Ethics Approval Process
While the majority of research completed in the Department does not need ethical approval, occasionally research does require the involvement of human participants or their data. In order to streamline ethical review processes and reduce the need to refer all applications to BSREC, BSREC has granted the Mathematical and Computational Sciences departments (Warwick Mathematics Institute, Department of Statistics, Department of Computer Science) the right to set up a delegated process for the ethical review of ‘low-risk’ student research projects. This covers undergraduate and taught postgraduate research projects. Only research projects that are risk assessed as ‘low-risk’ can be reviewed under this process. Doctoral and staff research projects cannot be reviewed under this process. For Doctoral and staff research projects which involve human participants or their data approval will be required from BSREC.
Department of Statistics internal Research Ethical Review Process
If the student research project is low risk, the internal ethical review process can be followed. ‘Low-risk’ research projects are defined as those that:
- are limited to interviews, focus groups, and questionnaire completion, or the evaluation of software and e-Learning materials and the secondary analysis of data;
- are with participants who are not vulnerable and not dependent (including, but not limited to those not receiving health or social care, primary or secondary education, or criminal justice services);
- do not investigate sensitive or intrusive matters (e.g. health status, criminal activity, or sexual history).
A flowchart has been designed to triage the projects that require internal ethical review. With the support of their supervisors, students should check their project against the flowchart and for projects that fall under the box ‘complete step 1’, the student must complete the ‘Ethics Application Form for Student Research Project’.
How to apply for internal ethical approval:
As soon as a research project has been identified, students should check their project against the flowchart and for projects that fall under the box ‘complete step 1’, the student must complete the ‘Ethics Application Form for Student Research Project’. The form will be submitted for initial review by a Support Administrator. The Support Administrator will check that the form has been correctly completed and that any relevant supporting documentation has been provided. If supporting documentation is required, the student will be required to use the delegated BSREC template as a guide. If any problems are identified (e.g. missing documentation, section not completed), the form will be returned to the student for amendment. Provided the form is complete, the application progresses to Step 2.
The Support Administrator will send the completed form (with where necessary supporting documents) to one Ethics Reviewer from the Department and one Ethics Reviewer from one of either the Statistics or Computer Science Departments. The Ethics Reviewers will independently assess the proposed project and send their decision to the Support Administrator based on the following categories:
- Approve subject to minor amendment(s)
- Approval not granted: return for resubmission
- Refer to BSREC
- Does not require ethical review
Any ethical concerns identified at any stage of the process will be raised with the researcher. For applications where agreement has been reached, the Support Administrator will feedback via email the decision, with guidance where appropriate, to the student and supervisor/course tutor.
If the Ethics Reviewers do not reach the same decision, the Support Administrator will send the application to the lead Ethics Reviewer from the third department for review. Their decision will be emailed to the Support Administrator, who will then seek guidance from the BSREC secretary for an external opinion on how to proceed.
It will be mandatory that all students undertaking projects with ethical considerations will complete and pass the Research Integrity Online Training Course (minimum concise version). Students should complete this before submission of the form at Step 1.
How to submit documents
Completed forms should be sent to the Research Development Manager for Mathematical Sciences Mr Adrian Fowle via A.R.Fowle@warwick.ac.uk
On an annual basis, 10% of all ethical review forms will be moderated by the ethic leads from each department. Leads would be required to jointly check the submitted documents to determine whether projects had been appropriately assessed for risk, and that all ethical and governance issues had been considered. Identification of any serious issues during the moderation process should be escalated to BSREC for advice on corrective actions. Identification of any minor issues should be highlighted to the relevant reviewers and further training completed where appropriate to avoid the same issues occurring moving forwards.
All applications will be formally recorded by the Support Administrator and stored securely by the student’s home department. A spreadsheet summarising the basic details of all applications reviewed (student name, level of study, project title, supervisor, applications outcome and date) will be maintained by the Support Administrator. The record of all projects reviewed will be shared with the BSREC Secretary to be reported to the Research Governance and Ethics Committee three times each year.