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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. 

Definition of 'human subjects' research

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 (see point 1 below).

All other undergraduate and PGT student projects involving human participants or subjects must be reviewed by a School Students Project Ethics Committee (SPEC) or an equivalent body. More information: Guidance on Ethical Review of Student Projects and Application form

All other (staff and PGR) research projects involving human participants or subjects must be reviewed by one of the University’s Ethical Review Panels, or by the School of Medicine Ethics Committee or by a recognised other external committee (see point 2 below).

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; and
  • the recently dead in NHS premises or facilities

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

Information regarding the application process for NHS Research Ethics Committee approval can be obtained via the following link: How to apply for an NHS REC.

Projects with ethical approval from an NHS Research Ethics Committee

If your project has received ethical approval from an NHS Ethics Committee please send a copy of your approval letter and completed University ethics application form (sections A, B and D) to Nicola Leighton, Research Governance Officer, Research & Enterprise Services, Dorothy Hodgkin Building, Keele University.

 

2.      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 the School of Medicine Ethics Committee (see below) 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 approva.

If researchers are uncertain whether their project is research or not, advice should be sought from the University Research Ethics Committee.  Researchers should contact Nicola Leighton at n.leighton@keele.ac.uk or telephone 01782 733306 in the first instance.

School of Medicine Research

If the majority of your research subjects will be School of Medicine staff and/or students and they are selected for study by virtue of their position in the School then your research should be reviewed by the School of Medicine Research Ethics Committee (provided that it does not require NHS review).  For further information contact Kirsty Hartley, Administrator School of Medicine Ethics Committee on 01782 733648 e-mail k.hartley@hfac.keele.ac.uk

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 Nicola Leighton, Research Governance Officer on 01782 733306 or e-mail n.leighton@keele.ac.uk for further advice.

How to apply to a Keele University Ethical Review Panel (ERP)

Please submit the following documentation (in electronic and hard copy format) to Michele Dawson, ERP Administrator, Research & Enterprise Services, Dorothy Hodgkin Building, e-mail m.dawson@uso.keele.ac.uk

  • Completed and signed ERP Application Form . Please allow five working days for colleagues to review and sign applications
  • A summarised project proposal (no more than two sides of A4)

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 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.

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 participant information sheets and consent forms can be accessed via the following link Ethics Information Sheet and Consent Form

Amendments

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 Michele Dawson e-mail m.dawson@uso.keele.ac.uk

 Meeting Dates & Deadlines for ERP 2012

Meeting Date

Deadline for submission of papers

Thurs  12 January (Meeting Full)

Wednesday  21 December

Thurs 26 January (Meeting Full)

Friday 13 January

Thurs 9 February (Meeting Full)

Friday 27 January

Thurs 23 February (Meeting Full)

Friday 10 February

Thurs 8 March (Meeting Full)

Friday 24 February

Thurs 22 March

Friday 9 March

Thurs 12 April 

Friday 30 March

Thurs 26 April

Friday 13 April

Thurs 10 May 

Friday 27 April

Thurs 24 May

Friday 11 May

Thurs 14 June 

Friday 1 June

Thurs 28 June

Friday 15 June

Thurs 12 July

Friday 29 June

Thurs 26 July

Friday 13 July

Thurs 6 September

Friday 24 August

Thurs 20 September

Friday 7 September

Thurs 4 October

Friday 21 September

Thurs 18 October 

Friday 5 October

Thurs 8 November 

Friday 26 October

Thurs 22 November

Friday 9 November

Thurs 6 December

Friday 23 November

Thurs 13 December

Friday 30 November

 

Further information

If you have any queries or would like further guidance in completing your ERP application please contact Nicola Leighton on 01782 733306, e-mail n.leighton@keele.ac.uk or Michele Dawson on 01782 733588, e-mail m.dawson@uso.keele.ac.uk

 

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 Research & Enterprise Services.  Researchers should contact Nicola Leighton, Research Governance Officer, on 01782 733306 or e-mail n.leighton@keele.ac.uk in the first instance.

 

3.       Flow chart outlining the University ethics processes

 Ethics Flow Chart June 2011

*In the event that an application is rejected, an appeal may be made to the University Research Ethics Sub Committee via the Approved Appeals Procedure . For more information please contact Nicola Leighton, Research Governance Officer on 01782 733306 or e-mail n.leighton@uso.keele.ac.uk.

 

The following is a list of ethical guidelines (and links to websites) which may be useful:-   

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