Internal regulations Ethics Committee
The Ethics Committee is composed of a minimum of 8 members and a maximum of 15 members, the majority of whom are physicians employed by the Europe Hospitals. At least 2 members are not physicians. They are appointed in accordance with the procedure set forth in the Royal Decree of 12/08/1994.
Each member's term of office has a duration of 4 years, which shall be renewed, by tacit renewal. The Ethics Committee elects from among its members a Chairman, a Vice-Chairman and a Secretary by a simple majority of its members. These were approved beforehand by the Europe Hospitals’ management.
Any member who resigns must ensure, insofar as he is able, to serve until a replacement is found for him.
Any member who has been absent for over a year without providing any justification, shall be deemed to have resigned and shall be replaced with no undue delay.
The Ethics Committee meets based on a schedule established beforehand alternating between the St-Elisabeth and St-Michel locations.
In the event that the plenary Committee fails to issue a decision within the time frame stipulated by the law of 7 May 2004, the Ethics Committee shall meet either officially as an emergency measure, in the presence of its Chairman or Vice-Chairman, secretary and at least one of its members. The decision issued shall be communicated to each member of the Ethics Committee by email, and it will have 7 days to issue its opinion, which will be communicated for information purposes at the following plenary meeting. Or, it may be decided by email if a consensus is received within 3 days of the digital invitation to vote in accordance with the terms of Article 11.
The Chairman sets the agenda for the meeting. Any member who wishes to add an item to the agenda shall make a request to the Chairman who will include this item on the agenda of the following Committee meeting.
Meeting notices and information are sent to the members of the Ethics Committee by the Chairman or the Secretary via email. They are sent before the date of the meeting with the relevant documents attached.
a/The Ethics Committee is deemed to have received a valid request for opinion on a research project only if the request is introduced with the Chairman or the Secretary by email with the complete documentation file.
The application must contain:
- The cover letter dated and signed and addressed to the Chairman or the Secretary of the Ethics Committee.
- The form requesting an opinion with an address for correspondence.
- A summary of a maximum of 2 pages of the study.
- The complete study protocol.
- The insurance certificate.
- The patient information sheets (FR/NL).
- The informed consent form.
- The financial contracts.
- Form granting prior consent from a university ethics committee.
The filing of these documents in their entirety must be done at least 8 days prior to the date of the meeting in order to be processed.
The deadlines established by the law of 7 May 2004 shall only begin to run once proof of payment is received.
b/The Ethics Committee is deemed to have received a valid request for opinion only after receipt of a written request for an opinion detailing the information on the issue raised.
Any member of the Ethics Committee who is involved in a project directly or indirectly must be sure to avoid any conflicts of interest, and refrain from participating in any deliberations on an opinion to be issued by the Committee concerning this project.
On an ad hoc basis, the Secretary may appoint one or more rapporteurs to address a theme or a specific issue raised by the committee, on the understanding that it is the committee members who will ultimately issue a decision on the issue raised after having the detailed opinion(s) of the rapporteur or rapporteurs.
The Committee may decide to invite any person it deems useful or insightful in the analysis of a matter.
Any study investigator can, on his own initiative or upon request, be heard by the Committee during the presentation of the project.
A deputy member may be appointed provided that the quota of the 15 members is not exceeded. He will not have the right to vote.
The Ethics Committee may invite a maximum of 2 external persons who would benefit from specific expertise, as invited guests, to participate in the meetings for a specified period. Spontaneous applications may be also transmitted. Their approval is granted by consensus among the members. The invited guests do not participate in the decision making and are bound to secrecy concerning the deliberations.
Apart from emergencies, the deliberations of the Ethics Committee are only deemed valid if at least 6 members are present, with at least half the physicians. If the quorum is not reached, the subject must be mentioned on the agenda specifying that another review date be scheduled. The same applies to votes by email.
The decisions are adopted by consensus.
Strict compliance with Regulation 2016/679 GDPR and professional secrecy will be observed. Data will in principle be processed anonymously. If personal data need to be exchanged, they will be exchanged exclusively subject to the confidentiality of the discussions which is ensured at meetings of the Ethics Committee. The documentation to be provided to members will only be emailed from the address of the Europe Hospitals. The documentation of the Ethics Committee will be archived centrally through the secretary.
These internal regulations were approved by the Ethics Committee at its meeting held on Monday, 27 May 2019.