All research involving human participants, their data or samples, requires ethical review and a favourable opinion before the research starts. This includes observation-based research and research using social media.
The term 'research' refers to a process of investigation leading to new insights.
Applications for ethics review must be for a specific study or project that is time-limited, clearly defined in scope or aims, and where the data, participants and methods used are specified. The only exception to this is teaching module applications.
Exemptions from ethical approval
The following types of work do not require ethics review:
- Service evaluation. This is work to monitor, improve or test a service being delivered, where a 'service provider' (or someone acting on their behalf) collects information from a 'service user'. For example, a module coordinator seeking feedback on a module from their students, or an employer seeking feedback on its support activities from its staff.
- Audit. This is work to ascertain whether an activity was undertaken as it should have been.
- Research involving only deceased subjects. If the subjects are deceased, and the information collected will not contain sensitive information about the living, then ethics review is not normally required. However, research involving the use of health and census information that is less than 100 years old does require ethics review.
- Literature reviews. Literature reviews, including systematic reviews and meta-analyses, do not require ethical review unless:
- The review includes analysis of the underpinning raw data or of a dataset attached to a publication (for which researchers should follow the guidance on using secondary data).
- The review will raise ethical issues such as around social profiling, data management issues such as managing sensitive personal data, or access issues that are best addressed by completion of the ethical review process.
If you are unsure whether your project is research or one of the above, contact your School ethics committee for guidance.
Other application scenarios
Blanket or generic applications
Applications for the following will not be accepted:
- ‘Blanket or ‘umbrella’ applications to cover several projects or studies, a lab or research group’s activities, or an ongoing programme of research.
- Generic applications where researchers will pick from several potential methods, topics, or participant groups, including where these are vague or not specified.
- Applications to cover only the use of a specific research method, technique, or piece of equipment.
- Open-ended iterative sequences of experiments or similar
This does not preclude applications for a single project with multiple experimental arms, participant groups, or methods if:
- The project has a well-defined focus such as a specific research question or aim.
- The ethical issues associated with each element of the study are accounted for.
- The study’s elements, their timing, and their relationship to each other and the overall study end point and outcomes are clearly specified, defined, and justified.
Keep these points in mind when amending an existing project - your SEC may require you to submit a full application. All favourable opinions must be renewed with a full application after five years. See the guidance on amendments and extensions.
Multi-phase, long-term and open-ended research
In large studies with multiple phases or long-term/open-ended research programmes each phase or ‘chunk’ of activity should be submitted for review as a separate application. This ensures the application’s records and documents, including any subsequent amendments, are clear and manageable. Applications can be made as each phase or activity arises (sequentially) or at the same time (in parallel).
Student researchers and student projects
Students sometimes assist on a project or study led by a member of staff which already has a favourable opinion, using the data or outcomes in an assessed piece of work – in these cases the staff research lead must ensure:
- The project is, or remains, in line with the guidance on this page
- Students are included in, or added to, the ethics approval
- Research participants, if any, are aware of how their data will be used.
PhD (and often Honours and Masters dissertation) research, as a piece of ‘independent research’, will normally require its own ethics review.
Autonomous student projects
Students undertaking an autonomous research project (an independent self-led project which is not carried out as part of a course, assessed work, or University-affiliated programme such as a Laidlaw Scholarship) may wish to seek advice or obtain an ethics opinion from a University ethics committee.
To request this, the student must identify an academic member of staff to voluntarily ‘sponsor’ the ethics application.
The sponsor should:
- Provide advice on the application and project.
- Check that adequate processes are in place to ensure the ethical conduct of the project.
- Determine if their School’s SEC has capacity to review the application.
If appropriate, an ethics application can then be submitted to the sponsor’s SEC.
The SEC may, at their discretion, review the application and provide feedback, recommendations, and issue an opinion on the ethics of the project, such as reporting a favourable outcome.
This does not constitute University ‘ethics approval’, endorsement or affiliation and should not be represented as such, for example in participant information or by using University branding.
Student researchers in this scenario should also ensure they are familiar with data protection legislation and how this applies to their project, given it does not come under the remit of the University.