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: Both databases are accessible as below: Research Projects database 2023 and Research Projects database 2022download Research Projects database 2022
All applicants are required to submit the following documents:
1. An application form available here: Download 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 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: The submission deadlines for 2023 are as follows:
|Deadline for submission||Date of REC meeting|
|January 17th||January 31st|
|February 41th||February 28th|
|March 41th||March 28th|
|April 11th||April 25th|
|May 16th||May 30th|
|June 13th||June 27th|
|July 11th||July 25th|
|August 15th||August 29th|
|September 12th||September 26th|
|October 17th||October 31st|
|November 14th||November 28th|
|December 12th||December 26th|
Research protocolsThe 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 consentSigned 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 this link scientific-coordinating-committee or download them from here directly Download Adult Consent Form Or Download Child consent Form
Once you have completed your trial, please complete the end of study form Download REC End of Study Form and submit to the REC for information. Please contact the REC Chair Prof Ousman Nyan ....@...([email protected] or [email protected])> or Secretary ([email protected]) should you require any clarifications or further information.