Do I need ethical approval?

The University is committed to promoting a quality research culture by ensuring high standards of research integrity. This means that no research can take place until all of the required approvals and authorisations have been given from the appropriate institutions.

Any University of Warwick student or member of staff who wishes to undertake research with ethical implications or research that involves human participants, their data, or their tissue, must obtain appropriate ethical approval from a University Research Ethics Committee.

The British Psychological Society's Code of Human Research Ethics defines human participants as including...

"...living human beings, human beings who have recently died (cadavers, human remains and body parts), embryos and foetuses, human tissue and bodily fluids and human data and records (such as but not restricted to medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic achievements)."

Before proceeding, please note the following:

Ethics approval should be sought before a project begins. It is not possible for a University Research Ethics Committee to issue retrospective approval.
Obtaining all other necessary approvals is the responsibility of the investigator.
Amendments should be submitted to the original approving Research Ethics Committee.

The following tabs provide guidance on what types of research require ethical review. If you are unsure about your research, please contact HSSREC@warwick.ac.uk or BSREC@warwick.ac.uk.

Please ensure you read all sections before determining whether ethical review is required for your research.

Once you have determined whether ethical review is required, please refer to the Ethical Review Decision Making Tool for further guidance.

Whilst these pages provide general advice, it is not possible to state that a certain category of research activity will never require ethical review.

Section A: Research involving the following will require ethical review

Please note: Those activities marked with an asterisk* may be eligible for light touch review.

The NHS and social care. This includes research with NHS staff or patients. Some NHS research will require ethical review by an NHS Research Ethics Committee. All NHS & Social Care research will require University Sponsorship and in most circumstances Health Research Authority (HRA) approval. More information is available here. This includes NHS clinical audits or NHS health/social care service evaluation and development projects. More information on study classification can be found here.
Animals: Any project involving animals as defined by the Animals and Scientific Procedure Act. More information is available here.
Humans: Any projects involving human participants, their tissue or data. (N.B. If you are accessing tissue from UHCW's Arden Tissue bank, you will not need to apply for University REC approval if Arden have already issued their ethical approvalLink opens in a new window).
Research involving vulnerable and/or dependent participants (including but not limited to those receiving health or social care, in primary or secondary education, or criminal justice services).
Research raising sensitive issues or investigating sensitive or intrusive matters (e.g. health status, criminal activity, or sexual history).
Where a patient or a member of the public is to be approached with the potential to be a 'participant' in a research study (whether data is collected or not).
Service evaluations on human subjects that will have scholarly outputs.
Research involving the internet and social media including the following:
- To recruit participants
- As a data source
- As a data collection tool (e.g. through online interviews, surveys, archiving, or automated means of data scraping).
- For communication into focus groups, chat rooms, or interviews

Despite appearing ‘publicly available’ this data has important associated ethical considerations and this type of research will require ethical review. Further guidance on internet research can be accessed here.

Secondary data (e.g. data collected by other researchers) not covered by the content in Section C. Examples of secondary data that require ethical review include:

- Research using previously collected data from human participants which are not publicly available*
- Research using previously collected data in which human participants are individually identifiable or recognisable*
- Research using routinely collected patient data within a clinical care team, or outside a clinical care team*
- Research using routinely collected student assessment data within a course or Department/School*
- Research using publicly available data which may require consent (For example, as mentioned above, data from social media websites)*

Section B: Research with the following additional factors will require governance review and may require ethical review

In addition to Section A, you must contact BSREC / HSSREC before commencing your research if it involves any of the following:

Where the conduct of research may cause upset, harm or place members of the public, participants or staff at undue risk.
Where a third party is involved and the original source of the funding is unknown or cannot be identified.
Where a funding organisation wishes to place inappropriate restrictions on publication and exploitation of research which may lead to substantial ethical difficulties.
Where a funding organisation is attempting to exert pressure to suppress or alter the results of the research which do not further, or may damage, its interests, commercial or otherwise.
Where accepting funds from one source may compromise the ability of the University to apply for or accept funds from another source.
Where the practices of a potential funder or their motives in commissioning the research may conflict with the mission, aims and objectives of the University.
Where the ethical and political implications of undertaking research or accepting research funding from a particular source could result in negative publicity and/or may seriously damage the reputation of the University.
Where a member of staff may have an interest in a funding organisation or where the project involves any actual, potential or perceived conflicts of interest.
Where data is covered by the Official Secrets Act 1989 or the Counter-Terrorism and Security Act 2015 and PREVENT:

- Is the research commissioned by the military?
- Is the research commissioned under an EU security call?
- Does the research involve the acquisition of security clearances?
- Does the research concern terrorist or extremist groups?

Where the research involves viewing or disseminating illegal materials.
Quantitative research on human subjects involving “big data” which deals with patterns of behaviour in big groups, and where the data appears to be anonymised (this research may still require ethical review and this should be determined on a case-by-case basis).

Section C: Research limited to the following will not normally require ethical review

Please note: If your research includes any of the considerations mentioned at Section A or B, ethical or governance review will still be required.

The following activities will not normally require ethical review:

Those not undertaken for the purposes of research. The university uses the Frascati definition of research. Please note, some non-research activities will still require ethical review if any factors stated in Section A or B apply.
Literature/systematic reviews.
Documentary analysis.
Interviews/consultation with key informants/service users during the development of research proposals.
Research using established human cell lines and adult stem cells are exempt from ethical review, as long the topic of research does not raise any sensitive issues. Please note that this does not include embryonic stem cells, which may require ethical review.
Data collected for evaluation purposes, including student course and assessment data. However, this data cannot later be used for research purposes, including but not limited to publication, without ethical review.
Stakeholder consultations during the developmental stage of research proposals.
Public and patient involvement (PPI) in the NHS.

Research using secondary data (e.g. data collected by other researchers) of the following types:

Information freely available in the public domain. For example, published biographies, newspaper accounts of an individual's activities and published minutes of a meeting. This does not include all information sourced from the internet (please see Section A for details). 
Anonymised records and data sets that exist in the public domain, both within and outside the UK. For example, datasets available through the Office for National Statistics (ONS) or the UK Data Archive where appropriate permissions have already been obtained and it is not possible to identify individuals from the information provided.

Collaborative research:

If the University of Warwick is not the sole lead organisation for the research and another institution (such as the lead or co-lead) has granted formal research ethics approval, it may not be necessary to also gain BSREC / HSSREC ethics approval. Please submit a copy of the ethics approval granted to either BSREC / HSSREC before the research commences. This ethical approval must clearly cover the activities to be conducted at Warwick. The BSREC / HSSREC Secretary will advise as to whether further ethical review is required.