Ethical approval by a Research Ethics Committee (REC) is not needed for the PPI element of the research study. This is because PPI contributors are involved in the design, implementation and management of the research process itself, rather than being participants or subjects of the research. They are acting as specialist advisers, providing valuable knowledge and expertise based on their experience of a health condition or public health and social care issue.
Although formal ethical approval is not required, the principles of informed consent apply in PPI. PPI contributors need full information about what they are being asked to do, to have the opportunity to ask questions, and the option to withdraw from the work. Their personal contact details should remain confidential, and they may be asked to formally agree to keep details of the study confidential.
For most research it is not appropriate for PPI contributors to also be participants in the study or trial, as that can compromise both the researcher and the person involved. However, many participants do go on to become actively involved as PPI contributors when their participation in the study or trial is over.
Where PPI may raise ethical concerns
There are some situations where PPI involvement may raise ethical concerns. Examples are when PPI contributors are involved with collecting and analysing data, such as helping to analyse survey data, conducting interviews with participants, or facilitating focus groups. In these situations please see guidance from the Health Research Authority below.
The REC will be seeking assurances that the following ethical issues have been fully addressed by the applicant:
- The well-being and safety of the people who are actively involved as researchers. They may find that looking at and discussing the data or talking to other people with a similar condition reminds them of their own negative experiences. This can cause distress, in which case the patient/member of the public who is carrying out the research may need additional counselling/ support. A REC will need to check this additional support is available
- The well-being, safety and preferences of the people who are taking part in the research as study participants. It is important to ensure that there are no additional risks to or concerns for people taking part in a study. A REC will also need to consider any additional issues or sensitivities that may arise for those taking part in the research, for example some patients are not comfortable being recruited by other patients as opposed to staff
- In consideration of the well-being and safety of the people involved as researchers and those taking part in the research as study participants, the REC will also check that any patient or member of the public carrying out the research has adequate training, support and supervision appropriate and proportionate to the circumstances in the same way as they do for any other member of the research team. They will also consider whether the proposed contribution including any direct contact with study participants is appropriate
(Source: Public involvement in research and research ethics committee review)
Find out more:
- Dr Mark Sheenan BRC Ethics Fellow – focus on ethics
- Guidance from the Health Research Authority and INVOLVE (full version of document): Impact of public involvement on the ethical aspects of research (PDF)