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• Some projects may have more than one aim, in which case the PI is required to make a judgement on the primary aim of the project and follow the appropriate guidance.
• Any substantial amendments to ethically approved applications are required to be submitted for further ethical approval.
• If PIs leading projects that would not normally require ethical review have any ethical concerns regarding aspects of their activities, such as working with vulnerable participants during a service evaluation, they can submit an application for proportionate ethical review.
• Individuals conducting consultancy, service evaluation or audit and who wish to publish their findings in an academic journal, should seek a proportionate ethical review 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 request ethical approval articulating how consent for the original participants will be addressed.

Research and experimental development (R&D) activities comprise of creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of humankind, culture and society, and the use of this knowledge to devise new applications.

Projects of this nature must be submitted for ethical approval if they directly involve humans, human tissue, data relating to humans, or other ethical issues.

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, the PI should seek ethical approval prior to any work being undertaken.

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.

Ethical approval for these projects should be sought via HoD consultancy project approval. Should the HoD have any concerns regarding ethical approval, they can request that project gains proportionate review via the appropriate FREC.

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).

These type of projects do not normally need ethical review.

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.

These type of projects do not normally need ethical review. Document reference: 0419-02 (Review requirements)