SPORT AND HEALTH SCIENCES

SHS Ethics Committee

Policy and Procedures

2010/11

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Contents

SHS Ethics Committee .................................................................. …………………….. 3 Terms of Reference ............................................................................... ………………. 3 Membership ............................................................................... ……………………….. 3 Terms of Office ........................................................................................................... . 3 Dates of Committee Meetings 2010/11 ...................................................................... .. 3 Deadlines for Path A Applications 2010/11 .................................................................. 4 Regularity of Meetings and Availability of Minutes ..................................................... .. 4 Principles of Ethical Research ................................................................................... .. 4 Ethical Issues........................................................................................................... … 5 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………………………………………….. 10 Appendices……………………………………………………………………………………… 11 APPENDIX 1a: APPLICATION FORM - PATH A (STAFF/PGR) AND PATH B ……… 12 APPENDIX 1b: APPLICATION FORM - PATH A (UG/MSc PROJECTS)………… 16 APPENDIX 2: GUIDANCE FOR PREPARING AN INFORMATION SHEET… ………. 20 APPENDIX 3: EXAMPLE CONSENT FORM ............................................................. .. 22 APPENDIX 4: WORKED EXAMPLE FOR SAMPLE SIZE ESTIMATION…………… . .. 23 APPENDIX 5: CERTIFICATE OF ETHICAL APPROVAL ......................................... … 24 APPENDIX 6: EXTENSION/CHANGE IN PROTOCOL …………………………………. 26 APPENDIX 7: CHECKLIST FOR RESEARCHERS AND REVIEWERS…………………. 27

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SPORT AND HEALTH SCIENCES 1.0 SHS Ethics Committee The primary purpose of the SHS Ethics Committee is to maintain procedures for the consideration of ethical issues arising from the teaching, research and other activities of the Discipline. A designated officer is appointed with specific responsibility for the management of such procedures. The SHS Ethics Committee follows the guidelines laid down by the University Ethics Committee. 1.1 Terms of Reference

i.) To ensure that SHS 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 SHS Research Committee;

viii.) To ensure effective liaison with appropriate University and Discipline Committees; ix.) To encourage staff development in the area of research ethics.

1.2 Membership Chair: Dr Ann Rowlands (Physiology) Representatives: Mr David Childs (Senior Technician)

Dr Rosey Davies (Physiology) Mr David Salway (Assistant College Manager: Infrastructure and Technical Services) Dr Vicky Stiles (Biomechanics) Dr Daryl Wilkerson (Physiology) Dr Mark Wilson (Psychology)

Social Science Advisor: Dr Cassie Phoenix 1.3 Terms of Office As agreed with individual members. 1.4 Dates of Committee Meetings 2010-2011 Wednesday 20 October 2010, 2pm Wednesday 8 December 2010, 2pm Wednesday 23 February 2011, 2pm

Wednesday 4 May 2011, 2pm Wednesday 6 July 2011, 2pm

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1.5 Deadlines for Path A Student applications 2010- 2011 Month Deadline for s ubmission

of application

September

17

October

22

November

12

December

10

January

14

February

18

March

18

April

15

May

13

June

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1.6 Regularity of Meetings and Availability of Minu tes The SHS Ethics Committee will meet on a regular basis and in response to applications submitted to it. An annual report will be submitted to the University Ethics Committee. Copies of all minutes will be held by the Chair of the Committee and the Assistant College Manager: Infrastructure and Technical Services 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 Sport and Health Sciences Discipline 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 Discipline 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 SHS Ethics Committee will be regularly reviewed in light

of developments concerning the Research Governance Framework (DoH, 2001).

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3.0 Ethical Issues The University Ethics Committee sets out the nature of some of the major ethical issues which might face University Discipline 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 Discipline of Sport and Health Sciences formal vetting includes registration with the Independent Safeguarding Authority scheme which includes a Criminal Records Bureau check. For staff and students joining the Discipline from abroad a self-disclosure form should be completed available from Alison Hume.

3.9 In all these respects the University and its Disciplines have the responsibility for ensuring

that:

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(i.) ethical principles are explicitly taught (ii.) ethical practices are followed

4.0 Sport and Health Sciences 4.1 Each Discipline 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 Discipline 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 Discipline involved in professional training? If so, what additional ethical

issues are raised? vii.) Does research within the Discipline involve sponsorship or external contracts? If

so, what additional ethical issues are raised, particularly in respect of the publication of findings?

viii.) Do any Discipline 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 Discipline staff, postgraduate and undergraduate students (via their

supervisors) must be approved by the SHS 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 SHS 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 SHS ethics committee. Researchers should consult with the Chair of the SHS 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

SHS 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 SHS 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 SHS 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 SHS 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.

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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 SHS Ethics Committee.

6.4 When approval cannot be resolved at Discipline level, or for matters which require specific

consideration due to the implications they may have for broader University activities, the SHS 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 SHS 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 SHS 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 appropriate 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.

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8.0 Preparing an Application to the Ethics Committe e 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 SHS Ethics Committee or the

appropriate Local Research Ethics Committee1. Prepare your submission using the 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.

8.3 The SHS application form allows for applications to follow either path A or path B. It is

expected that the majority of undergraduate and taught masters’ dissertations should follow Path A and there is a specific Path A application form for student dissertations.

8.4 Path A

Path A is intended for studies which:

i.) Involve low risk, asymptomatic adults (18 years or above) – see Appendix 5 for SHS

screening questionnaire. ii.) Include no more than one maximal effort test per 24h period (e.g. VO2 max, short term

power, strength) or involve only submaximal effort. iii.) Do not involve children or vulnerable adults. iv.) Do not involve novel exercise protocols or substantially modified protocols. v.) Do not involve administration of any substances to manipulate exercise responses

(unless listed on the SHS Health and Safety website as being suitable for a Path A ethics application).

vi.) Include only non-invasive procedures (single post-exercise fingertip blood sampling is permitted).

vii.) Applications involving MRI and/or venous blood samples can be submitted as a Path A ethics application as long as all Health and Safety Guidelines/risk assessments are followed.

8.5 Application procedures for Path A

i) Following discussion with supervisor of an appropriate topic the ethics application form should be completed by the student, submitted to the supervisor for approval and posted into the ethics pigeon hole in the foyer.

ii) UG and PGT applications should be submitted on the UG/MSc Projects Path A application form. There will be a monthly deadline for submitting applications falling in the middle of each month from September to July (consult dissertation handbook for exact dates) to enable applications to be considered in batches.

iii) Earlier or later approvals for both UG and PGT may be considered via request to the Chair of the Ethics Committee from the supervisor.

iv) Staff/PGR applications: Three copies of the application form and supporting documents (including Information Sheet, Consent Form and other letters) should be submitted to ethics pigeon hole at any time.

v) UG and PGT applications will be reviewed by the relevant Ethics Committee member (by research area) returned to Sophie Thomas with a decision. Sophie will distribute

1 Projects receiving LREC approval are subject to NHS audit requirements. If selected for audit, the principal investigator will receive a minimum of 48 hours notice. Please notify the Head of School and the Chair of the SHS Ethics Committee if you receive notification that your project has been selected for audit.

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them back to the students. The committee member should discuss any concerns with particular applications with the Chair of the committee before a decision is made.

vi) Staff applications will be reviewed by a member of the committee with advice from the Chair/other committee members as appropriate.

vii) For Path A applications a decision should be available to the applicant within one month of submission.

8.6 Path B Path B is intended for:

i.) All studies excluded by Path A. ii) Complete the SHS application form in Appendix 1 for Path B applications. Append all

required documents. iii.) Sign and date the form and submit to the Head of Discipline to sign. iv.) Submit 8 hard copies of your application to the pigeon hole in the RB Foyer 1.5 weeks

before the meeting of the Ethics Committee at which you would like your submission to be reviewed.

v.) A decision should be available within two weeks of the date of the meeting.

9.0 Contact Details College queries

Mr David Salway Assistant College Manager: Infrastructure and Technical Services Room Annex B, Hatherly Labs, Streatham Campus. Tel: (01392 26) 3798 Email: D.M.Salway@exeter.ac.uk

LREC queries

Mrs Lesley Holman N&E Devon Research Ethics Committee Administrator Department of Research Ethics and Medical Affairs Old Kenn Ward Royal Devon & Exeter Hospital (Wonford) Barrack Road, Exeter, EX2 5DW Tel/Fax: (01392) 402369 Email: Lesley.Holman@rdehc-tr.swest.nhs.uk http://www.corec.org.uk/

10.0 General Conditions of Approval 10.1 The SHS Ethics Committee will offer ethical approval subject to the following general conditions:

i) There is no divergence from the original protocol without first contacting the committee.

ii) The project is started within 3 years of the date approval is given; extensions can be applied for using the form in Appendix 7.

iii) Adverse events are notified to the SHS Ethics Committee.

10.2 Application for ethical approval for changes to the original protocol must be submitted on the form in appendix 7. These are usually considered by Chair’s action on an ad hoc basis.

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11.0 Chair’s Action 11.1 Chair’s action will never be used to decide an initial proposal via Path B. It is appropriate

for confirming minor amendments in applications approved subject to amendment where the principal researcher has fulfilled the requirements. It is also appropriate for determining whether amendments to applications already approved are sufficiently substantive to require consideration by the full Committee or whether they are sufficiently minor to be approved by Chair’s action. Decisions made under Chair’s action will be reported to the next meeting of the Committee.

12.0 Data Protection 12.1 Researchers should contact the University Data Protection Officer, Caroline Dominey

(C.H.Dominey@exeter.ac.uk or dataprotection@exeter.ac.uk), to discuss research proposals in light of the Data Protection Act. This also allows the University’s data protection notification which covers research to be updated. Specific guidance relating to Collecting Personal Data and Data Protection Guidance for Research students should be consulted by all individuals proposing to carry out research. These can be found on the university data protection website at:

www.admin.ex.ac.uk/academic/datapro/data_protection/Guidance/shtml

13.0 Additional Resources for Ethical Considerations 13.1 References Drowatzky, J. N. (1996). Ethical Decision Making in Physical Activity Research. Leeds: Human Kinetics. Kimmel, A. J. (1996). Ethical Issues in Behavioral Research. Oxford: Blackwell. Jago, R. & Bailey, R. (2001). Ethics and paediatric exercise science: Issues and making a submission to a local ethics and research committee. Journal of Sports Sciences, 19, 527-535. Laine, M. (2000). Fieldwork, Participation and Practice: Ethics and Dilemmas in Qualitative Research. London: Sage. Royal College of Paediatrics, Child Health: Ethics Advisory Committee (2000). Guidelines for the ethical conduct of medical research involving children. Archives of Disease in Childhood, 82: 177-182. Sales, B.D. & Folkman, S. (Eds.)(2000). Ethics in Research with Human Participants. Washington, D.C.: American Psychological Association Smith, T. (1999). Ethics in Medical Research: A Handbook of Good Practice. Cambridge: Cambridge University Press 13.2 Selected Websites 1. The Research Governance Framework for Health and Social Care. The full text of the

framework can be found on the Department of Health web site http://www.dh.gov.uk/ Follow the links – Policy and Guidance – Research and Development – Research Governance – Research Governance Framework for Health and Social Care

2. Ethics and Research Governance – Medical Research Council. http://www.mrc.ac.uk (follow the links – Ethics and Research Governance)

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Appendices Appendix 1a: Application form - Path A (Staff/ PGR) and Path B Appendix 1b: Application form – Path A (Undergraduate/MSc Projects) Appendix 2: Guidance for preparing information sheets Appendix 3: Example consent form Appendix 4: Worked example of sample size calculation Appendix 5: Certificate of ethical approval Appendix 6: Extension/change in protocol request form Appendix 7: Checklist for researchers and reviewers

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APPENDIX 1a: APPLICATION FORM

SPORT & HEALTH SCIENCES APPLICATION FOR ETHICS APPROVAL

Tick box: ���� STAFF Project ���� MPhil/PhD Project Tick one box: ���� PATH A ���� MSc Project ���� UNDERGRADUATE Project ���� PATH B Title Of Project:

Lead researcher/supervisor

Other investigators (staff)

Other investigators (student)

(Please indicate PG or UG)

Location(s) of data collection

Start Date (estimated) Signature of Ethics Committee Member

End Date (estimated)

……………………………………………………………..

SECTION 1: General To be completed by all applicants

YES NO N/A

1 Will you detail in writing the main experimental procedures to

participants in advance, so that they are fully informed about what to

expect?

2 Will you tell participants that their participation is voluntary?

3 Will you obtain written, informed consent for participation?

4 If the research is observational, will you ask participants for their consent

to being observed?

5 Will you provide contact details (phone, email, address) of the

researchers to participants?

6 Will you ask participants to complete the appropriate SHS recent health

questionnaire prior to involvement?

7 Will you tell participants that they may withdraw from the research at

any time and without giving a reason?

8 With questionnaires, will you give participants the option of omitting

questions they do not wish to answer?

9 Will you tell participants that their data will be treated with full

confidentiality and that, if published, it will not be identifiable as theirs?

10 For U/G & P/G applications will the supervisor read and approve any

information sheets and consent forms distributed to participants?

11 Where appropriate, will you debrief participants at the end of their

participation?

12 Will you offer participants the opportunity to obtain a summary of the

results of the study?

If you have ticked No to any of Q1-12, and intend to tick PATH A overleaf (Section 4), please give an explanation on a separate sheet. (Note: N/A = not applicable)

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YES NO N/A

13 Will your project involve deliberately misleading participants in any way

regardless of whether or not you intend to debrief them?

14 Is there a realistic risk of any participants experiencing either physical or

psychological distress, pain or abnormal discomfort?1 If Yes, give details on a separate sheet and state what you will tell them to do if they should

experience any problems (e.g. who they can contact for help).

15 Will your project involve administering a drug or substance or

manipulating diet etc.

NB If you have ticked Yes to 13 – 15 you should normally follow PATH B but refer to

Health and Safety webpage for question 15 or obtain further advice prior to submitting

the application.

YES NO N/A

16 Do participants fall into any of the following special groups? If they

do you must follow PATH B. Please note that Independent Safeguarding Authority

clearance, or equivalent for overseas participants, is required

for individuals working with children/vulnerable groups. NB Undergraduate research should not involve these groups

unless as part of an existing staff/PhD project.

a. School children (under 18

years of age)

b. People with learning or

communication difficulties

c. People currently receiving

medical treatment for a condition

(known to the researcher) that

may impact on the proposed

procedures.

d.Those at risk of psychological

distress or otherwise vulnerable

e. People in custody

f. People engaged in illegal

activities (e.g. drug taking)

NB There is an obligation on the lead researcher to bring to the attention of the SHS

Ethics Committee projects with ethical implications not clearly covered by the above checklist in section 1.

SECTION 2: DATA Protection

To be completed by all applicants

YES NO N/A

17 I understand that all collected data are the property of the SHS and

are to be used for research purposes only (e.g. theses, publications,

presentations etc.)

18 Data will be stored securely in coded form with access limited to the

named researchers.

19 Samples of human tissue as defined by the Human Tissue Act

(2004) including body fluids, DNA etc. will be destroyed at the end

of the project*

20 Audio tapes/video tapes etc. will be destroyed once transcribed.

1 Projects involving a single maximal effort test per 24H (e.g. VO2 max, Wingate etc.) or submaximal protocols in healthy asymptomatic adults may follow path A in the first instance but may be referred to path B at the discretion of the Chair of the Ethics Committee

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YES NO N/A

21 Data retention and disposal

(Complete either a b or c)

a) All raw data will be destroyed on

award of degree (BSc/MSc)

b) Data will be retained from the

date of collection until …………………

(date) when it will be destroyed by

…………………………………..(name)

c) Data will be retained indefinitely

in secure storage with access

controlled by ..…………………….(name)

for the purposes of informing future

research.

*If you answer no to question 19 please provide further details of storage and

proposed use of samples.

SECTION 3: Risk Assessment

To be completed by all applicants Please provide the SHS risk assessment reference(s) for all protocols in the study as appropriate (http://SHS.exeter.ac.uk/healthandsafety.htm). Do not attach forms.

SHS/HAZ/ SHS/HAZ/ SHS/HAZ/ SHS/HAZ/ SHS/HAZ/

* If no, please contact David Childs to arrange for a risk assessment to be

conducted before submitting for ethical approval.

SECTION 4: PLEASE PROVIDE THE DETAILS REQUIRED IN SUPPORT OF YOUR APPLICATION FOR EITHER PATH A OR PATH B. (If you tick path A and have answered

‘NO’ to any of the questions 1-12, please give an explanation on a separate sheet)

PATH A. I consider that this project has no additional ethical implications to be

brought before the Departmental Ethics Committee.

On 1 side of A4 (approx 500 words), provide details of the research study including the number of participants (supported by power calculation where appropriate1),

methods including participant recruitment and test where appropriate. Please include an informed consent form and information sheet.

This form (and any attachments) should be submitted to the SHS Ethics committee where it will be

considered by a member for approval. The project may not be started until written approval

has been given.

1 Power calculations should always be included. If not please justify. Please see worked example in Ethics Policy.

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PATH B. I consider that this project may have ethical implications that should be brought before the SHS Ethics Committee, and/or it will be carried out with children

or other vulnerable populations as defined in Q. 14 above.

Please provide all the further information listed below in a separate attachment.

1. Title of project.

2. Provide a lay abstract of 250 words

3. Purpose of project and its academic rationale.

4. Description of all proposed methods and measurements.

5. Participants: Recruitment methods, number (including power calculation if appropriate2),

age, gender, exclusion/inclusion criteria.

Please attach any posters/advertisements to be used for recruitment.

6. Consent and participant information arrangements, debriefing. Please attach intended

invitation/information letters and consent forms.

7. A clear but concise statement of any specific ethical considerations raised by the project

and how you intend to deal with them.

This form plus attachments should be submitted to the SHS Ethics Committee via the pigeon

hole in the foyer for consideration.

If any of the above information is missing, your application will be returned to you.

Signed……………………………………………………. Print Name………………………………………. Date…………..

(Lead Researcher or Supervisor)

Email………………………………………………..

Signed………………………………………….………… Print Name………………………….………….. Date……………

(UG/PG Researcher(s), if applicable)

Email………………………………………………..

Signed……………………………………………………. Print Name………………………………………. Date…………..

(Head of Discipline)

2 Power calculations should always be included. If not please justify. Please see worked example in Ethics Policy.

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SPORT & HEALTH SCIENCES APPLICATION FOR ETHICS APPROVAL

Undergraduate/Msc Projects (Path A)

Tick box: � MSc Project � Undergraduate Project

Title Of Project:

Student investigator

Supervisor (staff)

Other investigators (staff)

Other investigators (student)

(Please indicate PG or UG)

Location(s) of data collection

Start Date (estimated) Signature of Ethics Committee Member

End Date (estimated)

SECTION 1: General

To be completed by all applicants

YES NO N/A

1 Will you detail in writing the main experimental procedures to

participants in advance, so that they are fully informed about what

to expect?

2 Will you tell participants that their participation is voluntary?

3 Will you obtain written, informed consent for participation?

4 If the research is observational, will you ask participants for their

consent to being observed?

5 Will you provide contact details (phone, email, address) of the

researchers to participants?

6 Will you ask participants to complete the appropriate SSHS recent

health questionnaire prior to involvement?

7 Will you tell participants that they may withdraw from the research

at any time and without giving a reason?

8 With questionnaires, will you give participants the option of omitting

questions they do not wish to answer?

9 Will you tell participants that their data is confidential and that any

published data will be anonymised?

10 Will the supervisor read and approve any information sheets and

consent forms distributed to participants?

11 Where any deception is used, will you debrief participants at the end

of their participation?

12 Will you offer participants the opportunity to obtain a summary of

the results of the study?

If you have ticked No to any of Q1-12, please give an explanation on a separate sheet.

(Note: N/A = not applicable)

YES NO N/A

13 Will your project involve deliberately misleading participants in any

way regardless of whether or not you intend to debrief them?

14 Is there a realistic risk of any participants experiencing either

physical or psychological distress, pain or abnormal discomfort that

are not normally experienced during sport and exercise

participation?3 If Yes, give details on a separate sheet and state

what you will tell them to do if they should experience any problems

3 Projects involving a single maximal effort test per 24H (e.g. VO2 max, Wingate etc.) or submaximal protocols in healthy asymptomatic adults may follow path A in the first instance but may be referred to path B at the discretion of the Chair of the Ethics Committee

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YES NO N/A

15 Will your project involve administering a drug or food or drink?

16 Do participants fall into any of the following special groups? If Yes

please consult your Supervisor

a. School children (under 18

years of age)

b. People with learning or

communication difficulties

c. People currently receiving

medical treatment for a condition

(known to the researcher) that

may impact on the proposed

procedures.

d.Those at risk of psychological

distress or otherwise vulnerable

e. People in custody

f. People engaged in illegal

activities (e.g. drug taking)

NB If you have ticked Yes to 13 – 15 you should normally follow PATH B but refer to

Health and Safety webpage for question 15 or obtain further advice from a member of

ethics committee (via Alison Hume) prior to submitting the application.

NB There is an obligation on the lead researcher to bring to the attention of the School Ethics

Committee projects with ethical implications not clearly covered by the above checklist in section 1.

SECTION 2: DATA Protection

To be completed by all applicants

YES NO N/A

17 I understand that all collected data are the property of the SSHS and

are to be used for research purposes only (e.g. theses, publications,

presentations etc.)

18 Data will be stored securely in coded form with access limited to the

named researchers.

19 Samples of human tissue as defined by the Human Tissue Act

(2004) including body fluids, DNA etc. will be destroyed at the end

of the project*

20 Audio tapes/video tapes etc. will be destroyed once transcribed.

21 Data retention and disposal

(Complete either a b or c)

a) All raw data will be destroyed on

award of degree (BSc/MSc)

b) Data will be retained from the

date of collection until …………………

(date) when it will be destroyed by

…………………………………..(name)

c) Data will be retained indefinitely

in secure storage with access

controlled by ..…………………….(name)

for the purposes of informing future

research.

*If you answer no to question 19 please provide further details of storage and proposed use of

samples.

SECTION 3: Risk Assessment

To be completed by all applicants

22 Please provide the SSHS risk assessment

reference(s) for all protocols in the study as

appropriate

(http://sshs.exeter.ac.uk/healthandsafety.htm).

Do not attach forms.

SSHS/HAZ/

SSHS/HAZ/

SSHS/HAZ/

SSHS/HAZ/

SSHS/HAZ/

18

SECTION 4: PLEASE PROVIDE THE DETAILS REQUIRED IN SUPPORT OF YOUR APPLICATION (If

you have answered ‘NO’ to any of the questions 1-12, please give an explanation on a separate

sheet)

PATH A. I consider that this project has no additional ethical implications to be brought

before the Departmental Ethics Committee.

On 1 side of A4 (approx 500 words), provide details of the research study including

the number of participants (MSc students are strongly encouraged to include power calculations to

justify the appropriateness of the sample size), methods including participant recruitment and tests

where appropriate. Use the following headings: Background and rationale; Methods of recruitment;

Procedures and protocols;

Data Analysis methods; Likely value of results.

This form (and any attachments) should be submitted to the School Ethics committee via

the Hand-in

box in the School Office. The project may not be started until written approval has been given

Signed……………………………………………………. Print Name………………………………………. Date…………..

(Lead Researcher or Supervisor) Email………………………………………………..

Signed………………………………………….………… Print

Name………………………….………….. Date…………… (UG/PG Researcher(s), if applicable) Email………………………………………………..

19

Comments of Ethical Reviewer

20

APPENDIX 2: GUIDANCE FOR PREPARING AN INFORMATION S HEET

• Both information sheet and consent forms should be printed on University and Discipline headed notepaper.

• Contact details for the principal researcher must be included in addition to the contact

details for the individual/s running the project day to day.

• The information sheet and consent form should be written for a lay audience. Technical terms should not be used unless fully explained.

• Not all of the suggestions or headings on this template will necessarily apply to all

projects.

• Setting out the information sheet in short paragraphs under headings presented as questions is generally regarded as an ideal way to ensure the potential participant has received all the information necessary for them to give informed consent.

[Date] [TITLE OF PROJECT]

INFORMATION SHEET FOR

[PARTICIPANTS or PARENTS / CAREGIVERS ETC.]

Thank you for showing an interest in this project. Please read this information sheet carefully before deciding whether or not to participate. If you decide to participate we thank you. If you decide not to take part there will be no disadvantage to you of any kind and we thank you for considering our request. What is the Aim of the Project? [Mention if the project is part of a specific course e.g. This project is being undertaken as part of the requirements for the PhD in Sport and Health Sciences.] [Clear and concise explanation, in lay terms, of the major aim(s) of the project i.e. why are you doing it, what are the potential benefits..etc.] What Type of Participants are Needed? [Brief statement of the type of participants being sought; whether participation is limited to males or females and/or certain ages ] (The following section will not be relevant to all proposals) People who are in one or more of the categories listed below will not be able to participate in the project because, in the opinion of the researchers and the Ethics Committee of Sport and Health Sciences, it may involve an unacceptable risk to them:- • [exclusion criteria .....] What will Participants be Asked to Do? Should you agree to take part in this project, you will be asked to ...... [Clear and concise explanation in lay terms of precisely what participants will be asked to do, and the amount of time which might be involved both at each testing session and over any repeat sessions] [Reference to any potential harm or discomfort and to any benefit to the participant must be included] Please be aware that you may decide not to take part in the project without any disadvantage to yourself of any kind.

21

Can Participants Change their Mind and Withdraw fro m the Project? You may withdraw from participation in the project at any time and without any disadvantage to yourself of any kind. You may also request that any information collected from you to date be destroyed or deleted and not used either now or in the future. What Data or Information will be Collected and What Use will be Made of it? [ What data or information will be collected? ] [ If the project involves any form of open questioning technique, i.e. where the questions have not been prescribed in advance and consequently not reviewed by the Ethics Committee, a statement along the lines of that set out in the Note below should be included at this point in the Information Sheet ] [Purposes for which the data or information is being collected] [The use which will be made of the data and who will have access to it] Results of this project may be published but any data included will in no way be linked to any specific participant. You are most welcome to request a copy of the results of the project/copy of any transcripts etc. should you wish. The data collected will be securely stored in such a way that only those mentioned above will be able to gain access to it. [For data protection purposes the researcher should state how long data will be held for from the date of collection and who will take responsibility for destroying it if appropriate]. What if Participants have any Questions? If you have any questions about our project, either now or in the future, please feel free to contact either:- [Name of Student Researcher] or [Name of Supervisor] University Telephone Number:- [......] University Telephone Number:- [......] [Home contact details of student researchers should not be included unless a special case is been made to, and approved by, the Ethics Committee]

This project has been reviewed and approved by the Ethics Committee of Sport and Health Sciences

Note: To be included if an open-questioning technique is involved: This project involves an open-questioning technique where the precise nature of

the questions which will be asked have not been determined in advance, but will depend on the way in which the interview develops. Consequently, although the Ethics Committee is aware of the general areas to be explored in the interview, the Committee has not been able to review the precise questions to be used.

In the event that the line of questioning does develop in such a way that you feel

hesitant or uncomfortable you are reminded of your right to decline to answer any particular question(s) and also that you may withdraw from the project at any stage without any disadvantage to yourself of any kind.

22

APPENDIX 3: EXAMPLE CONSENT FORM

(Note: Not all of the suggestions on this template will necessarily apply to all projects; for some projects, additional information may also be required) The consent form must be printed on University/Discipline headed paper. Studies using child participant should provide for both parent/caregiver consent and written assent from the child.

[TITLE OF PROJECT]

CONSENT FORM FOR

[PARTICIPANTS or PARENTS / CAREGIVERS ETC]

I have read the Information Sheet concerning this project and understand what it is about. All my questions have been answered to my satisfaction. I understand that I am free to request further information at any stage. I know that:- 1. my participation in the project is entirely voluntary; 2. I am free to withdraw from the project at any time without any disadvantage; 3. the data [video-tapes / audio-tapes] will be destroyed at the conclusion of the project

but any raw data on which the results of the project depend will be retained in secure storage for a period of x years from collection;

4. [ mention of open-questioning technique (see Note below) if applicable]; 5. [mention of any discomfort or risks]; 6. [mention of any remuneration or compensation issues]; 7. the results of the project may be published but my anonymity will be preserved. I agree to take part in this project. .............................................................................

(Signature of participant) (Date)

This project has been reviewed and approved by the Ethics Committee of Sport and Health Sciences

23

APPENDIX 4: WORKED EXAMPLE FOR SAMPLE SIZE ESTIMATI ON Power calcuations Notice that the example provides sufficient information to allow the calculations to be replicated. Altman’s (1990) nomogram is a simple method of estimating sample size. Sackett (2006) describes other methods of estimating sample size, including online calculators, such as that on Rollin Brant’s Web site: http://stat.ubc.ca/~rollin/stats/ssize/index.html Example: cross-sectional study Sample size was determined using the standardised difference, which is the ratio of the difference of interest to the standard deviation of the trait (Altman, 1990). LDL-cholesterol concentration was chosen as the primary outcome variable because it is a powerful cardiovascular disease risk factor (National Cholesterol Education Program, 2002) and is among the most variable of blood borne risk factors (Ricos et al., 1999). Cross-sectional data suggest that LDL-cholesterol concentration is around 0.8 mmol·l-1 lower in habitual exercisers than in sedentary men (O'Donovan et al., 2005; Williams et al., 1986). The standard deviation in LDL-cholesterol among 5,460 men was 0.96 mmol·l-1 (Kohl, Gordon, Scott, Vaandrager, & Blair, 1992). Thus, the standardised difference is 0.8/0.96 = 0.83. When this value is used in Altman’s nomogram (1990) there is a around a 98% probability at the 5% level of significance of detecting differences in LDL-cholesterol of 0.8 mmol·l-1 with 45 subjects in each group. References General reference: Altman, D. G. (1980). Statistics and ethics in medical research: III How large a sample? Br Med J, 281(6251), 1336-1338. Altman, D. G. (1990). Practical statistics for medical research. Broca Raton, Florida: Chapman &

Hall/CRC. Kohl, H. W., 3rd, Gordon, N. F., Scott, C. B., Vaandrager, H., & Blair, S. N. (1992).

Musculoskeletal strength and serum lipid levels in men and women. Med Sci Sports Exerc, 24(10), 1080-1087.

National Cholesterol Education Program. (2002). Third report of the expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. NIH publication No. 02-5215. Bethesda, MD: National Heart, Lung and Blood Institute.

O'Donovan, G., Owen, A., Kearney, E. M., Jones, D. W., Nevill, A. M., Woolf-May, K., et al. (2005). Cardiovascular disease risk factors in habitual exercisers, lean sedentary men and abdominally obese sedentary men. Int J Obes Relat Metab Disord, 29(9), 1063-1069.

Ricos, C., Alvarez, V., Cava, F., Garcia-Lario, J. V., Hernandez, A., Jimenez, C. V., et al. (1999). Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest, 59(7), 491-500.

Sackett, D. (2006). The tactics of performing therapeutic trials. In R. B. Haynes, D. L. Sackett, G. H. Guyatt & P. Tugwell (Eds.), Clinical epidemiology: how to do clinical practice research (3rd ed., pp. 137-146). Philadelphia: Lippincott Williams & Wilkins.

Williams, P., T, Krauss, R., M, Wood, P., D, Lindgren, F., T, Giotas, C., & Vranizan, K., M. (1986). Lipoprotein subfractions of runners and sedentary men. Metabolism, 35, 45-52.

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APPENDIX 5: CERTIFICATE OF ETHICAL APPROVAL

SPORT AND HEALTH SCIENCES St Luke's Campus Heavitree Road EXETER EX1 2LU Telephone: +44 (0)1392 264803 Fax: +44 (0)1392 264726 Email: SHS-school-office@exeter.ac.uk Web: www.exeter.ac.uk/SHS

CERTIFICATE OF ETHICAL APPROVAL

Title of Project:

Names/Titles of Project Research Team Members:

This project has been approved for the period

From:

To:

SHS Ethics Committee Approval Reference Number:

Signature: Date:

Name/Title of Chair (BLOCK CAPITALS):

Your attention is drawn to the attached paper which reminds the researcher of

information that needs to be observed when Ethics Committee approval is given.

25

Guidance for Researchers when Ethics Committee

Approval is Given

SPORT AND HEALTH SCIENCES St Luke's Campus Heavitree Road EXETER EX1 2LU Telephone: +44 (0)1392 264803 Fax: +44 (0)1392 264726 Email: SHS-school-office@exeter.ac.uk Web: www.exeter.ac.uk/SHS

1. Researchers are reminded that the research project has been given approval only in relation to its acceptability from an ethical point of view. It is not the role or

responsibility of research ethics committees to give legal advice, nor are they

liable for any of their decisions in this respect. Irrespective of the decision of a

research ethics committee on a particular application, it is the researcher and/or

sponsor who has the responsibility not to break the law.

2. Requests for extensions to the finish date of the project or proposed

changes to the methodology and protocols outlined in the original submission

must be submitted to the Chair of the Committee via the Ethics Committee

pigeon hole using the appropriate form (Appendix 7 of the Policy and

Procedures document) for approval. The principal investigator and his or her

research sponsor, and not the SHS Ethics Committee, are responsible for

ensuring that a study follows the agreed protocol and for monitoring its

progress.

3. A report should be made to the SHS Ethics Committee if any serious and unexpected adverse reactions are noted during the course of the study.

4. If a study is terminated or suspended the researcher must provide the SHS Ethics Committee with a detailed written explanation of the termination or

suspension. 5. Researchers are reminded that ethical issues are given added salience where

teaching and research involves children. The University of Exeter has published

guidelines for staff working with children. These may be found at the following

website: http://www.ex.ac.uk/safety/docs/otherpolcp/ChildrenOnCampusPolCopGnsV1final11.pdf

Guidelines for the appropriate conduct of research studies involving children and

exercise are available in the Children’s Health and Exercise Research Centre

laboratory manual.

26

APPENDIX 6: EXTENSION/CHANGE IN PROTOCOL If an extension is sought to a research project or there is a minor change in protocol, submit the original ethical application form and a one page summary with the following sub-headings to Alison Hume: Project Number

Title of Project

Principal Investigators

Progress Report

Suggested Change/s

Justification of Suggested Change/s

Identify New Ethical Issues of Note

27

APPENDIX 7: CHECKLIST FOR RESEARCHERS AND REVIEWERS This checklist should help you meet your obligations to your subjects and your ethical committee. Ensure that you also check the local, regional or national requirements pertaining to informed consent and that you follow them to the letter.

• Make sure that you get voluntary, written, first-person informed consent. • Check institutional or legal guidelines about parental consent, and about

obtaining a child’s assent. In the case of using children as research subjects, obtain the necessary parental consent, and the child’s assent.

• When using vulnerable populations (e.g., the aged, wards of the state or other agencies), check that you comply with any ethical requirements specific to that group. For example, you may need witnessed consent for cognitively impaired subjects.

• How will the participants be selected? • Satisfy yourself that subjects understand the nature of the project, including any

risks or potential benefits. Describing the project to them verbally will often assist in this process.

• Explain to subjects that they are free to ask questions at any time, and that they can withdraw from the project whenever they want to without any prejudice to services or care that they may be receiving.

• Make sure that no coercion occurs during the recruitment process. (Here you need to be clear on issues such as the researcher also being a teacher or assessor of subjects’ work, for example in the case of students.)

• Allow subjects a "cooling off" period to consider their participation (the time between reading the form and actually agreeing to take part).

• Assess the risk of physical, psychological, or social harm to subjects. Does the research present no more than negligible risk and what can be done to alleviate or minimize risk?

• Provide medical or other appropriate backup in the event of any potential harm in the categories mentioned above.

• Provide medical or other screening, as appropriate. • Assess the impact of any cultural or gender issues that may pertain to your

subjects, and/or the dissemination of your findings. • Provide adequate assurances regarding privacy, confidentiality, anonymity, and

how you will securely store and treat your data. • Satisfy yourself that any payments or inducements offered to subjects do not

adversely influence their ability to make an informed assessment of the risks and benefits of participation.

• If your study involves deception, state the reasons and indicate how you will debrief the subjects about the deception.

• When and where will the research be conducted and by whom? • Set measures in place to provide subjects with feedback/information on

completion of the project. • How will the results be disseminated (published)?