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Research Ethics Approval Processes
Keele University is committed to maintaining high standards in research undertaken by its staff and students.
Research involving human participants, their tissues, or personal information must be approved by a recognised research ethics committee before the research can commence.
Dignity and Respect
Any correspondence/communications between the applicant and the Ethical Review Panel are expected to comply with University's Dignity and Respect Frameworks.
More information on research ethics can be accessed via Research Ethics leaflet
- Human Participants: Human participants (or subjects) are defined 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).
- Research: Research is defined as any form of disciplined inquiry that aims to contribute to a body of knowledge or theory.
Most research in the health and social care areas needs to be reviewed by an NHS Research Ethics Committee or the Social Care Research Ethics Committee (see points 1 and 2 below).
All other (staff and PGR) research projects involving human participants or subjects must be reviewed by one of the University’s Ethical Review Panels (see point 3 below) or by a recognised other external committee.
All other undergraduate and PGT student projects involving human participants or subjects must be reviewed by a School Student Project Ethics Committee (SPEC) or an equivalent body (see point 4 below).
Upholding the University’s reputation
The University’s ethical review panels are responsible for ensuring that research through the University is carried out to the highest ethical standards and conforms to the University´s Research Ethics Policy. Consequently, all research involving human participants, their data or their tissues/samples must be reviewed by an appropriate ethics committee and meet necessary standards.
With regard to any wider implications and potential risks involved (eg projects that may have an impact on the University’s reputation), it remains the responsibility of researchers to ensure that their work meets the high standard of professional and ethical practice expected at Keele University. If a researcher (or their supervisor) anticipates that their project may raise reputational issues, central University approval from the Deputy Vice Chancellor should be obtained subsequent to ethical approval.
All staff in research management roles have a responsibility to assess and consider the wider implications and potential risks involved in any proposed research projects that are sanctioned within their area. They should seek appropriate advice from the Deputy Vice Chancellor where necessary in order to further ensure that these research projects meet the high standard of professional and ethical practice required by the University.
1. Research requiring review by an NHS Research Ethics Committee
The Research Governance Framework for Health and Social Care states that independent ethical review is undertaken of all health and social care research. Ethical approval must be obtained from an appropriate NHS Research Ethics Committee (REC) for any research proposal (including student projects) which involves:-
- Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions;
- individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above;
- access to data, organs or other bodily material of past and present NHS patients;
- fetal material and IVF involving NHS patients;
- the recently dead in NHS premises or facilities; and
- Research falling under the Mental Capacity Act 2005 (To undertake research with those who lack capacity, the MCA requires a researcher to obtain approval from an ‘appropriate body'. An appropriate body in England is a research ethics committee (REC) recognised by the Secretary of State; in Wales, this recognition is by the Welsh Assembly Government. Currently only RECs operating under the National Research Ethics Service (NRES) are so recognised, including the new Social Care REC).
The latest edition of Governance Arrangements for Research Ethics Committees: a harmonised edition(GafREC) comes into effect on 1 September 2011
One of the main revisions to GafREC is that research involving NHS staff or resources are no longer required to obtain NHS REC approval. Although such projects will not require NHS REC approval since they involve human subjects/participation these projects will require ethics approval from one of the University's Ethical Review Panels (ERPs).
If the research involves both NHS patient and NHS staff components the whole study can be reviewed by an NHS REC (please include information regarding both components in your NHS REC application). However, if the research comprises of two separate studies then the patient study should be reviewed by an NHS REC and the staff study by a University ERP.
How to apply to an NHS Research Ethics Committee
Click here for more information regarding the application process for NHS Research Ethics Committee.
2. Research requiring review by the Social Care Research Ethics Committee
The Social Care REC reviews applications involving the adult social care sector (e.g. in local authority, private and voluntary care settings), as well as studies which cross sector boundaries. The REC reviews:
- Social care studies funded by Department of Health.
- Research commissioned directly through the Policy Research Programme.
- Health and Social Care Information Centre (HSCIC) studies (i.e. those to be designed by HSCIC for implementation by Councils with Adult Social Services Responsibilities, who do not then individually need to seek additional review).
- Studies commissioned by or through National Institute for Health Research (NIHR) School for Social Care Research.
- Social care studies funded (in rare cases) through NIHR.
- Social care research that involves people lacking capacity in England and Wales and requires approval under the Mental Capacity Act 2005. The Social Care REC is recognised by the Secretary of State as an Appropriate Body for this purpose.
- Social care research involving sites in England and another United Kingdom country.
- 'Own account' research undertaken by Councils with social services responsibilities, where the Chief Investigator and/or sponsor feels there are substantial ethical issues.
- Studies of integrated services (health and social care), provided that there is no clinical intervention involved.
- Studies taking place in NHS settings with NHS patients where the approach uses social science or qualitative methods, provided that the research does not involve any change in treatment or clinical practice.
- Intergenerational studies in social care, where both adults and children, or families, are research participants.
- Other social care studies not suitable for review by other NRES RECs, subject to the capacity of the Social Care REC. This could include service user-led research.
- Adult social care research involving changes in, or the withdrawal of, standard care.
Social care research does not require review by the Social Care REC if it is reviewed by another committee operating in accordance with the ESRC's Framework for Research Ethics, unless sections 1 or 9 above apply or the research involves NHS patients or service users as research participants. A review is required if there is a legal requirement for REC review e.g. under the Mental Capacity Act. Student research within the field of social care should ordinarily be reviewed by a University REC (UREC). If a UREC review is not available to a student, they can contact the manager for advice.
The Social Care REC does not consider any research involving clinical interventions. Such research should be reviewed by another appropriate REC within the NRES.
How to apply to the Social Care Research Ethics Committee
Click here for information regarding the application process for the Social Care Research Ethics Committee
3. All other research involving human participants or subjects
All other research involving human participants/subjects carried out by Keele University staff and research (PGR) students must be reviewed by one of the university’s Ethical Review Panels or by a recognised other external committee (see below).
For the purposes of this policy, the expression “research on human subjects/participants” covers: experimentation on human beings, observation of human beings for research purposes, and the recording, storage, or use of personal data for research purposes; the expression “personal data” covers all information, including data obtained from interviews, (excluding that already in the public domain) about existing individual persons or those who have died within living memory.
Purely documentary research on sources that are already in the public domain will not normally require ethical review. Historical, literary, and theoretical research (etc.) will not normally require ethical review (unless it makes use of personal data, as defined above).
As of January 2011, any new research project which involves interviews with individuals representing or acting in their professional capacity will now require ethical review by an Ethical Review Panel (ERP)
Service evaluation and audit will not normally require ethical review. Human tissue for our purposes only normally includes materials that are relevant for the Human Tissue Act. Therefore, for example, research involving immortalised cell lines or hair or nails from living persons does not require University ethical approval.
If researchers are uncertain whether their project is research or not, advice should be sought from the University Research Ethics Committee. Researchers should contact the Research Integrity team by email email@example.com in the first instance.
Projects with ethical approval from a non-NHS external research ethics committee
If your research project has already been reviewed by a non-NHS external research ethics committee, please contact the Research Integrity team on 01782 733371 or email firstname.lastname@example.org for further advice.
How to apply to a Keele University Ethical Review Panel (ERP) - route for Staff and PGR students only
Please submit the following documentation in electronic format to ERP Administrator, Directorate of Engagement and Partnerships, iC2 Building, e-mail email@example.com. Where electronic signatures are not available a hard copy of the application form should be sent to ERP Administrator, Directorate of Engagements & Partnerships, IC2 Building, Keele University, ST5 5NH.
- Completed and signed ERP Application Form Please allow five working days for colleagues to review and sign applications
And if they are applicable
- A letter of invitation for participants;
- An information sheet which should include the following sections;
- why the participant has been chosen;
- what will happen to participants if they take part;
- a discussion of the possible disadvantages, risks and benefits of taking part;
- the procedures for ensuring confidentiality and anonymity;
- the proposed use of the research findings;
- contact details of the principal investigator plus details of additional support agencies (if necessary);
- A copy of the participant consent form:
- Copies of any questionnaire, interview schedules or topic guides.
This list of documents reflects the fact that the role of the ERP is to assess whether the proposed application of research methods is ethically acceptable. Projects should only be submitted to an ERP when final drafts of the above documents are available. Submission will also normally only take place after some form of peer (or supervisory) review of academic/scientific quality has taken within the Research Institute (or equivalent).
Once received and validated, applications will be reviewed at the next available ethical review panel meeting. A list of ERP meeting dates and deadline dates for submission of applications is detailed below. Applicants will be informed of the outcome of their review within 10 working days from the date of the meeting at which their application was considered. The possible outcomes are; approved, minor revisions required and the revisions will be reviewed by chair's action, major revisions required and the revisions will be reviewed by panel at the next available meeting, and rejected (re-submission required). All revisions and re-submitted applications will continue to reviewed by the initial reviewing ethical review panel, therefore is strongly recommended that applicants factor in sufficient time for ethical review and approval.
If your research involves a phased approach then each phase can be applied for separately. Each phase will need to be reviewed by the initial reviewing ethical review panel.
For research that is undertaken overseas the ERP may request a site specific assessment to be undertaken by a relevant local organisation with respect to locality issues that the ERP may not be aware of.
Participant information sheet and consent forms
Templates for Ethics Information Sheet and Consent Form are available.
Details of amendments to projects after a favourable ethical opinion has been given must be submitted to the Ethical Review Panel for approval using the Application to amend study form. This form must be submitted to the panel via e-mail firstname.lastname@example.org
If you have any queries or would like further guidance in completing your ERP application please contact the Research Integrity team on 01782 733371 or email email@example.com.
4. Undergraduate/PGT students
Schools are responsible for ensuring that that all student projects involving human participants are subject to ethical review by a Student Project Ethics Committee (or an equivalent body) before any contact is made with prospective participants.
Please contact your School for information on how to submit an undergraduate/PGT student project for ethical review.
If researchers are uncertain whether their project is research or not, advice should be sought from Directorate of Engagement and Partnerships. Researchers should contact the Research Integrity team on 01782 733371 or email firstname.lastname@example.org in the first instance.
4.1 Regulation 8 Section 11
Point 11.5 of Regulation 8 Section 11 states that 'Student projects which involve the participation of human subjects must not be undertaken without the prior approval of a School Student Project Ethics Committee (or another Ethics Committee recognised for this purpose by the relevant School)' Please access the link for further information about the Process for investigating alleged ethics offences at School Level and the range of possible penalties that could be imposed.
5. Flow chart outlining the University ethics processes
*In the event that an application is rejected, an appeal may be made to the University Research Ethics Sub Committee via the ERP appeals procedure. For more information please contact the Research Integrity team on 01782 733371 or email email@example.com.
6. Ethical Guidelines and additional links:
- Association of Social Anthropologists of the UK and Commonwealth
- British Educational Research Association (BERA)
- British Psychological Society
- British Sociological Association
- CIOMS 2002
Council for International Organisations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects
- ESRC Research Ethics Framework (2015)
- European Textbook on Ethics in Research
- GMC 2002
General Medical Council, Research: the role and responsibilities of doctors,
- MRC Good Research Practice: Principles and Guidelines
- Royal College of Nursing
- Royal Statistical Society
- World Medical Association
The leaflet produced by the National Patent Safety Agency may be useful to determine whether projects are audit, service evaluation or research. The leaflet is available from this following link
7. University Research Ethics Committee
Head of Academic Legal Services
Co-opted - Chair RDC
Co-opted - KPA Chair (student representation)
8. Ethical Review Panel Membership 2015/16
Faculty of Humanities and Social Sciences
Dr James Tartaglia
Dr Monica Mookherjee
Dr Colin Rigby
Dr Samantha Weston
Dr Panos Sousounis
Faculty of Natural Sciences
Dr James Grange
Dr Alexandra Kent
Dr Lisa Lau
Dr Helen Price
Dr Andrew Rutherford
Dr Katie Szkornik
Faculty of Medicine and Health Sciences
Ms Valerie Ball
Dr Milisa Bucknall
Dr Pensee Wu
Dr Rosie Lacey
Dr Kate Lillie
Dr Karen Schofield
Dr Rebecca Venables
Dr Jackie Waterfield
For more information about Research Ethics, please contact: firstname.lastname@example.org