The checklist below describes the information about public involvement that Research Ethics Committees (RECs) are looking for to help them with the review of your application.
You can use this to review what you include in your application.
Public involvement checklist
Who was involved?
- Is it clear how many people you involved and what lived experience they have which is relevant to the research?
How and when have they been involved?
- Is it clear what they did to help with the design of the study: the tasks, meetings, and activities that people got involved with, when, and how often?
- Is it clear whether the involvement is going to continue once the research begins and how?
How has the input of the people you involved made the study ethically acceptable?
- Is it clear how the involvement has made the research more likely to be important, relevant and acceptable to the people who will take part in it, and to the people it is intended to benefit?
- It is helpful to demonstrate to the REC that you have worked with or sought advice from people with relevant experience of the ethical issues which are likely to be important to potential participants, and to demonstrate how what they have said has informed your approach to addressing these issues, which include: the risks and burdens; the practical arrangements; the acceptability of the participant facing information and how consent will be asked for.
Invite a patient or member of the public to the REC meeting
RECs find it helpful if one of the people who worked with you can attend the meeting with you to help respond to the questions on public involvement.
Please ensure that you show any patients or members of the public who attend with you the guidance for attending a REC meeting and that you give them the opportunity to discuss with you any questions they may have about their attendance.
Guidance for specific questions on IRAS
There are some specific questions on IRAS where you can tell the REC about the public involvement you have carried out.
Read our guidance on how to answer these questions.
Frequently asked questions (FAQs)
Do I have to use the checklist?
No, you do not have to use the checklist although we would recommend its use as a guide when preparing your application and in preparing for the REC meeting.
Do I have to change my IRAS form as a result?
No you do not have to change your IRAS form.
Will the REC ask me these questions at the REC meeting?
The REC may or may not ask these questions at the REC meeting. The checklist is there to guide you in preparing your application.
Will my study be approved if I have not involved the public in its design?
We strongly recommend involving people with experience relevant to your research from the onset of your study design and planning because it is likely to help address much of what the RECs will look at.
Participant information developed without public involvement will not normally receive a favourable opinion from REC. If the public involvement described in the Integrated Research Application System (IRAS) application does not meet our design principles, we will normally request further involvement before a study is given a favourable opinion.
What do I do if the public involvement was done by another team or organisation?
You should ensure you receive information from the team or organisation who undertook the public involvement to be able to describe in your application the details covered in this checklist.
If you’re a commercial sponsor you should ensure that you give details on what public involvement has been carried out to the teams responsible for setting up and carrying out your clinical trials . You should provide them with this before any applications for approvals begin. This will help them in preparing the applications so they can communicate to the review bodies what public involvement has been obtained so far.