EFSTH REC Guidance for applications; vers 3.0; Jan 6th 20


Submitting your research application to the EFSTH Research Ethics Committee (REC)

Guidance

The EFSTH REC meets once 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 detail for the Committee to understand clearly what your project involves for the 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 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.
All applicants are required to submit:

1. A research protocol
2. An application form EFSTH REC application form vers 3.0 Jan 6th 2022
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 note that you must submit electronic versions of all documents to [email protected] with a copy to [email protected]. No paper copies are required.

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.

For student projects, protocols can be quite short but still need to contain the required information. Student projects can often be approved by the REC Chair and forwarded to the REC for information.
If appropriate, please submit the same protocol version that has received approval from other ethics committees.
Ethical basis for decision-making in research ethics committees for more details; Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants; WHO 2011. https://www.who.int/activities/ensuring-ethical-standards-and-procedures-for-research-with-human-beings
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 selection and recruited
• How informed consent will be secured, if required, including when children or adults who lack mental capacity will be recruited

• How research participants’ privacy and confidentiality will be protected
• Any risks and potential benefits to research participants, EFSTH staff and the broader hospital community where relevant

Participant information sheet


An information sheet is required for research participants explaining the study, clearly outlining any risks and benefits and also what participating in the study will mean for them. It should also 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
For studies that involve direct contact between the researcher and the participant including interviews or completing a questionnaire together, a signed (or thumbprint) informed consent form is required.
Signed informed consent is usually not required for self-administered questionnaires where the participant can decide whether or not to complete and return the questionnaire and there is no direct contact with the researcher(s). In this case, returning a questionnaire confirms consent for the information to be used. The exception is when sensitive information is being collected where signed informed consent would be appropriate.
Please contact the REC Chair ([email protected]) or Secretary ([email protected]) should you require any clarification or further information.


Stephen Allen; Chair, EFSTH REC

Samba Bah; Secretary, EFSTH REC