EFSTH REC Guidance for applications

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.

In addition, you must check that your project is original and does not duplicate another project that has already been approved or has been completed. Please review the database of approved projects to check: <>

All applicants are required to submit the following documents:
1. An application form available here: <>
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 submit the same version of the protocol that has received approval.
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.
Please submit electronic versions of all documents to Ms. Mam Jarra Touray, Administrative Assistant: [email protected]. No paper copies are required.
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. Applications submitted after the submission date will be held over until the following month’s meeting. The submission deadlines and dates for REC meetings in 2022 are as follows:

Deadline for submission Date of REC meeting
July 12th July 26th
August 16th August 30th
September 13th September 27th
October 11th October 25th
November 15th November 29th
December 13th December 27th

The submission deadlines for 2023 are as follows:
Deadline for submission Date of REC meeting
January 17th January 24th
February 21th February 28th
March 21th March 28th
April 17th April 24th
May 22th May 29th
June 20th June 27th
July 12th July 26th
August 16th August 30th
September 13th September 27th
October 11th October 25th
November 15th November 29th
December 13th December 27th

Research protocols

The REC follows WHO guidance when reviewing applications. Standard 7 of this guidance is useful for ensuring your protocol meets the required standards.
Research protocols should provide adequate details including:
• The main aim(s) and objective(s) of the study
• The study design and how the study will be conducted
• Details of the study participants (e.g. sex/gender, age range, clinical diagnosis, occupation) and how they will be selected and recruited
• If required, how informed consent will be secured including when children or adults who lack mental capacity are recruited
• How research participants’ privacy and confidentiality will be protected
• Any risks or potential benefits to research participants, EFSTH staff and the broader hospital community where relevant
If appropriate, the information sheet should encourage the participant to discuss their involvement in the study with their family members, friends or other trusted individuals before giving consent.
The information sheet should usually include statements emphasising the participant’s autonomy such as:
• You are free to decide whether or not to participate in the study. If you choose not to participate, you are not required to give a reason and the usual care that you will receive will not be affected in any way.
• You may withdraw from the study at any time without giving a reason.

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. Returning a self-administered questionnaire signifies consent for the information to be used. The exception is where personal identifiers or sensitive information is being collected where signed informed consent would be required.
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. Where the participant cannot read the Participant Information Sheet themselves and it is explained to them, there must be an independent witness present. The witness is required to sign and date the consent form to confirm that the study has been explained appropriately to the participant.
For clinical trials, one copy of the signed/thumbprinted consent form should be given to the participant and one copy filed in the case record.
Templates for consent forms are available from scientific-coordinating-committee
Please contact Ms. Mam Jarra Touray, Administrative Assistant: [email protected], the REC Chair /([email protected]) or Secretary ([email protected]) should you require any clarifications or further information.