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University of Edinburgh

MORAY HOUSE SCHOOL OF EDUCATION ETHICS COMMITTEE

Application Form

(This form is for completion electronically)

This form should be used for all research carried out under the auspices of Moray House School of Education. A four-tier system of ethical approval has been developed,

administered by the Ethics Sub-committee and the Research Support Office. The levels

within the system are explained below. Please tick the appropriate box to indicate which level applies to your research.

All applications should be submitted well in advance of a required date of approval, particularly in the case of Level 3. Applications will normally be processed within 2-4

weeks, but this cannot be guaranteed.

Level 0: If your research project is completely desk-based, i.e. does not involve participants you are not obliged to apply for ethical approval. However, you may find it

useful to do so to ensure that you are conforming to confidentiality guidelines.

Level 1: applies to 'straightforward' non-intervention, observational research (e.g.

analysis of archived data, classroom observation, use of standardised questionnaires).

Level 2: covers novel procedures or the use of atypical participant groups – usually

projects in which ethical issues might require more detailed consideration but were

unlikely to prove problematic.

Level 3: applies to research which is potentially problematic in that it may incorporate an

inherent physical or emotional risk to participants.

Colleagues are reminded that all researchers working directly with children and other

groups as listed in 4.3 in the application form should ensure they have prior Disclosure

Scotland clearance (formerly Scottish Criminal Record Office). This is a confidential

process and forms are available from hr.hss@ed.ac.uk. Members of staff who have current clearance through GTC membership are already covered.

Applicants must indicate their commitment to following the ethical guidelines appropriate to their research (e.g. BERA, BSA, BPS, BASES).

Name Dr. Tony Turner Department PESLS

Ethical guidelines followed BASES

Has your Head of Department/Supervisor approved this application Yes You may find it helpful to copy and paste this symbol beside the relevant box when answering: !

!

!

X

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SECTION 1: PROJECT DETAILS 1.1 Title of Project: Thermoregulatory, cardiovascular and selective attention demands in

Rallying 1.2 Proposed start date 12/06/2009 1.3 Duration of the project 3 days 1.4 List the following details of the Principal Investigator, and any Co-Investigator(s)

1.5 If funding is necessary to proceed with the study, has it been secured? NO If YES, give details of the agency/agencies supporting the project. If a funding submission is planned, give details of the agency/agencies to which a funding application(s) has been made. 1.6 Does the project require the approval of any other institution and/or ethics committee? YES

If YES, give details and indicate the status of the application at each other institution or ethics committee (i.e. submitted, approved, deferred, rejected). This project has been approved by the FIA Medical Commission, the international governing body for rally.

Principal Investigator Name: Tony Turner Title: Dr. Department: PESLS Address: Moray House School of Education, St. Leonards Land, Holyrood Rd, Edinburgh

Tel: 0131 651 6003 Email: Tony.Turner@ed.ac.uk

Co- Investigator Name: Hugh Richards Title: Mr. Department: PESLS Address: Moray House School of Education, St. Leonards Land, Holyrood Rd, Edinburgh

Tel: 0131 0131 651 6092 Email: Hugh.Richards@ed.ac.uk

Co-Investigator Name: Title: Department: Address:

Tel: Email:

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SECTION 2: DESCRIPTION OF THE RESEARCH Please attach a brief description (no more than 500 words) of your proposal. This should include, as appropriate, the aims and objectives of the study, the research question and/or hypothesis to be investigated, details of the sample, and data collection methods. AIMS & OBJECTIVES: To assess cardiovascular and thermoregulatory demands, and associated changes in selective attention, during a World Rally Championship event. Monitored fluid intake will enable correlational relationships of changes in variables to be assessed. Driver / co-driver differences will also be evaluated. Comparison to equivalent ‘normals’, experiencing same ambient temperature without additional demands of competition, performance and rally clothing requirements will be included. POTENTIAL IMPACT OF PROPOSED WORK: This work will directly feed into our capacity to offer specific advice to the drivers and co-drivers in the Pirelli Star Driver (PSD) scheme. The information will improve driver awareness of the impact during a rally and the importance of hydration during event and physical conditioning prior to events. The information will be prepared for wider publication to enhance knowledge of this unique competitive sport that has been under-researched in applied science and further enhance the reputation of the support opportunities provided to Pirelli Star Drivers. The information will also benefit members of future schemes so that training & advice can be based on systematically collected evidence from the performance environment. This interdisciplinary project will use validated technologies (core body temperature measurement using telemetric pills) in combination with established physiological measurement (heart rate measurement) and validated tests of selective attention in a competitive sporting environment. RESEARCH DESIGN The research will be descriptive in nature, testing participants in-event and with minimal disruption to their normal routine and performance. Participants from the PSD scheme who agree to participate will be monitored, with continuous heart rate (HR) and fluid-intake monitoring, with core temperature (CorT) and attention (Attn) being recorded during 20-minute scheduled service breaks during a competition day, as detailed in the following schematic. The testing time required to achieve this will be a maximum of two minutes.

3 D

ays

prio

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pre

In-event analysis

Ne

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rnin

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Attn Baseline

CorT start

CorT HR Attn

CorT HR Attn

CorT HR Attn

CorT HR Attn

CorT HR Attn

CorT HR Attn

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SECTION 3: POTENTIAL RISKS TO PARTICIPANTS 3.1 Could the research induce any psychological stress or discomfort in the particpants?

NO If YES, state the nature of the risk and what measures will be taken to deal with such problems. 3.2 Does the research require any physically invasive or potentially physically harmful

procedures? YES If YES, give details and outline procedures to be put in place to deal with potential problems. The telemetric pills to be used to monitor core temperature (CorTemp Core Body Temperature Sensors) are swallowed by participants with fluid and a small meal several hours before data collection is due to commence. The pills are specifically designed for this purpose and have been used in international peer-reviewed research in medicine, applied physiology and sport science. The pills are not harmful to the participants, provided that participants exhibiting the following contraindicators are excluded, as per manufacturer’s instructions: ! Any subject whose body weight is under 80 pounds. ! Presence of any known or suspected obstructive disease of the gastrointestinal tract,

including but not limited to diverticulitis and inflammatory bowel disease. ! Any subject exhibiting or having a history of disorders or impairment of the gag reflex. ! Any subject with previous gastrointestinal surgery. ! Any subject with felinization of the esophagus. ! Any subject who might undergo Nuclear Magnetic Resonance (NMR) / Magnetic Resonance

Imaging (MRI) scanning during the period that the sensor is within the body. ! Any subjects with hypomotility disorders of the gastrointestinal tract, including but not limited

to the ileus. ! Any subject having a cardiac pacemaker or other implanted electromedical device. Therefore, all participants will complete the following medical questionnaires and in light of the above any participant exhibiting any of these contraindications will be excluded from the study.

3.3 Does the research involve the investigation of any illegal behaviours? NO If YES, give details. 3.4 Is it possible that this research will lead to the disclosure of information about child abuse

or neglect? NO If YES, indicate the likelihood of such disclosure and your proposed response to this. If there is a real risk of such disclosure triggering an obligation to make a report to Police, Social Work or other authorities, a warning to this effect must be included in the Information and Consent documents. 3.5 Is there any purpose to which the research findings could be put that could adversely affect

participants? NO If YES, describe the potential risk for participants of this use of the data. Outline any steps that will be taken to protect participants.

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3.6 Could this research adversely affect participants in any other way? YES

If YES, give details and outline procedures to be put in place to deal with such problems. One issue listed above (3.2) relates to MRI use being restricted until the CorTemp sensor is passed from the body. In the unfortunate event of an accident, restrictions on medical procedures constitute the only potential risk of the project beyond those risks that are already inherent within the sport. Having consulted with a qualified medical doctor currently working in accident and emergency and a senior clinical nurse who trains medical emergency teams it is apparent that use of MRI is very unusual for immediate management of a critical patient. Detection of internal bleeding for traumatic brain injury usually is completed through other procedures (e.g. CT scan). Thus to minimise any risk the project would need to ensure that relevant medical personnel (event doctor) is notified of this issue, and that participants wear a wrist tag (English & Greek) indicating the presence of a core probe and limitation to the use of MRI. Advice from qualified and experienced medical staff indicates this is unlikely to impede any management of them as emergency patients in the event of an accident.

3.7 Could this research adversely affect members of particular groups of people?

NO If YES, describe these possible adverse effects and the protection to be put in place against them. 3.8 Is this research expected to benefit the participants, directly or indirectly? YES If YES, give details. The information will directly inform the participants of their physiological and cognitive responses during a competitive rally. Feedback will include advice as to how the participants could improve their behaviours in future rallies and hence possibly improve their performance. Indirectly, the information collected will also feed into the Knowledge Transfer work as part of the Pirelli Star Driver scheme. 3.9 Will the true purpose of the research be concealed from the participants? NO If YES, explain what information will be concealed and why. Will participants be debriefed at the conclusion of the study? If not, why not? 3.10 At any stage in this research could researchers’ safety be compromised or could the research induce emotional distress in the researchers? NO If YES, to either or both, give details and outline procedures to be out in place to deal with potential problems.

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SECTION 4: PARTICIPANTS 4.1 How many participants is it hoped to include in the research? Twelve (12) 4.2 What criteria will be used in deciding on the inclusion and exclusion of participants in the

study? All participants are already members of the Pirelli Star Driver scheme and will be offered this service as part of the scheme. Their participation in the research is voluntary and their participation will in no way impact in the service provided, aside from less information being available to inform the process. The only exclusions are those listed above for medical reasons. 4.3 Are any of the participants likely to: be under 16 years of age? NO

children in the care of a Local Authority? NO

known to have special educational needs NO

physically or mentally ill? NO

vulnerable in other ways NO

members of a racial or ethnic minority? NO

unlikely to be proficient in English? YES

in a client or professional relationship with the researchers? YES

in a student-teacher relationship with the researchers? NO

in any other dependent relationship with the researchers? NO

have difficulty in reading and/or comprehending any printed material distributed as part of the study? NO

If YES to any of the above, explain and describe the measures that will be used to protect and/or inform participants. Some of the participants on the Pirelli Star-Driver scheme do not speak English as a first language. However, they are able to read English and have understood during previous communications. Therefore, all materials will be circulated to the participants before the event, such that they have adequate time to read the materials and ask any questions. As detailed above, the relationship between participants and University staff as part of the KT project will not be adversely affected by participation in, or results of, the study. If any participant does not wish to take part then they will still be given support in the event, but the level of feedback will be less as there will be less information available on their responses during the event. 4.4 How will the sample be recruited? All participants in the Pirelli Star Driver scheme will be invited to participate and provided with information sheets and consent forms (as below). 4.5 Will participants receive any financial or other material benefits because of participation? NO If YES, what benefits will be offered to participants and why?

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Before completing Sections 5 & 6 please refer to the University Data Protection Policy to ensure that the relevant conditions relating to the processing of personal data under Schedule 2 and Schedule 3 are satisfied. Details are Available at:

http://www.dataprotection.ed.ac.uk/principles.html

http://www.dataprotection.ed.ac.uk/activities/DPPolicyFINAL.htm SECTION 5: CONFIDENTIALITY AND HANDLING OF DATA 5.1 Will the research require the collection of personal information from e.g. universities,

schools, employers, or other agencies about individuals without their direct consent? NO If YES, state what information will be sought and why written consent for access to this information will not be obtained from the participants themselves. 5.2 Will any part of the research involving participants be audio/film/video taped or recorded

using any other electronic medium? YES If YES, what medium is to be used and how will the recordings be used? Heart rate and core body temperature will be recorded onto a laptop computer via telemetry. 5.3 Who will have access to the raw data? Investigators and staff team on the Pirelli Star Driver scheme. 5.4 How will the confidentiality of data, including the identity of participants, be ensured? Aside from approved staff viewing named data, all other data will be anonymised using participant ID numbers 5.5 Specify where the datafiles/audio/video tapes, etc. will be retained after the study, how long

they will be retained and how they will eventually be disposed of. Electronic data will be stored on password-protected computers until completion of the project and for up to 2 years following publication of the data in a scientific journal, if successful. After which time the data will be deleted. 5.6 How do you intend for the results of the research to be used? Dissemination of information to individuals via written feedback, as well as to the Pirrelli Star Driver scheme and other rally schemes that we are involved in via written reports and oral presentations. It is also our intention to submit the findings for publication in a peer-reviewed scientific journal. 5.7 Will feedback of findings be given to participants. YES If YES, how and when will this feedback be provided? The participants will be given verbal feedback during the event and then full written feedback with 2 weeks of the event being completed.

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SECTION 6: PARTICIPANT INFORMATION AND CONSENT 6.1 Will written consent be obtained from participants? YES If YES, attach a copy of the information sheet and consent forms (covering project details,

confidentiality, freedom to withdraw at any stage of the project). If NO, explain why not. Administrative consent may be deemed sufficient: a) for studies where the data collection involves aggregated (not individual) statistical

information and where the collection of data presents:

(i) no invasion of privacy; (ii) no potential social or emotional risks:

b) for studies which focus on the development and evaluation of curriculum materials,

resources, guidelines, test items, or programme evaluations rather than the study, observation, and evaluation of individuals.

6.2 Will administrative consent (eg. from a headteacher) be obtained in lieu of participants’

consent? N/A

If YES, explain why individual consent is not considered necessary. 6.3 In the case of minors participating in the research on an individual basis, will the consent or

assent of parents be obtained? N/A If YES, explain how this consent or assent will be obtained. If NO, give reasons. 6.4 Will the consent or assent (at least verbal) of minors participating in the research on an

individual basis be obtained? N/A If YES, explain how this consent or assent will be obtained. If NO, give reasons. 6.5 In the case of participants whose first language is not English, will arrangements be made

to ensure informed consent? YES If YES, what arrangements will be made? As detailed above, information will be provided in advance of the event and staff on the Pirelli Star Driver scheme will confirm that each participant has received and understands the information before providing informed consent. If NO, give reasons.

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6.6 In the case of participants with special educational needs will arrangements be made to ensure informed consent?

N/A If YES, what arrangements will be made? If NO, give reasons. SECTION 7: CONFLICT OF INTEREST The University has a draft ‘Policy on the Conflict of Interest’ (copies available from the Research Support Office). Regarding research the draft states that a conflict of interest would arise in cases where an employee of the University might be “ compromising research objectivity or independence in return for financial or non-financial benefit for him/herself or for a relative or friend.” The draft policy also states that the responsibility for avoiding a conflict of interest, in the first instance, lies with the individual, but that potential conflicts of interest should always be disclosed, normally to the line manager or Head of Department. Failure to disclose a conflict of interest or to cease involvement until the conflict has been resolved may result in disciplinary action and in serious cases could result in dismissal. 7.1 Does your research involve a conflict of interest as outlined above NO

If YES, give details.

N.B. Have you included copies of participants information sheet(s) and consent sheet(s) if appropriate? Yes

Please take time to check through your application to ensure that you have answered all relevant questions.

Electronically completed forms should be submitted to Sandra.Orr@ed.ac.uk Research Support Office, Old Moray House, School of Education

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Pirelli Star-Driver Rally Scheme

Thermoregulatory, cardiovascular and selective attention demands in Rallying

At the Acropolis Rally the staff members of the ESP team will be monitoring some of the physical and mental responses, of drivers and co-drivers, to the particularly challenging demands of the rally. The project has been sanctioned to go ahead by the FIA and the rally organisers and having obtained the necessary equipment to track 10 individuals simultaneously, we would like to invite you to take part. This offer is being made first to all members of the Pirelli Star Driver scheme. What’s in it for you?

• Individual profile of your core temperature and heart rate response throughout an event

• Index of your attention performance changes within an event • Detailed feedback on your hydration behaviour • Comparison of your profile to mean average of the group during recce and

on event. • Individual recommendations based on your profile and behaviour designed

to enhance your performance What do you have to do?

• Take the temperature sensor, swallowed as a pill • Wear a small heart rate belt • Tell us about your fluid intake and complete a map search task (total 2

minutes approx) in main and final service (on Saturday) • Complete this on two days; a recce day (Wed) and on the Saturday of the

event

Details: Temperature sensor: The core temperature sensor (http://www.hqinc.net/ ) is a completely harmless and non-invasive technology. Once you have swallowed this with some water you will be completely unaware of the pill and it will send data by telemetry to a small recording device that the scheme will be fitted to the back of your rally seat. You will not need to do anything with this or the heart rate monitor once they are in place. After the day we will collect the heart rate monitor and the data recorder. In the hours/day following testing the pill will be passed naturally and easily from the body. N.B. As there is a very small amount of metal in the device it is important that you do not undergo a magnetic scan (MRI or NMR) until the pill is passed. However this will not prevent or slow down your treatment at a hospital in the unfortunate case of an accident as this form of scanning is not normally used in an emergency. You will wear a wrist-band to notify medical staff of this. The medical team at the event have been informed of this and the FIA medical commission have approved the study.

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Heart rate monitor: We will use a belt sensor similar to that which you wore in testing at Edinburgh Map search task: This simple attention task is similar to that used during the heat chamber workshop

The monitoring is quick and easy and will give you an accurate and detailed picture of how your body responds under extreme rally conditions and, importantly, what you can do to reduce any negative responses. We hope that you will see the advantages of taking part in this unique opportunity which is, as far as we know, the first of its kind to be used at a major rally. In addition to giving you individual performance feedback we also hope to publish the overall group results to contribute to scientific knowledge about motor sport (individual information will not be identifiable). The project is, in the first instance, being made available to every member of the PSD programme. However please note that your membership of the scheme is not affected by decision to take part, or not, in this project. We will work through details with you on the Monday prior to the event, in the meantime if you would like to confirm your participation or have any specific questions about it then please e-mail: Brian - brian@elitesportsperformance.org We look forward to seeing you in Greece! Kind regards, Brian, Robert, Hugh and the team.

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Pirelli Star-Driver Rally Scheme

Thermoregulatory, cardiovascular and selective attention demands in

Rallying

Participant Consent Form

As a participant in this rally development programme you have been invited to participate in this research project conducted by staff from the University of Edinburgh. You should read the Information Sheet for this project carefully and complete the Medical Questionnaire before agreeing to participate. Briefly, you will have your body temperature and heart rate monitored during the Acropolis Rally event, as well as recording your fluid intake. You will also complete some short tests of attention at set-points during the event. Your data will be collected as an individual and your own data will only be discussed with you and the staff on the Pirelli Star Driver scheme, not with other participants. Any further dissemination of data and information within the scheme and beyond will only contain anonymous data from which you will not be identifiable.

I hereby acknowledge that I have read these instructions and completed my medical questionnaire honestly. I fully understand the procedures to be used and provide consent to participate in the research outlined to me. I agree to wear a wrist tag that informs medical personnel that I have ingested an electromedical device that precludes an MRI scan whilst the device is in my digestive system. I consent to my results being discussed with members of PSD scheme staff who will maintain appropriate confidentiality of the information.

Name:……………………………………………...........................................

Signed:…………………………………………...........................................

Parent’s signature if aged under-18: ………........................................

Date: ……………………………………...........................................

Witnessed by: ………………...................................................

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Pirelli Star-Driver Rally Scheme

Medical Questionnaire

Before we can carry out any physiological tests on you, we have to check that you are in satisfactory condition. We would therefore like you to fill-in the following questionnaire about yourself (circle one answer where appropriate). All information given will be treated as strictly confidential.

Name...................................…...................... Date of Birth………………….

1. How would you describe your present level of activity in both work and recreation?

Sedentary Moderately Active Active Highly Active

2. In terms of fitness, how would you describe your present level of fitness?

Very Unfit Moderately Fit Trained Highly Trained

3. How do you view your current bodyweight? Are you;

Underweight Ideal Weight Slightly Overweight Very Overweight

4. Are you, or have you ever been, a smoker? Yes / No

If yes, how many do you/did you smoke per day?

5. Do you drink alcohol? Yes / No

If yes, how would you describe yourself?

Very light drinker Light drinker Heavy drinker Very heavy drinker

6. Have you had to consult your doctor in the last six months? Yes / No

If yes, say briefly why.................................................................................

7. Have you suffered from a viral or bacterial infection in the last two weeks? Yes / No

If yes, give details ...................................................................................….

8. Are you presently taking any form of medication? Yes / No

If yes, give details ............................................................………………...........

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9. Do you suffer, or have you ever suffered, from any form of gastrointestinal (digestive

system) diseases or problems? Yes / No

If yes, give details........................................................................................

10. Do you have a pacemaker, or other electromedical device fitted? Yes /

No

If yes, give details .....................................................................................

11. Have you had, for any reason, to suspend your normal training for the past two

weeks prior to this test? Yes / No

If yes, give details.....................................................................................

12. Lastly, is there anything to your knowledge to prevent you from successfully

participating in the research that has been outlined to you?

Yes / No

If yes, give details.....................................................................................

Participant’s signature: Date:

Parent’s signature (if under 18): Date:

Checked by: Date:

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Pirelli Star-Driver Rally Scheme

Thermoregulatory, cardiovascular and selective attention demands in Rallying

Use of the Core temperature sensor should not occur with individuals who have

any of the following contraindications. Please check the following and sign.

! I do not weigh less than 36kg

! I have no known or suspected obstructive disease of the

gastrointestinal tract

! I have not got, or have not had, a disorder or impairment of the gag

reflex

! I have not had gastrointestinal surgery

! I have not been diagnosed with felinization of the oesophagaus

(concentric circular ridging in throat)

! I am not planning to undergo NMR or MRI scanning in the next 10

days

! I do not have hypo motility of the gastrointestinal tract

! I do not have cardiac pacemaker or other implanted electro-medical

device

Signed:

Date: