Helping to ensure public involvement informs ethical review

Question A14-1, the existing question on public involvement. Describe here [in the free text box] the people who have been involved in designing the study and in what ways. Include the numbers involved and what they did when as well as what experience they brought to the study and why that is relevant. Also include information about what the people involved will do to help with the conduct, management and or dissemination of the study.

This is to explain to the REC the range of input and how it is appropriate to the study and more directly relevant than most of the REC members’ insights are likely to be.

For the each of the questions below include how the people described in A14-1 have helped address the issues raised by the question and how that has been used either in the design of the study or in how it will be conducted, managed, or disseminated:

Question A6-2, which asks applicants to summarise the main ethical, legal, or management issues arising from their study and say how they have addressed them. 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.

Question A13, which asks for a summary of the design and methods to make it clear exactly what will happen to the research participants, how many times, and in what order. It is helpful to demonstrate to the REC that people with relevant experience think that participants will understand and accept what will happen to them in the study.

Question A22, which asks applicants what the potential risks and burdens are for participants and how they will minimise them. It is helpful to show the REC that people with relevant experience think the risks and burdens, including the practical arrangements, are likely to be acceptable to potential participants.

Question A30-1 about gaining informed consent. It is good practice to involve relevant patients, carers, service users or members of the public in producing the Participant Information Sheet, consent form, and any other patient-facing information. It will be helpful to show the REC the details of how this has been done. This could also include how the consent process has been shaped by the involvement.

Question A51 about the dissemination of the results. RECs think it is important that the results of the study are made available and see a role for the public in helping to do this well in a way which is accessible to multiple audiences.

Attending the REC meeting

In some cases, it may be helpful for you if one of the people who worked with you in designing the study can attend the REC meeting with you (on Zoom) to help explain to the REC how and why the study design is likely to be acceptable to the potential participants.