Checklist for applicants and reviewers

What to consider when applying for ethical approval or reviewing a research ethics application.

This checklist is designed to help you to consider all aspects of the research ethics application that you are reviewing and should address most of the concerns that might come up. However, please remember that this is not exhaustive, and each application will raise its own questions.

Summary of the research

• Is there likely to be a worthwhile outcome? The purpose is not to conduct a methodological review, but research should be of sufficient merit to justify the time and effort contributed by participants.
• Do the potential benefits of the research balance against the potential risks to participants?

About the participants

• How will permission or access to participants be obtained? Are the gatekeepers involved identified/on board with evidence provided?
• What are the inclusion/exclusion criteria for participants? Are these appropriate?
• How will consent be obtained? Is this method appropriate? Can the researcher be sure that participants can give their informed consent that is free from coercion? (Informed consent is not necessarily required in all cases, but if it is not to be gained there must be a good reason).
• What is the potential for harm to participants – pain, discomfort, stress? (almost all research involving participants will have some potential for physical or psychological harm and the risk should be acknowledged). How will this be minimised/addressed/managed?
• Is the researcher likely to uncover any issues unrelated to the research? (e.g. illegal activity, illness or disease etc). How will the researcher handle such an eventuality?
• Are participants able to withdraw from the research and how will this be done?
• Are participants potentially vulnerable (i.e. because of the situation they find themselves in e.g. asylum seekers, refugees) or vulnerable? Are the implications of this addressed?

About the data

• What measures have been taken to ensure anonymity, confidentiality, and security of personal information concerning research participants? Are these appropriate to the research? Are these realistic?
• Who will have access to the data?
• How long will data/recordings/samples be held? Does this take into account any intended future use?
• How will they be stored?
• Are there any implications for the Data Protection Act 1998 or General Data Protection Regulation (GDPR)?

Supporting documentation

• Are relevant supporting documents included? E.g., information sheets, consent forms, interview schedules or interview topic guides, or non-standardised questionnaires.
• Are the materials for participants clear and free from technical terms, jargon and abbreviations as far as possible to enable participants to give their ‘fully’ informed consent to take part in the research?
• Are the materials appropriate for the intended audience (e.g. children and young people)?
• Is it clear to participants in the information sheet:
  • Whether their data will be anonymous/confidential/aggregated? 
  • How to withdraw?
  • What is being asked of them and what they are contributing to?
  • What their data will be used for and any potential future use?
  • How the data will be managed?
  • How to complain if they wish to do so? 
  • Who is leading the research and how to get in contact with them?

General considerations

• Is there enough detail in the application?
• Are the dignity, rights, safety, and well-being of participants considered?
• Will the researcher be safe? Is there a procedure in place for risks to the researcher?
• Does the research have any implications for the reputation of the University?
• Are there any obvious gaps, ambiguities or uncertainties in how the research will be carried out?

How to avoid common mistakes

Most applications will require some revision after submission before they are approved, however, many applications are approved on their first submission. For those that are 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. Listed below are common reasons for applications being returned:

• 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 backup team at the University (to include the principal 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 including 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 for 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 ethical 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 the 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.