Centre de Recherches Médicales de Lambaréné

Institutional Ethics Committee

The committee has received funding from the European and developing countries clinical trials partnership (EDCTP). This grant helped the installation of the committee and train members. Members are representatives of CERMEL, local authorities and faith institutes, and community.

Scientific and professional experts are represented as well as laymen. The Institutional Ethics Committee is a partner of the National Ethics Committee. The CEI is a member of the MARC network (Mapping African Research ethics review Capacity) and is registered with OHRP (Registration Office for Human Research Protections) with the numbers: IORG0007336 / IRB00008812.

Forms

To request a review of the project by the CEI, it should first be seen by the Scientific Review Committee of CERMEL. Send the protocol and the informed consent form to the secretariat.

You can download the submission form here

Jurisdiction of the Ethics Commission of CERMEL

The Institutional Ethics Committee (CEI) of CERMEL is responsible for the ethical review of all applications submitted by the CERMEL staff and by its composition it provides to the extent possible, that the consistency and completeness of international ethics approval is obtained.

CEI meetings

The CEI meetings are organized by the Steering Board, responsible for all administrative aspects of the ethics review process. The Director Board consists of President, Vice President and Secretary of the CEI. The secretary of the CEI does not participate in the process of decision making.

The CEI defines the annual calendar of meetings and makes that information publicly available. The CEI meets on Friday / Saturday of every third week of the month, except during the month of August, 11 times a year. In case the date of the meeting corresponds to a holiday, the meeting is cancelled, unless the accumulated files require a special meeting whose date is decided in session by the President.

The meetings are held behind closed doors in CERMEL

CEI Review of Protocols (new applications)

The CEI-CERMEL is properly addressed a request for an opinion on a draft clinical study or investigation by submitting to the CEI secretariat a complete file Before requests are submitted to the CEI they will be considered by the Secretary; incomplete applications will be returned to the Principal Investigator (PI) for completion prior to submission to the CEI.

The following documents must be included with each application, depending on the type of study:

1. 1. Submission form completed, signed and dates addressed to the President of CEI-CERMEL by the applicant investigator
2. 2. Protocol of the original study with version number and Date
3. 3. Summary/Synopsis of the protocol in French (if protocol in another language)
4. 4. Information to the participants, if applicable
5. 5. Informed consent form, if applicable
6. 6. The approval of the Scientific Review Committee of CERMEL
7. 7. Any other relevant documentation, ex. brochure of the investigator, insurance contracts, etc.

When the application is complete, the CEI secretariat shall notify the applicant within three working days after receipt of the request.

Calendar of meetings

The CEI defines the annual calendar of meetings and makes that information publicly available. Meetings to review applications are held on Friday / Saturday of every third week of the month, except during the month of August, 11 times a year. In case the date of the meeting corresponds to a holiday, the meeting is cancelled, unless the accumulated files require a special meeting whose date is in session by the President.

The application closing date is no later than 14 working days before each scheduled meeting of the CEI.

Calendar of meetings for the year 2017 available here