Ethics Committee - Keele University

School of Medicine

School of Medicine Ethics Committee

Introduction

The scope of SOMEC is to consider and oversee good practice in all matters within the School of Medicine relating to:

    * Ethical issues associated with students’ research projects undertaken as part of a taught undergraduate or postgraduate course
    * Ethical issues related to the content or design of taught courses and associated teaching activities.
    * Ethical issues related to staff research in Medical Education which involves students and/or staff in the School of Medicine

The full terms of Reference for the committee together with its Ethical guidelines for these activities can be downloaded here:

SOMEC Terms of Reference March 2008.pdf (password protected file).

The purpose of these web pages is to provide guidelines to individuals who may be undertaking education research activities within the School of Medicine, Keele University

If you wish to carry out an education research project within the School of Medicine as a member of staff, as a post-graduate or undergraduate student or if you are based in another department, or institution, and wish to recruit staff or students within the School of Medicine as research participants for educational research then you must first gain approval from SOMEC

Curriculum evaluation and development vs education research

Evaluation is a core requirement of all university courses; all medical courses are required by the GMC to undertake course evaluation.   Where a project is an evaluation of an aspect of the curriculum which is a routine part of quality assurance, no ethics committee approval is required to undertake the activity.  However, all evaluation should be conducted, ethically, and within University & School guidelines.  Evaluations are to be conducted only with the approval of the relevant Module leader(s) and Programme Director

Educational research

Where a proposed project involves a study of any aspect of student learning or teaching, which is not part of the normal quality assurance activity of the School, SOMEC approval is required.  Examples of such projects include research into a new educational intervention not incorporated as part of the curriculum, any intervention in which it is proposed to randomise students, observation or assessment of student learning which is not a normal part of QA e.g. additional questionnaires or focus groups or observation or videotaping of tutorials.  Where there is any doubt, the School of Medicine Ethic Committee can advise.

Educational research based on routine evaluation and course development.  If data arising from routine evaluation and development activities are submitted for publication in journals or presentation at meetings, formal ethics committee approval is not required, with specific provisos that are outlined in SOMEC guidelines.  If data arising from such work is to be published, it must be sent to the chair of SOMEC to confirm that the study meets the criteria for evaluation, not research, prior to submission for publication.

Guidelines for applicants
All applicants should read the guidelines available from this site and complete the appropriate application form.  This form should be submitted, together with the relevant supporting documentation to SOMEC via the committee chair or administrator.

Typically, the application will include:

    * The application form (see below)
    * The project proposal
    * Participant information sheets and consent forms
    * The wording of any the invitations/advertisements to participate in the research
    * Any other relevant documentation for the project (eg questionnaires)

SOMEC must be satisfied that the aims, design and analysis of the project reach an acceptable scientific standard.  For undergraduate projects, review by the lead supervisor is usually sufficient.  Staff research projects and Postgraduate student projects will require independent peer review.  Whilst applicants may propose reviewers, they should not solicit the review themselves.  Please discuss the arrangements for peer review with the SOMEC chair.  The independent review must be completed before any application for ethical review and applicants should allow time for this in their project planning.

 
Documents available for download

Requirements for School of Medicine Ethics Committee approval for educational studies involving School students or staff (SOMEC Education research Policies): including

    * Quality Assurance and Evaluation vs. Medical Education Research
    * Accessing students as participants in research
    * Informed consent procedures for students or staff who participate in Medical Education Research

Procedures for Ethical Review – Postgraduate projects

    * Procedures for Ethical Review PG projects
    * Pro-forma for approval of dissertation protocol
    * SoM Masters Dissertation proposal form
    * Pro-forma for peer review of postgraduate student projects that need evidence of peer review for LREC approval
    * SOMEC Peer reviewer’s proforma

Procedures for Ethical Review – Staff research in Medical Education

    * Proforma for staff research
    * SOMEC Staff application proforma
    * Pro-forma for peer review of staff projects
    * SOMEC Peer reviewer’s proforma

Contacts
Lauren Brooks
Chair, School of Medicine Ethics Committee
School of Medicine
Keele University
Staffs ST5 5BG

Tel: 01782 734656
Email: l.brooks@keele.ac.uk

 

Kirsty Hartley
Education Office Manager and Administrator to the School of Medicine Ethics Committee
School of Medicine
Keele University
Staffs ST5 5BG

Tel: 01782 583648
Email: k.hartley@keele.ac.uk

March 2008