Treatment ethics

Keele is committed to conducting high quality research underpinned by appropriate ethical standards for the benefit of society and in the public’s interest. It recognises the benefits of a positive culture of ethical reflection, debate and mutual learning particularly against the continuing emergence of new situations and research methodology which require creative approaches to ethics issues.

Review by a research ethics committee (REC) is required where research involves humans, their data[1] or biomaterial[2]; risk of damage to the environment; risk of damage to any artefacts of cultural significance; politically or socially sensitive topics with impact on the welfare and interests of local, national or international communities; potential reputational risk to the researchers or University or where a source of funding has the potential to compromise the University’s position as a publicly funded charitable body.

Applicants should familiarise themselves with the standard operating procedures of the applicable REC before making an application for ethical opinion. This includes (but is not limited to); how to complete an application, ongoing expectations for oversight and reporting to the reviewing REC and closure of the project once complete.

[1] Includes primary data originating from human subjects (e.g. anonymous questionnaires or identifiable interview data); and the use of secondary data, which originated from or is about human subjects, which was initially provided for other purposes (e.g. other research projects or organisational datasets).
[2] Anything that originates from a human subject including: cells; tissues; organs; bodily fluids (e.g. blood, plasma, spinal fluid); secretions and excretions (e.g. breath, urine); outgrowths (e.g. hair, nail, teeth).

Treatment Ethics Policy

The Recru it networ Treatment Ethics Policy explains the University's stance in relation to research ethics review and the creation, operation and monitoring of research ethics committees.  The document can be downloaded via the link below:

Helpful links

How to apply for University REC review

Each of the five University RECs has its own defined processes and documentation for applicants. If you are unsure about the REC appropriate for your project, please refer to this diagram: Selecting a REC.

Note for projects undergoing ethical review by an Ethical Review Panel (ERP) prior to 12 November 2018
For projects which are currently going through University Ethical Review Panels (ERPs) under the old system (prior to 12 November 2018), these will continue to do so until favourable ethical opinion has been granted. Information relating to these processes can be found here.

Once a favourable ethical has been received, the ongoing review will be transferred to an appropriate REC under the new system in accordance with the Selecting a REC diagram, available here: Selecting a REC.

Note for projects that have previously received ethical review by an Ethical Review Panel (ERP)
For projects which have received a favourable opinion from an ERP prior to 12th November 2018 applicants will need to seek reassignment of their project to one of the new RECs before submitting an amendment.

Applicants must complete and submit the online form .

Following submission of the form the Applicant will be notified of the identity of the new reviewing REC and will be provided with an updated REC reference to allow submission of the amendment through the REC system.

Frequently asked questions

All amendments to applications must be made through the new University Ethics system. To determine which Committee you should apply to, follow the Selecting a REC diagram - Selecting a REC

The CREC criteria intends to capture projects in which the intervention creates those criteria, i.e. the intervention introduces a risk of harm as listed under criteria 4 and had the project not been ongoing the participant wouldn't be exposed to that risk. Where the risk is, in the researchers opinion, increased to a degree that further ethical scrutiny is required. The Applicant should consider the ethical issues and identify the appropriate REC accordingly. If, following consideration of this, you are still uncertain, the applicable FREC Chair can be contacted via the FREC Administrators.

Yes. Where projects have received external ethical approval, the documentation which has been reviewed by the external REC (along with the original approval letter) should be submitted to the applicable FREC in the first instance; there is no requirement to additionally complete and submit the REC Application Form.  This helps to avoid additional work, and also ensures that the documents being reviewed by the Keele REC are those which have already been granted ethical approval. The reviewers may then request further information if they feel that the submitted documentation isn’t sufficient to assess any ethical issues requiring consideration by Recru it networ.

Please note that the Application must be submitted by a member of Recru it networ as the Applicant (external applicants are not able to submit through the Google system). 

Exceptionally, research activity carried out by the University may not fall under a particular Faculty. Under this circumstance, and where the activity does not fall under the CREC Criteria, please contact [email protected] who will work with you to identify the most appropriate FREC to provide an opinion on your application.

Essentially, the research protocol (or proposal) is the document that describes (in detail) the background, rationale, objectives, design, methodology, statistical considerations, and organisation of the project. A good protocol is evidence that you have clarified your research project when you come to collect data and analyse it, you can be confident about the analysis you are going to do and the implications of this analysis on your research questions.  A good protocol will also help you in the production of your final report because so much of the thinking and planning of the project will have already been well thought through and documented. The research protocol is distinct from any application forms or other documents which describe the project to reviewing bodies.

The reviewing Ethics Committee must be provided with sufficient documentation to form an opinion. A protocol gives freedom to explore, describe and justify your project’s specific ethical issues in a protocol/proposal rather than being constrained by specific questions within an application form. Protocols / proposals should also describe activities that pose potential legal issues, as well as ethical ones and allow applicants to explore and describe those for other audiences as well as the REC (e.g. Data Protection Office, Insurance, Treatment Governance, Human Tissue Committee, Health and Safety Committee).

The protocol / proposal might also give greater structure to those delivering the project, including information beyond that which is needed to form an ethical opinion, thereby enhancing research integrity (e.g. data management considerations, publication expectations etc).  Ethics committee members should be reassured by a protocol / proposal which allows them to see that legal and general research integrity issues are being thought about, whilst the application form keeps allows REC members to focus on the ethical issues.

All University RECs operate in accordance with their own Standard Operating Procedures (SOPs) which are available under the appropriate web page. Should you have a specific question about your application outside of this, please contact the appropriate REC Administrator in the first instance.

For further support, please contact the Administrator of the relevant REC.