Introduction
Each research project that involves participation of human subjects or use of data or samples obtained from humans must have approval by an Ethics Committee before it can commence. This is in keeping with international ethics standards.
The Gambia Government/MRC Joint Ethics Committee is an independent research ethics committee that reviews and approves all human research projects conducted in The Gambia to ensure that the required ethical standards are achieved.
Before the Gambia Ethics Committee (EC) considers a project, it must have been approved by a recognised Gambia scientific committee such as the Medical Research Council’s (MRC) Scientific Coordinating Committee (SCC) or the University of The Gambia’s relevant committee. The SCC includes Government members representing the Director of Health Services, the Medicines Board and Royal Victoria Teaching Hospital, DoSH.
The MRC (UK) The Gambia, is the host institution for the Gambia Ethics Committee and provides the venue for meetings, and a secretariat for the administration of the committee. The Secretarial Assistant processes the SCC and EC documents and maintains communication between the Committees and the applicants.
Projects that are sponsored by the MRC are also submitted to the Research Ethics Committees of the London School of Hygiene & Tropical Medicine (LSHTM) for review. Final ethical decisions on such projects rest with the local Gambia Government/MRC Joint Ethics Committee.
The meeting Calendar of the Gambia Government/MRC Joint Ethics Committee and the Scientific Coordinating Committee are available on the MRC website or from the Secretarial Assistant scc@mrc.gm.
Most of the submissions to the EC are currently reviewed by the SCC and the documents for submission to the EC are provided through the SCC after final approval. Only notifications to the Ethics Committee that do not need a scientific review will be sent directly to the EC (e.g. notification of changes to information sheets and consent forms, safety reports, reports on protocol deviations, etc. of ongoing projects that were already approved) via the Secretarial Assistant.
All submissions should be sent by email to scc@mrc.gm.
Procedures for Applicants to the SCC
The deadline for submissions by applicants is 12 days before the actual meeting of the SCC. The meetings of the SCC are held on the first Saturday of every month at 9:00 at MRC Fajara.
New projects (proposals) or new adjunct studies to ongoing projects are to be submitted in a completed SCC Application Form (available through the Secretarial Assistant scc@mrc.gm or for MRC employees at https://open.mrc.gm / SCC Archive / SCC Guides and Documents) along with accompanying documents such as information sheets for participants, consent forms, questionnaires, CVs, etc. For every project including external projects proposed from outside The Gambia, a local institution and the name and contact information of a collaborator located in The Gambia needs to be stated in the SCC Application form. The Principal Investigator (PI) or his/her representative will normally present the proposal to the members of the SCC at its meeting.
Other submissions such as amendments to ongoing projects, requests for further use of data or samples, adjunct studies to ongoing projects that use population, samples or data from ongoing studies, etc are to be sent by a letter together with relevant documents.
The documents should be submitted by email in Word-format for easier processing by the committees’ Secretarial Assistant. A paper document or scanned PDF file can be submitted in addition to the word-file, where signatures are needed. The Secretarial Assistant assigns identification numbers to each submission.
All documents must be sent to scc@mrc.gm and not to any personal email address.
Please do not send PDF files that bear copied signatures!
After the SCC meeting, the Chair of the Committee will provide a letter to the Principal Investigators by email with the conclusions of the committee usually within three to four working days with regard to the approval, approval in principle pending clarification, request for resubmission or rejection of a project. If clarifications are needed, the PI is requested to provide them in writing. Clarifications must be addressed in a letter and/or in a revised SCC Application form with accompanying documents. If the submission should be reviewed by the EC at its meeting held in the same month, the documents must be submitted at the deadline for the EC meeting.
Review by the EC
The EC meets on the last Friday of every month at MRC Fajara. As described above, submissions to the EC are usually provided through the SCC after final approval with the exception of notifications or projects that are scientifically approved by another Gambian body; the approval letter must be attached to the submission.
At the end of each EC meeting, the Chair of the Committee will provide a letter to the Principal Investigators by email with the conclusions of the committee usually within one week. This should be the final approval of the project, the principle approval pending clarification or the rejection of a project. If clarifications are needed the PI will be requested to forward them in writing through the Secretarial Assistant to scc@mrc.gm.
The Gambia Government/MRC Joint Ethics Committee works in accordance with its Constitution. The Constitution, members and guiding documents are available through the Secretarial Assistant scc@mrc.gm or for MRC employees at https://open.mrc.gm / SCC Archive / Ethics Guides and Documents).
For clinical trials on medicinal products approval by the National Regulatory Agency, the Medicines Board is required after EC approval.
