Non-clinical research ethics application procedure

Applicants will need to read and follow the University of Dundee Policy for non-clinical research involving human participants.

All research projects involving human participants will need to have appropriate ethical approval before they begin. To determine whether your project requires ethical approval from a School Research Ethics Committee (SREC) please complete Checklist 1: does the Project Require Ethical Approval?. If you are still unsure whether your project requires ethical approval, please contact the Convener of the relevant SREC.

Checklist 2: Is your project ‘low’ or ‘medium’ or ‘high’ risk? will be used to determine whether your application is low, medium or high risk. Depending on the risk level you will be required to use one of two forms. Form A is required for low risk applications, Form B needs to be used if the application is medium or high risk.

All applications need to contain the following documents:

• Checklist 2: Is your project ‘low’ or ‘medium’ or ‘high’ risk?
• Form A: Low Risk Application or Form B: Medium/High Risk Application‌
• Participant Information Sheet (if required)
• Consent Form (if required)
• Participant Debriefing Sheet (if required)
• A copy of any non-validated questionnaires/survey instruments (if any are used in the project)
• An outline of questions/themes for interviews/focus groups (if conducted)
• Relevant permissions or covering letters (if needed)

Data protection

All researchers should familiarise themselves with and take account of  General Data Protection Regulation before submitting an application for ethics review and approval. An Initial Data Risk Assessment and Data Protection Impact Assessment should be used to identify whether or not any proposed processing of personal data requires a full risk assessment via a Data Protection Impact Assessment (DPIA).

Health and Safety

Researchers need to consider health and safety in any work they do. The level of detail and control measures required will be relative to the complexity and level of risk posed by the work. Policy and guidance on the management of health and safety is available to researchers from Safety Services, who can also provide advice if required. Advice and assistance can also be sought from the School health and safety adviser, who will have local knowledge.

Templates for undertaking risk assessments are available and it is recommended that advice is sought from the School health and safety adviser when completing risk assessments if there is any uncertainty over what needs to be included. Please note that risk assessments must be completed by the researcher, not the health and safety adviser, and must be signed off by the researcher’s manager once completed. Students should assist in producing the risk assessment for activities they are involved in, but their academic supervisor must take responsibility for the risk assessment.

Application Procedure Contacts

Please submit the application form, Checklist 2 and any other required documents by e-mail to the relevant SREC. In most cases, the relevant SREC will be the applicant's home School within the university. If you are conducting research out with a School you should contact UREC ([email protected]) in the first instance to seek review and/or identify the most appropriate SREC to process the application.

Please note, UREC and associated SRECs can only process applications involving staff and students at the University of Dundee. If your research is external to the University it falls beyond our remit and you should seek external approvals.

Contacts

The research must not start until ethical approval has been issued. 

You should hear from the reviewers within 3 weeks of submission of your application, but reviews may take longer during busy times.

Changes to Approved Studies

Approval of a study applies only to the submitted documents. If you wish to amend the application in any way, you should complete a request for amendment and submit it to the relevant SREC, pausing the project until you receive approval. Approval is valid for the duration of the project, as stated in the original application. 

Should you wish your study to continue beyond the stated timeline, you must request an extension to this approval a minimum of 3 months before the project end date. The forms to make changes to approved studies are provided below.

• Post-Approval Request for Amendment
• Post-Approval Request for an Extension 

Ethical Standards

All researchers must abide by the University of Dundee Policy for non-clinical research involving human participants. The University may audit projects to ensure that ethical standards are being maintained. Researchers should also follow the guidelines of other relevant bodies.