- 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’ approval to cover several projects or studies, a lab or research group’s activities, or an ongoing programme of research.
- Generic approval where researchers will pick from several potential methods, topics, or participant groups, including where these are vague or not specified.
- Approval 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 ethical approval - your SEC may require you to submit a full application. All approvals 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 ethics approval, 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 approval.
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.
Why ethical review and approval is required
Ethical review is a peer-review process to help researchers fulfil their personal responsibility to act in accordance with the University’s Principles of Good Research Conduct (Policy) and fully account for ethical issues related to research involving humans. This minimises risk to the project, the researcher, the participants and the University. Failure to obtain and adhere to ethical approvals is defined as research misconduct.
Who should complete the application
The lead researcher, whether that is a member of staff or student, should complete the ethical review application form (Word) . For student projects, supervisors must check and countersign the application form. Failure to do so may delay approval. The form should name all researchers associated with the project so that ethical approval covers everyone involved. The same applies to an ethical amendment application.
Which documents to complete
- ethical review application form (Word)
- participant information sheet (PIS) (Word)
- consent form (Word) .
You may also need to include copies or drafts of:
- participant advertisement (Word) : when an advert (electronic or hardcopy) will be used to recruit participants
- participant debrief (Word) : when participants may need referral to support services or additional information about the purpose of a project following completion
- surveys or questionnaires: when using surveys or questionnaires to collect data, append copies to the application - for online surveys or questionnaires, append screenshots of the initial and final pages, and the list of questions.
- interview or focus group schedules or topic guides: when using interviews or focus groups to collect data, append copies to the application
Depending on the nature of your research project, there are other additional documents related to policies and procedures outwith the ethical approval process, which may need to be obtained prior to research commencing and might need to be appended to your application.
Some School ethics committees (SECs) require their own forms to be submitted alongside the ethical application form. For more information, contact your SEC.
Research involving child participants
If the research involves child participants or is taking place in educational establishments (schools) you should include the appropriate documents:
- Letter to schools: when research is within an educational establishment. There is an initial letter to school - agreement in principle (Word) and a follow-up letter to school - study commencing (Word)
- letter to parent or guardian (Word) : when research is with child participants
- Age-appropriate documents: when research is with child participants. There are age-appropriate versions of the template PIS and consent forms (on the templates page under 'PIS and consent for child participants').
Where to submit your application
Following the completion of the form, most Schools require that you email it to your School ethics committee (SEC), however you should check with your SEC if they have specific instructions for submission. You should submit your application as far in advance of needing to start research as possible to ensure it can be reviewed in time for your project. Take care in completing your application form - application forms which are poorly completed, incomplete or unsigned will be returned and may delay approval. Student applications should be checked and countersigned by their supervisor.
Research involving child participants
If your research will involve child participants you should seek guidance from the Child Panel Representative (Dr Barbara Dritschel, email bd9@st-andrews.ac.uk) before submitting the application to your SEC. Researchers from the Schools of Geography and Sustainable Development, Medicine and Psychology and Neuroscience may send their applications directly to their SEC as usual.
The review process
After you submit your fully completed and signed ethical review application, it is reviewed by your School ethics committee (SEC). You can be invited to attend a meeting.
Standard and proportionate review
At the start of the ethical review application form there are a set of filter questions to determine whether the research should undergo standard or proportionate review. This lets the School ethics committee (SEC) determine how they should review the application:
- Proportionate review - this means that it can be reviewed and approved by a single SEC member without being taken to a full SEC meeting
- Standard review - this means that it will be reviewed by three SEC members or taken to a full SEC meeting
Filter criteria and why they are used
The criteria are detailed in the filter form at the start of the ethical review application form (Word)
Research which is complex or that brings more substantial ethical considerations can be valuable and rewarding. However, it is important to consider whether the research is appropriate given the potential participants, nature of the project, experience of the researcher, and circumstances. Projects meeting the filter criteria undergo standard review processes to ensure these aspects are fully considered, while more straightforward projects can often undergo a 'lighter touch' proportionate review.
If an application reviewed under the proportionate review route is found to involve substantial ethical considerations it may be escalated into the standard review route for consideration by the SEC in full.
Developing a standardised protocol for research that is complex or which brings substantial ethical considerations
Researchers, research groups or Schools that frequently conduct research projects that would normally come under the standard review route can choose to develop a proposal with a protocol or 'standard operating procedure' (SOP) that puts in place a standardised approach that mitigates the ethical issues.
If approved, this means any subsequent research projects which strictly follow that protocol or procedure can be reviewed through the proportionate review route.
Protocols or SOPs should be submitted to the School ethics committee for approval in principle. The SEC will then seek final sign off from the University Teaching and Research Ethics Committee.
Review process and outcomes
- Immediate approval: the SEC decides that your application meets the requisite standard and is approved. This is rare because, as a peer-review process, revisions (even if minor) are often requested.
- Requires revisions: the SEC has identified a need for you to make revisions to your application. Make the required revisions, explicitly highlighting them in the application form, and resubmit the application as instructed by your SEC. Substantial revisions may need to be reviewed at a SEC meeting.
- Escalation to the University Teaching and Research Ethics committee (UTREC): sensitive or complex ethical applications may need to be referred to UTREC for further guidance and approval. For most SECs, applications involving child participants must be escalated to UTREC.
If the SEC escalates your application to UTREC review and approval might take longer. If you anticipate that your project will require review by UTREC, please make sure that you submit your application to the SEC in good time so as not to delay the start of your project. Once reviewed at UTREC (at a meeting of the committee), you should be informed within three days of their decision. For information on UTREC and their meetings, refer to the UTREC web page.
How to complain
If you have evidence that your application has not been properly processed by the SEC, please refer to the guidance on concerns and complaints.
Addressing a request for revisions
- Statutory: the committee cannot approve anything that does not meet statutory requirements. For example, if the proposed project fails to comply with data protection legislation.
- Discretionary: the committee exercises judgment over ethical issues. For example, it may judge that the project entails risk out of proportion to the benefits it may bring or that the researcher has not adequately considered (or detailed in the application form) the ethical issues arising from the proposed research.
Using the committee’s comments, you should revise your application and address any issues. There is guidance available on the ethical issues to consider when planning your research or completing the application form.
When resubmitting your application, make sure to explicitly highlight where you have dealt with the committee’s concerns.
If you are unsure about how to revise or resubmit your application, contact your SEC.
Once your application is approved
You must wait for confirmation of approval from your SEC before you can start your research. This is normally in the form of an approval code, issued in a formal letter. Approval is valid for five years. Once you have received approval, if your research changes and no longer reflects that which you described in your original application then you should submit an amendment application. If you need to extend your approval then you should submit an extension application. Ensure you apply or an extension in good time, before your current approval is due to expire. If any adverse events occur during your research you should contact your SEC and any other relevant contacts.
Contact
To submit an application or for further assistance, get in touch with your School ethics committee.
Application forms
- Ethical review application form (Word)
- Ethical amendment application form (Word)
- Ethical amendment application form (simple) (Word)
- Ethical review application form - exemplars (PDF)
Template documents
Template documents, including a range of participant documents.
Additional documents
Additional documents that you may need to obtain prior to research commencing.
Guidance on ethical issues
Guidance on ethical issues to consider when completing your application forms.
