends less than half of the meetings during a working year without giving a written opinion is automatically resigning unless valid reasons have been communicated to the chairman.
The members agree that their name, expertise and sex may be disclosed to the sponsors of the researched studies and on its website.
The hospital has taken out a civil liability insurance for the members of the EC Research UZ/KU Leuven.
At least 2 paediatricians are part of EC Research, for handling files involving minors.
If deemed necessary, the opinion of experts outside EC Research UZ/KU Leuven is sought because of their specific knowledge in certain fields. They are subject to the same conditions of non-disclosure and regulations on conflicts of interest.
Possible conflicts of interest in a specific study are reported to the chairman by the committee member in question before the start of the discussion of the file. The chairman, or the vice-chairman, will decide whether the member in question can attend the discussion or has to leave the meeting. However, the member in question shall always refrain from any intervention in the decision-making process.
Members also agree to report all forms of conflicts of interest in writing using a form that has to be completed annually; these declarations are available on the EC Research UZ/KU Leuven website.
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.