Introduction

This guidance is intended to assist with decision making around ethics approval requirements for different types of activity. The requirement for research projects to undergo an ethics review, where specific criteria are met, is clearly articulated on this webpage.

If Principal Investigators leading projects that would not normally require ethics review have any ethical concerns regarding aspects of their activities, such as working with vulnerable participants during a service evaluation, they should submit an application for ethics review.

Individuals conducting consultancy, service evaluation, impact activity or audit and who wish to publish their findings in an academic journal or similar output, should seek ethics approval prior to the commencement of their project.

It may be possible to gain ethical approval for research using data collected from participants during an impact project, consultancy, service evaluation or audit. In these cases, the applicant must submit an ethics application to use a dataset which already exists; the key issue the applicant must address is how consent was obtained for future use of that data (this will usually be an anonymised dataset).

Patient and Public Involvement (standalone activity) - does not need ethics approval

Patient and public involvement entails research being carried out ‘with’ or ‘by’ members of the public, rather than ‘to’, ‘about’ or ‘for’ them. The word public can refer to patients, potential patients, carers and people who use health and social care services, people from organisations that represent people who use services as well as members of the public. Patient and public involvement is often abbreviated to PPI and may also be known as Patient and Public Involvement and Engagement (PPIE).

Although standalone PPI activity does not require ethics approval, it is now mandatory for anyone applying for NHS REC review to include PPI activity.

As part of the Participant Information: Quality Standards, applicants for NHS Ethics Review must now make clear that people with relevant experience as patients, family members, carers and members of the public were involved in the development of the participant information. Specifically, applicants must demonstrate WHO was involved, HOW MANY people were involved and HOW the feedback was used to develop the information, see:

Participant Information Quality Standards

Impact Projects - can require ethics approval

Impact is defined as an effect on, change or benefit to the economy, society, culture, public policy or services, health, the environment or quality of life, beyond academia.

Impact projects to gather evidence for REF Impact Case Studies, or other funder reporting requirements, do not need ethical approval. However, if the project directly involves humans, human tissue, data relating to humans or other ethical issues and the data collected is also to be used for a research project (by staff or students), the PI should seek ethics approval prior to any work being undertaken.

Individuals conducting consultancy, service evaluation, impact activity or audit and who wish to publish their findings in an academic journal, or similar output, should seek ethics approval prior to the commencement of their project.

Consultancy (undertaken via the University) - does not normally require ethics approval

Consultancy is the provision of expert advice based on existing knowledge. The purpose of undertaking consultancy is not to create new original knowledge, although new information based on the application of expertise to a client’s challenge or problem may result from the work.

This type of work does not normally need ethics review.

Individuals conducting consultancy, service evaluation, impact activity or audit and who wish to publish their findings in an academic journal or similar output, should seek ethics approval prior to the commencement of their project.

Service Evaluation - does not normally require ethics approval

The aim of service evaluation projects is to define or evaluate a current service, often with participants who use or deliver the service. They involve an intervention where there is no change to the standard service being delivered (e.g. no randomisation of service users into different groups).

Service evaluation is designed to answer the question: “What standard does this service achieve?” This is normally addressed by asking those in receipt of the service. Service development or improvement seeks to find out what improvement can be achieved within that service only.

These types of projects do not normally need ethics review.

Individuals conducting consultancy, service evaluation, impact activity or audit and who wish to publish their findings in an academic journal, or similar output, should seek ethics approval prior to the commencement of their project. Students who may be undertaking a service evaluation project for which use of the data obtained will be included as part of a thesis, dissertation or otherwise be assessed as part of an educational qualification, will require an ethical review.

Audit - does not normally require ethics approval

Audit is defined as assessing the level of service being provided against a set of pre-determined standards. This generally involves analysing existing data with results usually being used/distributed locally in order to effect change to improve/change the level of service currently being provided.

Audit is designed to answer the question: “Does this service reach a predetermined, recognised or preestablished standard?”

These types of projects do not normally need ethics review.

Individuals conducting consultancy, service evaluation, impact activity or audit and who wish to publish their findings in an academic journal, or similar output, should seek ethics approval prior to the commencement of their project. Students who may be undertaking an audit project for which use of the data obtained will be included as part of a thesis, dissertation or otherwise be assessed as part of an educational qualification, will require an ethical review.