Ethics Committee & REC Review

Resources, guidance, and information from the EFSTH Research Ethics Committee.

Application Form 3

APPLICATION FORM-3

Download Attachment M4ARLrHu77c1mKG3GTBhvigBi77ay7TwLkrYo4FV.docx
Informed Consent form

Informed Consent form template for Observational In-Patient Clinical Trials

Download Attachment 49XOQa9JDzJg3amT6tMxhK8s5PXyLKoX9dObmilB.doc
Consent Form

WHO ethics informed consent clinical studies

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EFSTH REC Application Form

EFSTH REC application form_vers 7.0 Nov 10th 2022

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EFSTH REC General overview
The Edward Francis Small Teaching Hospital (EFSTH) Research Ethics Committee (REC or Institutional Review Board, IRB) reviews and monitors all research conducted under the auspices of the hospital.
The over-riding responsibility of the REC is to protect the well-being of study participants.
The specific purposes of the REC are:

a) To review all research proposals that involve patients, their families and the broader community receiving care at the hospital, staff and others working under the auspices of the hospital
b) To protect research participants from possible harm or danger, to preserve their rights and to reassure the community and sponsoring organisations that this is being done
c) To maintain a register of all research undertaken under the auspices of the hospital
d) To ensure that procedures are carried out in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) standards (1996)

The REC meets on the last Tuesday of every month to review research applications. Research projects include biomedical, behavioural, social science, and epidemiological research. These are submitted by hospital staff and also students mainly from the departments of Medicine and Nursing, University of The Gambia School of Medicine and Allied Health Sciences and the Gambia College School of Nursing and Midwifery. We also review applications for external organisations and students (e.g. American International University West Africa) that wish to involve members of the hospital community.
We welcome observers to attend REC meetings. This must be arranged in advance with the REC Secretary, strict confidentiality must be maintained, and an observer must not be present when proposals that they are connected with in any way are reviewed.
Please note that for clinical trials or other intervention studies, approval is also required from the Joint Gambia Government/MRCG Research Ethics Committee: scientific-coordinating-committee

For any questions or for further information,

Please contact Ms. Tida Camara, Administrative Assistant [email protected], the REC Chair, Prof Ousman Nyan [email protected] or [email protected]
or Secretary, Mr Samba Bah [email protected]

EFSTH REC Guidance
The EFSTH Research Ethics Committee (REC) meets monthly to review research applications for ethical approval. This guidance aims to assist applicants in submitting proposals that meet the Committee's requirements.

Please note that your application must contain sufficient details for the Committee to understand clearly what your project involves for EFSTH patients, staff and the broader hospital community. The Committee's primary concern is the safety and well-being of research participants. You must highlight any issues that may raise safety or ethical concerns. Also, you must describe your research methods adequately; to avoid unnecessary inconvenience or risks to research participants, the REC will not approve projects that are unlikely to achieve their stated aims.

Required Documents:
1. An application form
2. A research protocol or proposal
3. Forms that will be given to participants such as participant information sheets, consent forms and self-administered questionnaires
4. Copies of approval letters from other ethics committees if appropriate.

Please ensure that all documents include a version number and date. The version number and date should be updated if documents are modified and re-submitted.
In addition, for larger projects and clinical trials, please submit the CV and evidence of GCP training within the last 2 years for the Chief/Principal Investigator.

Submission Deadlines:
Applications submitted for approval by the EFSTH REC will be reviewed during the REC meetings held on the last Tuesday of every month. All applications must be submitted at least 2 weeks before the date of the forthcoming REC meeting to be included on the agenda.

Informed Consent:
Signed informed consent is not required for self-administered questionnaires where the participant can decide whether or not to complete and return the questionnaire. For studies that involve direct contact between the researcher and the participant, including interviews or completing a questionnaire together, a signed/thumbprinted informed consent form is required.

Please contact the REC Chair Prof Ousman Nyan ([email protected] or [email protected]) or Secretary Mr Samba Bah ([email protected]) should you require any clarifications or further information.