What information do you need to include?
In developing this website, we interviewed representatives of several major research funders. As we said in our section on what needs to go into the ethics statement for funders, many commented that all research designs have ethics considerations.
In our experience, one of the most common delays to the process of ethics review is lack of information in the ethics application, or an assumption that ‘this work raises no ethics considerations’. Lack of information in the initial application can mean that the committee refers the application back to you (sometimes even before it is reviewed) with a request for more information - so the whole process is slowed down.
Most committees produce guidance on completing their ethics application forms - check with the committee secretary if you are not sure where to find guidance for your particular committee. You need to spend time reading through this guidance before you start writing. We interviewed a representative of NRES (the system that encompasses NHS Research Ethics Committees and the Social Care Research Ethics Committee) and her advice was that you should accept the need to spend the time on this - and that you start by making a mug of tea.
Beyond committee-specific guidance, you can think of the information you include as falling into two categories:
(1) The rationale for the ethics of what you are doing (in answer to the questions on the form)
In our section on building ethics into the research design, we outlined some of the ethics considerations associated with different designs. Use the questions in these sections as a starting point for your reflection and discussion, and for writing your ethics application. These are the sorts of questions that reviewers may have in mind when reading your ethics applicaation. In general, the more thoroughly you can address the questions in your ethics application form, the less likely it is that the committee will come back to you with queries. A thorough response has the side benefit of reassuring them that you take research ethics seriously - see our section ‘who are you writing for?’
(2) The documentation that you need to include
Your ethics committee guidance will usually stipulate the documentation that you are expected to include. If you think it does not, it is worth checking with the committee secretary/coordinator.
In some cases (such as NHS Research Ethics Committees) you may be advised not to submit an application until you have all your research materials - information sheets, interview guides or questionnaires, and so on. Check the guidance carefully to make sure you have included everything that is required - otherwise the application could be sent back, which will delay things. Application packs often have a checklist of what to include (and if they do not, you may want to construct your own - it is surprisingly easy to forget something critical).
If you are not including all the requested documentation for any reason, you must clearly explain and justify why that is the case. For example, many ethics committees expect to see information sheets for participants. These may not be appropriate for your study - but because they are used so commonly, you can expect an ethics committee to want to know why you have decided not to use them.
Including documentation may also be problematic if you have an iterative research design, for example, if you are using pilot work to develop your research instruments. See our section on iterative designs for specific guidance.