Required study documents

Note: information regarding standard operating procedures (SOPs) can be found here. 

Alongside completing the ethics application form in OREMS, you will also need to submit the below documentation where relevant:

All documentation that will be seen by your participants. This will include: 

  • Recruitment materials – you will need to provide all materials used to recruit participants, such as email templates, the planned content of social media posts, flyers, posters, scripts for in-person recruitment.  
  • Participant information sheet – this is given to your participants before they decide whether to take part in your research and outlines everything they need to know about your project, including contact details should they have further questions.  
  • Consent form – this breaks down specifically what the participant is agreeing to, which includes the activities they will undertake, what data will be collected from them, where it will be stored and how it will be used. Participants will sign this as a record for you to keep of their informed consent.  

Any methodological documents that will be seen/heard by participants also need to be submitted. This could include: 

  • Topic guides for interviews or focus groups – this should include any preamble or disclaimers that will be read out at the beginning, as well as a list of the questions/topics you intend to cover. The committees understand that conversations can evolve naturally, and that it is not possible to include every possible topic that could come up, but they need to understand the kinds of conversations you intend to have, particularly if any sensitive questions will be asked.  
  • Questionnaires or surveys – these should be submitted in the format that participants will see them. If you are distributing an anonymous online survey, you can combine the participant information sheet and consenting statements into the beginning of your survey and do not necessarily need to include these as separate documents.   
  • Debriefing sheets – you will need to include any documentation that will be provided to participants after they have taken part in your study, where relevant. These might, for example, explain why deception was employed, or signpost to relevant follow up services. 

Your project may also require additional documentation that is not given to participants, but that the committee will need to see to ensure the ethical standards of your project. This could include: 

  • Site approvals - if you are conducting research on premises that require a site approval, such as in a business or school, you will need to provide confirmation from the appropriate authority that you are permitted on site to conduct research.   
  • Letters of access - if you are accessing a secondary data set, you will need to upload a letter of access from the data custodian or owner confirming that they are happy for you to use their data for your research.   

If there are any protocols relevant to your study, these will also need to be included, for example: 

  • Study protocol – a detailed description of your intended processes for the conduct of the study. Including; participant recruitment, any interventions or procedures, tests and data collection, follow-up, etc. This will particularly be necessary if the study is of such scope or complexity that it cannot be fully described in the OREMS form. 
  • Distress protocols – if you will be covering potentially upsetting topics with your participants, a distress protocol outlines how you will mitigate against participant distress, what you will do in the moment should a participant become distressed, and any support services you will signpost your participants to.  
  • Incidental findings protocols – if you are conducting any scans or tests that could result in incidental medical findings, this protocol will outline the process you will follow for informing participants.  
  • Safeguarding protocols – if you are working with potentially vulnerable participants, such as children or elderly people in care homes, this protocol will outline the process you would follow should you have any safeguarding concerns.