How to avoid your application being returned
Many applications are approved on their first submission where not, this is usually because the applicant has not addressed the following points in sufficient detail on their application form and as a result the application is returned. This document should be read in conjunction with the document entitled A Checklist for Research Ethics Reviewers to give you an idea of what ethics reviewers look for when reviewing an ethics application.
- ✘ The guidelines for the preparation of the application have not been followed.
The application guidelines are frequently updated to ensure that the application process is as smooth as possible. Following the guidelines avoids delays. You should always feel free to send in your feedback regarding the application form or process if you think the procedures can be improved.
- ✘ The application has not been submitted as a single pdf file with the application form and supporting documentation contained as a single file.
- ✘ Sections of the application form have not been completed.
Always mark any sections that are not relevant to your application “N/A”.
- ✘ The application form has not been signed by the Head of Department.
(or Chair of the Faculty/Departmental Ethics Committee if there is such a system in place within the applicant's department) or the checklist completed.
- ✘ Not describing your research in simple lay language.
You must explain your project in a clear and coherent form (avoid the use of acronyms and abbreviations and if they are used they should be defined) which a lay person could easily understand. Poorly written applications will be returned for editing, resulting in delays. The purpose of the application is not to convince the committee of the excellence and complexity of your project but that all ethical issues have been fully considered. You must outline the intended value of the project, giving necessary scientific background always under the perspective of what ethical implications this research has and you must describe the research protocol, type of procedure and/or research methodology (e.g. observational, survey research, experimental) with regards to the potential ethical challenges.
- ✘ Arrangements for confidentiality and anonymity have not been specified.
It should be made clear both in the application and Information Sheet to participants what arrangements have been made for confidentiality and anonymity. If your research guarantees anonymity, then there must be no possible way that participants might be identified. If the organisation being studied or the sample size is small, if job titles are specified, if the subject matter is very narrow or you are conducting focus groups, the potential for identification is much higher. In these cases, you must specify that all efforts will be made to keep participants identities confidential, but that complete anonymity cannot be guaranteed.
- ✘ The applicant has not fully assessed the risks to the participants themselves (and how these will be mitigated) or to the reputation of the university.
These must be answered fully even when seen as minimal.
Some examples of risks/conflicts of interest that may arise are:
- What would you do if a participant became distressed?
- Do participants know you or a member of the research team, and if so, is there a risk of them feeling pressured into taking part in the study?
- ✘ Potential risks to the researcher(s) have not been considered.
- What safety issues might there be for a researcher visiting a participant in their home?
- Will the researcher work with an assistant?
- Will the researcher have a back-up team at the University (to include the principle researcher) to ensure that there is an opportunity to raise any areas of concern?
- Is the research taking place in a high-risk area overseas? If so, has FCO travel advice been checked?
- ✘ Information about your participants
It is important that you provide detailed information about how participants will be identified, approached and recruited to the study to include whether there are any issues around a direct face-to-face method of recruitment and whether power relations might come into play i.e. participants feeling coerced into taking part and how that will be avoided.
It is also important to detail how many participants will be recruited to your study together with providing an upper and lower age limit and a power calculation.
- ✘ The Information Sheet/recruitment documents are poorly constructed and not presented in simple lay language.
In order to attract participants and ensure that they can give their ‘fully’ informed consent to take part in the research they must clearly understand what is being asked of them. It is therefore vital that the information provided is clear and has been carefully checked. If you are recruiting children and adults to your study we would expect to see a number of different information sheets which are appropriately designed for the target group.
- ✘ Ethical issues
All research raises ethical issues so it is very important that you provide a comprehensive reply to the direct question that asks you to specifically outline whether your research raises any specific ethics issues. Do not leave this section blank.
- ✘ Sharing results – Participants have the right to access the findings derived from their contribution to research.
Unless specified during the informed consent process, provisions must be made to ensure results are communicated back to participants e.g. through distribution of the dissertation, through web or other forms of publication etc. It is important that you articulate a means to share your results with participants.
- ✘ Proofreading – Ethics applications will be returned to you if they have not been properly edited and proofread.
Information sheets, consent forms and other supporting documentation must be legible and grammatically coherent.