Ethical Review Decision Making Tool
Any project that involves human participants, their data or tissue requires ethical review.
The type of ethical review required depends on the type of study, the participant group, and how participants are recruited/how data or tissue are collected.
The table below provides guidance to researchers on the specific ethics committees particular studies should be submitted to.
Ethics approval must be in place before the study begins.
Queries should be directed to the appropriate member of the Research Governance Team.
Type of study
Other approvals required
Research involving NHS patients, their identifiable data or tissue
May need CAG approval (access to identifiable data -without patient consent)
|Service evaluations and clinical audits involving NHS patients||No||YES||No||No||No||No||Notification to NHS Trust(s) R+D dept./audit dept.|
|Service evaluations and clinical audits (non NHS patients)||No||YES||YES||No||No||No|
|Research limited to the use of previously collected anonymous NHS patient data or tissue||No||YES||No||No||No||No||HRA +
|Research involving NHS staff (and not patients) recruited by virtue of their professional role||No||YES||No||No||No||No||HRA +
|Research limited to use of or access to a care organisation's/NHS premises or facilities||No||YES||No||No||No||No||HRA +
|The generation of new data or samples from human participants that are not NHS patients||No||YES||YES||No||No||No|
|Studies involving the Ministry of Defence personnel||No||No||No||No||No||YES|
|Studies involving Medical devices||YES||No||No||No||No||No||MHRA approval may be required|
|Studies involving adults lacking capacity||YES||No||No||No||YES||No|
|Studies involving human samples
|Prison research (requiring access to data, staff or offenders).||YES (if health care related)||YES||YES||No||No||No||HMPPS approval aka NOMS|
|Use of non-human in-vivo procedures||No||No||No||YES||No||No|
All studies taking place in the Faculty of Medicine and the Faculty of Science (excluding Psychology) that involve human participants, their tissue and/or their data (including those being conducted by staff and students/supervisors) that do not require NHS Research Ethics Committee approval are required to obtain Biomedical and Scientific Research Ethics Committee (BSREC) approval before the research can be undertaken. Research undertaken in the Faculty of Arts, Faculty of Social Science and the Department of Psychology should submit their ethics approval to Humanities and Social Sciences Research Ethics Committee (HSSREC).
*Which ethics committee needs to review studies involving human samples depends on where they are collected from, whether they are anonymous, and whether they have been collected with consent for use in research. Where samples have not been collected with consent for use in research, even when they are anonymous to the researcher, an application will need to be submitted to an NHS REC. Certain tissue banks can also issue ethical approval as part of the application process for obtaining human samples, providing these have been collected with consent for use in research. If studies involving samples falls under this category, please check the approval with the BSREC Secretary BSREC at warwick dot ac dot uk before the project begins.