Helping to ensure public involvement informs ethical review: checklist for applicants

Last updated on 1 Sep 2023

The HRA website has guidance about public involvement for applicants. The fourth of HRA’s Best Practice Principles for public involvement in research advises applicants to ‘Describe how it helps’. There is also a link to a section on helping to ensure public involvement informs ethical review with a summary of Question Specific Guidance (the ‘i’ information button) in IRAS for questions A14-1, A6-2, A13, A22, A30-1 and A51, or in the Combined Review REC Application form for questions A (Administrative Details) 9, A10, A11, B (Research Procedures, Risks and Benefits) 4, C (Transparency) 1, and H. (Recruitment and Informed Consent Procedure) 5, about how to write about public involvement in IRAS.

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 write in your application. If you think that you could provide more helpful information for the committee you can amend your application or use the checklist to prepare addition information to bring with you to the REC meeting to help you answer questions.

Have a question? Read our frequently asked questions.

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 in designing the study can attend the meeting with you to help explain to the REC how and why the study design is likely to be important, relevant and acceptable to the potential participants.

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.

Print out the checklist.

Frequently asked questions

  • 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?

The approval of your study by the REC and HRA is dependent on the nature of the study and various other factors. It is not solely dependent on what public involvement there has been. However, we do strongly recommend involving people with experience relevant to your research as patients, service users or carers from the onset of your study design and planning because it is likely to help address much of what the REC will look at.

  • I did not think about involving the public in my study design. How can I involve the public in my application?

In addition to the guidance provided, please refer to the resources page on the HRA website.

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