SCHOOL OF SPORT AND HEALTH SCIENCES
School Ethics Committee
Policy and Procedures
2009/10
Contents
School Ethics Committee …………………….. 3
Terms of Reference ………………. 3
Membership ……………………….. 3
Terms of Office . 3
Dates of Committee Meetings 2009-2010 .. 3
Deadlines for Path A Applications 2009-2010 4
Regularity of Meetings and Availability of Minutes .. 4
Principles of Ethical Research .. 4
Ethical Issues … 5
The School of Sport and Health Sciences .... 6
Remit .... 6
Procedures .... 7
Appeals Procedure .... 7
Preparing an Application to the Ethics Committee .... 8
Contact Details .... 9
General Conditions of Approval .... 9
Chair’s Action .... 10
Data Protection ..… 10
Additional Resources for Ethical Considerations………………………………………….. 11
Appendices……………………………………………………………………………………… 12
APPENDIX 1a: APPLICATION FORM - PATH A (STAFF/PGR) AND PATH B ……… 13
APPENDIX 1b: APPLICATION FORM - PATH A (UG/MSc PROJECTS)………… 17
APPENDIX 2: GUIDANCE FOR PREPARING AN INFORMATION SHEET… ………. 21
aPPENDIX 3: eXAMPLE CONSENT FORM .. 24
Appendix 4: wORKED EXAMPLE FOR SAMPLE SIZE ESTIMATION…………… .. 25
APPENDIX 5: CERTIFICATE OF ETHICAL APPROVAL … 26
APPENDIX 6: EXTENSION/CHANGE IN PROTOCOL …………………………………. 28
APPENDIX 7: CHECKLIST FOR RESEARCHERS AND REVIEWERS…………………. 29
SCHOOL OF SPORT AND HEALTH SCIENCES
1.0 School Ethics Committee
The primary purpose of the School Ethics Committee is to maintain procedures for the consideration of ethical issues arising from the teaching, research and other activities of the School. A designated officer is appointed with specific responsibility for the management of such procedures. The School Ethics Committee follows the guidelines laid down by the University Ethics Committee.
1.1 Terms of Reference
i.) To ensure that School staff, postgraduate and undergraduate students are supported in, and held to account for, the professional conduct of research;
ii.) To determine the approval, referral and/or rejection in writing of staff and student research investigations in accordance with the principles expressed by relevant professional bodies;
iii.) To monitor the appropriateness and effectiveness of procedures for granting or withholding ethical approval mechanisms of research;
iv.) To operate a system of appeals for researchers who have been refused permission to undertake research and/or research-related activities on ethical grounds;
v.) To refer to the University Ethics Committee cases which cannot be resolved or about which there is uncertainty;
vi.) To inform the University Ethics Committee of any changes in the ethical codes of professional bodies in relevant discipline areas in order that the University’s procedures remain valid;
vii.) To advise on policy issues related to research ethics as determined by the School Research Committee;
viii.) To ensure effective liaison with appropriate University and School Committees;
ix.) To encourage staff development in the area of research ethics.
1.2 Membership
Chair: Dr Jo Welsman (Physiology)
Representatives: Dr David Brown (QRU)
Dr Vicky Stiles (Biomechanics)
Prof Adrian Taylor (Psychology)
The Revd James Theodosius (Lay Member)
Dr Daryl Wilkerson (Physiology)
1.3 Terms of Office
As agreed with individual members.
1.4 Dates of Committee Meetings 2009-2010
Wednesday 21 October 2009, 2pm
Wednesday 9 December 2008, 2pm
Wednesday 24 February 2009, 2pm
Wednesday 5 May 2009, 2pm
Wednesday 7 July 2009, 2pm
1.5 Deadlines for Path A Student applications 2009-2010
Month / Deadline for submission of applicationSeptember / 18
October / 23
November / 13
December / 11
January / 15
February / 19
March / 19
April / 16
May / 14
June / 18
1.6 Regularity of Meetings and Availability of Minutes
The School Ethics Committee will meet on a regular basis and in response to applications submitted to it. Copies of non-reserved minutes of such meetings will be forwarded to the Research Committee. An annual report will be submitted to the Research Committee’s final meeting of each academic year in addition to the University Ethics Committee. Copies of all minutes will be held by the Chair of the Committee and Rosemary Davies for scrutiny.
2.0 Principles of Ethical Research
2.1 The primary responsibility for the conduct of ethical research lies with the researcher. It is a fundamental principle that staff and students engaged in research adopt a continuing personal commitment to act ethically, to encourage ethical behaviour in those with whom they collaborate, and to consult where appropriate concerning ethical issues.
2.2 The ethical position of the School of Sport and Health Sciences is based on the principle that in all research, teaching and professional activity, the interests and rights of others must be respected and protected. The ‘others’ whose interests and rights need protection include children, adults, other sentient beings and institutions with which we have professional contact.
2.3 The School acknowledges the importance of the professional codes of conduct of external agencies and organisations, and accords them primacy as a default position.
2.4 Research should be based, as far as possible, on the freely given informed consent of those under study.
2.5 The policies and procedures of the School Ethics Committee will be regularly reviewed in light of developments concerning the Research Governance Framework (DoH, 2001).
3.0 Ethical Issues
The University Ethics Committee sets out the nature of some of the major ethical issues which might face University Schools in research and teaching:
3.1 Ethical issues arise when the conduct of research or teaching involves the interests and rights of others. Perhaps the most obvious cases concern people who act as "subjects" in medical research involving innovatory and invasive treatments. However humanitarian are the long term prospects of the research, there may be immediate or impending threats to the participants' safety, comfort or convenience.
3.2 The adoption of an ethical position in respect of such research requires that the researcher observes and protects the rights of would-be participants and systematically acts to remit the participants to exercise those rights. Ethical practice in such cases requires that participants, at a minimum, be fully informed, free to volunteer without inducement, free to opt out without redress, and be fully protected in regard to safety to the limits of best practice.
3.3 Ethical practice in the management of this work requires that a body independent of the research team examines the research design and the system for protecting participants' interests with a view to adjudicating on their ethical acceptability and their accountability.
3.4 Ethical issues are much more broadly manifest than illustrated by the example in 3.2. Any research which involves others as participants creates the possibility of an invasion of the participants' interests or rights. Social research involving interviewing or observation especially where records (particularly on audio or video tape) are kept, may impinge on the confidentiality, privacy, convenience, comfort or safety of others. Such possibilities constitute ethical problems. An ethical approach to this work requires that participants, at a minimum, be fully informed of their rights, volunteer without inducement, be free to opt out and be given written undertakings as to how their rights and interests will be protected.
3.5 Ethical issues may also be raised by research which makes reference to named persons either living or with living relatives. Research which impacts only on the dead may similarly raise issues of privacy and confidentiality.
3.6 The above illustrations indicate that a great deal of work conducted by students and staff in science, social science and professional disciplines will inevitably raise ethical issues. Such work is not limited to research. A significant element of the education of professionals, whether it be pre- or in-service, involves working with others. It therefore involves a systematic regard for the rights and interests of those others as they may be affected by the professional relationship.
3.7 Similar considerations pertain to the involvement of living animals in research or teaching. Ethical practice requires that the use of animals is justified and pain, suffering, distress, lasting harm, or the disturbance of wild animals avoided or at least kept at a minimum. Statutory controls and codes of practice must be observed at all times.
3.8 Ethical issues are given added salience where research and teaching involves children. Legislation requires that all staff and students who work with children must be formally vetted. In the School of Sport and Health Sciences formal vetting includes registration with the Independent Safeguarding Authority scheme which includes a riminal Records Bureau check. For staff and students joining the School from abroad a self-disclosure form should be completed available from Alison Hume.
3.9 In all these respects the University and its Schools have the responsibility for ensuring that:
(i.) ethical principles are explicitly taught
(ii.) ethical practices are followed
4.0 The School of Sport and Health Sciences
4.1 Each School member must consider the precise nature of potential ethical issues in the conduct of research and teaching. The following questions are offered to guide such consideration:
i.) Does the School involve "others" (humans, animals, etc.) as subjects in this
research and teaching?
ii.) If so, does it have a forum for discussing and reviewing ethical issues related to
this work?
iii.) What rights do these others have? How are the rights observed and protected?
iv.) Are any especially vulnerable others involved (e.g. children, undergraduates)? If
so, do special procedures pertain?
v.) Do any programmes require student participation in types of group work that
may have ethical implications, e.g. peer assessment?
vi.) Is the School involved in professional training? If so, what additional ethical
issues are raised?
vii.) Does research within the School involve sponsorship or external contracts? If
so, what additional ethical issues are raised, particularly in respect of the
publication of findings?
viii.) Do any School activities raise issues of an ethical nature even if they do not
raise the questions listed above?
ix.) Generally, how are ethical principles in the conduct of research or professional
life taught?
x.) What evidence is there that they are learned?
5.0 Remit
5.1 All investigations by School staff, postgraduate and undergraduate students (via their supervisors) must be approved by the School Ethics Committee before the start of the study.
5.2 Studies which involve patients or premises of a NHS Health Authority must obtain the approval of the Local Research Ethics Committee. In these cases, researchers must also forward a copy of the application and any approval notices granted to the School Ethics Committee to allow monitoring of external research activities. In certain situations it may speed up the LREC process if ethical approval is initially sought and granted from the SSHS ethics committee. Researchers should consult with the Chair of the SSHS committee to ascertain whether this is appropriate in their case.
5.3 Where a research student is a member of staff at a different institution but supervised by a SSHS member of staff and the research is to be conducted at a different institution the ethical committee at that institution should, in the first instance, review the research proposal. In line with University of Exeter ethical guidelines, the SSHS Ethics Committee should receive copies of all documentation submitted to the other institutions’ ethical committees including any changes requested and their decision. Any additional issues raised by the SSHS ethical committee should be resolved prior to the research taking place.
If the research is taking place at an institution which does not have an Ethics Committee, the SSHS Ethics Committee will review the research proposal as usual.
5.4 All students will be offered appropriate education and training in research ethics in the Research Methods Module or its equivalent.
6.0 Procedures
6.1 How the Committee decides: The Code of Conduct, Ethical Principles & Guidelines of the British Psychological Society (BPS) guide decision-making. These are interpreted with consideration to the University’s overall procedures relating to ethics in research and teaching as well as relevant professional guidelines or legislation.
6.2 The Committee can make four kinds of decision:
i.) Request resubmission due to missing information;
ii.) Approve the project as it stands;
iii.) Accept the project subject to specified alterations;
iv.) Reject the project.
If the research is accepted subject to alterations, these must be submitted either to the Chair for Chair’s action, or to the next Committee meeting, depending on the nature of the alterations.
6.3 Members will keep confidential all paperwork and discussions connected with the work of the School Ethics Committee.
6.4 When approval cannot be resolved at School level, or for matters which require specific consideration due to the implications they may have for broader University activities, the School Ethics Committee will refer the matter to the University Ethics Committee.
7.0 Appeals Procedure
7.1 A researcher has the right to appeal in writing against a decision made by the School Ethics Committee within ten working days of the notification of that decision. There are two grounds for such appeal:
i.) Where the researcher feels that the Committee has been unfair in its consideration of a proposal and/or has not properly understood it;
ii.) Where there have been any irregularities in the procedures adopted by the Committee.
7.2 The Chair will convene a meeting of the Committee with the researcher to review the proposal and the grounds for the decision. This meeting will normally be held within ten working days of notification of the appeal. There will be at least two Committee members in addition to the Chair in attendance. At this stage the School Ethics Committee may:
i.) up-hold its original decision to reject the proposal;
ii.) up-hold the appeal of the researcher and approve the original proposal;
iii.) up-hold the appeal of the researcher but refer the decision until ppropriate revisions have been made to the proposal.
7.3 Following an unsuccessful appeal, and where the researcher is dissatisfied with the decision of the Committee, he or she has the right to submit a final appeal to the University Ethics Committee.
8.0 Preparing an Application to the Ethics Committee
8.1 Discuss any ethical issues you have about the conduct of your research with your co-investigator(s). A checklist of issues is provide in appendix 8 for reference.
8.2 Consider whether the proposal should be submitted to the School Ethics Committee or the appropriate Local Research Ethics Committee[1]. Prepare your submission using the School of Sport and Health Sciences application form provided (see Appendix 1). Guidance for preparing information sheets, consent forms and sample size calculation is provided in appendices 2,3 and 4 respectively.